Biovest International, Inc. has announced that it conducted a formal clinical guidance meeting with the U.S. Food and Drug Administration (FDA) to determine the most expeditious U.S. registration pathway for BiovaxID™, its personalized cancer vaccine for the consolidation treatment of follicular non-Hodgkin’s lymphoma that is manufactured in Coon Rapids.
During the FDA meeting, Biovest reviewed the unmet need in the U.S. where an estimated 50 percent of follicular lymphoma patients achieving first remission do not receive any treatment even though their cancer is at near-universal risk of relapse, according to Biovest President and Chief Executive Officer Samuel S. Duffey.
A primary contributing factor to this urgent medical need for additional consolidation agents is the immunosuppressive nature of all approved consolidation agents, which target the same antigen, CD20, used as part of induction therapy, Duffey said.
At the meeting, the FDA required that Biovest conduct a second Phase III clinical trial to confirm the clinical data generated in the Phase III trial BV301 and complete the company’s BiovaxID development program to support the filing of a Biologics License Application (BLA), he said.
Further, FDA offered to work out with Biovest a registration trial design for such a confirmatory Phase III study, Duffey said.
According to Duffey, Biovest intends to accept this FDA offer to meet within the next several months to advance the clinical development of BiovaxID to discuss a trial protocol that can most expeditiously generate registration data using agreed upon endpoints.
In the upcoming meeting with the FDA regarding the design of the confirmatory registration study, Biovest anticipates exploring the use of a specific subtype of the idiotype biomarker found in a retrospective analysis of the first Phase III clinical trial, BV301, Duffey said.
“Concurrent with FDA’s registration activities, Biovest will continue to advance seeking marketing approvals for BiovaxID in the European Union (EU) and Canada with those planned applications supported by evidence of clinical benefit from the three human clinical trials conducted to date in collaboration with the U.S. National Cancer Institute (NCI),” he said.
According to Duffey, the FDA has clearly defined the U.S. regulatory pathway to approval, which Biovest is firmly committed to achieving.
“I believe the FDA’s guidance, combined with the regulatory feedback received from Canada and Europe, will facilitate the process that is under way both in the U.S. and around the world to allow Biovest to seek potential strategic partnering and licensing relationships,” Duffey said.
“Importantly, Biovest remains committed to advancing the ongoing regulatory process seeking marketing approvals in Europe and Canada in advance of the U.S. to achieve our mission to make BiovaxID the first cancer vaccine available for lymphoma patients.”
In other regulatory news, Biovest reported that it will conduct an upcoming pre-submission meeting with the European Medicines Agency (EMA) in London, England, advancing plans to submit its Marketing Authorization Application (MAA) seeking EU marketing approval.
The EMA has granted orphan medicinal product designation to BiovaxID for the treatment of follicular lymphoma and mantle cell lymphoma, which are B-cell subtypes of non-Hodgkin’s lymphoma.
Orphan drug status in Europe provides Biovest a 10-year period of market exclusivity for BiovaxID on approval for each indication in the EU, thereby offering competitive protection from similar drugs of the same class, according to Duffey.
Headquartered in Tampa, Fla., Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc.