FDA calls for Biovest to conduct another Ph III trial of BiovaxID in NHL

US biotech firm Biovest International (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals (OTCQB: ABPI), saw its shares plunge nearly 27% to $0.30 on Tuesday, after it revealed negative news from a meeting with the US Food and Drug Administration to determine the most expeditious US registration pathway for BiovaxID, its personalized cancer vaccine for the consolidation treatment of follicular non-Hodgkin’s lymphoma (NHL).

At the meeting, the FDA requested that Biovest conducts 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). Furthermore, the FDA offered to work out with Biovest a registration trial design for such a confirmatory Phase III study. The company 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. In Biovest’s analysis of the first Phase III trial, the company identified the IgM subtype showing an 84% improvement in duration of first complete remission in patients with this biomarker who received vaccine compared to matched IgM isotype control vaccinated subjects (median of 52.9 months in vaccinated patients versus 28.7 in matched controls; adj p=0.001).