Evaxion to Present New Positive Data from Ongoing Phase 2 Study on Lead Vaccine Candidate EVX-01 at the American Society of Clinical Oncology Annual Meeting 2024

On May 23, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported its participation in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where it will present positive immune data form its ongoing EVX-01 Phase 2 study (Press release, Evaxion Biotech, MAY 23, 2024, View Source [SID1234643592]). The study assesses the personalized cancer vaccine EVX-01 in combination with anti-PD1 therapy in patients with advanced melanoma. The conference will take place in Chicago, IL, from May 31 – June 4, 2024.

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"We continue to see encouraging results from our ongoing Phase 2 study with EVX-01. The immune signatures induced by EVX-01 are both specific and strong, with booster immunizations pointing to further increased immune responses. The data makes us optimistic about the potential clinical benefit of EVX-01, and we eagerly await further data readouts on this novel personalized cancer vaccine. With our AI-Immunology platform, we can precisely select vaccine targets and design personalized vaccines that match each patient’s unique tumor signature and immune characteristics. This represents a novel approach to addressing an unmet medical need that remains dire, and we are excited about the interest we are seeing in the EVX-01 program," said Christian Kanstrup, CEO at Evaxion.

This ongoing Phase 2 study currently confirms findings from the previous Phase 1 study, reaffirming the ability of Evaxion’s AI-Immunology platform to precisely select therapeutically relevant vaccine targets and generate new valuable insights. Key highlights from the Phase 2 study are:

Analyses of patient samples demonstrated EVX-01 vaccine-induced specific and robust immune responses, mediated by both CD4+ and CD8+ T-cells
Booster immunizations tended to increase the immune response and did not impose any safety concerns
The EVX-01 vaccine candidate was found to be well-tolerated with only grade 1 and 2 adverse events
Poster Details:

Abstract Title: "Immunogenicity of an AI-designed personalized neoantigen vaccine, EVX-01, in combination with anti-PD-1 therapy in patients with metastatic melanoma"
Abstract #: 9561
Poster Bd #: 345
Track: Melanoma/Skin Cancers
Location: Hall A – McCormick Place
Date/Time: Saturday, June 1, 1:30 – 4:30 p.m. CDT
Presenter: Mads Lausen Nielsen, Senior Scientist

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab (more commonly known as KEYTRUDA) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.