October 2, 2017
By Alex Keown, BioSpace.com Breaking News Staff
BERKELY, Calif. – Dynavax Technologies Corporation is close to regulatory approval for its hepatitis B vaccine, Heplisav-B. Even before the U.S. Food and Drug Administration gives its approval though, some sources say the company is looking for a potential buyer for the treatment – which has experienced numerous delays and causes for concern throughout its development.
Citing “people familiar with the matter,” Reuters reported that Dynavax is quietly shopping Heplisav-B around to buyers or companies hoping to strike a licensing deal. Heplisav-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. The FDA is set to make a decision on Heplisav-B in November. In July, an FDA advisory panel moved the drug one-step closer to final approval, despite some safety concerns, including death and cardiac issues.
News of the possible deal seems to have investors excited. Shares of Dynavax are up more than 6 percent this morning, trading at $22.80 as of noon.
Heplisav-B will go head-to-head with GlaxoSmithKline ’s Engerix-B. In Phase III trials, Heplsav-Bs showed non-inferiority against the GSK drug. Heplisav-B, Reuters noted, has a distinct advantage over GSK’s drug. Heplisav-B is administered with fewer doses, which could cause some physicians to turn to the newer treatment. If Heplisav-B receives expanded approval, the drug’s market share could grow even more, Reuters said.
Heplisav-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. The medicine is administered twice per month, according to Dynavax.
If Dynavax finds a buyer, the company is likely to use the funds to develop its immuno-oncology pipeline. In March, Dynavax announced it was shifting much of its focus to developing new cancer treatments, which includes its SD-101 program. SD-101 is a TLR9 agonist CpG-C class oligodeoxynucleotide.
In November 2016, the FDA rejected Heplisav-B. In a Complete Response Letter the FDA sought “clarification “regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments.” Over the past year, the company has worked furiously to comply and is now awaiting the November approval.
Dynavax was initially expecting an approval for Heplisav-B in August, but the FDA requested more information about the company’s post-marketing plans, which delayed the anticipated approval.
