Evaxion's AI-Designed Cancer Vaccine Shows Promising Results in Phase 2 Trial

Evaxion reports promising phase 2 trial results for cancer vaccine By Investing.com

COPENHAGEN - Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage company focused on developing artificial intelligence-powered vaccines, has announced positive interim results from its phase 2 trial of EVX-01, a personalized cancer vaccine. The trial, which investigates the vaccine in combination with KEYTRUDA® (pembrolizumab), has shown a 69% Overall Response Rate (ORR) in patients with advanced melanoma. The data, presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, over the weekend, indicates that 15 out of 16 patients experienced reductions in their tumor target lesions. Additionally, the vaccine triggered a targeted immune response in 79% of the cases, which is notably high compared to other approaches. EVX-01 is designed using Evaxion's AI-Immunology™ platform to target neoantigens, which are unique to each patient's tumor, thereby enhancing the immune system's ability to fight cancer. The positive correlation between the platform's predictions and the immune response observed in patients, with a p-value of p=0.00013, suggests a robust predictive capability of the AI technology. The commercial potential of EVX-01 is significant given the rising global incidence of melanoma, which is projected to reach 510,000 new cases by 2040. With the melanoma treatment market expected to grow to $7.4 billion by 2029, EVX-01 could represent a considerable advancement in the field. Evaxion's CEO, Christian Kanstrup, expressed optimism about the vaccine's clinical profile and potential to transform cancer treatment. The company will further discuss the data at a webinar on Monday, featuring Professor Georgina V. Long, a key opinion leader and principal investigator of the trial. EVX-01's development is part of Evaxion's broader commitment to addressing unmet medical needs in cancer, bacterial diseases, and viral infections through its AI-Immunology™ platform. This report is based on a press release statement and presents the latest findings from Evaxion's ongoing research into innovative cancer treatment options. Final results from the phase 2 trial are anticipated in the third quarter of 2025. In other recent news, Evaxion Biotech reported significant advancements in its clinical trials and research. The company's phase 2 trial of EVX-01, a melanoma treatment, showed promising interim results, with 69% of patients achieving an objective clinical response. Furthermore, the company's AI-Immunology™ platform demonstrated its versatility, with promising pre-clinical results for the EVX-B2 mRNA vaccine candidate targeting gonorrhea. These developments are part of Evaxion's ongoing commitment to leveraging its AI-Immunology™ platform to address various health challenges. The company's CEO, Christian Kanstrup, expressed optimism about the potential of EVX-01 as a personalized cancer treatment and the predictive capabilities of their AI platform. Evaxion's financial outlook also appears positive. In its Q2 earnings call, the company reported progress in its EVX-01 program and is hopeful about generating $14 million in business development income. Current cash reserves are expected to fund operations until early 2025. Mads Kronborg has been introduced as the new VP of Investor Relations and Communication, reinforcing the company's focus on multi-partner collaborations and the pursuit of key milestones. In conclusion, these recent developments underscore Evaxion's commitment to exploring and expanding the potential of its AI-Immunology™ platform, as well as its determination to maintain financial stability and progress in the face of global uncertainties. Evaxion Biotech A/S (NASDAQ: EVAX) has recently made headlines with promising results from its phase 2 trial of EVX-01. As investors and analysts assess the company's prospects, several key metrics and insights from InvestingPro provide a deeper understanding of its financial health and market performance. According to InvestingPro data, the company's market capitalization stands at a modest $16.73 million. This relatively small market cap reflects the early stage of the company and its focus on developing innovative treatments with significant potential for growth. Despite the positive trial results, analysts highlight that Evaxion is quickly burning through cash, which is a common scenario for clinical-stage biotech companies investing heavily in research and development. This is further substantiated by the company's negative P/E ratio, which currently stands at -0.77, indicating that it is not yet profitable. Moreover, the stock has experienced a notable decline over the last week, with a 1-week price total return of -7.69%. This volatility may be of interest to investors looking for short-term trading opportunities, especially considering that Evaxion's stock price often moves in the opposite direction of the market, as noted in one of the InvestingPro Tips. For those considering long-term investment, it's important to note that while Evaxion operates with a moderate level of debt and its liquid assets exceed short-term obligations, analysts do not anticipate the company will be profitable this year. Additionally, the stock is trading at a high revenue valuation multiple, which suggests that the market may be pricing in future growth expectations. Investors seeking a comprehensive analysis of Evaxion's financials and market performance can find additional InvestingPro Tips on the InvestingPro platform, which currently lists 11 more tips for a more informed investment decision.

