Moderna Shares Jump More Than 90% After Cancer Vaccine Shows Positive Phase 3 Results
Key Takeaways
- •Moderna said intismeran autogene produced positive Phase 3 results in melanoma, sending the stock up more than 90%.
- •The therapy is a personalized mRNA cancer treatment developed with Merck and previously known as mRNA-4157 or V940.
- •The FDA granted Breakthrough Therapy Designation to the combination with KEYTRUDA in February 2023 after Phase 2b data showed a 44% lower risk of recurrence or death versus KEYTRUDA alone.
- •The program is being studied in Phase 3 trials for resected high-risk melanoma and non-small cell lung cancer.
- •No individualized neoantigen therapy has yet been approved, and key questions remain around manufacturing speed, cost, and scale.
Moderna shares surged more than 90% after the company reported positive Phase 3 results for its investigational mRNA cancer therapy, intismeran autogene, which is being developed with Merck for the treatment of melanoma (CNBC-TV18, August 19, 2026). The move comes after a multi-year decline that had left the stock far below its pandemic-era highs, with attention long since shifted to whether Moderna's mRNA platform can succeed beyond COVID-19.
About the therapy
Intismeran autogene, formerly designated mRNA-4157 (V940), is an individualized neoantigen therapy (INT). The approach is personalized to each patient: neoantigens identified through sequencing of an individual's tumor are encoded in an mRNA construct, which is intended to train the immune system to recognize and attack mutations specific to that patient's cancer.
The candidate is being studied in combination with KEYTRUDA (pembrolizumab), Merck's anti-PD-1 immunotherapy and one of the world's best-selling cancer medicines. In February 2023, the US Food and Drug Administration granted the combination Breakthrough Therapy Designation based on data from the Phase 2b KEYNOTE-942 trial in patients with resected high-risk melanoma; in that trial, the combination reduced the risk of recurrence or death by 44% compared with KEYTRUDA alone. The companies have since advanced the program into Phase 3 testing, with INTerpath-001 in resected high-risk melanoma and a separate study, INTerpath-002, in non-small cell lung cancer.
No individualized neoantigen therapy has yet received regulatory approval, which places the Moderna–Merck candidate among the furthest advanced in an emerging class. BioNTech, Moderna's mRNA peer, is pursuing a similar strategy with autogene cevumeran, an individualized neoantigen therapy partnered with Roche's Genentech. Because every dose of an INT is manufactured from a patient's own tumor mutations, production turnaround time, cost, and scale remain open questions for the class as it moves toward potential commercialization.
The partners
Moderna (Nasdaq: MRNA), headquartered in Cambridge, Massachusetts, built its business on messenger RNA technology and became widely known for its COVID-19 vaccine, Spikevax. The mRNA platform works by instructing cells to produce specific proteins that prime the immune system against a target disease. With Spikevax sales well below their pandemic peak, the company's oncology pipeline now carries particular weight for its outlook.
Merck & Co. (NYSE: MRK), known as MSD outside the United States and Canada, is a major oncology-focused pharmaceutical company. The two companies have collaborated on individualized neoantigen therapies since 2016. KEYTRUDA, now the world's top-selling drug, is expected to lose market exclusivity later this decade, a timeline that has made oncology combinations a focus of Merck's pipeline strategy. Milestones ahead for the program include presentation of the full Phase 3 dataset, clarity on regulatory filing plans, and results from additional tumor types under study.
Source: CNBC-TV18
