EVM14 / Everest Medicines - LARVOL DELTA

Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Everest Medicines (Beijing) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Oncology • Solid Tumor

The first patient had received the first dose of EVM14 injection in a global, multi-center Phase I clinical trial of Everest Medicines' Tumor-Associated Antigen (TAA) Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States, marking an important milestone in its global clinical development. (The Manila Times) - "Monotherapy dose escalation is expected to be completed in 2026, with initial safety and tolerability data anticipated."

P1 data • Trial status • Lung Non-Small Cell Squamous Cancer • Squamous Cell Carcinoma of Head and Neck

Discovery and pharmacological evaluation of EVM14, a novel mRNA cancer vaccine encoding five TAAs targeting multiple cancer types (SITC 2025) - "The combination of EVM14 with ICIs significantly enhanced the anti-tumor activity. EVM14 is planning to enter Phase I trial in 2025."

IO biomarker • Oncology

Everest Medicines…announced that the first patient has been enrolled in a global multi-center Phase I clinical trial of its Tumor-Associated Antigen Cancer Vaccine EVM14 at NEXT Oncology Virginia in the United States. (The Manila Times) - "In the global multi-center Phase I clinical trial of EVM14, participating clinical sites include NEXT Oncology Virginia, MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center in the United States and Shanghai Chest Hospital in China, among others."

Trial status • Solid Tumor

Everest Medicines Announces NMPA Approval of IND Application for Tumor-Associated Antigen Cancer Vaccine EVM14 (PRNewswire) - "EVM14, an off-the-shelf therapeutic mRNA cancer vaccine, is developed based on Everest Medicines' proprietary mRNA platform. It is formulated with mRNA encoding 5 tumor-associated antigens (TAAs) and is designed to treat various squamous cell carcinomas, including squamous non-small cell lung cancer (sq-NSCLC) and head and neck squamous cell carcinoma (HNSCC)."

New trial • Lung Non-Small Cell Squamous Cancer • Squamous Cell Carcinoma of Head and Neck

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

Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors (clinicaltrials.gov) - P1/2 | N=94 | Not yet recruiting | Sponsor: Everest Medicines (Beijing) Co., Ltd.

Monotherapy • New P1/2 trial • Oncology • Solid Tumor

Everest Medicines Announces Successful Release of First Clinical Batch of Tumor-Associated Antigen Vaccine EVM14 at Jiashan Manufacturing Site (PRNewswire) - "Everest Medicines...announced the successful release of the first clinical batch of EVM14, a Tumor-Associated Antigen (TAA) vaccine, from its Jiashan manufacturing site, Zhejiang Province in China. This batch will support the clinical trials of EVM14 in both China and the United States (US)....This release marks another milestone in advancing Everest's proprietary mRNA platform with end-to-end capabilities spanning antigen design, lipid nanoparticle (LNP) based delivery, CMC process development and GMP manufacturing, laying a solid foundation for future pipeline progression and commercialization."

Commercial • Solid Tumor

Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14 (PRNewswire) - "Everest Medicines...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine....EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer....In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion - all well correlated with its anti-tumor activity."

IND • Preclinical • Head and Neck Cancer • Non Small Cell Lung Cancer