rdeano221
3 months ago
$EVAX Jan. 24, 2024, 07:32 AM
InvestorPlace - Stock Market News, Stock Advice & Trading Tips
Evaxion Biotech (NASDAQ:EVAX) stock is on the rise Wednesday after the company revealed a stake held by Merck (NYSE:MRK).
A filing with the Securities and Exchange Commission (SEC) notes that Merck now holds an 11.4% stake in Evaxion Biotech. That comes from the 2,297,884 shares of EVAX and warrants to acquire another 2,297,704 shares that the company owns.
The stake that Merck holds is based on the 40,204,700 shares outstanding as of Jan. 11, 2024. That comes from 37,906,996 shares of MRK stock outstanding and 2,297,704 shares issuable upon the exercise of warrants.
subslover
3 months ago
NEWS
Evaxion Announces Completion of ADS Ratio Change
COPENHAGEN, Denmark, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announced that the Company’s previously disclosed change to its ratio of its American Depositary Shares (“ADSs”) to its ordinary shares, DKK 1 nominal value (the “ADS Ratio”), has been made effective. The ratio has changed from one (1) ADS representing one (1) ordinary share to a new ADS Ratio of one (1) ADS representing ten (10) ordinary shares (the “ADS Ratio Change”). The ADS Ratio Change became effective on January 22, 2024 (the “Effective Date”).
For the Company's ADS holders, the change in the ADS Ratio has the same effect as a one-for-ten reverse ADS split and is intended to further support the liquidity in the Company’s ADSs and to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. The exchange of one (1) new ADS for every ten (10) then-held (existing) ADSs occurred automatically on the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by The Bank of New York Mellon, the depositary bank (the “Depositary”). Registered holders of the Company’s ADSs held in certificated form were required on a mandatory basis to surrender their certificated ADSs to the Depositary for cancellation and received one (1) new ADS in exchange for every ten (10) existing ADSs then-held. Holders of uncertificated ADSs in the Direct Registration System (DRS) and The Depository Trust Company (DTC) had their ADSs cancelled and automatically exchanged, receiving one (1) new ADS for every ten (10) existing ADS then-held. The Company’s ADSs continue to be traded on The Nasdaq Capital Market under the ticker symbol “EVAX”.
The ADS Ratio Change affects all shareholders uniformly and will not alter any shareholder’s percentage interest in the Company’s equity, except to the extent that the ratio change would have resulted in a shareholder owning fractional ADSs. No fractional new ADSs were issued in connection with the change in the ADS Ratio. Instead, fractional entitlements to new ADSs will be aggregated and sold by the Depositary, and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) will be distributed to the applicable ADS holders by the Depositary.
As a result of the ADS Ratio Change, the ADS trading price is expected to increase proportionally, although the Company can give no assurance that the ADS trading price after the ADS Ratio Change will be proportionally equal to or greater than the previous ADS trading price prior to the change or that the Ratio Change will have any effect on the liquidity in the Company’s ADSs.
subslover
11 months ago
Evaxion’s AI technology identifies cancer vaccine targets associated with longer progression-free survival of melanoma patients in the EVX-01 Phase 1 clinical trial
The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability
Positive clinical responses were reported in 8 out of 12 EVX-01 treated patients
High-quality neoantigens, predicted by AI technology, were associated with longer progression-free survival
Strong vaccine-specific immune responses were induced in all 12 EVX-01 treated patients
Higher EVX-01 dose induced a stronger immune response and was associated with improved clinical outcome
COPENHAGEN, Denmark, June 03, 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 EVX-01 Phase 1 dose escalation trial in metastatic melanoma at the 2023 ASCO annual meeting in Chicago, Illinois.
The Phase 1 trial successfully met primary endpoints for safety and tolerability of EVX-01 in metastatic melanoma patients and demonstrated positive clinical responses in 8 out of 12 (67%) treated patients. In addition, Evaxion’s proprietary AI technology PIONEER™ was able to identify high-quality cancer vaccine targets, so-called neoantigens, associated with longer progression-free survival.
