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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 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.
Evaxion Biotech (NASDAQ: EVAX) has entered into a Vaccine Discovery Collaboration Agreement with ExpreS2ion Biotech Holding AB. This partnership aims to develop a novel cytomegalovirus (CMV) vaccine candidate utilizing Evaxion's AI platform, RAVEN, for antigen design. Costs for the collaboration will be split evenly until 2025. A potential future agreement could provide Evaxion with milestone payments and royalties based on CMV asset sublicensing. CMV represents a significant unmet medical need, especially for immunocompromised individuals and congenitally infected infants.
Evaxion Biotech A/S (NASDAQ: EVAX) announced promising interim data from its Phase 1/2a clinical trial for its DNA-based cancer immunotherapy, EVX-02. The treatment, aimed at melanoma, showed a well-tolerated safety profile with only mild adverse events. All patients exhibited robust CD4+ and CD8+ T-cell responses, highlighting the efficacy of their AI-driven technology for personalized cancer treatment. A full report of the trial results is expected in Q2 2023, as the company looks forward to advancing their next-generation DNA technology.
Evaxion Biotech (NASDAQ: EVAX) announced its Q3 2022 financial results, highlighting the enrollment of the first patient in a Phase 2b trial for its cancer immunotherapy EVX-01. The company reported cash and equivalents of $17.9 million, sufficient to support operations into mid-2023. The R&D expenses decreased to $4.1 million compared to $4.4 million in Q3 2021, while general and administrative expenses rose to $2.0 million. Despite a net loss of $5.7 million for the quarter, Evaxion is focused on its oncology assets and pursuing strategic partnerships. Guidance remains optimistic for ongoing projects.
Evaxion Biotech (NASDAQ: EVAX) announced a strategic shift to focus on its leading oncology assets, EVX-01 and EVX-02/03, aiming for clinical proof of concept before potential out-licensing. New CEO Per Norlén emphasized the need for concentration on personalized cancer immunotherapies while preclinical infectious disease programs will seek partnerships. The Phase IIb trial for EVX-01 is underway, with mid-2023 data expected for EVX-02. Promising pre-clinical results for EVX-03 suggest superior efficacy, with plans for regulatory submission following EVX-02 outcomes.
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