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EVAX Positive Sentiment Score: 85/100

Evaxion announces promising clinical data for DNA-based personalized cancer immunotherapy EVX-02: Phase 1/2a trial met both primary and secondary endpoints - All 10 patients with late stage melanoma who completed EVX-02

Key Takeaway: Evaxion Biotech A/S announced promising results from its Phase 1/2a trial for the DNA-based cancer immunotherapy EVX-02, showing that all 10 patients with late-stage melanoma remained relapse-free. The study successfully met its primary endpoints regarding safety and immunogenicity, as well as a secondary endpoint on clinical efficacy. Evaxion's AI platform was validated through these results, which support the company's plan to accelerate the development of the next-generation therapy, EVX-03. The findings were presented at the 2023 AACR meeting, highlighting the potential of EVX-02 in personalized cancer treatment.

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POSITIVE FACTORS

  • All 10 patients in the trial remained relapse-free during the study.
  • The trial met both primary and secondary endpoints successfully.
  • The data shows clear signs of a protective cancer vaccination effect.
  • Evaxion plans to fast track the next-generation immunotherapy, EVX-03.

Full Press Release Details

Evaxion announces promising clinical data for DNA-based personalized
cancer immunotherapy EVX-02: Phase 1/2a trial met both primary and secondary endpoints
Copenhagen, Denmark, April 18, 2023 (GLOBE NEWSWIRE)
- Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company
specializing in the development of AI-powered immunotherapies, today presented promising clinical data from its Phase 1/2a first-in-human
study of its DNA-based personalized cancer immunotherapy, EVX-02 in combination with the checkpoint inhibitor nivolumab. Data were presented
in the Late Breaking Research: Clinical Research 2 session at the 2023 AACR (American Association for Cancer Research) meeting in Orlando,
The study, in patients with resected melanoma, showed that:
"We are extremely happy to share the positive clinical data
from our Phase 1/2a EVX-02 study at AACR. We met both our primary endpoints on safety, tolerability and immunogenicity and our secondary
endpoint on clinical efficacy. With all 10 patients who completed the EVX-02 treatment being relapse-free during the trial and with robust
and treatment-specific immune responses, we see clear signs of a protective cancer vaccination effect", said Per Norl n,
Chief Executive Officer of Evaxion. "The EVX-02 data affirm our ability to select the right neoantigens, matched to the cancer
of each patient, and provide further validation of our AI platform PIONEERTM. They also support our plan to fast track our
next-generation DNA-based personalized cancer immunotherapy, EVX-03, to the clinic in Q4."
About the Phase 1/2a Study with EVX-02
The open-label, single-arm, multi-center Phase 1/2a study (NCT04455503)
was designed to evaluate the combination of EVX-02 plus nivolumab in
patients who had undergone complete surgical resection of late stage melanoma and were at high risk for recurrence. The primary objectives
of the 12-month study were to assess the safety, tolerability and immunogenicity of EVX-02 plus nivolumab. In addition, the study was
intended to evaluate relapse free survival. Evaxion reported initial, interim safety and immunogenicity data from the first 8
patients in the study in November 2022.
Evaxion Biotech A/S is a clinical-stage biotech company developing
AI-powered immunotherapies. Evaxion's proprietary and scalable AI technologies 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. The company is located in H rsholm, Denmark, and is listed on the Nasdaq New York stock
exchange. For more information, please visit: www.evaxion-biotech.com.
For more information
Evaxion Biotech A/S LifeSci Advisors LLC
Per Norl n Corey Davis, Ph.D.
Chief Executive Officer Managing Director
pno@evaxion-biotech.com cdavis@lifesciadvisors.com
212-915-2577
Source: Evaxion Biotech
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 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.

Frequently Asked Questions

What are the key results from the EVX-02 trial?

The EVX-02 trial met its primary endpoints on safety and immunogenicity, as well as a secondary endpoint on clinical efficacy.

What type of cancer is EVX-02 targeting?

EVX-02 is a personalized cancer immunotherapy targeting resected melanoma.

How many patients completed the EVX-02 treatment?

All 10 patients who completed the EVX-02 treatment remained relapse-free during the trial.

What is Evaxion's next step after EVX-02?

Evaxion plans to fast track its next-generation therapy, EVX-03, to the clinic in Q4.

What technology powers Evaxion's therapies?

Evaxion's therapies are powered by its proprietary AI technology that decodes the human immune system.

Last updated: Apr 18, 2023