Evaxion receives approval from FDA to proceed with the clinical Phase 2b study for EVX-01
Evaxion Biotech A/S (NASDAQ: EVAX) has received FDA approval to proceed with its Phase 2b clinical trial of EVX-01 for treating metastatic melanoma. The trial will investigate the efficacy of EVX-01 in combination with KEYTRUDA and is currently enrolling patients in Australia, with plans to expand to the U.S. and Europe. The FDA's endorsement is a significant milestone for Evaxion’s personalized cancer vaccine initiative, enhancing its capability to demonstrate clinical benefits. A response regarding the Fast Track designation is expected in Q1 2023.
- FDA approval for Phase 2b trial of EVX-01 enhances credibility.
- Trial actively enrolling patients in Australia, indicating progress.
- Collaboration with Merck for KEYTRUDA strengthens the study.
- None.
COPENHAGEN, Denmark, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, 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.
In November 2022, the Company submitted an Investigational New Drug Application (“IND”) along with a Fast Track designation application to the FDA for a 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 issued approval for the Company to proceed with its Phase 2b trial. The Company anticipates a response to the Fast Track designation submission in the first quarter of 2023.
“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. 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,” says Erik Heegaard, Chief Medical Officer at Evaxion.
The Phase 2b study will be conducted at clinical sites across the United States, Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®. The trial was first initiated in Australia with the enrollment of the first patient in September 2022.
Read about EVX-01 Ph2b on clinicaltrials.gov: NCT05309421.
About Evaxion
Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies. With our proprietary and scalable AI technology, we decode the human immune system to discover and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Evaxion has a broad pipeline of novel product candidates, including three personalized cancer immunotherapies. It is located in Hørsholm, Denmark, with 70 employees.
Source: Evaxion Biotech
For more information, please contact:
CEO Per Norlén
pno@evaxion-biotech.com
Or:
Katrine Hertz Mortensen
VP, Communications and Public Relations
khm@evaxion-biotech.com
+45 3010 0203
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FAQ
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