Tempus Expands Multi-Year Moderna-Merck Collaboration on Intismeran

Tempus announced on October 7, 2026, an expanded, multi-year collaboration with Moderna and Merck, known as MSD outside the United States and Canada, to support the potential commercialization of intismeran autogene (V940/mRNA-4157), an investigational mRNA-based individualized neoantigen therapy being evaluated in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma and other cancer types. Financial terms of the collaboration were not disclosed.

Under the collaboration, Tempus will manage the timely collection and transfer of tumor tissue and blood samples required for next-generation sequencing (NGS). Subject to applicable regulatory approvals, Tempus will also provide NGS services to support the intismeran autogene design and manufacturing process. Intismeran autogene is jointly developed by Moderna and Merck. Tempus said the expanded arrangement builds on joint efforts the companies initiated last year.

“Bringing an individualized therapy like intismeran autogene from clinical development toward potential commercialization requires a seamless, highly reliable diagnostic network,” said Said Francis, Moderna’s Chief Business Officer and General Manager, Individualized Neoantigen Therapies. “Working with Tempus allows us to leverage their commercial footprint and advanced sequencing capabilities as we work to deliver individualized neoantigen therapies to patients at scale.”

Jannie Oosthuizen, President, Global Oncology and MSD International, said every individualized neoantigen treatment is designed around the biology of an individual patient’s tumor, which requires a carefully coordinated end-to-end process from collecting a patient’s tumor sample and generating sequencing data to designing and manufacturing an individualized therapy. Oosthuizen said collaborations like the one with Tempus are helping build the infrastructure needed to bring the approach to patients.

“Individualized therapies represent the future of precision medicine, but delivering on their promise requires an end-to-end clinical workflow that works in the real world,” said Eric Lefkofsky, founder and CEO of Tempus. “By combining our operational scale and deep clinical integration with Merck and Moderna’s mRNA innovation, we are building the infrastructure needed to bring individualized cancer vaccines to patients.”

Tempus describes itself as a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, with one of the world’s largest libraries of multimodal data and an operating system to make that data accessible and useful.

Phase 3 INTerpath-001 Results

The expanded collaboration follows positive topline results that Merck and Moderna announced on August 19, 2026, from the Phase 3 INTerpath-001 trial evaluating adjuvant intismeran in combination with KEYTRUDA in patients with completely resected stage IIB-IV melanoma. At a pre-specified interim analysis, the trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS) in patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not undergone prior treatment with systemic therapy. Merck and Moderna described the readout as the first positive Phase 3 result for an individualized neoantigen therapy and for an mRNA-based cancer therapy, and the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone, a standard-of-care immunotherapy, in the adjuvant setting for patients with resected melanoma.

The companies stated that the safety profiles of intismeran and KEYTRUDA in the trial were consistent with those observed in previously reported studies for the combination, with no new safety signals observed. In accordance with the trial protocol, the study will continue to evaluate other key secondary endpoints, including overall survival. Merck and Moderna plan to present the data at an upcoming international medical meeting, share them with regulatory authorities, and engage with regulators on filing submissions for intismeran in combination with KEYTRUDA.

Trial Design and Development Program

INTerpath-001 (NCT05933577) is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial. It enrolled 1,137 patients who, following complete surgical resection, were randomized 2:1 to receive intismeran at 1 mg every three weeks for up to nine doses plus KEYTRUDA at 400 mg every six weeks for up to nine cycles, versus KEYTRUDA alone, continuing until disease recurrence or unacceptable toxicity, for a total treatment duration of up to approximately 56 weeks. The primary endpoint is RFS, defined as the time from randomization to any disease recurrence (local, locoregional, regional or distant) as assessed by the investigator, or death due to any cause. Key secondary endpoints include DMFS, overall survival, safety, tolerability and quality of life.

The Phase 3 readout builds on previously reported Phase 2b results from the KEYNOTE-942/mRNA-4157-P201 trial. Five-year follow-up data presented at the 2026 ASCO Annual Meeting showed the combination demonstrated a 49% reduction in the risk of recurrence or death (HR=0.51; 95% CI, 0.294-0.887) and a 59% reduction in the risk of distant metastasis or death (HR=0.411; 95% CI, 0.200-0.843) compared to KEYTRUDA alone, according to Merck and Moderna’s August announcement.

Merck and Moderna are advancing the broader INTerpath clinical development program, which evaluates intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The program consists of nine total Phase 2 and Phase 3 trials across tumor types including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma, alongside the Phase 2b KEYNOTE-942 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative non-small cell lung cancer.

Each intismeran therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is designed and produced using a patient’s tumor sample to identify the unique mutational signature of their cancer. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Under the collaboration announced October 7, 2026, Tempus’s role covers the sample-driven steps of that per-patient process: managing the collection and transfer of the tumor tissue and blood samples required for sequencing and, subject to regulatory approvals, providing the NGS services that support the design and manufacturing of each individualized therapy.