AstriVax NV

LEUVEN, Belgium I June 24, 2024 I The first participants have been dosed in a Phase I clinical study to test the safety and efficacy of AstriVax’s prophylactic vaccines for yellow fever (AVX70120) and rabies (AVX70481) in healthy adults. The first-in-human safety and immunogenicity data generated by this study will be a stepping stone in advancing AstriVax immunotherapies to clear chronic infections such as Hepatitis B and human papillomavirus (HPV) infections. The company’s first-in-human clinical study, called SAFYR, will be conducted in two Belgium-based, world-class vaccine clinical trial sites: the Centre for Vaccinology in Ghent and Vaccinopolis in Antwerp. The study will evaluate the safety and characterize the immune response of the company’s prophylactic vaccines for yellow fever and rabies in close to 100 healthy adults aged 18 to 40. The results are also expected to provide clinical proof of concept for the AstriVax vaccine platform. Mathieu Peeters, MD, Chief Development Officer at AstriVax : “This clinical trial evaluates our cutting-edge technology in a clinical proof-of-concept study. We use plasmids that deliver live-attenuated virus vectors along with the target viral antigen. This self-amplifying mechanism is designed to elicit strong and long-lasting immune responses with only microdoses.” The novel AstriVax vaccines are potential game-changers in the fight against viral pathogens. Developed with the company’s innovative vaccine platform, they are easy to produce, have limited cold chain requirements, and are expected to trigger a strong and lasting immune response. Paving the way for immunotherapies Today, AstriVax is a clinical-stage company with a rich pipeline targeting viral infections, including treatment of infectious diseases with critical unmet medical needs like chronic Hepatitis B, which affects over 250 million people, and HPV infections, a leading cause of cervical cancer. Hanne Callewaert, Ph.D., CEO and co-founder of AstriVax : “Less than two years ago, our journey began with solid, academically developed technology and a €30 million seed round. In May 2023, we were awarded a grant from Flanders Innovation & Entrepreneurship (VLAIO) to further advance our technology. I’m deeply grateful to my exceptional team for shaping the company into what it is today, and I look forward to continuing our journey towards better global health together. We anticipate our chronic hepatitis B immunotherapeutic will enter the clinical phase in 2025, marking yet another significant milestone for AstriVax. ” Media contact Hanne Callewaert, Ph.D, CEO of Astrivax, corporate@astrivax.com . About AstriVax Founded in 2022, AstriVax NV aims to address global challenges in vaccinology with its innovative plug-and-play vaccine platform. The 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 well-known investors V-Bio Ventures, Fund+, Flanders Future TechFund managed by PMV, Thuja Capital, Ackermans & van Haaren, OMX Europe Venture Fund (Mérieux Equity Partners and Korys), 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 astrivax.com . SOURCE: AstriVax

Experienced industry executive Marco Timmers takes helm as CEO, bringing over two decades of drug development experience Corporate venture veteran Jeanne Bolger moves from member to Chair of Sapreme’s Board of Directors Company establishes SAB to support next stage of preclinical pipeline towards clinical proof-of-concept with Prof. Steven Dowdy, Prof. Annemieke Aartsma-Rus, Prof. Philip Van Damme, and Prof. Hendrik Fuchs BILTHOVEN, The Netherlands--(BUSINESS WIRE)-- Sapreme, a biotechnology company focused on developing next-generation RNA therapeutics for patients with genetically driven diseases, today announced the appointment of Marco Timmers, PhD, as Chief Executive Officer and Jeanne Bolger, MD, to Chair of the Sapreme Board of Directors (BoD). Additionally, the company has established its Scientific Advisory Board (SAB), comprised of experts in diseases with high unmet medical need, as well as the rapidly expanding field of RNA delivery. Marco Timmers has cultivated a career spanning over 25 years in pharmaceutical R&D and has held various leadership positions at international biotechnology and pharmaceutical corporations. Before joining Sapreme, he was CEO of Byondis (formerly Synthon Biopharmaceuticals), a clinical-stage biopharmaceutical company developing Antibody-Drug