AVAX cancer vaccines put on hold by FDA

Two autologous cancer vaccines in development at AVAX Technologies havebeen halted by the US Food and Drug Administration, which has informed the company that the clinical hold will remain until the agency receives additional information. Two senior executives at the company, executive vice president for R&D, Ernest Yankee, and vice president of operations Kamy Behzadi, have resigned "in a related matter," according to AVAX.

The company notes that it will take at least three months to respond to the agency's questions concerning the M-Vax and O-Vax products, for melanoma and ovarian cancer, respectively. These questions include issues related to the sterility of tumor cells and their handling, the preparation of the vaccines and AVAX' manufacturing practices. The FDA has also started an inspection of the firm's manufacturing facility. M-Vax is already on the market in Australia.

Crucially, the agency questions whether "M-Vax and O-Vax are sufficiently developed for ongoing clinical trials to be considered adequate to support a Biologics License Application."