Personalized Cancer Vaccine Program gets a Green Light

Evaxion Biotech A/S today announced that the U.S. Food and Drug Administration ("FDA") determined that the Company may proceed with its Phase 2b clinical trial of EVX-01.

The study (EVX-01 plus Pembrolizumab 25 MG/ML) was first initiated in Australia in September 2022.

EVX-01 is a peptide-based cancer therapy intended for the first-line treatment of various metastatic and unresectable melanoma.

In November 2022, the Company submitted an Investigational New Drug Application ("IND") along with a Fast Track designation application to the FDA for a

On December 22, 2022, the FDA issued approval for the Company to proceed with its Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA® for treating patients with metastatic melanoma.

"Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma," commented Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2022.

"Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,"

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®.

The U.S. NIH says melanoma is the third most common cutaneous malignancy after basal cell carcinoma and squamous cell carcinoma.

The treatment modalities currently used for metastatic melanoma include surgery, immunotherapy, targeted therapy, and chemotherapy.

The treatment paradigm of metastatic melanoma has changed dramatically within the last few years with the advent of immune checkpoint inhibitors and targeted therapy, says the NIH.

Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies.