Alveron Pharma commences the first clinical trial of new drug for the treatment of intracranial haemorrhage

We are pleased to announce that portfolio company Alveron Pharma has entered the clinical development stage by initiating its first clinical trial for OKL-1111. OKL-1111 is a new drug developed by Alveron, which reverses the action of several different types of commonly used anticoagulants (“blood thinners”). Anticoagulants are widely used to prevent thrombosis (“blood clots”) in patients at high risk (e.g. stroke, deep vein thrombosis etc.). However, as a side effect, anticoagulants may cause or worsen bleeds. When bleeds occur in patients taking anticoagulants, the anticoagulant effect often needs to be stopped quickly in order to effectively manage the bleed. OKL-1111 acts rapidly and universally to reverse the anticoagulant effect, without requiring identification of the type of anticoagulant used in a particular patient which can be difficult in many settings.   

Entering the clinical development stage is an important milestone for Alveron. In this first clinical study in healthy subjects, safety and tolerability will be explored as well as initial reversal data will be gathered to confirm the preclinical findings.

Please find the press release here.

Thuja promotes Lisanne Blauw to Associate

Thuja promotes Lisanne Blauw to Associate

We are pleased to announce that Lisanne Blauw has been promoted to Associate as per January 1st. Lisanne has started with Thuja a little less than two years ago as an Investment Analyst. 

Prior to joining Thuja she held a postdoc position at the University of Twente and the Leiden University Medical Center (LUMC). During her postdoc, she focused on the development of heart-on-a-chip models for drug discovery and co-founded a start-up company (River Biomedics) in this space. Lisanne holds a BSc degree in Medicine (Leiden University Medical Center, LUMC), a MSc degree in BioMedical Engineering (Delft University of Technology) and a PhD in Medicine (LUMC).

 Michel Briejer, Managing Partner at Thuja: “We have been impressed by the steep growth we have witnessed since Lisanne joined us. In addition, she is a true asset to the team and a joy to work with as a person.”

Lisanne meanwhile has joined the Supervisory Boards of EsoBiotec and Fundamental Pharma, in each case as an observer.

European grant enables Mellon Medical to move towards clinical trials

PRESS RELEASE

Delft, January 2023

European grant enables Mellon Medical to move towards clinical trials

At the beginning of December, Dutch company Mellon Medical received a significant grant from the Eurostars Program. The grant was awarded to support further research into the continued development of an innovative suturing instrument, the Switch suturing device. During the official ceremony held on 20 December in The Hague, the spotlight was put on all recipients of a Eurostars grant.

Jan Benschop, CEO Mellon Medical was among the recipients: “Thanks to this grant we can take the first steps towards clinical trials with the Switch. We will continue development and will manufacture multiple prototypes. We can then start with the initial pre- clinical studies at Erasmus MC this year. This will become the first ‘small bites’ suturing instrument in the world that will enable surgeons to place sutures faster and more precisely. This will allow them to reduce incisional hernias in the abdominal wall after operations by 50%. That means reduced inconvenience for patients and therefore a better quality of life. Furthermore, it helps drastically reduce care costs.”

Closing the abdominal wall after an operation normally is done using so-called ‘big bite’ sutures interspaced at approximately ten millimeters. Scientific research conducted under the leadership of Erasmus MC has shown that ‘finer’ sutures using ‘small bites’ interspaced at five to seven millimeters result in fewer complications. This ensures better results. However, for a surgeon suturing with ‘small bites’ using the conventional approach is time consuming due to the handling of the needle. Also, the curvature in the needle makes it more difficult to go through the tissue in a straight manner. Mellon Medical, founded in 2013, came up with a solution, the Switch suturing device. This instrument has two jaws that the surgeon can move towards each other enabling him/her to automatically move a straight needle from one jaw to the other. The surgeon has the other hand free to position the tissue to be sutured. This promotes precision and thus benefits the suture’s quality. Furthermore, it enables the surgeon to make the sutures twice as fast.

International cooperation
Mellon Medical engaged technology developer and producer Demcon for the further development and production of this innovative suturing instrument. In the spring of 2022, they founded a research consortium to be able to move towards clinical trials. The other consortium members include Erasmus MC and Assut Europe SPA from Italy, manufacturer of surgical sutures. In September, the consortium submitted a grant application for research in support of the Switch’s continued development.

Eurostars grant
Last month, Eurostars, a European program for SME companies that conduct research in cross-border R&D projects, awarded the grant. Of the total of 63 applicants from the Netherlands, Mellon Medical ended up in third place in the evaluation of the research proposals. The grant consists of a significant amount of funding for all Dutch partners and applies for a three-year research period.

Better quality of life
Naturally, Benschop is very happy with the award. “With this grant we will continue to further develop the Switch suturing device and manufacture multiple prototypes. In addition, we can start with the initial pre-clinical studies at Erasmus MC this year. This will then become the first ‘small bites’ suturing instrument in the world that will enable surgeons to make sutures faster and more precisely. This will allow them to reduce incisional hernias in the abdominal wall after operations by 50%. That means less inconvenience for patients who therefore experience a better quality of life. Furthermore, it helps drastically reduce care costs.”

Proud of consortium
Benschop above all is proud of the consortium that will be working on the continued development of Mellon Medical’s innovative suturing instrument. “Erasmus MC is a big name worldwide in abdominal wall research and studies into preventing incisional hernias. Our Switch is based on a suturing technique developed by an Erasmus MC surgical team. We have signed an official research agreement with them and our contact with them is very intensive and is based on high mutual trust. Assut Europe SPA is a recognized specialist in medical devices required for surgical suturing. They are going to develop a custom needle-thread combination for the Switch. Demcon contributes its broad expertise of medical product development and, based on the trust in our company and our technology, has also invested in this venture.”

Contributing to success
Demcon stays involved in minority interests such as Mellon Medical, says Gido Akse, managing director of Demcon innovation & technology. “We also try to support them in the area of public- private partnerships. Often there is a financing issue and we then start looking for suitable opportunities.”

Jemy Pauwels, managing director of Demcon investment, adds: “This support is part of the proactive role Demcon investment assumes for minority interests. We can take a share and, furthermore, offer practical support in the day to day operation of a company. The partnership between Mellon Medical, Demcon innovation & technology and Demcon investment is a nice example of this. It demonstrates that we are genuinely interested in contributing to the success of a company.”

Source: Mellon Medical
Press release: English language or Dutch language

Pan Cancer T Appoints Dr. Rachel Abbott as Chief Scientific Officer

Press Release

Pan Cancer T Appoints Dr. Rachel Abbott as Chief Scientific Officer
- Strengthening of T cell research expertise to develop next-generation T cell therapies for patients with limited or no treatment options

ROTTERDAM, January 17, 2023 - Pan Cancer T B.V., a biotech spin-off from Erasmus MC dedicated to the discovery and development of next-generation TCR-T therapies against solid tumors, today announced the appointment of Dr. Rachel Abbott as Chief Scientific Officer.

