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COPENHAGEN - Evaxion A/S (NASDAQ:EVAX) announced Monday the addition of EVX-04 to its research pipeline, a new therapeutic cancer vaccine candidate designed to target acute myeloid leukemia (AML). The clinical-stage biotech company, currently valued at $36.32 million, has seen its stock price rise to $5.75, reflecting a remarkable 266% gain over the past six months.
The preclinical-stage vaccine targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens identified through the company’s AI-Immunology platform. According to the press release, these antigens appear in tumors but not in normal tissue, potentially making them effective targets for cancer treatment.
Evaxion describes EVX-04 as an "off-the-shelf" vaccine that could be administered immediately after diagnosis, designed to be effective regardless of individual immune and tumor differences.
"EVX-04 is a great example of how AI-Immunology enables us to design and develop new therapies that could lead to better outcomes for patients," said Birgitte Rønø, CSO and interim CEO of Evaxion.
The company plans to present new preclinical data at the American Society of Hematology Annual Meeting in Florida on December 6, 2025. According to the announcement, this data demonstrates that EVX-04 induces T-cell responses and cancer cell killing.
ERVs are remnants of ancient viruses in the human genome that are often overexpressed in cancer but not in healthy tissue. AML is an aggressive blood cancer characterized by the rapid growth of abnormal myeloid cells that interfere with normal blood cell production.
Evaxion’s clinical pipeline includes other novel personalized vaccines and a preclinical infectious disease portfolio targeting bacterial and viral diseases.
The information in this article is based on a company press release statement.
In other recent news, Evaxion A/S has reported a series of capital increases following the exercise of investor warrants, resulting in a total share capital increase to nominal DKK 103,783,939. This was achieved through multiple share issuances between October 15 and October 28, contributing to an aggregate cash consideration of approximately $1,038,688. Additionally, Evaxion conducted an at-the-market offering on September 25, selling 1,018,000 American Depositary Shares, which generated net proceeds of about $4.3 million. These developments reflect the company’s efforts to bolster its financial position.
Furthermore, Evaxion’s personalized cancer vaccine, EVX-01, has shown promising results in its Phase 2 clinical trial, achieving a 75% objective response rate among advanced melanoma patients. The trial data indicated that 12 out of 16 patients responded positively, with four achieving complete responses. Notably, H.C. Wainwright reiterated its Buy rating on Evaxion with a $16 price target following the presentation of two-year follow-up data from the trial. Meanwhile, Jones Trading initiated coverage on Evaxion with a Buy rating and a $10 price target, highlighting the company’s focus on developing vaccines in oncology and infectious diseases.
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