The Philippine Food and Drug Administration (PFDA) has granted clinical trial approval for YS Biopharma’s YS-HBV-002, an immunotherapeutic vaccine aimed at treating chronic hepatitis B virus (HBV) infection.
YS Biopharma is set to commence a Phase I clinical trial of the vaccine in the Philippines in June.
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The double-blind, placebo-controlled, randomised, dose-escalation study will assess the vaccine’s safety, immunogenicity, and efficacy in adults with chronic HBV infection.
YS-HBV-002’s dual-target approach on humoral and cellular immune responses could aid in the treatment of chronic HBV.
A next generation therapeutic HBV vaccine, YS-HBV-002 builds on the technology and clinical findings from its predecessor, YS-HBV-001.
This advanced formulation includes recombinant core and surface hepatitis B antigens, combined with PIKA adjuvant of the company, to potentially elicit a stronger immune reaction against HBV.
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By GlobalDataYS Biopharma director, president and CEO Dr David Shao said: “The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection.
“At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life.
“With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat.”
Earlier this month, the company reported positive in9terim outcomes from the Phase III clinical trial underway to evaluate its next-generation PIKA Rabies Vaccine.
Leveraging YS Biopharma’s PIKA adjuvant technology, the vaccine can elicit a stronger immune response more rapidly than current rabies vaccines.
