^* The EVX-01 Personalized Cancer Vaccine Clinical Trial has the
met primary endpoints of safety and tolerability
* 8 of 12 patients treated with EVX-01 had positive clinical
reactions detected
* High quality neoantigens predicted by AI technology,
were associated with longer progression-free survival
* All 12 patients treated with EVX-01 developed strong
Vaccine-specific immune responses triggered
* A higher dose of EVX-01 elicited a stronger immune response and was associated with
associated with a better clinical outcome
COPENHAGEN, Denmark, June 04, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S
(NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical stage
active biotechnology company focused on the development of AI-based
immunotherapies, presented today at the ASCO Annual Meeting
2023 in Chicago, Illinois, promising clinical data from its Phase I
Dose escalation study of EVX-01 in metastatic melanoma.
In the phase I study, the primary endpoints for safety and
Tolerability of EVX-01 in patients with metastatic melanoma successful
achieved and positive clinical results in 8 of 12 (67%) treated patients
reactions detected. In addition, the company’s own AI
Evaxion’s PIONEER(TM) technology high-value cancer vaccine targets, so-called
Identify neoantigens, those associated with longer progression-free survival
keep in touch.
?We are excited that our AI technology effectively targets vaccine neoantigens
could identify those with a better clinical response and a
longer progression-free survival. And the data suggests
indicated a treatment effect with response rates nearly twice that of
observed in historical data for checkpoint inhibitors. The
The results of this study put us in a good position to
Patients who benefit from personalized cancer immunotherapy,
to identify prospectively for our upcoming studies, reducing the benefit
potentially even greater for patients,” said Per Norlén, Chief
Executive Officers of Evaxion.
The study showed that the PIONEER(TM) platform is able to
Identify vaccine targets that are associated with improved patient outcomes
are connected. Stratification using the PIONEER(TM) scores exceeded the
Tumor mutational burden as a predictive biomarker, with patients having high-grade
Neoantigens better response to treatment and longer
showed progression-free survival.
The evaluation of the treatment-related immune reactions revealed that all 12
Patients experienced strong neoantigen T cell responses in all cases
activated CD4+ T cells and in 7 of 12 patients by CD8+ T cells
were mediated. In addition, the magnitude of the immune response correlated with the
vaccine dose.
?The positive association between clinical outcome and prevalence
immunogenic cancer neoantigens validates the PIONEER(TM) platform for use
for personalized cancer vaccines and underscores the importance of a
robust AI system for the development of neoantigen vaccines. also was
the dose-dependent increase in responses critical to dose selection
in phase II of the ongoing clinical study. We have great expectations of them
pending phase II interim results to be presented later this year
should be,” continues Per Norlén.
About the Phase I study of EVX-01
The open-label, single-arm, single-center, phase I study, entitled
?Personalized neo-antigen vaccine in advanced solid tumors
(NeoPepVac)” (Identifier on ClinicalTrials.gov: NCT03715985
(https://clinicaltrials.gov/ct2/show/NCT03715985?term=NCT03715985&draw=2&rank=1))
was developed in collaboration with the DTU, the SSI, the Center for Genomic Medicine
carried out at the Rigshospitalet and the CCIT-DK and should ensure safety and
Efficacy of the EVX-01 vaccine in combination with anti-PD1 (Pembrolizumab
or nivolumab) in patients with metastatic melanoma. The design
consisted of several 15-27mer peptides containing one or more
contain patient-specific neoantigens and with the novel liposomal
adjuvant CAF®09b to enhance the immune response. The
primary objective was to assess the safety and tolerability of the combination of EVX-
01 and a checkpoint inhibitor. Other goals were
Evaluation of the manufacturing possibilities, the immune reactions and the clinical ones
Effectiveness.
About Evaxion Biotech
Evaxion Biotech A/S is a clinical stage company
Biotechnology company focused on harnessing the power of
to use artificial intelligence to boost the human immune system
decode and immunotherapies for cancer, bacterial diseases and
develop viral infections. With its proprietary AI platform
PIONEER(TM) Evaxion aims to revolutionize cancer care by delivering unique
and immunogenic neoantigens identified and individualized therapies
developed. The company’s goal is to make the life of
Cancer patients with unmet clinical needs through innovative and targeted
improve treatment options. For more information about Evaxion
Biotech and the breakthrough personalized cancer immunotherapies des
company, please visit www.evaxion-biotech.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act, 1933, as amended; and
Section 21E of the Securities Exchange Act of 1934 as amended
version. The words “goal”, “believe”, “expect”, “hope”, “aim”,
“intend”, “may”, “could”, “anticipate”, “consider”, “continue”,
?estimate”, ?plan”, ?potential”, ?predict”, ?project”, ?will”,
“may have”, “probably”, “should”, “would” and other words and
Words of similar import identify forward-looking statements. The
actual results may differ materially due to various factors
differ from those contained in such forward-looking statements,
including, but not limited to, risks related to: our
financial condition and need for additional capital; our development work;
the cost and success of our product development activities; and
preclinical and clinical studies; the commercialization of one
approved pharmaceutical product made using our AI
Platform technology was developed, including speed and
the level of market acceptance of our product candidates; our dependence on
Third parties, including conducting clinical trials and the
product manufacturing; our inability to form partnerships; state
Regulation; protecting our intellectual property rights;
employee matters and growth management; our ADSs and common stock,
the impact of international economic, political, legal,
Compliance, social and business factors, including inflation
and the impact of the global COVID-19 pandemic and the ongoing
conflict in the region around Ukraine and Russia on our business as well
other uncertainties affecting our business and financial condition
influence. For a further discussion of these risks, see the
Risk factors discussed in our most recent Annual Report on Form 20-F and
other filings with the US Securities and Exchange Commission (SEC).
Included are documents available at www.sec.gov (http://www.sec.gov/).
are.?We assume no obligation to update any forward-looking statements
update unless required by law.
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