“We are excited that our AI technology could effectively identify vaccine neoantigens associated with better clinical responses and longer progression-free survival. And the data suggest a treatment effect, with response rates nearly double of those observed in historical data for checkpoint inhibitors. Our findings in this study position us well to prospectively identify patients who will benefit from personalized cancer immunotherapy for our upcoming trials, potentially making the benefit for patients even greater,” said Per Norlén, Chief Executive Officer of Evaxion.
The study demonstrated the ability of the PIONEER™ platform to identify vaccine targets that are associated with improved patient outcomes. Stratification based on PIONEER™ scores outperformed tumor mutational burden as a predictive biomarker, with patients having high-quality neoantigens showing better treatment responses and longer progression-free survival.
The evaluation of treatment-related immune responses revealed strong neoantigen T-cell responses in all 12 patients, mediated by activated CD4+ T cells in all cases and CD8+ T cells in 7 out of 12 patients. Further, immune response magnitude correlated with the vaccination dose.
“The positive association between clinical outcome and prevalence of immunogenic cancer neoantigens validates the PIONEER™ platform for its use for personalized cancer vaccines and emphasizes the importance of a robust AI system for designing neoantigen vaccines. Moreover, the dose-dependent increase in responses has been instrumental for Phase 2 dose selection in the ongoing clinical trial. We have great expectations on the upcoming interim Phase 2 results that are planned to be presented later this year,” Per Norlén continues.
About the Phase 1 Study with EVX-01
The open-label, single-arm, single-center Phase 1 study, titled “Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)” (ClinicalTrials.gov Identifier: NCT03715985), was conducted in collaboration with DTU, SSI, the center for genomic medicine at Rigshospitalet and CCIT-DK and aimed to assess the safety and efficacy of EVX-01 vaccine in combination with anti-PD1 (pembrolizumab or Nivolumab) in patients with metastatic melanoma. The design consisted of multiple 15-27mer peptides comprising one or more patient-specific neoantigens formulated with the novel liposomal adjuvant CAF®09b to potentiate immune responses. The primary objective was to determine the safety and tolerability of the combination of EVX-01 and a checkpoint inhibitor. Additional objectives were to evaluate manufacturing feasibility, immune responses, and clinical efficacy.
About Evaxion Biotech
Evaxion Biotech A/S is a clinical-stage biotech company focused on harnessing the power of artificial intelligence to decode the human immune system and develop immunotherapies for cancer, bacterial diseases, and viral infections. Through its proprietary AI platform, PIONEER™, Evaxion aims to revolutionize cancer treatment by identifying unique and immunogenic neoantigens and designing individualized therapies. The Company is committed to transforming the lives of cancer patients with unmet clinical needs by providing innovative and targeted treatment options. For more information about Evaxion Biotech and its groundbreaking personalized cancer immunotherapies, please visit www.evaxion-biotech.com.
Forward-looking statementThis 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.
https://www.globenewswire.com/newsroom/ti?nf=MTAwMDgyMzM5NiM0MDE1NjI1MzEjMjI1MjA4Nw==
https://ml-eu.globenewswire.com/media/N2ViNDFkYmEtODcxYy00OWFiLTgzMzUtN2NkNTk5ZjZlMWI3LTEyNjM2NDA=/tiny/Evaxion-Biotech.png
Contact information
Evaxion Biotech A/S
Per Norlén
Chief Executive Officer
pno@evaxion-biotech.com
Source: Evaxion Biotech
subslover
11 months ago
Evaxion’s AI technology identifies cancer vaccine targets associated with longer progression-free survival of melanoma patients in the EVX-01 Phase 1 clinical trial
The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability
Positive clinical responses were reported in 8 out of 12 EVX-01 treated patients
High-quality neoantigens, predicted by AI technology, were associated with longer progression-free survival
Strong vaccine-specific immune responses were induced in all 12 EVX-01 treated patients
Higher EVX-01 dose induced a stronger immune response and was associated with improved clinical outcome
COPENHAGEN, Denmark, June 03, 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 EVX-01 Phase 1 dose escalation trial in metastatic melanoma at the 2023 ASCO annual meeting in Chicago, Illinois.
