Meningococcal vaccine group C conjugate(Pfizer Inc.)

Industry veteran, Tyler Martin, M.D., appointed as chief executive officer Management includes key members of the team that developed Prevnar vaccines Exclusive licensing agreement on pneumococcal vaccine composition patent in the U.S. and Japan LINCOLN, Neb.--(BUSINESS WIRE)-- Aeolian Biotech Corp. today announced the formation and launch of the Company to focus on the development of an improved pneumococcal conjugate vaccine, ‘iPCV22’, to address the threat of circulating and emerging pneumococcal serotypes. Aeolian’s iPCV22 vaccine will potentially cover 95 percent of invasive pneumococcal disease in adults. The management team possesses a diverse set of experiences across vaccine drug development and includes key members of the team that developed the Prevnar family of vaccines. Under an exclusive licensing agreement, Aeolian has been granted a license that includes compositions and methods of use of pneumococcal vaccines (U.S. Patent 11,058,757) in the U.S. and Japan, and pending in other geographies. This patent is expected to provide Aeolian with U.S. market exclusivity for its vaccine product until 2036, excluding any possible patent term extensions or patent term adjustments. The company has additional patents pending. “We are excited to announce the formation and launch of Aeolian and believe that the know-how, technologies and leadership within our Company provide the opportunity to develop a pneumococcal vaccine with improved coverage of circulating strains compared to commercially available vaccines and others in development,” said Tyler Martin, M.D., Chief Executive Officer of Aeolian. “There exists a well-established clinical and regulatory pathway for pneumococcal vaccines that forms the basis for advancing our iPVC22 program, and a clear opportunity to improve on the currently available pneumococcal vaccine coverage in adults. Despite the broad use of the current U.S. Food and Drug Administration approved pneumococcal vaccines available today, there remains approximately 900,000 pneumococcal pneumonia cases annually in the U.S., demonstrating that these current vaccines are not adequately addressing the strains causing disease.” Dr. Martin continued, “In addition, the announced exclusive licensing agreement is an important milestone in protecting our vaccine development program. Developing a strong and evolving patent estate around our drug candidates and technologies is an essential part of our business strategy.” Senior Management Team and Scientific Founders Tyler Martin, M.D. Chairman and Chief Executive Officer Dr. Martin has 30 years of experience in the biotechnology industry. Prior to joining Aeolian, Dr. Martin was Chairman and CEO of Adjuvance Technologies Inc., and before that was President, Dynavax Technologies Corporation. Dr. Martin was also Vice President, Development at Chiron Corporation. In his seven years at Chiron, Dr. Martin led the team responsible for the development of the influenza vaccine FLUAD®, which included the novel vaccine adjuvant MF59, the first vaccine adjuvant licensed by regulatory agencies since alum, now approved in Europe and the U.S. Bruce Forrest M.D., Chief Scientific Officer Dr. Forrest brings to Aeolian over 30 years of global leadership in pharmaceutical development, with extensive expertise in vaccines and biopharmaceuticals development in both major and emerging markets. Dr. Forrest was a divisional Senior Vice President at Pfizer, Inc. and before that, Wyeth Pharmaceuticals, Inc. He led clinical activities supporting the market authorization for RotaShield® (EU), Prevnar® (Global), and FluMist®, and developed successful strategies for the integration and coordination of development activities internationally. Jack Love, Ph.D., Head of Regulatory Affairs Dr. Love has over 30 years of regulatory affairs experience in vaccines, drugs and medical devices. He was Head of Worldwide Regulatory Affairs for the Vaccine Divisions at Wyeth and Pfizer. He led regulatory activities resulting in global approvals for Prevnar® and Prevnar 13®, Meningitec® and was the Wyeth Regulatory lead for FluMist®. As a consultant for Equitas/Reg LLC, he developed regulatory strategies for many other vaccine companies. He was a recipient of the Prix Gallen Award for Prevnar 13®. Paula M. Keith, Ph.D., Head of Technical Operations Dr. Keith is an experienced pharmaceutical development professional with more than 30 years of experience in bioprocess development, GMP production of vaccine clinical supplies and scale up to commercial operations. At Wyeth-Lederle Vaccines she led the team that developed the manufacturing process, produced the clinical supplies, and then directed the start-up of Prevnar® commercial production. She was also VP of Development at Alphavax, then Director, Technical Development at Novartis Vaccines and Diagnostics where she developed the first cell culture process for manufacture of influenza vaccines, as well as the adjuvant MF-59 now in commercial production as FlucelVax® and Fluad®. Joe O’Neill, Chief Business Officer Mr. O'Neill is an accomplished business development and commercial leader, having held senior roles at Johnson & Johnson and Sanofi-Genzyme, prior to joining Aeolian. About Pneumococcal Disease Pneumococcal disease (PD) is caused by bacteria (Streptococcus pneumoniae) that can attack different parts of the body. When these bacteria invade the lungs, they can cause pneumonia; when they invade the bloodstream, they can cause sepsis; and when they invade the covering of the brain, they can cause meningitis. PD is associated with significant morbidity and mortality. The bacteria can also cause milder common conditions like middle-ear infection (otitis media) and sinusitis. Anyone can get PD, but some groups are at increased risk including: children younger than age two years; adults over age 65 years; and children and adults with certain medical conditions, including chronic heart disease, lung disease, kidney or liver disease, diabetes, or illnesses that weaken the immune system, such as HIV and certain cancers, among others. Pneumococcal pneumonia hospitalizes about 150,000 people in the U.S. each year. About Aeolian Biotech Corp. Aeolian is committed to the development of an improved pneumococcal conjugate vaccine to address the threat of circulating and emerging pneumococcal serotypes.