OVX836

LYON, France & KUMAMOTO, Japan I September 10, 2024 I Osivax , a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating respiratory viruses, and KM Biologics Co., Ltd., a leading vaccine manufacturer in Japan, today announced a license option agreement granting KM Biologics an exclusive license option to develop, manufacture and commercialize Osivax’s broad-spectrum “universal” influenza vaccine candidates for the Japanese market. Osivax will receive an upfront payment for the execution of the license option agreement and, upon KM Biologics exercising the option, Osivax will be entitled to an additional upfront payment, payments upon achievement of several development and regulatory milestones, and tiered royalties per candidate. Financial details of the license option agreement have not been disclosed. “We highly value the opportunity to collaborate with KM Biologics, an experienced and established influenza vaccine developer and manufacturer in Japan. This presents an exciting opportunity for us to expand the reach of our broad-spectrum ‘universal’ influenza vaccine candidates to a country that is at the forefront of seasonal and pandemic flu prevention ,” said Alexandre Le Vert, CEO and Co-Founder of Osivax . “The license option agreement underscores the potential of our oligoDOM™technology to generate T-Cell vaccines capable of providing universal protection against current and future influenza strains on a global scale.” “We are impressed with the innovative potential of Osivax’s broad-spectrum ‘universal’ influenza vaccine candidates and oligoDOM™ technology ,” commented Toshiaki Nagasato, President and Representative Director of KM Biologics . “ This license option agreement opens the possibility for us to utilize KM Biologics’ capabilities, partnerships, and extensive market knowledge to bring Osivax’s novel influenza vaccines to Japan. The opportunity of this new approach to meeting the diverse needs in the influenza vaccine market will further improve vaccination rates and better control influenza disease burden, contributing towards the enhancement of the public health. ” About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM™, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum “universal” influenza vaccine candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 volunteers tested and encouraging efficacy proof of concept data. Osivax’s ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: https://osivax.com/ About KM Biologics KM Biologics is a pivotal member of the Meiji Group’s pharmaceutical segment. The company specializes in research, development, manufacturing, and supply of human vaccines and blood plasma products, as well as in newborn screening, and has been committed to enhancing the public health over 78 years history including its predecessor. The company has a proven track record of delivering a variety of high-quality vaccines and is a top manufacturer of the seasonal influenza vaccine in Japan. The company has been prepared and committed to, in the event of an influenza pandemic, supply vaccines to 57 million people. For more information, visit https://www.kmbiologics.com/en/ . SOURCE: Osivax

48 healthy volunteers enrolled in first-in-human trial Topline data read-out expected by Q4 2024 LYON, France--(BUSINESS WIRE)-- Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating respiratory viruses, today announced that it has completed enrollment in its Phase 1 trial (NCT06128382) with OVX033, the company’s broad-spectrum vaccine candidate against sarbecoviruses. The study is designed to evaluate the safety and immunogenicity of OVX033 at three dose levels (100µg, 250µg and 500µg). To date, no safety concerns or signals have been observed at any dose level, justifying a dose escalation up to the maximum dose level of 500µg. The single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study is being conducted at the Clinical Investigation Center in Vaccinology Cochin Pasteur (CIC) in Cochin Hospital in Paris (AP-HP, Inserm). “Sarbecoviruses remain a threat as evidenced by the Covid-19 pandemic, which continues to have long-term consequences for global health. By completing enrollment for our Phase 1 trial with OVX033, we are taking a significant step forward in addressing the need for a broad-spectrum vaccine to provide protection against these rapidly mutating viruses,” said Dr. Nicola Groth, CMO of Osivax. “The data gathered from the Phase 1 trial with OVX033 will be critical to its further development as an effective and safe protective measure against various strains of sarbecoviruses. We look forward to sharing the data readout later this year and thank all volunteers participating in this study,” commented Prof. Odile Launay, MD, PhD, Professor at Paris Cité University, the Principal Investigator. About OVX033 OVX033 is a first-in-class coronavirus vaccine candidate that targets the nucleocapsid (N), a highly conserved internal antigen. Unlike surface antigens such as Spike (S), N is much less likely to mutate, providing a broader and more universal immune response, with the objective of inducing broad-spectrum protection against all current and future variants of SARS-CoV-2 as well as against future pandemic coronavirus strains. Osivax’ oligoDOMTM technology enables the design and production of a recombinant version of the nucleocapsid which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX033 has demonstrated a preclinical proof of concept for cross-protective efficacy in hamster challenge model published in Frontiers in Immunology. Further preclinical studies and a First-In-Human clinical trial are ongoing. This project is supported by the French government, through France 2030, “Programme Investissements d’Avenir” operated by Bpifrance as projects DOS0123291, DOS0152140 and DOS0152141. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOMTM, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum “universal” influenza candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,200 volunteers tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: View source version on businesswire.com: Contacts Alexandre LE VERT, CEO contact@osivax.com +33 (0)9 70 30 13 80 For Media Inquiries Trophic Communications Desmond James or Valeria Fisher osivax@trophic.eu +49 (0) 151 678 59086 or +49 (0) 175 804 1816 Source: Osivax View this news release online at: