Merck & Co., Inc.

80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher frequency than what has been reported for other similar vaccine candidates The data underscores the precision of Evaxion’s AI-Immunology™ platform in selecting therapeutically relevant vaccine targets New findings show EVX-01 inducing a robust and durable immune response, further enhanced by booster immunizations The ongoing phase 2 trial with EVX-01 remains on track for two-year data readout in the second half of 2025 April 28, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data underscoring the ability of cancer vaccine EVX-01 to drive a targeted and robust immune response. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). New immune data from the ongoing phase 2 trial with EVX-01 will be presented at a poster session tomorrow at the American Association for Cancer Research (AACR) Annual Meeting taking place in Chicago. The data demonstrates that 80% of EVX-01 vaccine targets triggered a tumor-specific immune response. In earlier interim analyses presented at the ASCO and ESMO 2024 meetings, a vaccine target hit rate of 71% and 79%, respectively, was demonstrated. Now, with more long-term patient samples analyzed, we’ve improved this hit rate to 80%, reinforcing the potential of EVX-01 as a new and effective treatment for a broad range of solid tumors. “We are excited to report yet another positive set of data for our lead vaccine candidate EVX-01. Its ability to trigger an immune response is unprecedented compared to what has been reported by others. We are further encouraged by the data showing this response to be strong and long-lasting and increasing with additional booster immunizations. The data package for EVX-01 gets stronger and stronger and we are eagerly anticipating the two-year clinical readout,” says Birgitte Rønø, CSO of Evaxion. The trial previously yielded strong interim one-year clinical data and remains on track for readout of two-year clinical data in the second half of 2025. Additionally, the trial has been extended with a third year, allowing for a more comprehensive assessment of the full potential of EVX-01. The phase 2 trial investigates 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). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. AACR presentation details: Abstract title:T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumabAbstract#:4538Poster#:9Session (category):Immune responses to therapies including chemotherapy and radiotherapy (Clinical research)Location: Poster section 28Date/Time:April 29, 2025, at 9am-12pm CST/16-19 CET Presenter:Mads Lausen Nielsen, PhD, Project Manager at Evaxion 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 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 clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology™ predictions have been observed, underlining the predictive power of the platform. 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. The content above comes from the network. if any infringement, please contact us to modify.

AVC-Boosters are designed as dual agonistic antibodies to safely deliver targeted and potent monotherapy with broad application in oncology Lead product AVC-S-101 is a TROP2-targeting booster being developed for non-small cell lung cancer and multiple other cancer indications The company will present at upcoming medical meetings, AACR and ASCO April 24, 2025 -- Avidicure, a biotechnology company pioneering an entirely new multifunctional antibody modality with broad applicability in oncology, today announced its launch with a $50 million seed financing round, led by EQT Life Sciences with participation from Kurma Partners, BioGeneration Ventures, BOM, Curie Capital, and V-Bio Ventures. Avidicure is developing dual agonistic, multifunctional and avidity engineered antibodies, “AVC-Boosters”, that can safely deliver targeted and potent cancer monotherapy. AVC-Boosters unlock strong and orchestrated immunological responses, harnessing the full power of both the innate and adaptive immune system. The AVC-Booster design surpasses the best qualities of first-generation antibodies, checkpoint inhibitors, T-cell engagers, and antibody-drug conjugates (ADCs). “AVC-Boosters have the potential to change the treatment landscape for a wide range of cancers as first-in-class multifunctional antibody products that safely mobilize the full power of the immune system,” said Arthur Lahr, Chief Executive Officer of Avidicure. “Our products drive targeted and potent immune responses only in the tumor with reduced toxicity risk. We are eager to build a broad pipeline with our unique platform and progress our lead oncology product, AVC-S-101, into clinical development for solid tumors.” Avidicure’s fully owned proprietary platform leverages decades of antibody engineering and in silico protein design capabilities, and immunology expertise. Through the AVC-Booster plug-and-play functionality, multiple products can be developed. Avidicure’s lead product, AVC-S-101, is a TROP2-targeting booster that is being developed for non-small cell lung cancer and multiple other indications. “Avidicure is taking an entirely new approach with broad clinical potential,” said Dr. Joern-Peter Halle, former Chief Strategy Officer and Global Head of Research at Merck KGaA and Chairman of Avidicure’s Scientific Advisory Board. “Avidicure’s multifunctional antibodies provide a novel treatment modality with a unique, differentiated mode of action. These products are well-positioned to make a significant impact in the treatment of cancer patients.” Avidicure is led by an experienced team with an established track record in drug discovery, development, and commercialization. The founding management team consists of Arthur Lahr (CEO), Dirk De Naeyer (COO), Robert Friesen (CSO), and Govert Schouten (CBO), who previously served as executive management in Crucell, Ablynx and Kiadis, and played key roles in the acquisitions of these successful European biotech companies. The Supervisory Board includes industry veterans Frank Verwiel (Intellia, Aptalis, Bavarian Nordic, Merck & Co.), Martijn Kleijwegt (EQT-LS), Hunter Smith (Rhythm), and Helen Collins (Five Prime, Enliven, Gilead, Amgen). The company will be presenting preclinical data at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April, and at the American Society of Clinical Oncology (ASCO) Annual Meeting in May. Avidicure is a biotechnology company pioneering an entirely new dual agonistic, multifunctional and avidity engineered antibody modality, “AVC-Boosters,” designed to safely deliver targeted and potent immune-modulating monotherapy for cancer patients. The AVC-Booster design surpasses the best qualities of first-generation antibodies, checkpoint inhibitors, T-cell engagers, and antibody-drug conjugates (ADCs). AVC-Boosters unlock strong and orchestrated immunological responses, harnessing the full power of the innate and adaptive immune system. Avidicure is based in the Netherlands and is supported by a syndicate of top-tier investors led by EQT Life Sciences. The content above comes from the network. if any infringement, please contact us to modify.

