Evaxion Biotech Announces Successful Production of Personalized Cancer Immunotherapies in Phase 1/2a Clinical Trial for EVX-02
Evaxion Biotech A/S (NASDAQ: EVAX) announced successful production of personalized cancer immunotherapies for all patients in its Phase 1/2a trial of EVX-02 for adjuvant melanoma. The team confirmed the feasibility of its complex production chain within a critical timeframe. The trial, involving 16 fully resected patients in Australia, aims to prevent disease relapse using AI-driven, DNA-based immunotherapies. This achievement strengthens Evaxion's capabilities for larger trials exploring clinical benefits, bolstering investor confidence in its AI-immunology platform and the future of personalized cancer treatment.
- Successful production of all batches of personalized cancer immunotherapies for the Phase 1/2a trial.
- Feasibility of the complex production process has been confirmed.
- Potential to progress DNA cancer immunotherapy programs into larger global trials.
- None.
COPENHAGEN, Denmark, May 10, 2022 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today that it has successfully produced all batches of personalized cancer immunotherapies for all patients enrolled in the Phase 1/2a clinical trial of EVX-02 in adjuvant melanoma.
Birgitte Rønø, Chief Scientific Officer of Evaxion, said: “I am extremely proud that the team behind EVX-02 has shown that this complex production chain is feasible and that we can provide truly unique, personalized DNA vaccines within a critical time window. And we are delighted that we mastered all steps in the production process. Every cancer is unique, as is every immune system, and this is why we create cancer therapies that are one size fits one – and only one.”
She continues: “With the release of the final batch, we confirmed our manufacturing process, which we believe will allow us to progress our DNA cancer immunotherapy programs into larger global trials to explore the clinical benefits of the compounds further. We have again demonstrated our capabilities to timely deliver personalized cancer treatment tailored to the unique cancer profile of every patient in a clinical trial.”
The production process of the personalized drug product consists of multiple steps. The sequencing of the tumor DNA is followed by AI-powered identification of the most promising therapeutic targets developed by Evaxion's proprietary PIONEER™ technology. This leads to designing the personalized multi-target vaccine drug product, which is then manufactured, released to the clinical sites, and administered to the patient.
This is the second time Evaxion has conducted a clinical trial with personalized cancer immunotherapy, having previously used a peptide-based treatment.
About EVX-02
Our EVX-02 program (NCT04455503) treats adjuvant melanoma patients with our patented DNA-based immunotherapy in combination with standard of care. The patients are fully resected before the trial, meaning that their tumors have been successfully removed (surgically). In the study, the focus of the therapy is to prevent disease relapse. The EVX-02 program is a multicenter study conducted in Australia. There are currently 16 patients enrolled in the trial.
About Evaxion
Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, bacterial diseases, and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates, including three patient-specific cancer immunotherapies.
For more information
LifeSci Advisors LLC
Corey Davis, Ph.D.
Managing Director
cdavis@lifesciadvisors.com
+1 (212) 915 2577
Source: Evaxion Biotech
Forward-looking statement
This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company’s future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “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 similar meaning or the negative thereof. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company’s financial condition and need for additional capital; risks associated with the Company’s development work; cost and success of the Company’s product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company’s AI platform technology, including the rate and degree of market acceptance of the Company’s product candidates; risks related to the Company’s dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company’s inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company’s intellectual property rights; risks related to employee matters and managing growth; risks related to the Company’s ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company’s business operations and financial condition.
Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, see the risks described in the “Risk Factors” section included in the Company’s prospectus filed on February 5, 2021 and the Company’s current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
FAQ
What is the purpose of the EVX-02 clinical trial?
How many patients are enrolled in the EVX-02 trial?
What technology does Evaxion use for its immunotherapies?
What are the next steps for Evaxion after the trial's success?
When was the EVX-02 trial announced?