Dr. Abbott will succeed Pan Cancer T co-founder Prof. Reno Debets, who will continue supporting the Company from his academic position as Head of the Laboratory of Tumor Immunology at Erasmus MC. Prior to joining Pan Cancer T, Rachel Abbott had been Senior Director, Head of TCR Pipeline and Dark Antigen Research at Enara Bio from March 2021 to January 2023. In this role, she was responsible for building and delivering on strategic research frameworks, with a particular focus on the discovery and validation of so-called dark antigens, i.e., unconventional cancer immunotherapy targets that arise from the aberrant transcription of normally silenced regions of genomic dark matter. Moreover, she focused on the identification of dark antigen-specific TCRs that can be advanced for therapeutic development. Before joining Enara, Rachel spent over 6 years at Adaptimmune, developing cancer-specific TCR T cell therapies. Her career at Adaptimmune started in the lab, before progressing into management, culminating in her role as Head of Pipeline Cell Biology. Previously, Rachel was a Research Fellow at the University of Birmingham for seven years, where she investigated CD8+ T cell responses to Epstein Barr virus. She holds a DPhil, awarded for her structural studies on the complement system regulator CD55 and its ligands, and a MBiochem in Molecular and Cellular Biochemistry, both from the University of Oxford.

We warmly welcome Rachel Abbott to our management team,” said Katrien Reynders-Frederix, CEO of Pan Cancer T. "Rachel has tremendous industry experience, including developing T cell therapies, leading scientific research teams and managing collaborations with big pharma and academic institutions. This knowledge will be very important for further defining Pan Cancer T’s scientific direction and execution.

I am honored to take over the position as Pan Cancer T´s Chief Scientific Officer,” said Dr. Rachel Abbott. "I would also like to thank my predecessor Prof. Reno Debets, who has done an excellent job in establishing the scientific foundation of Pan Cancer T, maturing it into one of the leading European TCR T companies. I am excited to build on this strong foundation. My goal is to further advance the next-generation TCR T therapeutics into powerful treatments for more patients and multiple solid tumors.

### 

About Pan Cancer T
Pan Cancer T was founded in late 2020 as a spin-off from Erasmus MC (Rotterdam, the Netherlands) to advance next generation TCR T cell therapies for hard-to-treat solid tumors. The Company’s approach includes two differentiating elements. First, it exploits unique targets for T cells that are exclusively and robustly expressed by multiple solid cancers. Second, it develops technologies that enhance the durability of the T cells. The Company has ongoing R&D programs to develop safe and effective adoptive T cell therapies amenable to large cohorts of patients with triple negative breast cancer as well as cancers of the bladder, ovarium, colorectum, prostate, skin, esophagus, lung, or brain. For more information, please visit: www.pancancer-t.com

Contact Pan Cancer T
Marconistraat 16
3029 AK, Rotterdam
The Netherlands
katrien.reynders@pancancer-t.com

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 67

Press release - Indigo Diabetes Business Update

Indigo Diabetes Business Update

• SHINE clinical trial enrolment progressing well following positive results from the GLOW early feasibility trial.

• Several key senior appointments made in Europe and the US, reflecting the growth and evolution from an early stage to a development stage organisation with clinical proof of concept

BELGIUM – Ghent, 4 January 2023 – Indigo Diabetes N.V. (‘Indigo’ or the ‘Company’), a pioneering developer of Continuous Metabolite Monitoring (CMM™) devices utilising proprietary nanophotonics technology, today provides an update on recent and ongoing business activities.

Indigo is developing a fully implantable CMM system for people living with diabetes to access accurate information on their glucose, ketones and lactate levels. The CMM sensor is inserted subcutaneously, avoiding the need for people with diabetes to wear an external device on their body. It is designed to give people living with diabetes and their caregivers instant access to the augmented metabolic information they need to better manage their diabetes and improve therapeutic decision-making.

Clinical study progress
In September 2022, Indigo announced the enrolment of the first participant in the SHINE clinical trial at the Antwerp University Hospital, Belgium. SHINE is designed to evaluate the longer-term stability of Indigo’s continuous multi-metabolite (‘CMM’) device. This represented the first of up to 15 participants to be recruited in the trial across Belgium, France and Slovenia, the latter two sites of which are due to start enrolment in Q1 2023.

The GLOW clinical trial was a prospective, single-center early feasibility study conducted at the Antwerp University Hospital, Belgium to evaluate the safety of Indigo’s CMM sensor and its short-term integration into the tissue. Data was collected from the seven trial participants (three healthy subjects, and four subjects with type 1 diabetes) and the results have helped progress the development of the device to allow real-time, continuous measurement of glucose, ketone, and lactate levels in adults with diabetes. The full GLOW trial results have recently been submitted to a peer reviewed journal.

Towards the end of 2022 Indigo received the ISO 13485:2016 medical recertification from TüV SUD for the provision of its design and development of biomarker sensing devices and services. This achievement is a significant milestone for Indigo highlighting the suitability of the Company’s Quality Management System and its commitment to quality. ISO 13485:2016 is an internationally recognised quality standard specific to the medical device industry that ensures the quality of medical devices.

Key appointments
A number of senior hires were made during 2022 taking the total headcount to 45, reflecting the ongoing growth of the business and evolution from an early stage to a development stage organisation with clinical proof of concept.

In October, Indigo appointed Peter Devlin as President of Indigo Medical US Inc, establishing its presence in the US, a market that it has identified as having significant potential for its CMM devices. Peter, who is based in Boston, ismanaging and overseeing Indigo Medical’s activities. His focus is on accelerating product development for the Company’s CMM devices, driving business development, and facilitating talent acquisition in the US.

Another key hire was made in May, with the appointment of Emmet Lydon as Chief Operating Officer. Emmet brings more than 30 years of experience working as a senior leader operating in a multinational life sciences environment with extensive experience in Asia, North America and Europe.

In addition, Indigo appointed Michael Malecha as VP, Digital. Michael now leads the software team, developing digital strategies for Indigo’s CMM device.

Dr. Danaë Delbeke, CEO, Inventor and Co-founder of Indigo Diabetes, commented: “2022 was a great year for the team at Indigo where we achieved a number of key milestones including the enrollment of the first participant in the SHINE trial and establishing our presence in the US. We look forward to the year ahead where we continue to work towards our mission to provide an innovative, accurate and convenient monitoring solution to light up the life of millions of people living with diabetes.”

 Dr. Danaë Delbeke, CEO and Peter Devlin, President of Indigo Diabetes will be visiting San Francisco in January at the time of the 41st JP Morgan Healthcare conference and are currently arranging meetings with investors and partners. Please contact the company directly if you would like to arrange a meeting.

- Ends -

Contacts
Indigo Diabetes N.V.
Dr Danaë Delbeke, CEO
Email: info@indigomed.com

Consilium Strategic Communications
Ashley Tapp, Alexandra Harrison
Tel: +44 (0)20 3709 5700
Email: indigodiabetes@consilium-comms.com

About Indigo Diabetes N.V.
Indigo Diabetes N.V. (Indigo) is a pioneering developer of medical devices that utilise proprietary nanophotonics technology. Indigo was founded by Danaë Delbeke and her team in 2016. Today Indigo is developing the world’s first subcutaneously inserted sensor for people living with diabetes to address their need for continuous accurate glucose, ketone and lactate monitoring with nothing worn on the body. Indigo utilizes ground-breaking photonics technology to transform diabetes management. Indigo is based in Ghent, Belgium. Find out more at www.indigomed.com.

About Indigo Diabetes’s CMM™ sensor
Indigo Diabetes’s CMM™ sensor is the world’s first, subcutaneously inserted evanescent field sensor to measure multiple metabolites in vivo simultaneously and continuously. The inert, miniature integrated silicon photonics chip measures the absorption of light in interstitial fluid to quantify the concentration of a broad range of metabolites simultaneously without the use of enzymes or fluorophores. Once inserted under the skin the CMM sensor is invisible to the naked eye and will connect securely and wirelessly to mobile devices to show and capture the concentration profiles of the metabolites for the user. A rechargeable sensor battery powers the measurements. It is expected that the sensor will have a lifetime up to 2 years. Preclinical studies have successfully demonstrated proof of concept with promising accuracy with GLOW early feasibility study results providing further validation.

