Everest Medicines will present the first-in-human trial data of its mRNA personalized cancer therapeutic vaccine EVM16 at the 2026 AACR Annual Meeting

Shanghai, China – March 31, 2026 – Everest Medicines (HKEX 1952.HK, hereinafter referred to as the “Company”), a biopharmaceutical company focused on innovative drug research and development, clinical development, manufacturing, and commercialization, announced today that it will present the first-in-human trial data of EVM16, its self-developed mRNA personalized cancer therapeutic vaccine, at the 2026 American Association for Cancer Research (AACR) Annual Meeting. The AACR Annual Meeting is one of the largest and most influential academic conferences in the global oncology field. The 2026 AACR Annual Meeting will take place from April 17 to 22, 2026, in San Diego, United States.

The data being presented in poster format are from the first-in-human trial of EVM16 as monotherapy and in combination with the PD-1 antibody (tislelizumab) for the treatment of advanced solid tumors. This clinical trial project, EVM16CX01 (NCT06541639), was jointly initiated by Peking University Cancer Hospital and Fudan University Shanghai Cancer Center, with the first patient dosing completed in March 2025.

EVM16 is an innovative mRNA personalized cancer therapeutic vaccine independently developed by Everest Medicines, driven by AI algorithms for identifying tumor neoantigens. Based on each patient’s unique tumor cell mutations, the company uses its proprietary and self-iterative EVER-NEO-1 'Magic Calculation' tumor neoantigen artificial intelligence system to identify neoantigens with high immunogenicity and designs an mRNA therapeutic vaccine encoding dozens of these neoantigens. Preclinical studies have shown that it can effectively activate neoantigen-specific T cells and significantly inhibit tumor growth while demonstrating good safety and tolerability.

Data Summary

Reference Number: CT122

Title: First-in-human (FIH) study of EVM16, a personalized mRNA neoantigen vaccine, as monotherapy and in combination with tislelizumab in advanced solid tumors

First-in-human study (FIH) of EVM16 (a personalized mRNA neoantigen cancer vaccine) as a monotherapy and in combination with tislelizumab for the treatment of advanced solid tumors

Summary: Aims to evaluate the safety, tolerability, and immunogenicity of EVM16 in patients with advanced solid tumors.

Lead author: Lin Shen, Peking University Cancer Hospital

Local time: April 20, 2026, 2:00 PM - 5:00 PM

About the EVM16CX01 Study

This study is a dose escalation and expansion study evaluating the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with a PD-1 antibody for the treatment of subjects with advanced or recurrent solid tumors. It is also the first-in-human trial of EVM16. The primary objectives include assessing the safety and tolerability of EVM16 as a monotherapy and in combination with a PD-1 antibody in subjects with advanced or recurrent solid tumors, and determining the recommended Phase II dose (RP2D) of EVM16. Secondary objectives include evaluating the immunogenicity of EVM16 in subjects with advanced or recurrent solid tumors, and assessing the preliminary efficacy of EVM16 in combination with a PD-1 antibody in these subjects.

About EVM16

EVM16 is a novel personalized mRNA cancer vaccine independently developed by Everest Medicines. EVM16 is prepared using linearized plasmid DNA derived from a seed bank as a template, followed by in vitro transcription, purification, and sterile filtration to produce the mRNA bulk solution. Lipid nanoparticle (LNP) technology is used to encapsulate the mRNA bulk solution within nanoscale lipid particles composed of specific lipid components, with other excipients added during sterile filling. Based on each patient's unique tumor cell mutations, EVM16 uses the company's proprietary EVER-NEO-1 'Smart' Neoantigen AI algorithm to identify neoantigens with high immunogenic potential. The LNP delivery system delivers mRNA capable of efficiently expressing neoantigens into the human body. After vaccination with EVM16 injection, the mRNA is delivered into cells to generate neoantigen peptides, inducing a neoantigen-specific T-cell immune response that kills and clears tumor cells expressing the neoantigens, thereby suppressing tumor growth and treating cancer.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on innovative drug research and development, clinical development, manufacturing, and commercialization, committed to addressing unmet medical needs in global markets. The management team of Everest Medicines possesses deep expertise and extensive experience from leading pharmaceutical enterprises in China and globally. The company owns a commercial-scale global production base in Jiashan, Zhejiang, constructed strictly in accordance with the GMP requirements of the National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), as well as the WHO PQ standards.

The company focuses on disease treatment areas such as autoimmune disorders, ophthalmology, critical care, and CKM (cardiovascular, kidney, and metabolic diseases). It has built a commercial platform integrating an omnichannel commercial system and full lifecycle commercial capabilities for pharmaceuticals. Based on its proprietary mRNA platform with global rights, the company is advancing existing pipelines, including mRNA in vivo CAR-T and mRNA tumor vaccines. Additionally, through the introduction and ecosystem incubation of promising platforms, Everest Medicines continues to expand its R&D capabilities while strengthening its global footprint to accelerate international development. For more information, please visit the company's official website: www.everestmedicines.com.

Forward-Looking Statements

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