On September 21, 2022 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reached an important milestone reported that it had enrolled its first patient in the global phase 2b clinical trial of EVX-01, the Company’s personalized cancer therapy for the treatment of melanoma (Press release, Evaxion Biotech, SEP 21, 2022, View Source [SID1234621295]).
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In the company’s first phase 2b clinical trial, Evaxion is evaluating the efficacy and safety of EVX-01 in adults with metastatic melanoma. The trial is being conducted globally at clinical sites across the US, Europe, and Australia in collaboration with Merck & Co., Inc., 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. Evaxion is responsible for the conduct of the trial and Merck will supply the required KEYTRUDA. Evaxion and Merck will continue to collaborate as the data mature.
Erik Heegaard, Evaxion’s Chief Medical Officer, said:
"We are extremely proud to take EVX-01 into the next clinical development phase, enrolling our first patient in the clinic. We believe that this will help to support our efforts in developing new and more efficacious treatments for patients suffering from malignant melanoma. With this phase 2b trial, we are addressing a major unmet medical need in an indication that has become a multi-billion-dollar market. Together with our collaborators at Merck, we hope to further validate the promising data generated in our phase 1/2a study, which we believe may potentially pave the way for much needed improvement in the treatment landscape for melanoma and possibly other cancers."
Background:
●EVX-01 is a novel personalized cancer immunotherapy based on Evaxion’s proprietary PIONEER AI technology, for the treatment of patients with melanoma.
●Data from the Phase 1/2a clinical trial of EVX-01 has shown that 67% of nine patients benefitted from EVX-01 in combination with a PD-1 inhibitor (KEYTRUDA) for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from a PD-1 inhibitor alone
●22% of the patients in the Phase 1/2a clinical trial achieved a complete response (full recovery) with EVX-01 in combination with a PD-1 inhibitor (KEYTRUDA).
●The first patient in the Phase 2b clinical trial has now been enrolled
●The Company anticipates interim topline data readout in H2 of 2023
●For further information, please refer to clinicaltrials.gov: KEYNOTE – D36 NCT05309421
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.