Meet Eleanor Price, Investment analyst at Thuja

We have started with a series of interviews. In every newsletter one of our team members will be interviewed. In that way you get to know us a little better. 

This interview is with Eleanor Price. Eleanor joined Thuja in February 2022 as an Investment Analyst. She holds a BSc in Cellular and Molecular Medicine (University of Bristol), a PhD in Cardiovascular Regenerative Medicine (University of Oxford) and she completed an online MBA at the Quantic School of Business and Technology.

What are your main activities at Thuja?
I am an investment analyst at Thuja. I typically source and evaluate investment propositions that come into Thuja. Then, once we have decided it may be of interest, I conduct a deeper assessment of the opportunity, looking into key aspects such as the scientific data, the market opportunity, competitors, exit potential and healthcare impact potential, to name a few. It’s my job to identify all the opportunities and risks, to support the decision of whether we should invest.  

What do you enjoy most about working at Thuja?
I have always been impact driven, so I love the fact I get to work for a company that invests in and helps build companies which could transform the lives of patients. Take our latest investment in FundaMental Pharma. They are developing novel drugs for neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS), for which there is currently no adequate treatment, so the impact potential is huge.

As we typically invest in technologies coming straight out of universities, we get to delve into cutting-edge scientific research, in many different fields, which I really enjoy. It also means we interact with many top academics and aspiring entrepreneurs, which is always incredibly motivating.

What’s your background?
I come from a scientific background originally, completing my PhD in Cardiovascular Regenerative Medicine at the University of Oxford. During my studies I helped set-up an accelerator programme, PanaceaStars, to support entrepreneurial academics with turning their scientific ideas into a business proposition. After finishing my PhD I took on a full-time position, running the overall operations of PanceaStars, whilst completing a part-time MBA.

I then moved to the Netherlands at the beginning of 2020 (I know, perfect timing) and worked several years as a consultant at IQVIA. I worked on a broad range of strategic projects for large Pharma, such as market access and commercial launch, and carried out commercial due diligence to support private equity investments in healthcare.

What do you enjoy doing when you are not working?
Honestly, anything related to food. I really enjoy cooking, baking, and also eating out and trying new places, so recommendations are always welcome.

I also love to go and listen to live music and living in Amsterdam is a great place for that. At the weekends I enjoy exploring different cities and towns in the Netherlands, and neighbouring countries (and trying out the local delicacies of course).

You are quite a reader, can you name your top 3 favourite Books?
Ah, that is too difficult to answer. But my top 3 from the last couple of years would have to be ‘Girl, Woman, Other’, ‘The Binding’ and ‘Where the Crawdads Sing’. All beautiful books which I would highly recommend.

Let’s end this interview with something fun, name one silly fact or anecdote about you.
I have a small electric sloep boat in Amsterdam called Winkel Wagen (shopping cart). It got its name because it was one of the first Dutch words I learnt (thanks to online shopping), and we thought it looked a bit like a floating cart.

Thuja Portfolio Day 2022

Last month, we hosted our annual Portfolio Day at Green Village in Nieuwegein, The Netherlands. During the event, our LPs received an update on our latest fund, Thuja Capital Healthcare Fund III.

The half-day program combined company presentations and keynote lectures with ample networking time to connect and meet with portfolio companies’ management, as well as fellow LPs. The portfolio companies presented this year were:

Fundamental Pharma: a neuroscience company spun-out of Heidelberg University, developing first-in-class small molecule inhibitors for treatment of a range of devastating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS) and Huntington’s Disease. FundaMental Pharma is our newest portfolio addition, launching with a €10M seed financing round in November 2022.

Pan Cancer T: a spin-off company of Erasmus Medical Center Rotterdam, developing novel adoptive T cell therapeutics for the treatment of solid tumors that currently have a poor prognosis.

EsoBiotec: a Belgium-based biotech company, developing next generation in vivo cell therapy for cancer treatment, with the aim to offer previously unattainable treatment options to the largest possible number of patients.

InnoSign: a precision medicine company spun-out from Royal Philips, developing a unique diagnostics platform that can predict how patients will respond to targeted cancer drugs.

Astrivax: a KU Leuven spin-off company, developing a highly innovative vaccine platform for the development of effective vaccines to treat and prevent infectious diseases in areas of critical unmet needs.

This year we also organized two keynote lectures: Jerome Custers, Sr. Scientific Director Vaccine Research at Janssen Vaccines gave us insight into the intriguing development of the Janssen Covid vaccine and Prof. Deborah Nas, taught us about technology-based innovation and the promise of quantum computing.

We will continue to build our portfolio, and are already looking forward to next year’s Portfolio Day!

FundaMental Pharma launches with EUR 10 million in Seed financing led by BGV and Thuja Capital to advance a First-in-Class neuroprotectant

FundaMental Pharma launches with EUR 10 million in Seed financing led by BGV and Thuja Capital to advance a First-in-Class neuroprotectant

Heidelberg, Germany – 17 November 2022 – FundaMental Pharma GmbH (“FundaMental”), a preclinical neuroscience company spun out of Heidelberg University, today announces that it has launched with EUR 10 million in seed financing led by BioGeneration Ventures (BGV) and Thuja Capital, with participation from other investors, including coparion and High-Tech Gründerfonds (HTGF).

Built on the pioneering research of Professor Hilmar Bading and Dr. Jing Yan published in Science[1], the founders of FundaMental have identified first-in-class small molecule inhibitors for treatment of a range of neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS) and Huntington’s Disease. FundaMental’s novel approach relies on separating the normal neuroprotective effect of synaptic glutamate from its neurotoxic extra-synaptic actions, which are eliminated by the inhibitors.

“I am convinced that the successful development of FundaMental’s small molecule inhibitors will mark a milestone in neuropharmacology and possibly beyond,” emphasized Dr. Thomas Schulze, CEO and co-founder of FundaMental. “It has been a privilege to have worked with Professor Bading`s team since 2010 and to have put together such a strong leadership team. Having found visionary investors whose aims are aligned with the founder’s goals of stopping neurodegeneration, this vision can now become reality after many years of dedication and persistence.”

“It is probably no exaggeration to call the discovery of the new therapeutic principle of ‘inhibition of an extra-synaptic glutamate-activated death signaling complex’ a breakthrough in neuroscience”, said Professor Hilmar Bading, Director of the Department of Neurobiology and the Interdisciplinary Center for Neurosciences at Heidelberg University and Co-Founder of FundaMental. “These inhibitors have the potential to revolutionize therapies for currently untreatable neurodegenerative diseases and offer hope to many affected and suffering patients.”

In conjunction with the financing, FundaMental also announced several key senior management appointments as well as the Board of Directors of the company. Dr. Gabriele Hecker-Barth has joined as Chief Medical Officer and Dr. Jing Yan as Senior Director of Research. Dr. Keno Gutierrez of BGV and Dr. Michel Briejer of Thuja Capital, Professor Hilmar Bading and Dr. Thomas Schulze have been appointed to the company’s Board of Directors.

“FundaMental’s novel therapeutics provide new hope to patients of ALS, Huntington’s disease and spinocerebellar ataxia 3, which remain devastating diseases that have an immense impact on the quality of patients’ lives,” said Dr. Keno Gutierrez, new Chairman of FundaMental’s Board of Directors and Partner at BGV. “We are excited to invest and support the FundaMental team as they endeavor to make these molecules ready for the clinic.”