The Phase 1 trial successfully met primary endpoints for safety and tolerability of EVX-01 in metastatic melanoma patients and demonstrated positive clinical responses in 8 out of 12 (67%) treated patients. In addition, Evaxion’s proprietary AI technology PIONEER™ was able to identify high-quality cancer vaccine targets, so-called neoantigens, associated with longer progression-free survival.
“We are excited that our AI technology could effectively identify vaccine neoantigens associated with better clinical responses and longer progression-free survival. And the data suggest a treatment effect, with response rates nearly double of those observed in historical data for checkpoint inhibitors. Our findings in this study position us well to prospectively identify patients who will benefit from personalized cancer immunotherapy for our upcoming trials, potentially making the benefit for patients even greater,” said Per Norlén, Chief Executive Officer of Evaxion.
The study demonstrated the ability of the PIONEER™ platform to identify vaccine targets that are associated with improved patient outcomes. Stratification based on PIONEER™ scores outperformed tumor mutational burden as a predictive biomarker, with patients having high-quality neoantigens showing better treatment responses and longer progression-free survival.
The evaluation of treatment-related immune responses revealed strong neoantigen T-cell responses in all 12 patients, mediated by activated CD4+ T cells in all cases and CD8+ T cells in 7 out of 12 patients. Further, immune response magnitude correlated with the vaccination dose.
“The positive association between clinical outcome and prevalence of immunogenic cancer neoantigens validates the PIONEER™ platform for its use for personalized cancer vaccines and emphasizes the importance of a robust AI system for designing neoantigen vaccines. Moreover, the dose-dependent increase in responses has been instrumental for Phase 2 dose selection in the ongoing clinical trial. We have great expectations on the upcoming interim Phase 2 results that are planned to be presented later this year,” Per Norlén continues.
About the Phase 1 Study with EVX-01
The open-label, single-arm, single-center Phase 1 study, titled “Personalized Neo-antigen Vaccine in Advanced Solid Tumors (NeoPepVac)” (ClinicalTrials.gov Identifier: NCT03715985), was conducted in collaboration with DTU, SSI, the center for genomic medicine at Rigshospitalet and CCIT-DK and aimed to assess the safety and efficacy of EVX-01 vaccine in combination with anti-PD1 (pembrolizumab or Nivolumab) in patients with metastatic melanoma. The design consisted of multiple 15-27mer peptides comprising one or more patient-specific neoantigens formulated with the novel liposomal adjuvant CAF®09b to potentiate immune responses. The primary objective was to determine the safety and tolerability of the combination of EVX-01 and a checkpoint inhibitor. Additional objectives were to evaluate manufacturing feasibility, immune responses, and clinical efficacy.
About Evaxion Biotech
Evaxion Biotech A/S is a clinical-stage biotech company focused on harnessing the power of artificial intelligence to decode the human immune system and develop immunotherapies for cancer, bacterial diseases, and viral infections. Through its proprietary AI platform, PIONEER™, Evaxion aims to revolutionize cancer treatment by identifying unique and immunogenic neoantigens and designing individualized therapies. The Company is committed to transforming the lives of cancer patients with unmet clinical needs by providing innovative and targeted treatment options. For more information about Evaxion Biotech and its groundbreaking personalized cancer immunotherapies, please visit www.evaxion-biotech.com.
Forward-looking statementThis 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.
https://www.globenewswire.com/newsroom/ti?nf=MTAwMDgyMzM5NiM0MDE1NjI1MzEjMjI1MjA4Nw==
https://ml-eu.globenewswire.com/media/N2ViNDFkYmEtODcxYy00OWFiLTgzMzUtN2NkNTk5ZjZlMWI3LTEyNjM2NDA=/tiny/Evaxion-Biotech.png
Contact information
Evaxion Biotech A/S
Per Norlén
Chief Executive Officer
pno@evaxion-biotech.com
Source: Evaxion Biotech
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