mRNA-4359

Moderna has shared early data in patients with an advanced form of skin cancer who received its cancer antigen therapy designed to elicit targeted T cell responses. The biotech’s mRNA-4359 combined with Merck’s PD-1 inhibitor Keytruda achieved a 24% overall response rate and a 60% disease control rate in 29 melanoma patients enrolled in a Phase 1/2 study. The participants had previously tried and failed at least one checkpoint inhibitor therapy, according to Sunday’s release . A subgroup of nine evaluable patients with PD-L1-positive tumors had a particularly strong response to treatment, with the ORR sitting at 67%. Moderna said its candidate successfully triggered antigen-specific T cell responses and novel T cell receptor clones in this cohort. Moderna plans to present the data on Friday at the European Society for Medical Oncology’s annual meeting in Berlin. Notably, there were zero responses in the 13 patients with no PD-L1 expression, according to an abstract published on Monday on the ESMO website. Moderna said the data “support PD-L1 as a potential predictive biomarker” for the treatment. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Jeremy Hanna. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Kyle Holen, Moderna’s head of development for therapeutics and oncology, said in the release that checkpoint inhibitors serve to restore broad T cell activity, but cancer antigen therapies (CAT) can induce T cells directed toward a particular target. That’s because the CATs encode epitopes of specific resistance pathways, he said. Moderna’s asset encodes for the PD-L1 and IDO1 pathways. The candidate also has a second mechanism of action, which depletes the immunosuppressive cells that “shield” cancers from the immune system. It has now advanced to the Phase 2 part of the study. At Bernstein’s strategic decisions conference last month, Moderna’s head of research Rose Loughlin described mRNA-4359 as having “pipeline-in-a-product” potential. She also mentioned plans to expand into other disease settings, including first-line non-small cell lung cancer and first-line melanoma. Editor’s note: This article was updated to add more information from an ESMO abstract.