The Company already conducts the successful EVX-01 program with clinical testing in
In the EVX-02 study encouraging preliminary findings around its potential clinical benefit now allows Evaxion to accelerate the development program. Following the finalization of recruitment, Evaxion will advance into a dedicated Phase 2b clinical trial using its patented DNA-based immunotherapy.
For the patients enrolled in the Phase 1/2a clinical trial, Evaxion’s proprietary PIONEER™ AI technology identified a sufficient number of mutations to design a personalized treatment and so far, no serious side effects have been reported.
“Completion of recruitment for the Phase 1/2a clinical trial of EVX-02 is an important milestone, which supports our belief that the Evaxion approach is feasible. EVX-02 appears to be well tolerated and shows encouraging signs as a treatment for adjuvant melanoma patients. The T-cell activation is promising, which allows us to take data and insights from this clinical trial and move into a dedicated Phase 2 clinical trial.”
About the EVX-02 Program:
- Evaxion Biotech has completed recruitment of 16 patients and will now move directly into a dedicated phase 2b clinical trial in adjuvant melanoma.
- Final data from the current phase 1/2a clinical trial are expected to be announced and reported second quarter of 2023, which is earlier than previously communicated.
- Expected milestones for the EVX-02 phase 2b study are: Regulatory filing in H1 2022, First patient first visit in H2 2022 and an interim readout in 2023.
About Evaxion
For more information
cdavis@lifesciadvisors.com
+1 (212) 915 2577
Source:
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.
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