The approval is a special protocol agreement between Avax and the FDA regarding the trial design and surrogate endpoints to be used as a basis of filing for accelerated approval of M-Vax.
“We plan on submitting the data we have generated in support of our production and release assays to the FDA and will look forward to beginning patient accrual shortly thereafter,” noted David Berd, Chief Medical Officer of Avax.
The primary endpoints of the study are best overall anti-tumor response rate and the percentage of patients surviving at least 2 years. The data analysis plan for the study includes an interim analysis of best overall response rate. The comparison of the best overall response rates for M-Vax will be used as the basis for an expected Biologics license application submission which provides for accelerated approval in certain life threatening diseases.
The protocol is based on published data showing that administration of M-Vax alone can induce anti-tumor responses in patients with stage IV melanoma. Moreover, data from other clinical trials and from animal models suggest that the addition of low dose IL2 can also greatly increase anti-tumor response rates.
Vaccine production to source the phase III study will be manufactured by Genopoietic, Avax’s wholly owned subsidiary.