“Professor Bading and Dr. Yan have made a promising and important discovery, unlocking the possibility to inhibit glutamate neurotoxicity while leaving its physiologically important aspects unaffected,” said Dr. Michel Briejer, Board Member and Managing Partner at Thuja Capital. “We are thrilled to be part of this venture with a mission to impact the lives of patients suffering from these neurodegenerative diseases.”

[1]: https://www.science.org/doi/10.1126/science.aay3302?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

Read full press release here.

Indigo Diabetes Incorporates Fully Owned Subsidiary in the US and Appoints Peter J. Devlin as President, Indigo Medical US Inc.

PRESS RELEASE

Indigo Diabetes Incorporates Fully Owned Subsidiary in the US and Appoints Peter J. Devlin as President, Indigo Medical US Inc.

• Indigo establishes a US presence to drive business development and extend talent acquisition

• Peter brings over 30 years’ experience leading the development & commercialisation of medical devices, including devices for the diabetes marker

BELGIUM – Ghent, 27 October 2022 – Indigo Diabetes N.V. (‘Indigo’ or the ‘Company’), a pioneering developer of Continuous Metabolite Monitoring (CMMTM) devices utilising proprietary nanophotonics technology, today announces its expansion into the US via the incorporation of a fully owned subsidiary, Indigo Medical US Inc. (‘Indigo Medical’), and the appointment of Peter J. Devlin as President of the newly formed subsidiary, effective from 14 October 2022.

The Company is establishing its presence in the US, a market that it has identified as having significant potential for its CMM devices.

Peter, who will be based in Boston, will be managing and overseeing Indigo Medical’s activities. His focus will be on accelerating product development for the Company’s CMM devices, driving business development, and facilitating talent acquisition in the US. He will report directly to Danaë Delbeke, Chief Executive Officer of Indigo.

Indigo is developing a fully implantable CMM system for people living with diabetes to access accurate information on their glucose, ketones and lactate levels . The CMM sensor is inserted subcutaneously, preventing the need for people with diabetes to wear an external device on their body. It is designed to give people living with diabetes and their caregivers instant access to the augmented metabolic information they need to better manage their diabetes and improve therapeutic decision-making.

Peter J. Devlin, President, Indigo Medical US, commented: “I have worked for many years in both in- vitro diagnostics and diabetes care and am delighted to be joining the Indigo team and leading Indigo Medical Inc. It is an exciting time for the Company to be establishing a presence in the US, particularly as the focus increases on the commercial development of our subcutaneously implanted continuous metabolite monitoring sensor.”

Dr Danaë Delbeke, Chief Executive Officer, Inventor and Co-founder of Indigo Diabetes, added:

“Peter has worked successfully with us as a strategic advisor for the last year, and I am very pleased that he has chosen to join us full-time to lead our newly created US subsidiary. This represents a significant market for us, and with his wealth of experience, he will play a vital role in helping us bring our first device to the US and European markets.”

Peter brings over 30 years’ experience leading the development & commercialisation of medical devices. He has worked as a strategic advisor to Indigo for the past year advising on product development, market access, and the diabetes market. Before joining Indigo, he worked for a number of years as an independent director and strategic advisor to early-stage medical tech companies. Prior to that he worked as the Chief Commercial Officer of Insulet Corporation, the US medical devices

company, where he led Sales, Marketing, Business Development, Clinical Research and Customer Care operations. Whilst there, he helped develop and commercialise the OmniPod wearable insulin delivery system for people living with diabetes, leading the company to over $350 million in annual revenues.

Prior to joining Insulet, Peter spent eleven years at Abbott Laboratories, in roles of increasing responsibility, most recently serving as Divisional Vice President of Global Strategic Marketing, Diabetes Care. In this role, he was responsible for the development of ADC’s commercial strategies, global brand & product management, market research, and business analytics and forecasting. His career also includes his serving as Marketing Manager of i-STAT Corporation, a point-of-care blood analysis systems company, which was acquired by Abbott and at C.R. Bard Inc., where he held various product management and engineering roles.
Mr. Devlin holds a Bachelor of Science degree in Mechanical Engineering from the University of Massachusetts.

- Ends -

Contacts
Indigo Diabetes N.V.
Dr Danaë Delbeke, CEO Email: info@indigomed.com

Consilium Strategic Communications
Ashley Tapp, Alexandra Harrison
Tel: +44 (0)20 3709 5700
Email: indigodiabetes@consilium-comms.com

About Indigo Diabetes N.V.
Indigo Diabetes N.V. (Indigo) is a pioneering developer of medical devices that utilise proprietary nanophotonics technology. Indigo was founded by Danaë Delbeke and her team in 2016. Today Indigo is developing the world’s first subcutaneously inserted sensor for people living with diabetes to address their need for continuous accurate glucose, ketone and lactate monitoring with nothing worn on the body. Indigo utilizes ground-breaking photonics technology to transform diabetes management. Indigo is based in Ghent, Belgium. Find out more at www.indigomed.com.

About Indigo Diabetes’s CMMTM sensor
Indigo Diabetes’s CMMTM sensor is the world’s first, subcutaneously inserted evanescent field sensor to measure multiple metabolites in vivo simultaneously and continuously. The inert, miniature integrated silicon photonics chip measures the absorption of light in interstitial fluid to quantify the concentration of a broad range of metabolites simultaneously without the use of enzymes or fluorophores. Once inserted under the skin the CMM sensor is invisible to the naked eye and will connect securely and wirelessly to mobile devices to show and capture the concentration profiles of the metabolites for the user. A rechargeable sensor battery powers the measurements. It is expected that the sensor will have a lifetime up to 2 years. Preclinical studies have successfully demonstrated proof of concept with promising accuracy.

Indigo Diabetes Announces First Participant Enrolled in the SHINE Clinical Trial

BELGIUM – Ghent, September 29, 2022 – Indigo Diabetes N.V. (‘Indigo’ or the ‘Company’), a pioneering developer of medical solutions using nanophotonics, today announces the enrollment of the first participant in Belgium in the SHINE clinical trial, which is designed to evaluate the longer-term stability of Indigo’s continuous multi-metabolite (‘CMM’) device. 

Indigo’s subcutaneously inserted CMM device is in development for the continuous measurement of glucose, ketone and lactate levels in people living with diabetes.

This first participant enrollment, an important Company milestone, has taken place at Antwerp University Hospital (UZA) and represents the first of 15 participants to be recruited in the trial across Belgium, France and Slovenia. Indigo has recently submitted a paper on the data from its successfully concluded GLOW trial, the first-in-human clinical study of Indigo’s CMM sensor, to a peer-reviewed journal for publication.

Professor Christophe De Block, Principal Investigator of the SHINE trial at Antwerp University Hospital commented: “Continuous monitoring of glucose levels is key in managing diabetes to prevent devastating acute and long-term complications. The possibility of monitoring other biomarkers such as ketones and lactate will take continuous monitoring to the next level. It is a privilege to lead the SHINE clinical trial to evaluate the safety and performance of this ground-breaking novel technology.”

Dr. Danaë Delbeke, CEO, Inventor, and Co-founder of Indigo Diabetes, added: “The start of the SHINE trial is an important milestone for Indigo and follows the successful conclusion of the GLOW trial earlier this year, the results of which we’ve submitted to a peer-reviewed journal for publication. Many multi-metabolite monitoring devices under development sit on the skin and are highly visible, which some people do not like because they can feel self-conscious, stigmatized and uncomfortable. Indigo’s continuous multi-metabolite monitor is subcutaneously inserted and is designed to be inconspicuous. We look forward to seeing how it performs in this longer-term stability trial.”

