Evaxion Biotech Announces Publication of Clinical Data of EVX-01 Heading into Phase 2b in Collaboration with Merck
Evaxion Biotech A/S (NASDAQ: EVAX) announced the publication of a paper on its personalized cancer immunotherapy EVX-01 aimed at metastatic melanoma, published in OncoImmunology. The Phase 1/2a trial results indicate that EVX-01 is safe and shows early signs of antitumor activity when combined with standard anti-PD-1 treatment, supported by the company's PIONEER AI technology. The upcoming Phase 2b trial, in collaboration with Merck, is set to begin in Q2 2022, focusing on efficacy and safety in treatment-naïve patients.
- Publication of positive Phase 1/2a trial results for EVX-01 in metastatic melanoma.
- Demonstrated safety and encouraging early antitumor activity in combination with anti-PD-1 therapy.
- Plans for a Phase 2b trial in collaboration with Merck, expected to start in Q2 2022.
- None.
COPENHAGEN, Denmark, Jan. 26, 2022 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today the publication of a paper on personalized therapy with EVX-01 in patients with metastatic melanoma in the open access, peer-reviewed journal OncoImmunology.
The paper, entitled, “Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma”, outlines results from a continuing Phase 1/2a trial of EVX-01, a novel personalized cancer immunotherapy based on Evaxion’s proprietary PIONEER™ AI technology.
Results from five patients in the study demonstrated that EVX-01 is safe and has encouraging early indications of clinically and meaningful antitumor activity. Data showed EVX-01 is capable of eliciting T-cell responses in a clinical setting where the patients received concurrent standard immune therapy, i.e. anti-PD-1 treatment. Results demonstrated an antitumor effect in combination with anti-PD-1 treatment.
Identification of immunogenic neoantigens is the core of establishing an effective personalized cancer immunotherapy and the evidence from this trial supports the potential of Evaxion’s PIONEER platform to successfully overcome that challenge of correctly identifying neoantigens. The results of the trial also provide evidence that implementation of a timely manufacturing process of a personalized cancer immunotherapy is feasible.
Lars Wegner, CEO of Evaxion, said: “Personalized immunotherapy with neoantigens is a promising approach in cancer treatment. The clinical data generated on EVX-01 so far are very exciting and demonstrate PIONEER’s immense potential in developing truly personalized immunotherapies to improve treatment for patients with melanoma as well as other types of cancer. We are pleased that we are well financed to further investigating EVX-01’s potential in our new Phase 2b trial in collaboration with Merck, which we expect to start in Q2 2022.”
Evaxion’s planed Phase 2b study will evaluate the efficacy and safety of EVX-01 in combination with KEYTRUDA® (pembrolizumab), an anti-PD1 therapy, in approximately 100 checkpoint inhibitor treatment naïve adults with unresectable or metastatic melanoma, with overall response as the primary endpoint.
About Evaxion
Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.
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Source: Evaxion Biotech
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