- Dynavax Technologies is on the hunt for a pharma or financial partner to help advance its Heplisav-B program after the Food and Drug Administration rejected the hepatitis B vaccine over safety concerns.
- Shares in the California-based biopharma plunged nearly 75% Monday morning on the news. Investors were already skeptical of Heplisav B's chances for approval, having correctly interpreted a September decision by the FDA to cancel an advisory panel meeting on the drug as indicative of potential problems.
- According to Dynavax, the complete response letter (CRL) asked for clarification on "adverse events of special interest", as well as a "numerical imbalance" in cardiac events seen in the HBV-23 study.
Dynavax still believes Heplisav-B to be approvable but lacks the financial muscle to advance the program on its own.
"The CRL is consistent with our opinion that Heplisav-B is approvable and we are seeking to meet with the FDA as soon as possible," said Dynavax CEO Eddie Gray in a statement.
"However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner," he added.
As of September 30, Dynavax had roughly $23 million in cash and equivalents, along with another $86.5 million in marketable securities, to draw upon for funding of operations. At the time of reporting third quarter earnings, the company anticipated it had sufficient plans in place to meet its funding needs for one year.
The CRL from the FDA appears to have put a wrench in those plans, however, leaving Dynavax looking for options.
Dynavax said the letter would likely entail a target review period of six months for the biologics license application for Heplisav-B. While the FDA indicated its concerns with the vaccine's safety profile, it has not yet fully reviewed additional information Dynavax sent the agency in October.
In that response, Dynavax provided evidence it says shows the imbalance of cardiac events was due to an "unexpectedly low number of events in the comparator arm."
Heplisav-B is designed to be administered in two doses over one month, an easier regimen than current vaccines. Yet the CRL, coupled with past problems with immunogenicity, could make Heplisav-B a hard sell for potential partners. Further clarity on the FDA's opinion of Dynavax's October response could help.