• The scientific trial of the personalised most cancers vaccine EVX-01 met its major endpoints of security and tolerability
• Positive scientific responses have been reported in 8 out of 12 EVX-01 handled sufferers
• High-quality neoantigens, predicted by AI expertise, have been related to longer progression-free survival
• Strong vaccine-specific immune responses have been induced in all 12 EVX-01 handled sufferers 
• Higher EVX-01 dose induced a stronger immune response and was related to improved scientific end result

COPENHAGEN, Denmark, June 03, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology firm specializing within the growth of AI-powered immunotherapies, at the moment introduced promising scientific knowledge from its EVX-01 Phase 1 dose escalation trial in metastatic melanoma on the 2023 ASCO annual assembly in Chicago, Illinois. 

The Phase 1 trial efficiently met major endpoints for security and tolerability of EVX-01 in metastatic melanoma sufferers and demonstrated constructive scientific responses in 8 out of 12 (67%) handled sufferers. In addition, Evaxion’s proprietary AI expertise PIONEER™ was capable of determine high-quality most cancers vaccine targets, so-called neoantigens, related to longer progression-free survival.

“We are excited that our AI technology could effectively identify vaccine neoantigens associated with better clinical responses and longer progression-free survival. And the data suggest a treatment effect, with response rates nearly double of those observed in historical data for checkpoint inhibitors. Our findings in this study position us well to prospectively identify patients who will benefit from personalized cancer immunotherapy for our upcoming trials, potentially making the benefit for patients even greater,” stated Per Norlén, Chief Executive Officer of Evaxion. 

The examine demonstrated the power of the PIONEER™ platform to determine vaccine targets which can be related to improved affected person outcomes. Stratification based mostly on PIONEER™ scores outperformed tumor mutational burden as a predictive biomarker, with sufferers having high-quality neoantigens displaying higher remedy responses and longer progression-free survival. 

The analysis of treatment-related immune responses revealed sturdy neoantigen T-cell responses in all 12 sufferers, mediated by activated CD4+ T cells in all instances and CD8+ T cells in 7 out of 12 sufferers. Further, immune response magnitude correlated with the vaccination dose.  

“The positive association between clinical outcome and prevalence of immunogenic cancer neoantigens validates the PIONEER™ platform for its use for personalized cancer vaccines and emphasizes the importance of a robust AI system for designing neoantigen vaccines. Moreover, the dose-dependent increase in responses has been instrumental for Phase 2 dose selection in the ongoing clinical trial. We have great expectations on the upcoming interim Phase 2 results that are planned to be presented later this year,” Per Norlén continues. 

About the Phase 1 Study with EVX-01 
The open-label, single-arm, single-center Phase 1 examine, titled “Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)” (ClinicalTrials.gov Identifier: NCT03715985), was carried out in collaboration with DTU, SSI, the middle for genomic drugs at Rigshospitalet and CCIT-DK and aimed to evaluate the security and efficacy of EVX-01 vaccine together with anti-PD1 (pembrolizumab or Nivolumab) in sufferers with metastatic melanoma. The design consisted of a number of 15-27mer peptides comprising a number of patient-specific neoantigens formulated with the novel liposomal adjuvant CAF®09b to potentiate immune responses. The major goal was to find out the security and tolerability of the mix of EVX-01 and a checkpoint inhibitor. Additional goals have been to judge manufacturing feasibility, immune responses, and scientific efficacy. 

About Evaxion Biotech 
Evaxion Biotech A/S is a clinical-stage biotech firm targeted on harnessing the facility of synthetic intelligence to decode the human immune system and develop immunotherapies for most cancers, bacterial ailments, and viral infections. Through its proprietary AI platform, PIONEER™, Evaxion goals to revolutionize most cancers remedy by figuring out distinctive and immunogenic neoantigens and designing individualized therapies. The Company is dedicated to remodeling the lives of most cancers sufferers with unmet scientific wants by offering revolutionary and focused remedy choices. For extra details about Evaxion Biotech and its groundbreaking personalised most cancers immunotherapies, please go to www.evaxion-biotech.com. 

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