Evaxion Biotech Reports Promising Results in Vaccine Development

Evaxion obtains pre-clinical Proof-of-Concept for mRNA Gonorrhea vaccine candidate EVX-B2 - Evaxion Biotech (NASDAQ:EVAX)

New pre-clinical data demonstrates that the novel EVX-B2 mRNA vaccine candidate triggers a targeted immune response The specific immune response leads to the elimination of the gonorrhea bacteriaThe data confirm that Evaxion's AI-Immunology™ platform is delivery modality agnostic COPENHAGEN, Denmark, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S EVAX ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new pre-clinical data demonstrating the ability of its novel EVX-B2 mRNA Gonorrhea vaccine candidate in eliminating gonorrhea bacteria by triggering a targeted immune response. This new data, which will be presented today at the 18th Vaccine Congress taking place in Lisbon, Portugal, provides strong Proof-of-Concept (PoC) for the mRNA-based version of EVX-B2 in a pre-clinical setting. EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate for which pre-clinical PoC has already been obtained. The novel pre-clinical data for the mRNA-version of the vaccine substantiates that AI-Immunology™ identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities. The new data has been generated in collaboration with Afrigen Biologics. "We are pleased to announce the pre-clinical PoC for EVX-B2, thereby reaching another of our milestones for 2024 according to plan as we continue to execute on our strategy. It is exciting to see yet another validation of our AI-Immunology™ platform and its potential to help develop new and better treatments also for bacterial diseases. In the case of Gonorrhea, no vaccine exists today, so we have an opportunity here to develop a potentially groundbreaking treatment. Further, the data confirms that our platform is delivery modality agnostic, which is a very strong value proposition towards existing and new partners," says Christian Kanstrup, CEO of Evaxion. Petro Terblanche, CEO of Afrigen Biologics, expresses the company's excitement with the latest results from the collaboration between Afrigen and Evaxion: "As the antimicrobial resistance challenges globally escalate and effective interventions against increases in cases of Gonorrhea worldwide becomes a public health priority, we are excited to have achieved the pre-clinical PoC for the mRNA version of EVX-B2 as a potential future vaccine product." Presentation details: Abstract Title:Development of a broadly protective AI-Immunology™ identified Neisseria gonorrhoeae mRNA vaccineSession:Breakout Session 1 - Computational Design of New Vaccines (AI) (AI approaches in Vaccine Development)Date/Time:September 9 at 13.45-14.00 CETPresenter:Sophie Schussek, Project Manager, Infectious Disease at Evaxion About Gonorrhea (N. gonorrhoeae) Identified by the US Centers for Disease Control and Prevention (CDC) as one of the World's five most urgent antibiotic resistance threats, Gonorrhea can result in ectopic pregnancy, infertility, and life-threatening sepsis infection. Furthermore, Gonorrhea can increase the risk of getting and giving HIV 5-fold. According to the CDC, every year in the United States alone there are 1.14 million new gonorrhea infections, including 550,000 estimated drug-resistant infections related to Gonorrhea, that lead to annual direct medical costs of approximately $133.4 million. About Afrigen Biologics Afrigen Biologics is a biotech start-up company based in Cape Town, South Africa, and is a leading innovator in the field of medical biotechnology on the continent, dedicated to advancing healthcare through cutting-edge research and development. With a commitment to excellence and a passion for innovation, Afrigen strives to deliver transformative therapies that make a meaningful difference in patients' lives. Having successfully established the WHO/MPP mRNA Vaccine Technology Transfer hub in South Africa, Afrigen is well on its way to locally develop and manufacture mRNA vaccines focusing on disease burden in Africa and other low-middle-income countries. Furthermore, Afrigen, through international partnerships and local capacity building, has established the first-ever vaccine adjuvant production and formulation technology center on the African continent focusing on next-generation vaccine adjuvants, which are not only geared at preventing disease but have therapeutic value. Afrigen was founded by the Industrial Development Corporation, which holds 49% equity in Afrigen, while Avacare Health holds 51%. For more information in Afrigen, please visit https://www.afrigen.co.za/ About EVAXION Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology™. 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™, 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™ platform and vaccine pipeline, please visit our website. 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. We do not assume any obligation to update any forward-looking statements except as required by law. Contact information Evaxion Biotech A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] Source: Evaxion Biotech Market News and Data brought to you by Benzinga APIs

