LYON, France--(BUSINESS WIRE)--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.
“Vincent has amassed an impressive track record as a process development expert for several pharmaceutical and biotechnology companies developing innovative medicines,” commented Alexandre Le Vert, CEO and Co-Founder of Osivax. “His leadership and deep understanding of manufacturing and quality control operations will be important as we move OVX836 toward late-stage clinical development.”
Before joining Osivax, Dr. Bille spent 15 years as an independent consultant for biotech and pharmaceutical companies, providing support in a range of areas including externalized operations relationship management, process development and scale-up, manufacturing, and technology transfer management of complex therapeutic biomolecules. Prior to starting his consultancy, Dr. Bille served as Director of Sales at Lonza for the European and North American markets. He also initiated the commercial operations of UCB-Bioproducts’ US affiliate, where he held several senior leadership positions, most notably as the Head of Technical Operations between 1990 and 2000. Dr. Bille holds a PhD in Biochemistry from the University of Namur and an executive MBA from the Louvain School of Management.
Parallel to Dr. Bille’s appointment, the Federal Agency for Medicines and Health Products (FAMHP) has accredited Osivax’ quality control laboratory in Liège. This regulatory milestone is the result of an extensive quality management system which demonstrates Osivax’ adherence to rigorous international standards. Osivax’ quality control lab is now certified to provide analytical certification for releasing vaccine batches manufactured by industrial partners for use in in-human clinical trials. The roll-out of a quality control capability, operating in accordance with the Good Manufacturing and Distribution Practices (GM(D)P) guidance set forth by the FAMHP, is an essential element of Osivax’ manufacturing strategy to ensure the highest quality standards of the lead program and all future broad-spectrum candidates.
“I am very proud and honored to join Osivax at this exciting phase in the company’s journey,” commented Dr. Vincent Bille, Chief Manufacturing Officer of Osivax. “The recent accreditation from FAMHP of our quality control lab in Belgium is the cornerstone of our strategy to meet the required level of integration between industrial and analytical development activities together with quality control analysis to support the ongoing and future production of OVX836.”
About OVX836
Osivax’ influenza vaccine, OVX836 targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOM® technology enables the design and production of recombinant version of the NP which self-assembles into a nanoparticle, thus triggering powerful T-and B-cell immune responses. OVX836 has shown promising safety, immunogenicity, and efficacy in preclinical and clinical trials (Phase 1 and Phase 2a) and continues to be evaluated in additional studies.
About Osivax
Osivax is a biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOM®, to transform current and new vaccines by generating superior T-cell responses in addition to strong and sustained B cell responses against highly mutating viruses. The company is establishing proof of concept with its highly validated lead influenza candidate, OVX836, which is currently in Phase 2 testing with over 800 subjects tested. Osivax is also exploring the broader application of its technology in a variety of indications. The company will expand into other infectious disease indications through combinations and collaborations worldwide.
For further information: www.osivax.com
