* EVX-01 induced positive clinically relevant immune responses in all assessed
patients
* Booster immunizations tended to increase the immune response
* The observed immune responses were mediated by both CD4+ and CD8+ T-cells
COPENHAGEN, Denmark, May 23, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S
(NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company
specializing in developing AI-Immunology(TM) powered vaccines, today announces its
participation in the American Society of Clinical Oncology (ASCO) Annual
Meeting, where it will present positive immune data form its ongoing EVX-01
Phase 2 study. The study assesses the personalized cancer vaccine EVX-01 in
combination with anti-PD1 therapy in patients with advanced melanoma. The
conference will take place in Chicago, IL, from May 31 - June 4, 2024.
"We continue to see encouraging results from our ongoing Phase 2 study with EVX-
01. The immune signatures induced by EVX-01 are both specific and strong, with
booster immunizations pointing to further increased immune responses. The data
makes us optimistic about the potential clinical benefit of EVX-01, and we
eagerly await further data readouts on this novel personalized cancer vaccine.
With our AI-Immunology(TM) platform, we can precisely select vaccine targets and
design personalized vaccines that match each patient's unique tumor signature
and immune characteristics. This represents a novel approach to addressing an
unmet medical need that remains dire, and we are excited about the interest we
are seeing in the EVX-01 program," said Christian Kanstrup, CEO at Evaxion.
This ongoing Phase 2 study currently confirms findings from the previous Phase
1 study, reaffirming the ability of Evaxion's AI-Immunology(TM) platform to
precisely select therapeutically relevant vaccine targets and generate new
valuable insights. Key highlights from the Phase 2 study are:
* Analyses of patient samples demonstrated EVX-01 vaccine-induced specific and
robust immune responses, mediated by both CD4+ and CD8+ T-cells
* Booster immunizations tended to increase the immune response and did not
impose any safety concerns
* The EVX-01 vaccine candidate was found to be well-tolerated with only grade
1 and 2 adverse events
Poster Details:
Abstract Title: "Immunogenicity of an AI-designed personalized neoantigen
vaccine, EVX-01, in combination with anti-PD-1 therapy in
patients with metastatic melanoma"
Abstract #: 9561
Poster Bd #: 345
Track: Melanoma/Skin Cancers
Location: Hall A - McCormick Place
Date/Time: Saturday, June 1, 1:30 - 4:30 p.m. CDT
Presenter: Mads Lausen Nielsen, Senior Scientist
About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based
personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-
sponsored, open-label, single-arm, multi-center trial carried out in
collaboration with Merck Sharp & Dohme LLC that, together with leading principal
investigators and research centers from Italy and Australia. It aims to evaluate
the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1
treatment pembrolizumab (more commonly known as KEYTRUDA(®)) in treatment-naive
patients with metastatic or unresectable malignant stage III or IV melanoma.
More information can be accessed under clinical trial ID NCT05309421
(https://clinicaltrials.gov/study/NCT05309421?term=EVX-01&rank=1).
About EVAXION
Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform,
AI-Immunology(TM). Evaxion's proprietary and scalable AI prediction models harness
the power of artificial intelligence to decode the human immune system and
develop novel immunotherapies for cancer, bacterial diseases, and viral
infections. Based upon AI-Immunology(TM), Evaxion has developed a clinical-stage
oncology pipeline of novel personalized vaccines and a preclinical infectious
disease pipeline in bacterial and viral diseases with high unmet medical needs.
Evaxion is committed to transforming patients' lives by providing innovative and
targeted treatment options. For more information about Evaxion and its
groundbreaking AI-Immunology(TM) platform and vaccine pipeline, please visit our
website (https://www.evaxion-biotech.com/).
Forward-Looking Statement
This announcement contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. The words "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 identify forward-looking statements. 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 related to: our
financial condition and need for additional capital; our development work; cost
and success of our product development activities and preclinical and clinical
trials; commercializing any approved pharmaceutical product developed using our
AI platform technology, including the rate and degree of market acceptance of
our product candidates; our dependence on third parties including for conduct of
clinical testing and product manufacture; our inability to enter into
partnerships; government regulation; protection of our intellectual property
rights; employee matters and managing growth; our ADSs and ordinary shares, the
impact of international economic, political, legal, compliance, social and
business factors, including inflation, and the effects on our business from the
worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region
surrounding Ukraine and Russia and the Middle East; and other uncertainties
affecting our business operations and financial condition. For a further
discussion of these risks, please refer to the risk factors included in our most
recent Annual Report on Form 20-F and other filings with the U.S. Securities and
Exchange Commission (SEC), which are available at www.sec.gov
(https://www.globenewswire.com/Tracker?data=3eX-
yULjXHj_fAO4jPRASPaehYEVHM4NmXNAs_0lw5UK0DHjLXk6aKS6LI4PyMob9UvuFpZpGQrWa4b_6WQY
1A==). We do not assume any obligation to update any forward-looking statements
except as required by law.
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