FDA determines Evaxion Biotech can proceed with Phase 2B trial of EVX-01

In a regulatory filing yesterday evening, the company stated: "As previously announced on September 21, 2022, Evaxion Biotech A/S (EVAX) reached an important milestone when it enrolled its first patient in Perth, Australia in the Company’s global Phase 2b clinical trial of EVX-01, the Company’s personalized, peptide-based cancer immunotherapy targeting melanoma, in combination with KEYTRUDA(R) an anti-PD-1 inhibitor developed by Merck &Co (MRK). In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation request to the FDA for the Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA for the treatment of patients with metastatic melanoma. On December 22, 2022, the FDA notified the Company that it had reviewed the Company’s IND and determined that the Company may proceed with its Phase 2b trial. The Company anticipates a reply from the FDA on its Fast Track designation submission in the first quarter of 2023. It is anticipated that the trial will be conducted globally at clinical sites across the United States, Europe, and Australia in collaboration with Merck, which is supplying the trial with its PD-1 inhibitor, KEYTRUDA. Patients enrolled in the Phase 2b clinical trial will receive standard of care treatment along with KEYTRUDA in combination with EVX-01, or in the event of progression, another standard of care treatment in combination with EVX-01. The Company is responsible for the conduct of the trial. The Company and Merck will continue to collaborate as the data mature. The Phase 2b clinical trial is a single arm trial evaluating the efficacy and safety of EVX-01 in combination with KEYTRUDA, or pembrolizumab, in adults with unresectable or metastatic melanoma. The trial will evaluate if EVX-01 improves the best overall response in patients with an initial assessment of stable disease or partial response after initiating KEYTRUDA treatment, as compared to historical outcomes with KEYTRUDA(R) alone in metastatic or unresectable melanoma. The Company has received approval of its Clinical Trial Applications for the Phase 2b trial from regulatory authorities in Australia, Italy and France. The Company subsequently informed the French regulators that it currently does not intend to conduct the trial in France. In addition, the Company submitted a CTA in Spain and is awaiting approval by the Spanish regulatory authorities." Shares of Evaxion Biotech are up 22% at $2.16 in pre-market trading.