ABIVAX and the Center for Genetic Engineering and Biotechnology (CIGB) announced that Cuban regulatory authorities have granted their first marketing authorization application for ABX203 (HeberNasvac), a first-in-class vaccine to treat chronic hepatitis B (CHB).
“The immune responses observed in CHB patients receiving ABX203, during clinical testing, clearly show that the therapeutic vaccine is able to help patients overcome the immune paralysis which is so typical for the chronic form of the disease,” Gerardo Guillen, PhD, director of Biomedical Research at the CIGB in Havana, said in a recent press release. “The previous studies with ABX203 provided clinical proof of the concept of therapeutic vaccination in chronic Hepatitis B. ABX203 (HerberNasvac) has demonstrated a unique sustained effect, which was achieved with a shorter duration of administration and better tolerability than peg-interferon (PEG-IFNα). In other words, the data indicate that ABX203 could deliver considerable therapeutic advantages over standard treatments for patients suffering from CHB.”
ABX203, being developed as a nasal spray solution and a subcutaneous injection solution, is designed to induce neutralizing serum antibodies to HBsAg — surface antigen — and strong cellular responses, typically weakened in CHB patients. The vaccine contains two recombinant proteins from the hepatitis B virus, the surface antigen (HBsAg) and the nucleocapsid (core) antigen (HBcAg).
ABIVAX owns the rights for clinical development and commercial use of ABX203 in over 80 countries in Asia, Europe and Africa. It acquired the licenses from the CIGB after demonstrating in clinical trials that ABX203 was well-tolerated and had an antiviral effect similar to that of PEG-IFNα. The new treatment also showed a prolonged efficacy with a simpler and shorter administration, suggesting it offers significant advantages over standard CHB treatment.
“We are very pleased with this first Marketing Authorization Approval (MAA) approval for ABX203. It represents a significant milestone for the CIGB, ABIVAX and, most importantly, patients suffering from chronic Hepatitis B. We are looking forward to making this long lasting treatment available to the millions of patients who currently need daily, life-long treatment to control this devastating disease,” said Hartmut Ehrlich, MD, the chief executive officer of ABIVAX.
CIGB has a record of successful market introductions, including its prophylactic vaccine for hepatitis B, registered in over 50 countries. ABIVAX is currently conducting its own Phase 2b/3 clinical trial with ABX203, a controlled, randomized, blinded study in 276 patients at clinical centers in Australia, New Zealand, Taiwan, Hong Kong, Thailand, Singapore, and South Korea. In the trial, one group of patients is receiving ABX2013 in addition to standard medication (nucleotide analogues, NUCS) while a control group receives NUCS. The study’s primary efficacy endpoint is the percentage of subjects with viral load inferior to 40IU/mL after 24 weeks of treatment, and results are expected to be reported in late 2016. The majority of CHB patients live in Asian-Pacific countries.