- Ends -

About Indigo Diabetes N.V.
Indigo Diabetes N.V. (Indigo) is a pioneering developer of medical solutions utilizing nanophotonics. Indigo was founded by Danaë Delbeke and her team in 2016. Today Indigo is developing the world’s first invisible sensor for people living with diabetes to address their need for continuous accurate glucose and ketone monitoring with an improved user experience. Indigo exploits groundbreaking photonics technology responsible for revolutionizing the Internet to transform diabetes management. Indigo is based in Ghent, Belgium. Find out more at www.indigomed.com.

About Indigo Diabetes’s CMM sensor
Indigo Diabetes’s CMM sensor is a small spectrometer-on a-chip to monitor in-vivo simultaneously and continuously multiple metabolites. The inert, miniature integrated silicon photonics spectrometer chip measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites simultaneously without the use of enzymes or fluorophores. Once inserted under the skin the CMM sensor is invisible to the naked eye and will connect securely and wirelessly to mobile devices to show and capture the concentration profiles of the metabolites for the user. A rechargeable sensor battery powers the measurements. It is expected that the sensor will have a lifetime up to 2 years. Preclinical studies have successfully demonstrated proof of concept with promising accuracy.

Further details on the SHINE Study
SHINE is an open label, interventional, multicentre, prospective feasibility study, designed to evaluate the safety of the implantation and preliminary performance of the SHINE SYSTEM. The device will be inserted for 6 months, with the overall study expected to last 12 months from the first participant, first visit (FPFV) to the last participant, last visit (LPLV.)

Up to 15 study participants with diabetes mellitus will be recruited across the following sites: University Medical Centre Ljubljana in Slovenia, Antwerp University Hospital in Belgium, and Lapeyronie Montpellier University Hospital in France.

All subjects will participate in 8 measurement visits over the 6 months of the study duration. During these visits data will be collected on the spectra of glucose, ketones and lactate and compared with the values of metabolites analysed directly from subject’s blood. Glucose levels will also be monitored by CGM device Dexcom G6.

Further details on the GLOW Study
GLOW, listed on www.clinicaltrials.gov under the identifier NCT04782934, was designed to evaluate the safety of the sensor and the short-term integration into the tissue and was a prospective, single-center early feasibility study conducted at Antwerp University Hospital, Belgium. Data was also collected from the seven study participants (three healthy subjects, and four subjects with type 1 diabetes) and used to develop the device to allow real-time, continuous measurement of key metabolite levels in adults with diabetes.
Participants receiving the CMM sensor had the sensor inserted up to 10 mm deep in the subcutaneous abdominal tissue using local anaesthetic. The sensor remained in situ for 30 days after which it was removed. Each participant had 6 measurement visits over the 30-day trial period, during which data for glucose, lactate and ketone levels was collected and compared to applicable standards under controlled circumstances (hypo/hyperglycaemia, anaerobic exercise, ketogenic conditions and during administration of potential interferents such as NSAIDS, vitamin C).

Contacts
Indigo Diabetes N.V.
Dr Danaë Delbeke, CEO
Email: info@indigomed.com

Communications
Consilium Strategic Communications
Ashley Tapp, Alexandra Harrison
Tel: +44 (0)20 3709 5700
Email: indigodiabetes@consilium-comms.com

Jeanne Bolger to chair Board of Directors of AstriVax

Dr. Jeanne Bolger to chair Board of Directors of Belgium-based vaccine technology company AstriVax

• Dr Jeanne Bolger brings over 35 years of management experience in the pharmaceutical industry to the new Belgium-based vaccine technology company.

• Last month, AstriVax closed its funding round – led by V-Bio Ventures and Fund+ – on 30 million euros.

• With this seed capital and the support of Dr Bolger, AstriVax will continue to build its innovative plug-and-play vaccine platform and bring its first vaccines to the clinical development stage.

Leuven, Belgium, 26 September 2022 – AstriVax has announced that Dr Jeanne Bolger will chair its Board of Directors as non-executive independent director. With over 35 years of management experience in the pharmaceutical industry, Dr Bolger offers invaluable expertise that will help AstriVax to continue to build its innovative vaccine technology platform and bring its first vaccines to the clinical development stage.

As the new Chair of the AstriVax Board, doctor and biotech investor Jeanne Bolger brings extensive experience in the pharmaceutical industry, with management roles across R&D, commercial and business development, and venture investments. She has held leading positions at GlaxoSmithKline as well as Johnson & Johnson, served as the sole pharma industry representative on two Irish government taskforces, and sits on numerous company and advisory boards.

Hanne Callewaert, CEO of AstriVax, said: “I am truly grateful that Dr Jeanne Bolger has agreed to chair our Board of Directors, and I very much look forward to working with her to continue to build this company and address key challenges in vaccinology. Jeanne brings a lot of valuable expertise to AstriVax, with ample life science industry experience in venture investments, business development, and active board roles.”

Dr Jeanne Bolger (MB BCh BAO) said: “I am delighted to accept the invitation to chair the Board of AstriVax and to support Hanne Callewaert’s impressive leadership. Hanne and her team, supported by a strong investor syndicate, will progress the vaccine platform technology from the KU Leuven Rega Institute labs of the renowned Professor Johan Neyts and Kai Dallmeier, with the exciting mission to deliver effective vaccines for multiple infectious diseases across the world.”

Plug-and-play vaccine platform

The announcement of Dr Jeanne Bolger’s new role in AstriVax comes mere weeks after the company closed its seed capital funding round – led by V-Bio Ventures and Fund+ – on € 30 million. AstriVax will use this seed capital to bring its first thermostable yellow fever vaccine to the clinical development stage, further advance two pipeline vaccine candidates towards clinical trials (vaccines to prevent rabies and treat chronic hepatitis B), and to fuel the preclinical pipeline with several prophylactic and therapeutic leads.

The company will also continue to build its highly innovative, first-in-class plug-and-play vaccine platformbased on the ground-breaking work of AstriVax co-founders Professor Johan Neyts and Kai Dallmeier, both affiliated with the KU Leuven Rega Institute. The technology of AstriVax can be used to develop a wide range of vaccines that address major challenges in vaccinology: they are easy to produce, offer long-lasting protection against various infectious diseases, and do not require a strict cold chain.

About AstriVax

Founded in 2022, AstriVax NV aims to address global challenges in vaccinology with its innovative plug-and-play vaccine platform. The Belgium-based company develops novel prophylactic and therapeutic vaccines that are easy to produce, have reduced cold chain requirements, and offer broad and long-lasting protection against various infectious diseases. AstriVax is supported by V-Bio Ventures, Fund+, Flanders Future TechFund, Thuja Capital, Ackermans & van Haaren, Mérieux Equity Partners (via OMX Europe Venture Fund), BNP Paribas Fortis Private Equity, and the KU Leuven Gemma Frisius Fund. AstriVax is located in the BioHub in Leuven. For more information, please visit www.astrivax.com.

Source: globenewswire
Source: astrivax

Portfolio company NutriLeads and Royal DSM Join Forces to Create Market-ready Immune Health Solutions with BeniCaros® for the US Market

September 6, 2022 – Portfolio company NutriLeads BV announced today that it has signed a commercial agreement with Royal DSM to bring premix and market-ready solutions to the U.S. supplement market. These products will feature BeniCaros®, NutriLeads’ natural, award-winning functional ingredient for immune health.

The partnership will enable accelerated innovation and product development of premixes and other custom solutions that support immunity via gut modulation, the top consumer health priorities, according to FMCG Gurus’ Prebiotic Global Report, 2022. The agreement brings together BeniCaros, a unique ingredient clinically proven to accelerate immune responses, and the unmatched product development expertise and broad-market access of Royal DSM, a global purpose-led science-based company.

