Evaxion Announces Encouraging Initial Phase 2 Clinical Data on Its Personalized Cancer Vaccine EVX-01
01 November 2023 - 2:14AM
Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a
clinical-stage TechBio company specializing in the development of
AI-Immunology™ powered vaccines, is pleased to announce initial
results from the EVX-01 Phase 2 clinical trial, confirming previous
successful Phase 1 findings. A comprehensive clinical update will
be presented at the Society for Immunotherapy of Cancer (SITC) 38th
annual meeting, taking place in San Diego, California, from
November 1-5, 2023.
Key highlights of the initial Phase 2 results
for the first five metastatic melanoma patients treated with EVX-01
include:
- Phase 2 data confirm the favorable
safety profile of EVX-01 observed in the Phase 1 trial
- Promising immunological and
clinical outcomes align with the Phase 1 outcomes
- Upon EVX-01 treatment, a pronounced
and ongoing tumor reduction was observed in a patient with
progressive disease
- Phase 2 data confirms Evaxion’s
AI-Immunology™ platform’s ability to identify therapeutically
relevant cancer vaccine targets
Christian Kanstrup, CEO of Evaxion, stated, “We
firmly believe that our AI-Immunology™ platform has the potential
to revolutionize the field of oncology and infectious diseases.
Today’s update underscores its promise in immuno-oncology, with our
EVX-01 vaccine safely eliciting robust immune responses in all
patients. Notably, a pronounced tumor reduction in a metastatic
patient with initial progressive disease following EVX-01 treatment
offers hope for those with life-threatening cancer. We are looking
forward to discussing these results with potential partners.”
Join us at the SITC meeting to explore the
poster titled “Effects of an AI-generated personalized
neopeptide-based immunotherapy, EVX-01, in combination with
pembrolizumab in patients with metastatic melanoma. A clinical
trial update”, presented on Saturday, November 4, between 9 a.m. -
8:30 p.m. PDT.
Additionally, don’t miss an in-depth
presentation of Evaxion’s EVX-01 Phase 2 clinical results by
joining an online webinar featuring the study’s principal
investigator, Professor Adnan Khattak, held on November 8 at 11:30
a.m. EST. To register for the event, please follow this link.
Earlier this year, Evaxion reported a successful
Phase 1 clinical trial for EVX-01 in combination with a checkpoint
inhibitor. The trial demonstrated a 67% clinical response rate
while meeting safety standards and reporting only mild adverse
events. Further, high-quality neoantigens predicted by
AI-Immunology™ were associated with longer progression-free
survival. To learn more, please read here.
About EVX-01 Phase 2 Clinical
Trial
EVX-01 is Evaxion’s lead clinical asset and
constitutes a peptide-based personalized cancer vaccine. The Phase
2 clinical study is a self-sponsored open-label, single-arm,
multi-center trial carried out in collaboration with Merck Sharp
& Dohme LLC, and together with leading principal investigators
and research centers from Italy and Australia aims at evaluating
the efficacy and safety of EVX-01 vaccination in combination with
anti-PD1 treatment (pembrolizumab) in treatment-naive patients with
metastatic or unresectable malignant stage III or IV melanoma. More
information can be accessed under clinical trial ID
NCT05309421.
About EVAXION
Evaxion Biotech A/S is a pioneering TechBio
company based upon its AI platform: AI-Immunology™. 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™, 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™ platform and vaccine pipeline,
please visit our website.
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. We do not assume any obligation to
update any forward-looking statements except as required by
law.
Source: Evaxion Biotech
Contact Information
Evaxion Biotech A/S
Christian Kanstrup
Chief Executive Officer
cka@evaxion-biotech.com
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