Evaxion receives FDA fast-track designation for personalized cancer immunotherapy
January 19 2023 - 8:45AM
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 that the
U.S. Food and Drug Administration (“FDA”) has granted fast track
designation for the Company’s personalized cancer therapy, EVX-01,
in combination with KEYTRUDA®.
In December 2023, Evaxion received FDA approval to proceed with
its Phase 2b clinical trial, where EVX-01 is given in combination
with KEYTRUDA® to patients with metastatic melanoma. On January 17,
2023, Evaxion furthermore received fast track designation for the
vaccine candidate. The fast track is designed to expedite the FDA’s
review of innovative, new drugs that demonstrate the potential to
address an unmet medical need.
”We are extremely pleased that our cancer vaccine candidate
EVX-01 has received the FDA fast track designation, as it enables a
potentially faster approval of the vaccine. This is first and
foremost to the benefit of the patients. And it is a great
validation of our AI platform, PIONEER, and our drug development
candidate,” says Per Norlén, CEO at Evaxion.
EVX-01 is a peptide-based cancer immunotherapy and is Evaxion’s
most advanced clinical asset. Under the program, a unique drug is
generated for each patient based on gene analysis of their tumors
and on matching with their immune system. This process is made
possible by the Company’s proprietary AI platform, PIONEER.
The ongoing Phase 2b study is conducted at clinical sites across
the United States, Europe, and Australia. It is carried out in
collaboration with Merck, supplying its PD-1 inhibitor
KEYTRUDA®. The trial was initiated in Australia with the
enrollment of the first patient in September 2022. Read about
EVX-01 Ph2b on clinicaltrials.gov: NCT05309421
About EvaxionEvaxion Biotech A/S is a
clinical-stage biotech company developing AI-powered
immunotherapies. With our proprietary and scalable AI technology,
we decode the human immune system to discover and develop novel
immunotherapies for cancer, bacterial diseases, and viral
infections. Evaxion has a broad pipeline of product candidates,
including three personalized cancer immunotherapies. It is located
in Hørsholm, Denmark, with 70 employees.
Source: Evaxion Biotech
For more information, please contact:CEO Per
Norlén pno@evaxion-biotech.com
Or: Katrine Hertz MortensenVP, Communications and Public
Relationskhm@evaxion-biotech.com+45 3010 0203
Forward-Looking Statements
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 COVID-19 pandemic and the ongoing conflict in
the region surrounding Ukraine and Russia; 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.
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