Conjugates (ADCs) targeting intractable cancers and auto-immune diseases. During his time at Byondis, Dr. Timmers also served as Chief Scientific Officer, guiding the company’s clinical strategies and growth. Before that, he held various positions of increasing responsibility at Organon, Schering-Plough and MSD, including Head of Medicinal Chemistry, Proof-of-Concept Team Leader and Site Lead Women’s Health and Endocrinology. He holds a MSc and a PhD in bio-organic chemistry from Leiden University in The Netherlands. “Sapreme’s endosomal escape technology holds great potential in enabling much-needed improved intracellular delivery for next-generation large molecule drugs. I look forward to working with the team at Sapreme to further advance this innovative platform and accelerate our pipeline of RNA therapeutic candidates addressing a range of genetically driven diseases,” said Marco Timmers, Chief Executive Officer of Sapreme. Jeanne Bolger is an experienced biopharma senior executive with extensive business development and investment expertise over her 35 years in the pharmaceutical sector. She served on the board of over a dozen life sciences companies during her 10 years as Vice President of Venture Investing at Johnson & Johnson Innovation-JJDC. Dr. Bolger’s drug development and commercial expertise spans numerous therapeutic fields, including oncology, neurology, psychiatry, respiratory, immunology, infectious disease and vaccines, and cell and gene therapy. She is a Non-Executive Board Director of Life Healthcare. She is also the Chair of the Board at ExeVir and at Astrivax. Dr. Bolger holds an MB BCh in Medicine from University College Dublin. She has been a member of the Sapreme Board of Directors since July 2023. “Marco’s deep R&D and leadership expertise, coupled with the newly formed SAB places Sapreme in an optimal position to deliver on its upcoming corporate and clinical goals,” commented Jeanne Bolger, Chair of the Board of Directors of Sapreme. “It is a great pleasure to support this dynamic team on its path to overcoming significant hurdles in next-generation therapeutics.” Scientific Advisory Board Appointments |Sapreme has established a SAB to guide the company as it advances its preclinical candidates toward clinical proof-of-concept. The new members of the Sapreme SAB include: Steven Dowdy, PhD Steven Dowdy is professor of cellular and molecular medicine at the University of California San Diego School of Medicine and is a leading expert in the field of endosomal escape. Dr. Dowdy has been advising biotech and pharmaceutical companies for 35 years, and he is currently a member of five biotech SABs. His research over the last 30 years has primarily focused on the delivery of macromolecular therapeutics, including siRNAs, ASOs, peptides, and proteins, and developing new chemistries to tackle the issue of rate-limiting endosomal escape. He received his PhD in molecular genetics from the University of California Irvine and was a postdoctoral fellow at the Whitehead Institute, MIT. Annemieke Aartsma-Rus, PhD Annemieke Aartsma-Rus is professor of translational genetics in the Department of Human Genetics at the Leiden University Medical Center (LUMC), and one of the most influential researchers in the field of Duchenne Muscular Dystrophy (DMD). Her research focuses on advancing therapeutic exon skipping for DMD into the clinic. Dr. Aartsma-Rus also serves as a scientific advisor for various DMD organizations. As a foremost expert in the field, Dr. Aartsma-Rus received the Duchenne Award from the Duchenne Parent Project for her dedication and research in DMD in 2011 and the Black Pearl Science Award from Eurordis in 2021. She received her PhD from Leiden University and was a postdoctoral fellow at the LUMC. Philip Van Damme, MD Philip Van Damme is professor of neurology at the University Hospitals in Leuven (Belgium), where he leads the Neuromuscular Reference Center. His current research focuses on genetic modifiers of amyotrophic lateral sclerosis (ALS) and disease pathways in pluripotent stem cell models derived from ALS patients. As a prominent medical expert in neurology, Dr. Van Damme has published over 200 papers in international peer-reviewed journals on ALS and related neuromuscular disorders, and he is the chair of the European Academy of Neurology (EAN) guideline panel on ALS. He holds an MD from KU Leuven University. Hendrik