- The clinical trial of the customized cancer vaccine EVX-01 met its main endpoints of security and tolerability
- Constructive clinical responses had been reported in eight out of 12 EVX-01 treated individuals
- Higher-high-quality neoantigens, predicted by AI technologies, had been related with longer progression-absolutely free survival
- Powerful vaccine-particular immune responses had been induced in all 12 EVX-01 treated patients
- Larger EVX-01 dose induced a stronger immune response and was related with enhanced clinical outcome
COPENHAGEN, Denmark, June 03, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology organization specializing in the improvement of AI-powered immunotherapies, now presented promising clinical information from its EVX-01 Phase 1 dose escalation trial in metastatic melanoma at the 2023 ASCO annual meeting in Chicago, Illinois.
The Phase 1 trial effectively met main endpoints for security and tolerability of EVX-01 in metastatic melanoma individuals and demonstrated good clinical responses in eight out of 12 (67%) treated individuals. In addition, Evaxion’s proprietary AI technologies PIONEER™ was in a position to determine higher-high-quality cancer vaccine targets, so-named neoantigens, related with longer progression-absolutely free survival.
“We are excited that our AI technologies could successfully determine vaccine neoantigens related with much better clinical responses and longer progression-absolutely free survival. And the information recommend a therapy impact, with response prices practically double of these observed in historical information for checkpoint inhibitors. Our findings in this study position us properly to prospectively determine individuals who will advantage from customized cancer immunotherapy for our upcoming trials, potentially generating the advantage for individuals even higher,” mentioned Per Norlén, Chief Executive Officer of Evaxion.
The study demonstrated the capacity of the PIONEER™ platform to determine vaccine targets that are related with enhanced patient outcomes. Stratification primarily based on PIONEER™ scores outperformed tumor mutational burden as a predictive biomarker, with individuals obtaining higher-high-quality neoantigens displaying much better therapy responses and longer progression-absolutely free survival.
The evaluation of therapy-connected immune responses revealed strong neoantigen T-cell responses in all 12 individuals, mediated by activated CD4+ T cells in all instances and CD8+ T cells in 7 out of 12 individuals. Additional, immune response magnitude correlated with the vaccination dose.
“The good association among clinical outcome and prevalence of immunogenic cancer neoantigens validates the PIONEER™ platform for its use for customized cancer vaccines and emphasizes the significance of a robust AI technique for designing neoantigen vaccines. In addition, the dose-dependent raise in responses has been instrumental for Phase two dose choice in the ongoing clinical trial. We have fantastic expectations on the upcoming interim Phase two benefits 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 study, titled “Personalized Neo-antigen Vaccine in Sophisticated Strong Tumors (NeoPepVac)” (ClinicalTrials.gov Identifier: NCT03715985), was performed in collaboration with DTU, SSI, the center for genomic medicine at Rigshospitalet and CCIT-DK and aimed to assess the security and efficacy of EVX-01 vaccine in mixture with anti-PD1 (pembrolizumab or Nivolumab) in individuals with metastatic melanoma. The style consisted of a number of 15-27mer peptides comprising one particular or additional patient-particular neoantigens formulated with the novel liposomal adjuvant CAF®09b to potentiate immune responses. The main objective was to decide the security and tolerability of the mixture of EVX-01 and a checkpoint inhibitor. Added objectives had been to evaluate manufacturing feasibility, immune responses, and clinical efficacy.
About Evaxion Biotech
Evaxion Biotech A/S is a clinical-stage biotech organization focused on harnessing the energy of artificial intelligence to decode the human immune technique and create immunotherapies for cancer, bacterial illnesses, and viral infections. Via its proprietary AI platform, PIONEER™, Evaxion aims to revolutionize cancer therapy by identifying one of a kind and immunogenic neoantigens and designing individualized therapies. The Business is committed to transforming the lives of cancer individuals with unmet clinical wants by offering revolutionary and targeted therapy possibilities. For additional facts about Evaxion Biotech and its groundbreaking customized cancer immunotherapies, please go to www.evaxion-biotech.com.
This announcement consists of forward-hunting statements within the which means of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of equivalent meaning identify forward-hunting statements. Actual benefits could differ materially from these indicated by such forward-hunting statements as a outcome of several aspects, such as, but not restricted to, dangers connected to: our economic situation and want for more capital our improvement operate expense and good results of our item improvement activities and preclinical and clinical trials commercializing any authorized pharmaceutical item created employing our AI platform technologies, such as the price and degree of marketplace acceptance of our item candidates our dependence on third parties such as for conduct of clinical testing and item manufacture our inability to enter into partnerships government regulation protection of our intellectual house rights employee matters and managing development our ADSs and ordinary shares, the influence of international financial, political, legal, compliance, social and enterprise aspects, such as inflation, and the effects on our business from the worldwide COVID-19 pandemic and the ongoing conflict in the area surrounding Ukraine and Russia and other uncertainties affecting our enterprise operations and economic situation. For a additional discussion of these dangers, please refer to the danger aspects incorporated in our most current Annual Report on Kind 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are offered at www.sec.gov. We do not assume any obligation to update any forward-hunting statements except as needed by law.