Evaxion receives approval from FDA to proceed with the clinical Phase 2b study for EVX-01
January 03 2023 - 7:30AM
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”) determined that the
Company may proceed with its Phase 2b clinical trial of EVX-01.
In November 2022, the Company submitted an Investigational New
Drug Application (“IND”) along with a Fast Track designation
application to the FDA for a Phase 2b clinical trial of EVX-01 in
combination with KEYTRUDA® for the treatment of patients with
metastatic melanoma. On December 22, 2022, the FDA issued approval
for the Company to proceed with its Phase 2b trial. The Company
anticipates a response to the Fast Track designation submission in
the first quarter of 2023.
“Receiving a green light from the FDA is a tremendous boost for
our personalized cancer vaccine program. EVX-01 is already actively
enrolling patients in Australia, and the FDA approval expands our
ability to move forward quickly with our lead program in malignant
melanoma. Moreover, the FDA is a universally recognized national
authority, and its endorsement is an important step towards
demonstrating a clinically meaningful benefit of our first
personalized cancer vaccine,” says Erik Heegaard, Chief Medical
Officer at Evaxion.
The Phase 2b study will be 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 first 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 novel 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
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statements within the meaning of Section 27A of the Securities
Act of 1933, as amended, and Section 21E of the Securities Exchange
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“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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