COPENHAGEN, Denmark, May 5, 2025 /PRNewswire/ -- Dawn Health, a global leader in digital health, has secured a funding round of €11.5 million from its existing investors: Chr. Augustinus Fabrikker, the Export and Investment Fund of Denmark (EIFO), and Trifork. The investment is aimed at supporting the company's strategy to deliver its platform and product suite to global pharma companies through a SaaS model, while continuing to invest in further offerings within the Dawn Product Suite. Since 2021, Dawn Health has been dedicated to developing a best-in-class platform designed specifically to accommodate the needs and use cases of the pharmaceutical industry. The Dawn Platform and Product Suite have already been widely adopted by five global industry leaders, including Merck and Novartis. The Dawn Platform is currently used in areas such as oncology, multiple sclerosis, and rare pediatric conditions like growth disorders. It helps patients manage their treatment, report symptoms, and stay in close contact with their healthcare team. The Dawn Platform and Product Suite empower pharma companies, patients, and healthcare professionals to improve outcomes and patient care by leveraging advanced capabilities in AI, data, evidence generation, clinical integrations, personalization, and connected health. By improving both data collection and analytics, these capabilities ultimately benefit patients and pharma companies alike, positioning the Dawn Platform as the foundation for therapy companions, disease management programs, and real-world evidence (RWE) solutions that enable the next generation of digital health. "Our ambition is to be the global leader in digital health, powering pharma's next-generation products – and ultimately improving the lives of patients worldwide," said Alexander Mandix Hansen, CEO of Dawn Health. "This funding allows us to bring our proven platform to more markets and deepen our impact." This next phase reinforces Dawn Health's position as a trusted partner to pharma companies, delivering valuable, scalable, regulatory-grade digital health products that evolve with the needs of modern medicine. "Since the major investment in December 2021, Dawn Health has grown its revenue significantly and expanded its footprint in global pharma. With more than 100 employees, unique solutions, and a strong regulatory infrastructure, we are prepared to further accelerate our growth," says Chairman Lars Marcher. About Dawn Health Dawn Health is a global leader in digital health, specializing in the development of Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and connected health solutions. Accelerating the launch of digital solutions to market, the Dawn Health product suite drives innovation to change the lives of people with chronic conditions. Through close partnerships with the life sciences industry, Dawn Health creates digital health products that transform patient care through an empathetic and human-centric approach. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED