HONG KONG, Apr 22, 2026 - (ACN Newswire via SeaPRwire.com) - Apr 20, Everest Medicines announced that the first-in-human (FIH) clinical trial data of EVM16, a proprietary personalized mRNA cancer vaccine, were presented at the 2026 American Association for Cancer Research Annual Meeting (AACR 2026). The data include results from EVM16 as a monotherapy and in combination with the PD-1 inhibitor tislelizumab in patients with advanced solid tumors. The results demonstrated that EVM16 has a favorable safety and tolerability profile, robust immunogenicity, and promising preliminary efficacy in patients with advanced solid tumors, supporting its further clinical development.The clinical trial (EVM16CX01, NCT06541639) was conducted jointly by Peking University Cancer Hospital and Fudan University Shanghai Cancer Center, with the first patient dosed in March 2025. EVM16CX01 is a first-in-human (FIH), dose-escalation, and expansion study evaluating the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with tislelizumab in patients with advanced solid tumors. The study follows a 3+3 dose-escalation design across three dose levels (0.1 mg, 0.3 mg, and 1.0 mg). Eligible patients are those with advanced or recurrent solid tumors who have failed standard of care and have at least one measurable target lesion. Patients receive 2 doses of EVM16 monotherapy once every two weeks, followed by combination therapy of EVM16 and tislelizumab. As of December 7, 2025, a total of 9 patients had been enrolled.No dose-limiting toxicities (DLTs) were observed. All patients experienced at least one investigational product (IP) related adverse event (AE), all of which were Grade ≤ 2 and resolved spontaneously. EVM16 elicited strong neoantigen-specific T cell responses in 8 of 9 patients, which showed a dose-dependent trend. A gastroesophageal junction cancer patient who failed 3 prior lines of systemic therapy achieved a confirmed partial response and a PFS of 126 days. Another 2 patients achieved stable disease. A non-small cell lung cancer patient who failed 3 prior lines of systemic therapy achieved a PFS of 88 days, and an esophageal squamous cell carcinoma patient who failed 3 prior lines of systemic therapy has been followed up for 112 days to date and has not experienced disease progression.“As a novel personalized mRNA cancer vaccine, EVM16 has demonstrated encouraging clinical development potential in its first-in-human clinical trial,” said Professor Shen Lin, Director of the Gastrointestinal Oncology Department at Beijing Cancer Hospital and Chair of the Gastric Cancer Expert Committee of the Chinese Society of Clinical Oncology. “The data show a favorable safety and tolerability profile in patients with advanced solid tumors, with no dose-limiting toxicities (DLTs) observed. Importantly, EVM16 stimulated neoantigen-specific T cell responses with a dose-dependent trend, highlighting its consistent immune activation capability. Preliminary anti-tumor activity signals, including partial response (PR) and stable disease (SD), were observed in patients who had failed multiple lines of standard-of-care therapies, suggesting potential clinical activity. These findings provide early clinical validation of EVM16 and reinforce its differentiated mechanism as a personalized mRNA cancer vaccine. While immunotherapies, including checkpoint inhibitors, have transformed the treatment landscape in selected tumor types, most patients, particularly those with heavily pretreated advanced solid tumors, still represent a significant unmet medical need. Personalized mRNA cancer vaccines represented by EVM16 may help expand the population benefiting from immunotherapy and provide additional treatment options.” “The favorable safety, tolerability, immunogenicity, and preliminary efficacy results for EVM16 provide initial evidence of its therapeutic potential and support the clinical value of our in-house mRNA platform,” said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Patients with advanced solid tumors, particularly those who have failed multiple lines of therapy, continue to suffer from limited treatment options. As our first in-house developed personalized mRNA cancer vaccine, EVM16 demonstrates the ability to induce immune activation and generate neoantigen-specific T cell responses, which may help reduce the risk of tumor metastasis or recurrence. This further underscores its potential as a novel approach in cancer immunotherapy. This project is powered by EVER-NEO-1, Everest’s proprietary AI-based neoantigen prediction algorithm. It analyzes patient-specific tumor mutations to identify highly immunogenic neoantigens and support the design of personalized mRNA vaccine candidates. The algorithm incorporates iterative learning capabilities designed to continuously improve neoantigen prediction accuracy and selection efficiency. Leveraging our leading mRNA platform, we will continue to advance the clinical development of EVM16 and bring this innovative therapy to more patients.”Everest Medicines has localized its clinically validated proprietary AI+mRNA platform, establishing an end-to-end integrated platform spanning antigen design, mRNA sequence optimization, lipid nanoparticles (LNP) targeted delivery and scalable manufacturing, with the potential to address significant unmet medical needs globally.EVM16 is a novel personalized therapeutic mRNA cancer vaccine in-house developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest’s proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. The vaccine uses a lipid nanoparticle (LNP) delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth.From an investment and market perspective, personalized cancer vaccines are in an early stage of breakthrough. According to Grand View Research, the global personalized cancer vaccine market is projected to reach $1.45 billion by 2030, with a staggering compound annual growth rate (CAGR) of 44.86% from 2025 to 2030. Myguide Securities points out that mRNA cancer vaccines have the potential to achieve pan-cancer coverage while offering the advantages of high accessibility, “off-the-shelf” availability, and personalization. As a highly promising new form of immunotherapy, it can enter clinical use as adjuvant therapies through extensive combinations, gradually unlocking a market space worth tens of billions of dollars.Against this backdrop, Everest Medicines is accelerating its strategic positioning in this field, progressively building a research and development pipeline with global competitiveness. Leveraging its proprietary AI+mRNA platform and its leading clinical position in China, Everest Medicines is currently at a critical juncture for industrialization and valuation growth. The upcoming readout of first-in-human (FIH) clinical trial data for EVM16 is expected to further release clinical and commercial potential, continuing to attract focus from the market and investors, and helping the company achieve a significant leap in value within the immunotherapy sector. Copyright 2026 ACN Newswire via SeaPRwire.com. All rights reserved. www.acnnewswire.com
