EVM 16 / Everest Medicines - LARVOL DELTA

EVM16CX01: EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Peking University | Trial completion date: Jun 2028 ➔ Dec 2028

Trial completion date • Oncology • Solid Tumor

First-in-human (FIH) study of EVM16, a personalized mRNA neoantigen vaccine, as monotherapy and combination with tislelizumab in advanced solid tumors (AACR 2026) - "EVM16 has demonstrated favorable safety and tolerability, robust immunogenicity, and promising efficacy signals, supporting further development. Subsequent studies are planned to explore the efficacy of EVM16 in early-stage treatment settings such as first-line and adjuvant therapies."

First-in-human • Metastases • Monotherapy • P1 data • Tumor-specific neoantigens • Esophageal Squamous Cell Carcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

Everest Medicines Announces Positive First-in-Human Data for Personalized mRNA Cancer Vaccine EVM16 at AACR 2026 (ACN Newswire) - "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."

First-in-human • P1 data • Esophageal Squamous Cell Carcinoma • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer

AACR 2026: EVM16 First-in-Human Data Demonstrate a Favorable Safety Profile, Robust Immunogenicity, and Promising Preliminary Efficacy (DGAP-EQS Group) - "As of December 7, 2025, a total of 9 patients had been enrolled, each dose level consisting of 3 patients. All had completed the DLT assessment and undergone at least one efficacy evaluation...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."

First-in-human • P1 data • Esophageal Squamous Cell Carcinoma • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer

Everest Medicines Announces Interim Results for First Half of 2025 (PRNewswire) - "EVM18, the in vivo CAR-T program, has completed multiple non-human primates (NHPs) trials and achieved preclinical proof-of-concept, with first-in-human data expected to initiate by the end of 2025....We expect to enroll first patient in the EVM14 program in the U.S. in the second half of 2025. We expect to receive IND approval on EVM14 from China's NMPA in the second half of 2025. We expect to achieve preclinical candidate milestone in the mRNA in vivo CAR-T program in the second half of 2025. We expect to complete patient enrollment of EVM16 IIT study in the second half of 2025."

New trial • Trial status • Oncology • Solid Tumor

EVM16CX01: EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Peking University | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2024 ➔ Mar 2025

Enrollment open • Trial initiation date • Oncology • Solid Tumor

Everest Medicines Announces First Patient Dosed with EVM16, Its First Internally Developed Personalized mRNA Cancer Vaccine (PRNewswire) - "Everest Medicines...announced that the first patient has been dosed with the Company's internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01. EVM16CX01 is the first-in-human (FIH) trial for EVM16, conducted jointly at Peking University Cancer Hospital and Fudan University Shanghai Cancer center, to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 as a monotherapy and in combination with a PD-1 antibody in patients with advanced or recurrent solid tumors."

Trial status • Solid Tumor

Everest Medicines Announces the Initiation of an Investigator-Initiated Clinical Trial (IIT) for Personalized mRNA Cancer Vaccine Program EVM16 (PRNewswire) - "Everest Medicines...announced the launch of an Investigator-Initiated Clinical Trial (IIT) for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human (FIH) trial for EVM16."

Trial status • Solid Tumor

EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Not yet recruiting | Sponsor: Peking University

Metastases • New P1 trial • Oncology • Solid Tumor