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Moderna Announces Presentation of Interim Data from Phase 1 Study of mRNA Triplet Program at 2021 SITC Annual Meeting
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and
About this update from Moderna, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced interim data from an ongoing Phase 1 clinical study of mRNA-2752 (Triplet) in patients with accessible solid tumors and lymphomas. The data showed that the Company’s mRNA Triplet program given in combination with AstraZeneca’s durvalumab (IMFINZI®) was tolerated at all dose levels tested and elicited evidence of anti-tumor activity. The recommended dose for expansion (RDE) is up to of 8mg mRNA-2752 + durvalumab.\n\n“We are encouraged by the interim data from our Triplet program, which combines three mRNAs into one therapy injected directly into the tumor. Our intratumoral mRNA technology allows for the delivery of mRNAs encoding for multiple proteins that act locally to modulate the tumor microenvironment, without systemic toxicity,” said Praveen Aanur, M.D., Vice President, Therapeutic Area Head for Oncology Development at Moderna. “These interim results demonstrate the potential role of immune modulation on clinical outcomes and we look forward to full results from the dose expansion arm of the study.”\n\nPresented today at the Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting, the study demonstrates evidence of immunomodulation and expected pharmacodynamics in the tumour immune microenvironment (TME) of both injected and un-injected lesions, in both monotherapy and combination cases, as indicated by increases in proliferating (activated) T cells, PD-L1 levels (marker of interferon signaling), and T cell-inflamed (GEP) and DC transcriptional signature score, with greatest changes observed in patients with clinical benefit.\n\nThis Phase 1 open-label, multicenter, dose-escalation study is evaluating the safety and tolerability of escalating intratumoral injections of mRNA-2752 alone and in combination with PD-L1 inhibitor (durvalumab) to define the maximum tolerated dose (MTD) or a recommended dose for expansion (RDE). The study consists of dose escalation and dose confirmation parts, which will occur in Arm A and Arm B, followed by a dose expansion part, which will occur in Arm B, and a Dose Exploration in Arm C as a neoadjuvant therapy for cutaneous melanoma. The Company presented the interim results of Part A at the 2020 ASCO Annua...