Evaxion reports 69% Overall Response Rate in its phase 2 trial on lead cancer vaccine candidate EVX-01 - Evaxion Biotech (NASDAQ:EVAX)

Topline data from a one-year interim analysis of the ongoing phase 2 trial show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate 15 out of the 16 patients had reduction of their tumors (target lesions)The complete one-year dataset will be presented at the ESMO congress this week and discussed at a webinar with key opinion leader Professor Georgina V. Long on September 18, 2024 COPENHAGEN, Denmark, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S EVAX ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new exciting clinical phase 2 data for its lead compound EVX-01. The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate (ORR). 15 out of the 16 patients had reduction of their tumors (target lesions). This topline data is part of a one-year interim analysis of the ongoing phase 2 trial assessing EVX-01 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). The complete one-year clinical data will be presented at a poster session at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024. "We are very excited about these data, which strongly support both the clinical profile of EVX-01 as a promising personalized cancer treatment and the unique predictive capabilities of our AI-Immunology™ platform. To present phase 2 efficacy data for an AI-designed vaccine is a major milestone for Evaxion. Huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could potentially be an improved treatment option for patients. We look forward to presenting the complete one-year dataset at ESMO, discussing the data with potential partners and advancing the phase 2 trial towards its completion next year," says Christian Kanstrup, CEO of Evaxion. Evaxion's innovative approach to develop personalized cancer vaccines builds on its AI-Immunology™ platform. The vaccines are designed to target the unique genetic makeup of an individual's tumor and are tailored to the patients' immune system, potentially enhancing the efficacy of treatment and improving patient outcomes. Webinar on September 18 Evaxion will be hosting an online webinar featuring key opinion leader and the trial's principal investigator, Professor Georgina V. Long, on September 18, 2024, at 19:00 CEST/13.00 EST. The webinar can be attended through registration via this link. In the webinar, Professor Long will present the data from the one-year interim analysis and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions. ESMO presentation details: Abstract Title:Phase 2 study of AI-designed personalized neoantigen cancer vaccine, EVX-01, in combination with pembrolizumab in advanced melanomaAbstract#:1084PPoster#:2904Track:Melanoma and other skin tumoursLocation:Hall 6Date/Time:September 14 at 12:00 - 13:00 CESTPresenter:Dr. Paola Queirolo, Director, Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institue of Oncology, Milan, Italy Link to abstract on the ESMO website: ESMO website. About EVX-01 EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion's lead clinical asset. EVX-01 is a personalized therapy designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In the completed Phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses. In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions was observed, underlining the predictive power of the platform. About EVX-01 phase 2 clinical trial The Phase 2 clinical study (NCT05309421) is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with leading principal investigators and research centers from Italy and Australia. The trial aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with MSD's anti-PD1 therapy KEYTRUDA® (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Merck Sharp & Dohme LLC supplies KEYTRUDA® (pembrolizumab) for the trial. About melanoma Melanoma accounts for approximately 1 in 5 of the 1.5 million new skin cancer cases estimated globally in 2020 with approximately 325,000 cases and 57,000 deaths. The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022). The global market for melanoma treatments is estimated to grow to $7.4 billion by 2029 (GlobalData). About EVAXION Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology™. 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™, 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™ platform and vaccine pipeline, please visit our website. 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. We do not assume any obligation to update any forward-looking statements except as required by law. Contact information Evaxion Biotech A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] Source: Evaxion Biotech Market News and Data brought to you by Benzinga APIs