Everest Medicines announced that the first-in-human (FIH) clinical trial data of EVM16, a proprietary personalised 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 tumours. The results demonstrated that EVM16 has a favourable safety and tolerability profile, robust immunogenicity, and promising preliminary efficacy in patients with advanced solid tumours, supporting its further clinical development.
The clinical trial (EVM16CX01, NCT06541639) was conducted jointly by Peking University Cancer Hospital and Fudan University Shanghai Cancer Centre, 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 tumours. 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 tumours 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 oesophageal 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.
