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Evaxion Biotech A/S (symbol: EVAX) is a clinical-stage biotechnology company founded in 2008 with the mission to address some of the most significant global health challenges using artificial intelligence (AI). The company has developed robust platforms for creating novel vaccines and therapies. Evaxion's primary AI platforms, PIONEER and EDEN, utilize advanced in silico tools including big data, AI, and supercomputing to predict, rank, and optimize epitopes and antigens that stimulate highly protective immune responses against cancers and infectious diseases.
Evaxion's EDEN platform focuses on the rapid discovery of new antigens eliciting cross-protective immune responses against bacterial pathogens. On the other hand, the PIONEER platform identifies epitopes of mutated proteins to activate the body's natural immune responses. Additionally, the company has developed two more AI platforms, RAVEN and ObsERV, to further enhance its drug development pipeline.
The company's leading product candidates include EVX-01 and EVX-02, which are under development for cancer treatment, as well as EVX-03, a pre-clinical candidate for non-small-cell lung cancer (NSCLC). With a strong focus on AI-driven drug discovery and development, Evaxion aims to create innovative immunotherapies with improved efficacy for patients with unmet medical needs.
Recent news highlights key company activities, such as:
- A replay of the R&D Day presentations is available on the company's website.
- Information about the EVX-01 Phase 2 clinical trial.
- The company resolved a Nasdaq equity deficiency issue stemming from the IFRS accounting treatment of investor warrants.
To learn more about Evaxion Biotech A/S and its innovative AI-driven approaches, please visit Evaxion Biotech.
Evaxion Biotech reported promising results from its Phase 1/2a clinical trial of EVX-02, a personalized cancer immunotherapy, presented at the 2023 AACR meeting. All 10 late-stage melanoma patients who completed treatment showed robust immune responses and remained relapse-free at their last assessment. The study, which combined EVX-02 with the checkpoint inhibitor nivolumab, demonstrated safety and tolerability, with only mild adverse events noted. The outcomes support the predictive capabilities of Evaxion's AI technology and pave the way for the development of EVX-03, expected to enter the clinic in Q4 2023.
Evaxion Biotech A/S (NASDAQ: EVAX) has published promising preclinical data in Frontiers of Immunology regarding its AI-driven viral vaccine discovery platform, RAVEN. Conducted with Pennsylvania State University, this study highlights the platform's ability to identify protective T-cell epitopes from SARS-CoV-2 in a COVID-19 mouse model, effectively preventing severe disease and mortality. The RAVEN platform is positioned to streamline vaccine development against a variety of viral diseases, with potential implications for enhancing both existing and new vaccines. Chief Scientific Officer Birgitte Rønø emphasized the significance of this research in tailoring vaccines for broad population protection. The study marks a pivotal point as the first instance of an AI-designed T-cell vaccine demonstrating in vivo protection against severe COVID-19, potentially paving the way for rapid responses to emerging viral threats.
Evaxion Biotech announces a strategic focus on its AI capabilities to enhance pipeline development, aiming for a clinical Phase 1/2a trial entry in Q4 2023. The Phase 2b clinical trial is reduced in size, with interim data expected on schedule. The company has identified new cancer treatment opportunities using endogenous retroviruses (ERVs) that may boost immunotherapy effectiveness. Evaxion's next program, EVX-03, is on track for timely clinical development. This renewed focus is set to significantly extend its cash runway, optimizing trial approaches and reducing staffing costs.
Evaxion Biotech (NASDAQ: EVAX) announced the introduction of its proprietary AI technology, ObsERV™, designed to identify viral targets for cancer immunotherapy. This innovation aims to treat patients with cold tumors, typically unresponsive to existing therapies.
Evaxion's research indicates that endogenous retroviruses (ERVs), which are overexpressed in certain cancers, significantly correlate with survival rates. The company has achieved complete tumor eradication in animal models targeting ERVs. CEO Per Norlén emphasizes the platform's potential to broaden treatment options for cancer patients. A preprint will be published soon, with a presentation scheduled for March 28, 2023, at the Immuno 2023 conference.
Evaxion Biotech A/S (NASDAQ: EVAX) announced it will present clinical data from its Phase 1/2a trial of EVX-02 at the 2023 American Association for Cancer Research Annual Meeting from April 14-19 in Orlando, Florida. The personalized DNA vaccine, designed to improve melanoma treatment, reportedly induces specific T-cell immune response in patients with resected melanoma. CEO Pér Norlen highlighted the potential of their AI platform, PIONEER, in developing innovative cancer immunotherapies. The presentation is scheduled for April 18, 2023, in the poster session.
The cancer immunotherapy market is projected to grow significantly, primarily due to the rising prevalence of cancer and increased exposure to carcinogens. DelveInsight's report indicates North America will maintain its dominance in the market, expected to reach USD 162.87 billion by 2027, with a CAGR of ~12% from 2022-2027. Key players include Amgen, AstraZeneca, and Merck, among others. Recent advancements include FDA fast-track designation for Evaxion Biotech's EVX-01 in combination with KEYTRUDA. However, challenges such as high treatment costs and adverse effects remain. The full report provides insights on market dynamics and key drivers.
Evaxion Biotech (NASDAQ: EVAX) and Pantherna Therapeutics announced successful preclinical proof of concept for combining their technologies, showing that tumor neoantigens identified by Evaxion's AI platform can inhibit tumor growth when delivered via Pantherna's lipid nanoparticle mRNA platform. This collaboration aims to enhance mRNA delivery and effectiveness in immuno-oncology and infectious diseases. Both companies express optimism about the potential of their combined technologies, with further exploration of optimal formulations for mRNA and DNA-encoded antigens expected.
Evaxion Biotech A/S (NASDAQ: EVAX) announced that the FDA granted fast track designation for its personalized cancer therapy EVX-01, in combination with KEYTRUDA®. This designation is aimed at expediting the approval process for innovative drugs addressing unmet medical needs. Evaxion's CEO, Per Norlén, emphasized the potential patient benefits and the validation of their AI platform, PIONEER. The ongoing Phase 2b trial is conducted in the U.S., Europe, and Australia, initiated in September 2022, with the first patient enrolled in Australia. This trial is a collaboration with Merck, utilizing the PD-1 inhibitor KEYTRUDA®.
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.
Evaxion Biotech A/S (NASDAQ: EVAX) announced plans to present data from its clinical trials on personalized cancer immunotherapies EVX-01 and EVX-02 in Q2 2023. The trials focus on metastatic melanoma and resected malignant melanoma. Promising interim results were reported, showing high response rates for EVX-01 and robust T-cell responses for EVX-02. EVX-01 is currently in Phase 2b, in combination with Merck's Keytruda. CEO Per Norlén expressed excitement about the advancements in their AI-driven immunotherapy programs, positioned to lead in next-generation cancer treatments.
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