The road toward developing a non-Hodgkin's lymphoma vaccine is littered with failures. Two companies, Genitope and Favrille, had trials fail in 2007 and 2008 and then quickly closed down shop. The challenges were writ large again last week when Biovest filed for bankruptcy--for the second time in 5 years.
It is the latest twist in an almost 30-year effort to bring the vaccine, BiovaxID, to market. The National Cancer Institute (NCI) began developing BiovaxID in 1986, with Biovest stepping in 8 years later to produce the treatment for initial Phase II trials in follicular lymphoma. Biovest took full control of the asset in 2004 and has edged the vaccine closer to approval. A Phase III trial closed in 2008--8 years after starting--but failed to hit recruitment targets. It filed for Chapter 11 reorganization then and emerged two years later. Biovest continued to work toward regulatory filings in Europe and Canada, and anticipates market approval late in 2014.
The project derailed again in November though when FDA asked for an additional Phase III trial. It was, Biovest said, a "significant and unexpected blow" that led to the bankruptcy filing. Extra funding is needed to push BiovaxID toward the finish line. And with $28 million in secured debt maturing weeks after the FDA decision, raising cash from capital markets is tough for Biovest. The goal now is to get BiovaxID to market in Europe and Canada, begin work on a Phase III trial for FDA, and secure a pharmaceutical partner. Successful negotiation of Chapter 11 is the first step.
In the meantime, Biovest has a long list of organizations asking for cash. In total, Biovest has 130 unsecured claims totalling $5.4 million. NCI tops the list of its unsecured claimants with $777,000 unpaid, court documents show. Imaging CRO WorldCare Clinical is waiting on almost $100,000, while fellow service providers Fisher Bioservices and Eurofins are each due more than $80,000.
- here's part of the Chapter 11 filing
- check out the claimant list