“We are pleased to partner with DSM to accelerate the availability of BeniCaros to U.S. consumers through innovative new premix and market-ready solutions,” said Joana Carneiro, PhD, NutriLeads Chief Executive Officer. “DSM’s deep expertise in every stage of product development will help BeniCaros more quickly achieve its tremendous potential.”

BeniCaros is a bioactive polysaccharide (fiber) derived from upcycled carrot pomace. It trains the immune system to be fit year-round through a unique dual action that both prepares innate immune cells and stimulates beneficial gut microorganisms that accelerates immune responses. Peer-reviewed clinical research demonstrates that BeniCaros accelerated protective immune responses and significantly reduced the severity and duration of symptoms after a controlled challenge with a common cold virus. BeniCaros’ small daily serving size of just 300 mgs makes it well-suited for premixes and combination products.

“Consumers increasingly recognize the link between immune health and gut health, as well as the importance of well-balanced microbiota to their overall health,” said Martin Dos Ramos, Vice President, Human Nutrition & Care, Dietary Supplements, DSM. “BeniCaros is an attractive, science-based immune health ingredient that supports these top consumer health concerns. We see excellent potential for product innovation. This agreement further strengthens our end-to-end offerings across the entire product development cycle and supports our partnership with customers to shape and drive new markets.”

source: nutrileads.com and globenewswire.com

Meet Lisanne Blauw, investment analyst at Thuja

From now on, we will include an interview with a member of the Thuja team in every newsletter. So you get to know all of us a little better.

The first interview will be kicked off by Lisanne Blauw. Lisanne joined the Thuja team in February 2021 as an Investment Analyst. She holds a Master’s in Biomedical Engineering, a PhD in Medicine, and above all is fun to work with.

Let’s start with a silly fact: What do most people not know about you?
I like to eat everything with a spoon, that includes salads. I can’t blame my parents, they really tried to get me to eat with a knife and fork. They gave up some time ago, it’s just one of the failed aspects of my upbringing.

When did you join Thuja and what is your role?
I have been working as an investment analyst at Thuja since Feb 2021.

What did you do before joining Thuja?
Before joining Thuja, I worked as a postdoc in the Leiden University Medical Center and the University of Twente. My research work was focused on cardiovascular genetics and heart-on-chip models. During my postdoc I was involved in the spin-out of a biotech company, which brought me for the first time into contact with venture capital, sparking my interest for my current job at Thuja.

What does your average workday look like?
An important part of my time is dedicated to evaluating incoming propositions of companies that are searching for investment. Mostly, we first receive a short slide deck, on the basis of which we decide to invite the company for a pitch. Next to that, I spend much time on the due diligence process, which we start when we decide to dive deeper into a proposition to explore our potential interest to invest. Due diligence has many aspects. Because Thuja is an early-stage investor, we spend a relatively large part of our due diligence on evaluation of the company’s scientific data, as well as the scientific field in which the company is operating, which I enjoy a lot! Once in a while, I also visit conferences or pitch events.

What do you enjoy most about the work you’re doing?
For me, there are clearly two outstanding aspects: The diversity of the work (I found out that I am more a generalist than a specialist) and the fact that we are in very close contact with the cutting edge science. I find it super inspiring to see where the future of medicine is going, and I am very happy to work at a company that can contribute to bringing that future a bit closer to the patient every day!

What do you like to do outside work?
At the moment, I am mostly using my free time to work on our new house, I really enjoy DIY work. My more standard hobbies are ice skating, cooking (very much!), drawing, sewing and working in the garden.

What series are you currently watching/or book are you currently reading?  
Series: The Umbrella Academy. It’s said to be as good as Stranger Things and Peaky Blinders, but I am not convinced of that yet ;-) Not so much time for a book now. I stopped somewhere halfway through ‘Bad Blood’, and then switched to the series (The Dropout).

KU Leuven spin-off AstriVax raises € 30 million to build vaccine platform

Today, 25 August, AstriVax, a KU Leuven spin-off company, announced that it raised €30 million seed capital to build its highly innovative vaccine platform.

We are excited to be part of the strong international investment syndicate.

“This is the second time Thuja invested in a company based on technology out of the Rega institute of the KU Leuven. Again, we were impressed by the scientific work done by the team of Professor Johan Neyts and Kai Dallmeier and are confident that their novel vaccine technology will enable the development of effective vaccines to treat and prevent infectious diseases in areas of critical unmet needs” said Harrold van Barlingen, Managing Partner of Thuja Capital Management.

For more information on the seed financing round of AstriVax, we refer to the press release.

Press release Dutch
Press release English
Press release French

InnoSIGN is developing a smart PCR test to predict which drug will work in a cancer patient

Since the COVID pandemic the PCR test has become generally known as a very accurate test to diagnose whether someone is infected with the Corona virus or not. However, PCR tests can be used for many more purposes than merely the diagnosis of viral infections. Since a PCR test measures the amount of DNA and/or messenger RNA (mRNA) in a sample, it can tell us what kind of RNA is actively ‘read’ in a cell. This may sound complicated, but when thinking of our DNA as a recipe book the concept is simpler to grasp: all the cells in our body have the same DNA (recipe book), but every cell reads different recipes out of that book (mRNA), leading to a wide variety of cells with all different characteristics, for example liver cells, kidney cells and skin cells. The mRNAs, which are measured by the PCR test, are reading certain sections of the book and make copies of those sections to tell the cell what to do. So, by measuring mRNA you can see which parts of the DNA are ‘active’.

Our latest portfolio company InnoSign, a spin-off from Philips, has developed a very smart PCR test to determine whether in cancer cells certain DNA's are actively read (so called ‘signaling pathways’) that make this cancer cell more susceptible to die from a certain drug. In other words, InnoSign’s test will be developed to inform a doctor on forehand whether a certain drug will work in a patient or not. In this way, it can be prevented that a patient is treated and has side effects from a drug that only later shows to be ineffective, which is what currently often happens.

InnoSign was able to develop this test over the past few years, by composing an extensive database of more than 100,000 different cell and tissue samples. By measuring the mRNA in all these samples, they were able to select the mRNAs that are most predictive for the activity of a ‘signaling pathway’. By doing so, the InnoSign test can now indicate the activity of seven signaling pathways by measuring only 96 different mRNA molecules. After taking a tissue sample from a patient, the outcome of the test is known within a day.

 Innosign aims to bring personalized and targeted cancer treatment to the patient. Paul van de Wiel is a cell biologist, co-founder and CEO of the startup. He explains how it works:

“Every patient has something different, and it is possible that different signaling pathways have been activated in one patient, but not in another. By gaining insight in those differences between patients, you can use drugs in a more targeted manner. Hormone therapy for breast cancer, for example, is directed against a specific signaling pathway. If that pathway is not active in a certain patient, hormone therapy will have little or no effect, and a doctor can better directly chose for another treatment."

Harrold van Barlingen led this Thuja investment and commented:

“It is known for decades that cancer is caused by mutations in the cell's DNA. Therefore, it was thought that measuring those mutations would be sufficient to determine the tumors aggressiveness and treatment response. Unfortunate this is not always the case and as such doctors need more information. This is the reason why we invest in InnoSign they developed a cleaver diagnostic tool measuring the activity of pathways in a cell delivering additional information enabling the doctor to target treatment in more detail and increasing the changes for the patient.”

“Shares of biotech company Argenx bloom like a flower in a desert”, headlines the Dutch financial newspaper FD.

