Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completed Dosing with Personalized Cancer Vaccine EVX-01
April 17 2024 - 8:00AM
Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a
clinical-stage TechBio company specializing in developing
AI-Immunology™ powered vaccines, announces that the first patient
in its EVX-01 Phase 2 trial in metastatic melanoma received the
last vaccine dose in combination with KEYTRUDA® (NCT05309421).
The Company initiated its Phase 2 clinical study
in September 2022 to assess the efficacy, safety and ability to
induce a tumor-specific immune response of the EVX-01 cancer
vaccine in metastatic melanoma patients. The EVX-01 vaccine was
designed using Evaxion’s proprietary AI-Immunology™ platform and is
an individualized therapy matching the unique tumor profile and
characteristics of the patient’s immune system. Each patient
enrolled in the trial receives a unique vaccine designed and
manufactured based on their individual biology. Patients are
administered ten EVX-01 doses over a period of 78 weeks in
combination with the anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab).
Birgitte Rønø, CSO of Evaxion, commented, “With
the progress made in the Phase 2 study, we are one step closer to
fulfilling our mission of saving and improving lives with
AI-Immunology™. We eagerly anticipate sharing the one-year clinical
readout in Q3 this year and look forward to being one step closer
to market with a novel personalized cancer vaccine.”
Professor Adnan Khattak at One Clinical
Research, Hollywood Private Hospital, Western Australia, expresses
enthusiasm, stating, “We are now entering into the era of
personalized cancer therapies, where we adopt a tailored approach
against an individual patient’s tumor. In other words, we are
treating each patient with the right drug. As a physician, I firmly
believe this is the future.”
At the end of 2023, Evaxion reported initial
EVX-01 Phase 2 data confirming the favorable safety profile and
promising immunological data as observed in the previously
successful Phase 1 clinical trial. To learn more, please read the
related press release.
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 that, together with leading principal investigators
and research centers from Italy and Australia, aims to evaluate the
efficacy and safety of EVX-01 vaccination in combination with
anti-PD1 therapy KEYTRUDA® (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.
Contact Information
Evaxion Biotech A/S
Christian Kanstrup
Chief Executive Officer
cka@evaxion-biotech.com
Source: Evaxion Biotech
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