Evaxion Announces Business Update and First Quarter 2023 Financial Results
COPENHAGEN, Denmark, May 31, 2023 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, announced today its first quarter 2023 financial results and provided a business update.
“Evaxion continues to make significant progress towards our mission of advancing AI-powered immunotherapies to save lives,” said Per Norlén, Chief Executive Officer of Evaxion. “Data, reported at AACR 2023 and to be presented at ASCO 2023, show that in our trials in melanoma with EVX-02 and EVX-01, respectively, patients experienced promising clinical responses, with good overall tolerability. These data provide important validation for Evaxion’s AI-driven approach to personalized cancer vaccines and underscore our enthusiasm for our next-generation vaccine candidate, EVX-03, slated to begin clinical trials by the end of this year.”
“We have also announced important advances in our proprietary AI-technology, including the new platform ObsERV™, which enables Evaxion to identify new patient-specific tumor targets, called ERVs, based on ancient viral remnants in our genome. It has the potential to further enhance the efficacy of our personalized cancer vaccine EVX-03, as well as broadening immunotherapy to patients that are currently unresponsive to such treatments” said Per, concluding, “We believe that the promising clinical data from our first-generation programs and the exciting technology advancement with our genetic adjuvant technology, position Evaxion at the forefront of the recent resurgence in interest for nucleic acid-based vaccines.”
*Subject to additional funding in the range of $ 5-10 million
Promising clinical data presented for EVX-01 and EVX-02
Clinical readout for the Phase 1/2a trial of EVX-02 was presented at AACR in April. All 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment.
EVX-01 will be presented at ASCO on June 3. The overall outcome of the trial was made public on May 25 with positive clinical responses in 8 out of 12 patients receiving EVX-01 in combination with a checkpoint inhibitor. The trial also met primary endpoints for tolerability and safety, with only mild AEs being related to EVX-01.
R&D Day Highlights Preclinical Data on genetic adjuvant technology
On May 25, Evaxion hosted a series of talks from its scientists and collaborators, sharing preclinical data on its proprietary genetic adjuvant technology developed to enhance the effectiveness of DNA and mRNA vaccines. The genetic adjuvant carries the code for CCL19, a molecule known to attract immune cells, notably antigen presenting cells, and can be encoded into either DNA or mRNA vaccines to boost the immune response. The technology boosts both B cell and T cell immune responses, making it applicable to a wide range of vaccines, both for cancer and for infectious disease.
Next-generation cancer immunotherapy based on ERVs
On March 23, Evaxion announced that it has developed a new proprietary AI platform technology, ObsERV™, identifying a new source of targets for personalized cancer therapy. ObsERV™ makes it possible to identify patient-specific virus targets, so-called ERVs (endogenous retroviruses), selectively expressed in cancer. Evaxion has demonstrated that ERVs are strongly associated with the overall survival of cancer patients, and notably of patients with cold tumors that are normally unresponsive to immunotherapy. Evaxion anticipates filing a clinical trial application (CTA) with the European Medicines Agency in Q3 2023 for its next-generation DNA-based cancer immunotherapy utilizing the OBsERV technology and intends to begin a Phase 1 trial in Q4 2023 in patients with solid tumors, subject to additional funding being obtained.
First Quarter of 2023 Financial Results
Source: Evaxion Biotech
Evaxion Biotech A/S
Consolidated Statements of Financial Position Data (Unaudited)
(USD in thousands)
Evaxion Biotech A/S
Consolidated Statements of Comprehensive Loss Data (Unaudited)
(USD in thousands, except per share data)
As mentioned 31. December 2022 the financial statement had been prepared using the going concern assumption. Based on the Company’s current cash position, with a cash runway until early December 2023, there is a need for further funding, to mitigate the Company’s ability to continue as a going concern.
For more information Evaxion Biotech A/S Per Norlén Chief Executive Officer [email protected] +45 53 53 49
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