Evaxion AS Stock Price, News & Analysis

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.

Abalos Therapeutics has appointed Thomas Bogenrieder, MD, PhD, as its new Chief Medical Officer. Dr. Bogenrieder brings over 17 years of international experience in clinical development, particularly in cancer immunotherapies. His expertise will bolster Abalos' efforts in clinical and regulatory strategies for its arenavirus-based product candidates aimed at treating solid tumors. Previously, he served as Chief Medical Officer at Evaxion Biotech and has held senior roles at Boehringer Ingelheim and GlaxoSmithKline. This leadership change is expected to enhance Abalos' innovation in cancer treatment.

Evaxion Biotech A/S (NASDAQ: EVAX) announces the appointment of Per Norlén as its new CEO, effective October 3, 2022. With over 20 years in biotech, Norlén aims to propel Evaxion's capabilities in developing AI-driven immunotherapies for cancer. He expresses confidence in the company’s potential, especially following promising phase 1 trial results in melanoma. Chairman Marianne Soegaard highlights Norlén's leadership as key to advancing the company's innovative clinical and preclinical results. Evaxion is focused on tailored therapies for cancer and other critical diseases.