* A 67% objective response rate (ORR) is reported in the publication
summarizing results from the Phase 1 study assessing Evaxion's personalized
cancer vaccine, EVX-01, in patients with metastatic melanoma
* The findings also demonstrate strong and clinically relevant immune
responses after EVX-01 administration to metastatic melanoma patients co-
treated with anti-PD-1 standard of care
* The clinical study results substantiate the precision and predictive power
of Evaxion's AI-Immunology(TM) platform
* Evaxion has advanced the EVX-01 program into a Phase 2 study, and strong
immune data readouts from the ongoing study were presented at ASCO in early
June. The one-year clinical efficacy readout from the Phase 2 study is on
track for Q3 2024
COPENHAGEN, Denmark, June 17, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S
(NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company
specializing in developing AI-Immunology(TM) powered vaccines, announces
publication of data from its Phase 1 dose escalation study of its lead
personalized cancer vaccine candidate, EVX-01, for metastatic melanoma. The
study results, published in the Journal for ImmunoTherapy of Cancer
(https://jitc.bmj.com/content/jitc/12/5/e008817.full.pdf), demonstrated that
eight out of 12 patients (67%) experienced objective clinical responses (ORR)
with six partial and two complete responses. Further, EVX-01 immunization did
not induce vaccine-related serious adverse events in patients co-administered
with anti-PD1 therapy.
The EVX-01 cancer vaccine is designed to target neoantigens - antigenic
sequences derived from cancer mutations - that are displayed on the surface of
cancer cells, allowing the immune system to recognize, attack and eliminate the
malignant cells. Since the neoantigen tumor profiles vary from one cancer
patient to another, the EVX-01 cancer vaccine is truly personalized and tailored
to the unique characteristics of each patient's tumor and immune system profile.
This represents a novel treatment paradigm with potential broad application in
cancer therapy.
At this year's ASCO annual meeting, the Company presented comprehensive immune
data from its ongoing EVX-01 Phase 2 study, with 71% of the administered
neoantigens inducing a specific T-cell response. Furthermore, a positive
correlation between the neoantigen prediction score assigned by AI-Immunology(TM)
and the reported induced immune response confirmed the Phase 1 study findings
and further substantiated the predictive power of Evaxion's AI platform.
"This publication provides a clear conclusion to our Phase 1 study, with peer-
reviewed validation of our reported outcomes. We are very impressed with EVX-01
achieving a 67% objective response rate in the trial. This is encouraging as it
verifies a true reduction in tumor burden following dosing and compares
favorably with historical data from anti-PD-1 monotherapy trials. With the
encouraging data from our ongoing Phase 2 study of EVX-01 presented at this
year's annual ASCO meeting, we are on track to report our one-year readout in
the third quarter of this year," said Christian Kanstrup, CEO of Evaxion.
For more information about the recent EVX-01 Phase 2 immune data presented at
ASCO, please visit our recent press release (https://investors.evaxion-
biotech.com/news-releases/news-release-details/evaxion-presents-positive-and-
validating-immune-data-ongoing).
About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based
personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-
sponsored, open-label, single-arm, multi-center trial carried out in
collaboration with Merck Sharp & Dohme LLC, together with leading principal
investigators and research centers from Italy and Australia. It aims to evaluate
the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1
treatment pembrolizumab (more commonly known as KEYTRUDA(®)) in treatment-naive
patients with metastatic or unresectable malignant stage III or IV melanoma.
More information can be accessed under clinical trial ID NCT05309421
(https://clinicaltrials.gov/study/NCT05309421?term=EVX-01&rank=1).
About EVAXION
Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform,
AI-Immunology(TM). 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(TM), 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(TM) platform and vaccine pipeline, please visit our
website (https://www.evaxion-biotech.com/).
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
(https://www.globenewswire.com/Tracker?data=3eX-
yULjXHj_fAO4jPRASPaehYEVHM4NmXNAs_0lw5UK0DHjLXk6aKS6LI4PyMob9UvuFpZpGQrWa4b_6WQY
1A==). We do not assume any obligation to update any forward-looking statements
except as required by law.
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