LakeShore Biopharma initiates BLA submission to DRAP for PIKA rabies vaccine

LakeShore Biopharma (LSB) announced the initiation of its Biologics License Application submission to the Drug Regulatory Authority of Pakistan for the conditional approval of its PIKA rabies vaccine for post-exposure prophylaxis. This submission is based on the results that met the primary endpoints of the vaccine’s global pivotal trial and demonstrated the vaccine’s potential to achieve accelerated protection and meet the WHO’s goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. The PIKA Rabies Vaccine, which utilizes LakeShore Biopharma’s proprietary PIKA adjuvant technology based on Toll-like receptor 3 immunological pathway, is designed to produce a more robust immune response in an accelerated timespan compared to existing rabies vaccines. It was granted orphan drug designation by the US FDA for prevention of rabies virus infection including post-exposure prophylaxis for rabies. The pivotal registration Phase 3 Trial was a randomized, comparator-controlled, double-blind, multicenter trial which includes 4,500 participants from the Philippines and Pakistan. It is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule, versus a globally marketed comparator following the standard 28-day regimen. The primary immunogenicity endpoints of the study were geometric mean titers of rabies virus neutralizing antibodies and RVNA seroconversion rate at Day 14 in the first 900 participants. This accelerated and higher seroconversion rate came at no cost to safety, with the safety profile of the PIKA Rabies Vaccine remaining highly tolerable.