Interesting read about the biotech company argenx, a former portfolio company of Thuja that was successfully exited. In this case, the desert refers to the market for biotech stock, which is currently not flourishing at all. Nevertheless, argenx achieved to raise $700M with the issuing of new shares last week and is likely to add another $100M in the near future. The Belgian biotech company develops medicines using antibodies from lamas, and recently marketed its first product.

You can read the entire article in the FD (link). The article is in Dutch. 

https://fd.nl/financiele-markten/1434393/argenx-aandeel-bloeit-als-een-bloem-in-de-woestijn-p1c2cabl0MJY

Thuja Capital Healthcare Fund III invests in InnoSIGN

Today, 22 March, InnoSIGN, a precision medicine company, announced that it raised an $8M Series A financing. Proceeds will be used to finance a spin-out from Royal Philips to form a standalone company centered upon the OncoSIGNal pathway activity profiling technology. Investors in the round include Casdin Capital, Life Science Angels, Thuja Capital and Brabant Development Agency. Philips owns a minority stake in the new company. 
 
InnoSIGN commercializes OncoSIGNal mRNA-based tests that measure the activity of signal transduction pathways in cancer and immune cells to predict how patients will respond to targeted drugs.

“We were impressed by the work done by Philips and the current InnoSIGN team in developing this unique diagnostic platform, for which we are confident it will be of great benefit for patients and physicians worldwide.”, said Harrold van Barlingen, managing partner of Thuja Capital Management.

With this investment, Thuja’s third fund (TCHF III) has now added a fifth company to its portfolio.

For more information on the Series A financing round in InnoSIGN, we refer to the press release.

EsoBiotec expanded its investor base through an investment by UCB Ventures

Gosselies, Belgium and Utrecht, The Netherlands, 21 December 2021 – Thuja Capital is pleased to announce that EsoBiotec, the Belgian company developing accessible next generation cell-based cancer treatments, has expanded its investor base through an investment by UCB Ventures. With this additional investor, the company has now raised EUR 6M from investors in total, on top of EUR 3M in non-dilutive Walloon government funding. Emmanuel Lacroix, partner at UCB Ventures, has joined the board.

Michel Briejer, board member of EsoBiotec and Managing Partner at Thuja Capital commented:

We are extremely pleased with the addition of UCB Ventures and with Emmanuel joining the board in particular, as he brings a lot of knowhow and network to EsoBiotec. We consider it also as a confirmation of the potential of EsoBiotec.

Thuja announces the final close of Thuja Capital Healthcare Fund III at EUR 76M (USD 86M)

Utrecht, The Netherlands – 16 December 2021 – Thuja Capital Management, an early stage life sciences investor, today announces the final close of its Thuja Capital Healthcare Fund III ("Fund III") at EUR 76M. Fund III is focused on investing in early stage companies that develop novel therapeutics, medical devices (including digital health) or nutraceuticals, based in the Netherlands, Belgium or Germany.

The European Investment Fund (EIF), ASR as well as several Dutch and Walloon regional investment agencies are part of a strong base of LPs supporting the fund. In addition, several universities and knowledge institutions, amongst which Sanquin, Utrecht University and UMC, Radboud UMC, Brightlands Maastricht, Delft Enterprises and KU Leuven have backed the fund.

The Fund will identify early stage investment opportunities, often still at an academic project/spin-off stage, and work actively with management to develop initial preclinical proof of concept and attract follow-on investment rounds, on its way to realize meaningful healthcare impact.

Fund III will build a portfolio of 10-12 investments, comprising promising and impactful Dutch, Belgian and German early-stage ventures. The fund has made three investments to date: Alesta Therapeutics (Leiden, The Netherlands), EsoBiotec (Gosselies, Belgium) and Pan Cancer T (Rotterdam, The Netherlands).

Harrold van Barlingen, Managing Partner and founder of Thuja, said:

We are very pleased with the closing of this new fund, which is more than double the size of our previous fund. It allows us to continue and accelerate our successful strategy of building life science companies and thus promote innovation to reach and benefit patients. We are now reinforcing our team to expand our reach and scale our successful model.

Michel Briejer, Managing Partner of Thuja, said:

We have expanded our network of academia and knowledge institutions within the framework of this new fund, are actively collaborating with these institutions. In this way we can access a rich source of innovation and at the same time provide support and advice to our counterparts, which is to the benefit of all involved. We are thrilled to have their vote of confidence and their contribution as an LP to the fund.

-ENDS-

For more information, please contact:
Harrold van Barlingen, Managing Partner, hvb@thujacapital
www.thujacapital.com

About Thuja
Thuja Capital Management (Thuja) is a dedicated life sciences venture capital firm with its office in Utrecht, The Netherlands. Thuja's team currently consists of 8 professionals (scaling to 10, of which 6 hold a PhD).

Thuja has been active as an early stage life sciences investor since 2008. Since then, it has operated several funds totaling in excess of EUR 125M under management. Since then, Thuja has been involved mostly as of the start, with various successful ventures, amongst which Argenx (market cap 16.5 Bn USD), Okapi Biosciences, NightBalance and MILabs. For the active portfolio we refer to our website. To date, Thuja invested in 25 life sciences companies.

Thuja is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Thuja selects investments that will positively affect the health and well-being of patients.

European Investment Fund
Participation of EIF in Fund III was structured through various mandates:

• InnovFin Equity, with the financial backing of the European Union under Horizon 2020 Financial Instruments and the European Fund for Strategic Investments (EFSI) set up under the Investment Plan for Europe. The purpose of EFSI is to help support financing and implementing productive investments in the European Union and to ensure increased access to financing;

• PanEuropean Guarantee Fund (EGF) implemented by the EIF with the financial support of the Participating Member States; 

• As fiduciary for the benefit and risk of Invest-NL Capital N.V.

argenx Announces U.S. Food and Drug Administration (FDA) Approval of VYVGART™ (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis

BREDA, Netherlands--(BUSINESS WIRE)-- Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211217005641/en/

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART™ (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. These patients represent approximately 85% of the total gMG population1. With this regulatory milestone, VYVGART is the first-and-only FDA-approved neonatal Fc receptor (FcRn) blocker.

“Today is the start of a new era for argenx and the gMG community as we honor our commitment to bring forward an innovative treatment option for people living with this debilitating disease. The approval of VYVGART represents many achievements: our first approved product; the first-and-only FDA-approved neonatal Fc receptor blocker; and the first approved therapy designed to reduce pathogenic IgGs, an underlying driver of gMG,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Importantly, we want to thank the patients, supportive caregivers, investigators and study teams who participated in the ADAPT trial, as well as our partners and dedicated employees for their hard work and collaboration – all of whom made this milestone possible.

Tim Van Hauwermeiren, co-founder and CEO of argenx NV (Photo: Business Wire)

“Our highly motivated commercial team is activated and ready to deliver VYVGART to patients. We believe the field of autoimmunity is on the precipice of an evolution, and we hope that this will be the first of many VYVGART launches, allowing us to help improve the lives of patients around the world," continued Mr. Van Hauwermeiren.

Generalized myasthenia gravis is a rare and chronic neuromuscular disease characterized by debilitating and potentially life-threatening muscle weakness. VYVGART is a human IgG1 antibody fragment that binds to FcRn, resulting in the reduction of circulating immunoglobulin G (IgG) antibodies. The action of AChR autoantibodies at the neuromuscular junction is a key driver of gMG2.

