- Originally planned as a
two-year study, the trial has been extended by an additional year
to collect three-year clinical outcome data
- The additional third year
of EVX-01 dosing may provide further insights into potential
enhanced treatment effects and durability of induced immune
response
- The trial already yielded
convincing one-year data and remains on track for two-year data
readout in the second half of 2025
COPENHAGEN, Denmark, February 25, 2025 - Evaxion
Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio
company specializing in developing AI-Immunology™ powered vaccines,
will further enhance the data package from its ongoing phase 2
trial with the company’s lead asset EVX-01 by extending the trial
from two to three years. Designed with Evaxion’s AI-Immunology™
platform, EVX-01 is a personalized cancer vaccine being developed
as a treatment for advanced melanoma (skin cancer).
Active participants in the trial will be given
the opportunity to enter the one-year extension after completing
the two-year protocol. They will receive additional EVX-01 doses as
monotherapy, with close monitoring to assess clinical response
duration and immune activation. In the first two years of the
trial, patients received EVX-01 in combination with standard
anti-PD-1 therapy.
The trial is progressing according to plan, with
two-year data readout expected in the second half of 2025. All
trial active patients have achieved reduction in tumor target
lesions and are faring well, which should allow for a seamless
transition into the extension of the trial.
“We are very pleased with how this trial has
been progressing and the encouraging data obtained so far. Patients
are responding positively to the therapy, which is generally well
tolerated. We are happy to support patients further by offering
additional EVX-01 treatment. Extending the trial also allows us to
collect even more data and further enhance the data package for
this promising new potential treatment option for advanced
melanoma. Adding another year might allow us to document even
better effects of the treatment than what will be observed after
one and two years”, says Birgitte Rønø, Chief Scientific Officer of
Evaxion.
EVX-01 is designed with Evaxion’s AI-Immunology™
platform and tailored to target the unique tumor profile and immune
characteristics of each individual patient. It engages the
patient's immune system to fight off cancer by mounting a targeted
response against tumors.
The phase 2 trial investigates EVX-01 in
combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA)
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with
advanced melanoma (skin cancer). Each patient enrolled in the trial
has received a unique vaccine designed and manufactured based on
their individual biology.KEYTRUDA® is a registered trademark of
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
Convincing one-year phase 2
dataConvincing interim one-year data from the trial was
presented at the European Society for Medical Oncology (ESMO)
Congress in September 2024. Data demonstrated a 69% Overall
Response Rate, reduction in tumor target lesions in 15 out of 16
patients, and a positive correlation between the AI-Immunology™
platform predictions and immune responses induced by the individual
neoantigens in the EVX-01 vaccine (p=0.00013). Further, 79% of
EVX-01’s vaccine targets triggered a targeted immune response,
which compares very favorably to what is seen with other
approaches.
About EVX-01EVX-01 is a
personalized peptide-based cancer vaccine intended for first-line
treatment of multiple advanced solid cancers. It is Evaxion’s lead
clinical asset.
EVX-01 is a personalized therapy designed with
our AI-Immunology™ platform and is tailored to target the unique
tumor profile and immune characteristics of each patient. It
engages the patient's immune system to fight off cancer by mounting
a targeted response against tumors.
In the completed phase 1/2a clinical trial
(NCT03715985), assessing EVX-01 in combination with a PD-1
inhibitor, eight of twelve metastatic melanoma patients (67%) had
objective clinical responses with two complete and six partial
responses.
In addition, vaccine-induced T cells were
detected in all patients and a significant correlation between
clinical response and the AI-Immunology™ predictions was observed,
underlining the predictive power of the platform.
Contact
information Evaxion Biotech A/SMads KronborgVice
President, Investor Relations & Communication+45 53 54 82
96mak@evaxion.ai
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 other significant geo-political and
macro-economic events; 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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