Articles from Osivax

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating respiratory viruses, today announced the successful first close of its Series B financing, raising €10 million from new and existing investors.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in a Phase 2a clinical trial (NCT06582277) evaluating OVX836, its broad-spectrum influenza vaccine candidate as a booster in participants previously administered with OVX836.

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.

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.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating viruses, today announced that all participants have completed their final visit in the Phase 2a clinical trial (NCT05734040) evaluating OVX836, Osivax’ broad-spectrum influenza A vaccine candidate, in combination with Quadrivalent Influenza Vaccines (QIVs). Topline results from this study are expected in the second half of 2024.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in its new Phase 1 trial (NCT06128382) evaluating OVX033, a broad-spectrum sarbecovirus vaccine candidate.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, announced today the appointment of Dr. Nicola Groth, MD, PhD to its executive committee as Chief Medical Officer. She brings over 25 years of experience in vaccine development with considerable expertise in influenza vaccines, from early-stage clinical development to approval and post-marketing commitments. Dr. Groth joins Osivax as the company advances the development of its lead candidate, OVX836, a best-in-class broad-spectrum influenza vaccine candidate currently being evaluated in several Phase 2 clinical trials. Dr. Groth takes over from Dr. Willems, whose contribution has been instrumental in advancing Osivax’ clinical strategy.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that it has received a grant of over USD 1.5M from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The grant (project number 1R01AI177376) will support preclinical studies evaluating the breadth of protection and immune response induced by the company’s lead, broad-spectrum influenza vaccine candidate, OVX836 against pandemic influenza strains.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that The Lancet Infectious Diseases published results from the company’s OVX836-003 study under the title, “Immunogenicity, safety and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: randomised, double-blind placebo-controlled, Phase 2a trial.” The research article presents results of the study evaluating the safety and immunogenicity of OVX836, a broad-spectrum influenza vaccine, at three dose levels in healthy adults (NCT05060887). An efficacy assessment of OVX836 was also planned as an exploratory endpoint. The publication can be accessed at the following link: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00351-1/fulltext.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced the publication of promising preclinical proof of cross-protection data against multiple SARS-CoV-2 variants with OVX033, its sarbecovirus vaccine candidate, in a hamster challenge model. The research report article was published under the title, “OVX033, a nucleocapsid-based vaccine candidate provides broad-spectrum protection against SARS-CoV-2 variants in a hamster challenge model,” in Volume 14 - 2023 of the journal Frontiers in Immunology.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that the first participant has been vaccinated in its new Phase 2a clinical trial (NCT05734040) evaluating broad-spectrum influenza vaccine candidate, OVX836 in combination with Quadrivalent Influenza Vaccines (QIVs).