Fuchs, PhD Hendrik Fuchs is professor at the Institute for Laboratory Medicine, Clinical Chemistry, and Pathobiochemistry at the Charité – Universitätsmedizin Berlin in Germany. Dr. Fuchs has spent more than 20 years researching the development of protein-based targeted anti-tumor therapeutics and is widely recognized as a pioneer in the use of saponins for endosomal escape. He was the coordinator of a large European project on targeted gene delivery and has published over 100 peer-reviewed articles. He holds a PhD from Free University of Berlin. About Sapreme Sapreme is developing next-generation RNA therapeutics for patients with genetically driven diseases. Our proprietary endosomal escape technology enables targeted delivery of large molecules such as PMOs, ASOs and siRNAs to intracellular targets in extrahepatic tissues as well as the liver. We have successfully translated the technology to non-human primates and have obtained in vivo PoCs in muscle, heart, kidney and tumor tissue. Sapreme is now building a broader pipeline to address high unmet needs in neuromuscular, renal, cardiometabolic diseases and beyond. Our lead candidate is designed as best-in-class in Duchenne Muscular Dystrophy and we are pursuing strategic partnerships to co-develop product candidates with selected pharma/biotech companies based on our endosomal escape platform. View source version on businesswire.com: Contacts For further inquiries, please contact: Marco Timmers, CEO +31 30 760 09 76 info@sapreme-technologies.com For media inquiries, please contact: Trophic Communications Desmond James or Valeria Fisher +49 151 67859086 or +49 175 8041816 sapreme@trophic.eu Source: Sapreme View this news release online at:

The government grant is awarded by Flanders Innovation & Entrepreneurship (VLAIO). The grant will be used to accelerate the development of the company’s therapeutic vaccine targeting chronic Hepatitis B. The non-dilutive financing builds upon the award-winning €30 million seed financing raised in 2022 and the first VLAIO grant of €2.5 million to advance the innovative vaccine platform. Leuven, Belgium, December 12, 2023 – AstriVax is pleased to announce that it has been selected for funding by Flanders Innovation & Entrepreneurship (VLAIO). The company has received a grant of €3 million to advance its innovative technology in clinical development for one of the lead indications, chronic Hepatitis B. Hanne Callewaert, Ph.D., CEO of AstriVax, said: “I am honored that VLAIO recognizes the potential of our candidate vaccine targeting chronic Hepatitis B. This therapeutic vaccination strategy may play a key role in the steps towards functional cure for those patients that suffer from a chronic Hepatitis infection. Our vaccine targets a huge unmet medical need with yearly over 800.000 people dying from the consequences of being chronically infected with Hepatitis B. With the support from VLAIO, we can further optimize the therapeutic potential of our vaccine platform technology in the globally recognized innovation ecosystem of Flanders.” AstriVax has been awarded a VLAIO research and development project grant, a type of funding companies can use for projects based on innovative ideas of strategic importance. Combined with the award-winning €30 million in seed capital AstriVax raised in 2022 and the first VLAIO grant awarded on the vaccine platform itself, this VLAIO grant brings the company significantly closer to making a lasting impact in the Hepatitis B field. The combination of private investment and non-dilutive government support also underscores the confidence in the company’s potential to revolutionize therapeutic vaccine development. Hanne Callewaert, Ph.D., CEO of AstriVax, info@astrivax.com. About AstriVax Founded in 2022, AstriVax NV aims to address global challenges in vaccinology with its innovative plug-and-play vaccine platform. The 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 well-known investors V-Bio Ventures, Fund+, Flanders Future TechFund managed by PMV, Thuja Capital, Ackermans & van Haaren, OMX Europe Venture Fund (Mérieux Equity Partners and Korys), 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 . About VLAIO Flanders Innovation & Entrepreneurship (Agentschap Innoveren & Ondernemen - VLAIO) is a Flemish Government agency that stimulates and supports R&D activities by innovative entrepreneurs and companies. More information: