Pharma Focus Asia

Invivyd and U.S. FDA Collaborate on Streamlined Path for COVID-19 Prevention and Treatment with Serial Monoclonal Antibodies

Monday, June 03, 2024

Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company specializing in combating severe viral infectious diseases, has revealed an accord with the U.S. Food and Drug Administration (FDA) regarding a streamlined pathway for potential emergency use authorizations (EUAs) for new monoclonal antibodies (mAbs) designed to prevent and treat symptomatic COVID-19. This alignment enables the creation of a master clinical trial protocol, eliminating the necessity for new protocols for each mAb evaluation. This pathway aims to efficiently assess new mAbs through compact clinical programs involving several hundred participants, with specific exposure numbers to be determined in consultation with the FDA. The estimated cost of generating necessary safety and pharmacokinetics (PK) data for this pathway is $25-40 million.

Invivyd's Chairman of the Board, Marc Elia, underscored the significance of this accord in addressing the urgent need for effective COVID-19 treatments. He emphasized the company's focus on developing pathways that match the pace of viral evolution.

Mark Wingertzahn, Invivyd's SVP of Clinical Development and Medical Affairs, highlighted the challenge of rapidly innovating and establishing clear pathways for clinical evidence to bring mAbs to patients efficiently. The company aims to explore innovative presentations, such as intramuscular delivery, to enhance patient accessibility.

PEMGARDA™ (pemivibart), an investigational mAb developed by Invivyd, targets the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting virus attachment to host cells. It has been authorized for emergency use by the FDA for pre-exposure prophylaxis in specific populations. An immunobridging approach was used to support the EUA for PEMGARDA, based on serum virus neutralizing titers. However, there are limitations to the data supporting its benefits, including variations in efficacy estimates and circulating SARS-CoV-2 variants.

Invivyd's agreement with the FDA marks a significant step forward in advancing treatments for COVID-19, with potential implications for global regulators.



Cytiva - Supor Prime filtersMFA + MMA 2024CPHI China || PMEC China 2024Asia Healthcare Week 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024