Evaxion announces promising results from Phase 1/2a clinical trial of personalized DNA cancer immunotherapy EVX-02
November 17 2022 - 6:59AM
Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a
clinical-stage biotechnology company specializing in the
development of AI-driven immunotherapies, today announced promising
clinical data from the Phase 1/2a first-in-human study of its
DNA-based cancer immunotherapy, EVX-02.
In the clinical study, EVX-02 is given in combination with a
checkpoint inhibitor and targets cancer mutations, neoantigens, in
patients with resected melanoma. The Company reported encouraging
interim safety and immunogenicity data from the Phase 1/2a study of
its personalized DNA-based immunotherapy, EVX-02. The results are
summarized below.
“We are thrilled to announce promising interim data from the
first eight patients in our Phase 1/2a study of EVX-02. We believe
that these results serve as validation of our DNA technology for
personalized cancer immunotherapy. All patients demonstrated a
specific T-cell immune response induced by the treatment,
confirming the potential capabilities of our AI platform
technology. And importantly, the treatment appeared to be well
tolerated in all patients, with only very mild adverse events (AEs)
observed,” said CEO Per Norlén.
Personalized cancer immunotherapy, like EVX-02, is particularly
challenging to produce because a new and unique drug is
manufactured for each patient.
“This is a tremendous achievement. Our team has successfully
completed this complex process, from biopsy, through genome
sequencing, a selection of the most promising cancer targets
through our AI platform technology, to manufacturing, quality
testing, and drug product production and delivery. And they
succeeded with every single step for each patient,” says Mr.
Norlén.“The promising EVX-02 data, demonstrating both proof of
mechanism and an encouraging safety profile, give us exactly what
we need for our upcoming clinical trial of EVX-03 and our
next-generation DNA technology.”
Interim results in summary:
- Safety: Treatment appeared to be well tolerated in all
patients, with only very mild adverse events (AEs) observed in
relation to EVX-02 treatment.
- EVX-02 induced CD4+ and CD8+ specific T-cell responses in all
patients, providing proof of mechanism for our DNA-delivery
technology, in that the delivered EVX-02-DNA gave rise to immune
reactions to its encoded neoantigen peptides.
- The T-cell responses were robust and long-lasting.
A full clinical trial report for the EVX-02 Phase 1 study is
expected in the second quarter of 2023.
About EvaxionEvaxion Biotech A/S is a
clinical-stage biotech company developing AI-powered
immunotherapies. A proprietary and scalable AI technology is used
to decode the human immune system to discover and develop novel
immunotherapies for cancer, bacterial diseases, and viral
infections. Evaxion has a broad pipeline of novel product
candidates, including patient-specific cancer immunotherapies. It
is located in Hørsholm, Denmark, with 70 employees.
Evaxion Biotech A/SPer NorlénChief Executive Officer (CEO)
For more information, please contactKatrine
Hertz MortensenVP, Communications and Public
Relationskhm@evaxion-biotech.com+45 3010 0203
Source: Evaxion Biotech
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Annual Report on Form 20-F filed on March 31, 2022 and the
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