Vivaldi Biosciences Inc., a clinical-stage biotechnology company developing genetically attenuated live influenza vaccines for seasonal and pandemic influenza, recently announced the appointment of Manfred Reiter, PhD as Senior Vice President, Manufacturing. Dr. Reiter has responsibility for Vero cell-based production of Vivaldi’s deltaFLU live attenuated influenza vaccines (LAIVs), including process optimization, scale-up, and manufacture in compliance with global quality standards. In the near-term, Dr. Reiter will lead production of a candidate deltaFLU LAIV for the company’s planned Phase 2 clinical program to demonstrate protection in vaccinated volunteers challenged with a strain not included in the vaccine. Demonstration of such cross-protection against heterologous (unmatched) strains would be a significant advantage over currently available influenza vaccines.
“Manfred Reiter brings to Vivaldi substantial pharmaceutical industry experience and technical expertise in production of human vaccines in Vero cell culture that will be invaluable in the scale-up, tech transfer, and GMP production of deltaFLU vaccines. We expect our advanced Vero cell manufacturing platform will provide significant advantages in terms of speed, scale-up, capacity, reliability, and cost versus egg substrate manufacturing, the standard method of influenza vaccine production. Manfred is an industry leader in process development and cell-based vaccine production. We are pleased he has joined the Vivaldi team,” said Thomas Muster, PhD, Chief Scientific Officer.
Dr. Reiter has more than 30 years of experience managing process development and manufacturing teams for the development of human vaccines and recombinant therapeutic proteins, including cell-based production with Vero and other platforms. He has substantial experience with technologies and processes utilized in pre-clinical, clinical, and commercial development of biologicals, including scale-up and technology transfer to contract manufacturing organizations (CMOs). Dr. Reiter’s career includes 14 years with Baxter Bioscience, initially as Director, Upstream Process Development, and then as Senior Director, Process Development, Vaccines & Therapeutics, with responsibility for a team of process scientists and engineers for process development, and clinical and commercial production of vaccines and therapeutic proteins. Prior to joining Vivaldi, Dr. Reiter was Vice President of Process Development & Manufacturing at Hookipa Biotech AG, managing process development and GMP cell-substrate production of viral and cancer vaccines. Dr. Reiter is an inventor on 25 vaccine and therapeutic protein patent families, with more than 700 international patent records.
About Vivaldi Biosciences Inc.
Vivaldi Biosciences Inc. is addressing the compelling need for more effective influenza vaccines with new-generation live attenuated influenza vaccines (LAIVs) based on the biology of influenza nonstructural protein 1 (NS1). Conventional influenza vaccines (“flu shots”) have reduced effectiveness when the vaccine strains are not well matched to circulating influenza strains, as is often the case. Vivaldi's deltaFLU LAIVs are a new vaccine approach showing potential for superior protection, including cross-protection against unmatched or genetically drifted influenza strains. Administered as a nasal spray, deltaFLU LAIVs stimulate the body’s production of interferon, achieving a natural adjuvant effectthat stimulates the immune system’s T cells and antibody-producing B cells. deltaFLU LAIVs have been evaluated successfully in three Phase 1 and one Phase 1/2 clinical trials, demonstrating a potent immune response including cross-neutralizing serum and mucosal antibodies, and safety advantages including absence of vaccine virus shedding. Vivaldi Biosciences Inc. is headquartered in Fort Collins, CO. Its European affiliate, Vivaldi Biosciences AG, is based in Vienna, Austria. For more information, visit http://www.vivaldibiosciences.com.
SOURCE: Vivaldi Biosciences Inc.