“The gMG community has long-awaited the FDA approval of VYVGART, especially for those patients who struggle with basic personal tasks such as speaking, chewing and swallowing food, brushing teeth and hair, and in some severe cases, breathing,” commented Samantha Masterson, President and Chief Executive Officer of the Myasthenia Gravis Foundation of America. “We thank argenx for its continued commitment to the gMG patient community, which led them to deliver this much-needed new treatment option with the potential to change the lives of many gMG patients.”

Proven clinical efficacy and safety profile

“People living with gMG have been in need of new treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” said James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine and Principal Investigator for the ADAPT trial. “Today’s approval represents an important new advance for gMG patients and families affected by this debilitating disease. This therapy has the potential to reduce the disease burden of gMG and transform the way we treat this disease.”

The approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle.

There were additionally significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.

VYVGART had a demonstrated safety profile in the ADAPT clinical trial. The most common adverse events in ADAPT were respiratory tract infection (33% vs 29% placebo), headache (32% vs 29% placebo), and urinary tract infection (10% vs. 5% placebo).

Access and My VYVGART Path

argenx is committed to supporting affordable access to VYVGART. As part of this commitment, argenx is launching My VYVGART Path, a program designed to connect patients and clinicians to personalized support throughout the treatment journey. Program resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. Patients and healthcare providers can visit VYVGART.com for more information.

Adults living with gMG each experience the course of the disease differently, contributing to variability of disease severity and response to therapies. argenx prioritized early and active engagement with leading payers to address questions around broader budget predictability. The Company has reached agreements in principle with several national and regional commercial payers to structure a value-based agreement. The agreements are meant to provide predictability of cost for payers and appropriate access for patients.

“Generalized myasthenia gravis imposes a significant lifestyle and treatment burden on patients, families, and the overall healthcare system. This autoimmune disease affects each patient differently which can create variability in dosing and the resulting cost per patient,” said Steve Miller, M.D., Executive Vice President and Chief Clinical Officer at Cigna Corp. “The approval of VYVGART promises to address a treatment gap for patients suffering from this disease. argenx has put forth an innovative, value-based approach to contracting that will help payers with cost predictability as they face the challenge of ensuring real-world dosing remains affordable. This was a direct result of early engagement between argenx and Evernorth leading up to approval. Cigna looks forward to continued collaboration with argenx to enable appropriate access to the gMG patients who will benefit from VYVGART.”

Marketing Authorization Applications for efgartigimod for the treatment of gMG are currently under review with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), with anticipated decisions from each agency in the first quarter and second half of 2022, respectively.

argenx has an exclusive partnership agreement with Zai Lab for the development and commercialization of efgartigimod in Greater China. Zai Lab is on track to file for approval in Greater China by mid-2022. Under the terms of the strategic agreement with Zai Lab, argenx will receive a $25 million milestone payment with this U.S. approval of VYVGART. In addition, argenx has an exclusive partnership with Medison for the commercialization of efgartigimod in gMG in Israel. Medison is on track to file for approval in Israel in the second quarter of 2022. BREDA, Netherlands--(BUSINESS WIRE)-- Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211217005641/en/

Tim Van Hauwermeiren, co-founder and CEO of argenx NV (Photo: Business Wire)

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART™ (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. These patients represent approximately 85% of the total gMG population1. With this regulatory milestone, VYVGART is the first-and-only FDA-approved neonatal Fc receptor (FcRn) blocker.

“Today is the start of a new era for argenx and the gMG community as we honor our commitment to bring forward an innovative treatment option for people living with this debilitating disease. The approval of VYVGART represents many achievements: our first approved product; the first-and-only FDA-approved neonatal Fc receptor blocker; and the first approved therapy designed to reduce pathogenic IgGs, an underlying driver of gMG,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “Importantly, we want to thank the patients, supportive caregivers, investigators and study teams who participated in the ADAPT trial, as well as our partners and dedicated employees for their hard work and collaboration – all of whom made this milestone possible.

“Our highly motivated commercial team is activated and ready to deliver VYVGART to patients. We believe the field of autoimmunity is on the precipice of an evolution, and we hope that this will be the first of many VYVGART launches, allowing us to help improve the lives of patients around the world," continued Mr. Van Hauwermeiren.

Generalized myasthenia gravis is a rare and chronic neuromuscular disease characterized by debilitating and potentially life-threatening muscle weakness. VYVGART is a human IgG1 antibody fragment that binds to FcRn, resulting in the reduction of circulating immunoglobulin G (IgG) antibodies. The action of AChR autoantibodies at the neuromuscular junction is a key driver of gMG2.

“The gMG community has long-awaited the FDA approval of VYVGART, especially for those patients who struggle with basic personal tasks such as speaking, chewing and swallowing food, brushing teeth and hair, and in some severe cases, breathing,” commented Samantha Masterson, President and Chief Executive Officer of the Myasthenia Gravis Foundation of America. “We thank argenx for its continued commitment to the gMG patient community, which led them to deliver this much-needed new treatment option with the potential to change the lives of many gMG patients.”

Proven clinical efficacy and safety profile

“People living with gMG have been in need of new treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” said James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine and Principal Investigator for the ADAPT trial. “Today’s approval represents an important new advance for gMG patients and families affected by this debilitating disease. This therapy has the potential to reduce the disease burden of gMG and transform the way we treat this disease.”

The approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which were published in the July 2021 issue of The Lancet Neurology. The ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle.

There were additionally significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.

VYVGART had a demonstrated safety profile in the ADAPT clinical trial. The most common adverse events in ADAPT were respiratory tract infection (33% vs 29% placebo), headache (32% vs 29% placebo), and urinary tract infection (10% vs. 5% placebo).

Access and My VYVGART Path

argenx is committed to supporting affordable access to VYVGART. As part of this commitment, argenx is launching My VYVGART Path, a program designed to connect patients and clinicians to personalized support throughout the treatment journey. Program resources include disease and product education, access support and benefits verification, and financial assistance programs for eligible patients. Patients and healthcare providers can visit VYVGART.com for more information.

Adults living with gMG each experience the course of the disease differently, contributing to variability of disease severity and response to therapies. argenx prioritized early and active engagement with leading payers to address questions around broader budget predictability. The Company has reached agreements in principle with several national and regional commercial payers to structure a value-based agreement. The agreements are meant to provide predictability of cost for payers and appropriate access for patients.

“Generalized myasthenia gravis imposes a significant lifestyle and treatment burden on patients, families, and the overall healthcare system. This autoimmune disease affects each patient differently which can create variability in dosing and the resulting cost per patient,” said Steve Miller, M.D., Executive Vice President and Chief Clinical Officer at Cigna Corp. “The approval of VYVGART promises to address a treatment gap for patients suffering from this disease. argenx has put forth an innovative, value-based approach to contracting that will help payers with cost predictability as they face the challenge of ensuring real-world dosing remains affordable. This was a direct result of early engagement between argenx and Evernorth leading up to approval. Cigna looks forward to continued collaboration with argenx to enable appropriate access to the gMG patients who will benefit from VYVGART.”

Marketing Authorization Applications for efgartigimod for the treatment of gMG are currently under review with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), with anticipated decisions from each agency in the first quarter and second half of 2022, respectively.

argenx has an exclusive partnership agreement with Zai Lab for the development and commercialization of efgartigimod in Greater China. Zai Lab is on track to file for approval in Greater China by mid-2022. Under the terms of the strategic agreement with Zai Lab, argenx will receive a $25 million milestone payment with this U.S. approval of VYVGART. In addition, argenx has an exclusive partnership with Medison for the commercialization of efgartigimod in gMG in Israel. Medison is on track to file for approval in Israel in the second quarter of 2022.

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