Sydney-based Benitec Biopharma has moved quickly to get word out on its hepatitis B candidate, weeks after saying it would wind up a Phase I/IIa clinical trial for hepatitis C candidate TT-034 as commercial prospects waned.
Using a "systems vaccinology" approach, researchers at Case Western Reserve University School of Medicine and Merck Research Laboratories have published findings that suggest a new way to predict and enhance vaccine effectiveness, in particular with hepatitis B vaccination.
The FDA has already rejected Dynavax's hepatitis B vaccine once, but the Berkeley, CA-based biotech is planning to resubmit its licensing application for the jab as it serves up promising top-line data from the third Phase III trial of Heplisav-B.
Initially approved by the FDA in 1989, GlaxoSmithKline's Engerix-B has been the standard-of-care against hepatitis B. But an analyst thinks Dynavax's experimental Heplisav is poised to swipe some market share once it's approved.
Abivax, a Paris-based biotech that acquired the rights to three commercial, Cuban-made vaccines in November, is gearing up for a €43.6 million ($49 million) IPO to take its hepatitis B candidate into Phase III. The cash will also go toward an HIV drug.
Abivax, an emissary of Cuba's well-regarded but closed-off biotech sector, is raising money to fund clinical trials of a hepatitis B vaccine. The vaccine was discovered by Cuba's Center for Genetic Engineering and Biotechnology and is now on the cusp of making the leap from the island to the wider world.
Janssen Pharmaceuticals has paired up with Ichor Medical Systems to develop and market DNA-based vaccine products to treat chronic hepatitis B. The partners will use the startup's TriGrid electroporation technology for clinical administration of a DNA vaccine.
RNAi specialist Tekmira Pharmaceuticals expanded its reach with the announcement of the purchase of OnCore Biopharma, developer of an all-oral candidate for hepatitis B, saying that a combination therapy approach is the optimal way to treat that disease.
Arrowhead Research Corporation is looking to add another entrant into the clinical trial-based race to commercialize the first RNAi-based compound, a market category that could become a new class of drugs akin to monoclonal antibodies and produce revenues exceeding $1 billion by 2020 according to one projection. The company recently announced that it has submitted its Investigational New Drug application for its RNAi candidate, ARC-520, for the treatment of the chronic hepatitis B virus.
Alnylam today announced the addition of RNA interference therapies for the hepatitis delta virus and chronic liver infections to its clinical pipeline at the American Association for the Study of Liver Diseases in Boston. The company also said it remains on track to select a candidate for its hepatitis B program by the end of the year and hopes to file an investigational new drug application with the FDA in late 2015.