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced that it has received a global pneumonia and pandemic preparedness grant of over USD 1M from the Bill & Melinda Gates Foundation to support additional research and development of its lead, broad-spectrum influenza vaccine candidate, OVX836.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, announced today the appointment of Dr. Chris Martin to its Board of Directors. Dr. Martin brings with him over 20 years of experience in the pharmaceutical and biotech sector. He is an accomplished company founder and director who has successfully brought technology from the lab to regulatory approval and global markets. He joins Osivax as the company advances its lead candidate, OVX836, a Phase 2 first-in-class broad-spectrum influenza vaccine candidate through clinical evaluation and prepares to enter the clinic with its universal coronavirus vaccine candidate, OVX033.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced the Last Patient Last Visit (LPLV) in two Phase 2a clinical trials evaluating Osivax’ lead T-cell based, broad-spectrum influenza vaccine candidate, OVX836. OVX836 has been developed using the company’s proprietary oligoDOM® nanoparticle technology platform and is designed to produce immune responses against the nucleoprotein (NP), an internal antigen highly conserved across flu strains. The LPLVs were completed in: a dose-optimization study (OVX836-003) underway in Belgium, extended to include elderly participants aged 65 years and older, and a co-administration study being conducted in Australia (OVX836-004) with OVX836 and a quadrivalent inactivated influenza virus (QIV) vaccine. Topline results from both studies are anticipated in the first half of 2023.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced the expansion of its leadership team with the appointment of Dr. Vincent Bille as Chief Manufacturing Officer (CMO). His years of experience and in-depth knowledge of Chemistry, Manufacturing and Control (CMC) will be instrumental for the scale-up of the manufacturing process for its lead program, OVX836, a broad-spectrum influenza vaccine candidate currently in Phase 2 clinical evaluation. Dr. Bille has already contributed to Osivax’ manufacturing strategy through the certification of his quality-control lab, located at the heart of the Liège Science Park, that will enable the release of OVX836 batches for use in clinical trials.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced upcoming oral presentations at the Universal Influenza Vaccines (UIV) 2022 event held September 5-7 in Oxford, UK and the Options XI for the Control of Influenza conference, held September 26-29 in Belfast, UK. Osivax’ Chief Business Development Officer, Delphine Guyon-Gellin, will present the most recent clinical and preclinical data for the company’s lead programs, OVX836, a broad-spectrum influenza vaccine, and OVX033 a broad-spectrum coronavirus vaccine. Additionally, two poster presentations providing further clinical and preclinical data for OVX836 will be presented at Options XI.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced that it has secured EUR 10M from Bpifrance to support the further clinical development of OVX836, its lead broad-spectrum influenza vaccine candidate. The grant financing is part of the Healthcare Innovation 2030 plan by the French government to promote leadership in medical innovation including enhanced preparation and response to pandemics and infectious diseases such as influenza. Osivax will apply the funds to prepare OVX836 for a Phase 2b field efficacy clinical trial to assess its efficacy against a broad range of circulating strains.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today provided an update on the clinical development plan of its lead candidate, OVX836. OVX836 is Osivax’ T-cell based influenza candidate developed using the company’s proprietary oligoDOM® nanoparticle technology platform and designed to produce immune responses against the nucleoprotein (NP), a highly conserved internal antigen across flu strains. Based on positive safety data from the ongoing Phase 2a trial, the company has initiated two additional Phase 2 clinical trials: a dose-escalation study in elderly subjects and a combination trial with a seasonal quadrivalent influenza vaccine (QIV), to broaden the scope of OVX836’s application in an effort to provide improved protection against influenza across strains.

Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, today announced that it has entered a research collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to conduct a preclinical evaluation combining Osivax’ T-cell based influenza candidate, OVX836, with a range of the NIAID Vaccine Research Center (VRC)’s influenza vaccine candidates. The immune responses produced by OVX836 involve T-cells against the nucleoprotein (NP), a highly conserved internal antigen across flu strains, and those produced by the NIAID VRC vaccine candidates involve B-cells against hemagglutinin (HA) surface antigens. As both approaches are directed to potential pandemic influenza strains, Osivax and NIAID will evaluate potential synergies between these respective immune responses and potential additive effects in animal challenge models in an effort to create improved, broad-spectrum influenza vaccines.

Osivax, a biopharmaceutical company developing vaccines to protect against highly mutating infectious diseases, announced today that the Phase 2a results for its broad-spectrum influenza vaccine candidate, OVX836, have been published under the title “Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine” in the journal Frontiers in Immunology. Developed using Osivax’ proprietary self-assembling nanoparticle technology, OVX836 targets an internal nucleoprotein (NP), a highly conserved antigen that is less susceptible to the constant mutations of surface antigens of the influenza virus. The study demonstrated that OVX836 induced a significant increase of NP-specific cellular immune responses, including CD4+ and CD8+ T cells, and initial efficacy signals while being safe and well-tolerated in 300 adult subjects.

Osivax, a biopharmaceutical company developing vaccines to protect against highly mutating infectious diseases, announced today the appointment of Dr. Michael Watson to its Board of Directors. Dr. Watson brings over 20 years of experience in the research, development and commercialization of vaccines from leading biotechnology and pharmaceutical companies, including Moderna and Sanofi. He joins Osivax as it advances its lead program, OVX836, an influenza vaccine candidate designed to activate both B cell and T cell immune responses against a highly conserved internal antigen, through Phase 2 clinical studies and prepares to enter the clinic with its universal coronavirus vaccine candidate, OVX033.