Rabies virus inactivated antigen, A

• A Phase 3 clinical trial demonstrates that rabies vaccine booster administered 6 months after Zagreb regimen produces higher antibody levels compared to Essen regimen, with both single and double-dose boosters proving effective. • The single-dose booster showed sufficient immunogenicity with GMC values well above the protective threshold of 0.5 IU/mL, offering a more cost-effective option for rabies prevention. • While Zagreb regimen groups experienced slightly higher rates of adverse reactions compared to Essen groups, all reported reactions were mild and transient, confirming the safety profile of the Speeda vaccine.

• Replicate Bioscience's innovative self-replicating RNA (srRNA) rabies vaccine demonstrates favorable safety profile and immunogenicity in first-in-human Phase 1 trial. • The optimized srRNA vaccine platform shows potential for single-dose effectiveness, marking a significant advancement over traditional rabies vaccines requiring multiple doses. • Results published in Nature Communications validate the company's srRNA technology platform, suggesting broader applications for infectious disease prevention.

• LakeShore Biopharma has initiated the BLA submission to Pakistan's DRAP for its PIKA Rabies Vaccine, targeting post-exposure prophylaxis. • Phase III trial data supports the application, demonstrating the vaccine's ability to accelerate protection against rabies. • The trial met primary immunogenicity endpoints, showing a rapid seroconversion rate and a tolerable safety profile. • PIKA Rabies Vaccine utilizes LakeShore’s PIKA adjuvant technology to elicit a stronger, faster immune response.

• LakeShore Biopharma has initiated a Biologics License Application (BLA) with Pakistan's Drug Regulatory Authority for its PIKA rabies vaccine. • Phase 3 trial data demonstrated the vaccine's ability to provide accelerated protection in a one-week regimen, compared to the standard three- or four-week regimens. • The trial, involving 4,500 participants, showed superior immunogenicity and safety, addressing a critical need in a country with high rabies prevalence. • PIKA rabies vaccine utilizes proprietary PIKA adjuvant technology to produce a robust immune response, and has received FDA orphan drug designation.