Evaxion reports convincing one-year data from phase 2 trial on AI-designed personalized cancer vaccine EVX-01 - Evaxion Biotech (NASDAQ:EVAX)

11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate15 out of the 16 patients had a reduction of their tumors (target lesions)79% of EVX-01's vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches A positive correlation was observed between the AI-Immunology™ platform predictions and neoantigen immune response (p=0.00013)EVX-01 as a novel potential melanoma treatment holds a significant commercial potential for EvaxionData will be discussed at a webinar with key opinion leader Professor Georgina V. Long on September 18, 2024 COPENHAGEN, Denmark, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S EVAX ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces positive one-year data from the ongoing phase 2 trial with its lead asset EVX-01, an AI-designed personalized cancer vaccine. "We are thrilled to present this groundbreaking data, which underscores the significant therapeutic potential of EVX-01. Among several promising individual data points, the 69% Overall Response Rate (ORR) is particularly impressive and encouraging. Building on an already strong data package for EVX-01, these new findings strengthen our confidence that we can meaningfully improve treatment options for advanced melanoma," says Birgitte Rønø, CSO of Evaxion. "The clinical findings are another validation of our AI-Immunology™ platform as a leading AI technology for fast and effective vaccine target discovery and design and clearly positions us as a leader in the field of AI immunology. The observed reduction in tumors in 15 out of 16 patients is offering great hope for patients with melanoma. We are looking very much forward to engaging with stakeholders to present the compelling clinical profile of EVX-01 as a transformative personalized cancer vaccine," says Christian Kanstrup, CEO of Evaxion. The data stems from a one-year interim analysis of the ongoing phase 2 trial investigating 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 data was presented during the weekend at a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Unique profile of EVX-01 supported by both clinical efficacy and immune data The data demonstrates 69% ORR, reduction in tumor target lesions in 15 out of 16 patients, an immunogenicity rate of 79%, and a positive correlation between Evaxion's AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Neoantigens are newly formed antigens generated from cancer-specific mutations. As a neoantigen vaccine, EVX-01 aims at triggering the patient's immune system to target these specific antigens and thereby eradicate the cancer cells. The 69% ORR is calculated based on 11 out of 16 patients in the trial having objective clinical responses. This rate may increase as more data are collected but will not decrease. Final results are expected in the third quarter of 2025. Further to the encouraging clinical data, the immunogenicity data from the trial are also impressive, demonstrating that 79% of EVX-01's neoantigens triggered a targeted immune response. This immunogenicity rate stands out as unprecedented compared to historical observations and compares very favorably to what is seen with other approaches. It also underlines and validates the precision of the AI-Immunology™ platform in identifying neoantigens which leads to detectable signals in patients. The new data also confirms the strong predictive capabilities of AI-Immunology™ with a positive correlation between its predictions and the neoantigen immune response detected in the patients with a p-value of p=0.00013. In other words, the data confirms that the neoantigens identified by the platform as the most relevant vaccine targets are also the ones that trigger specific immune responses in patients. Significant commercial potential 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), and the global market for melanoma treatments is estimated to grow to $7.4 billion by 2029 (GlobalData). Considering the prevalence of the disease and the size of the market, the development of EVX-01 as a novel potential melanoma treatment holds a significant commercial potential for Evaxion. As EVX-01 is also thought to have the potential to treat several other solid tumor cancers, the total commercial opportunity could be further enhanced by expanding into other indications. 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 EDT. 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. 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. Contact information Evaxion Biotech A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 mak@evaxion-biotech.com 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. Market News and Data brought to you by Benzinga APIs