RHX-317 / Rheos Medicines - LARVOL DELTA

Rheos Medicines Receives FDA “Study May Proceed” Letter to Initiate Phase 1 Clinical Study Under its Investigational New Drug Application for RHX-317 for Treatment of Autoimmune and Inflammatory Diseases (Businesswire) - "Rheos Medicines...today announced receipt of a 'Study May Proceed' letter from the U.S. Food and Drug Administration for a Phase 1 study under the Company’s Investigational New Drug (IND) application for RHX-317, a MALT1 inhibitor. The Phase 1 clinical trial in healthy volunteers will assess the safety, pharmacokinetics and pharmacodynamic responses of RHX-317 as a novel therapeutic strategy to treat autoimmune and inflammatory diseases, including chronic graft-versus-host disease (cGVHD). The trial is expected to initiate in 2H 2022....'FDA clearance of the IND for RHX-317 marks an important milestone for our lead program. Based on the preclinical data for RHX-317...'"

IND • New P1 trial • Chronic Graft versus Host Disease • Graft versus Host Disease

Rheos Medicines Presents New Data Supporting MALT1 Inhibition as Novel Strategy for Precision Medicine-Based Approach to Treating Chronic Graft-Versus-Host Disease (Businesswire) - "Rheos Medicines...today announced new preclinical data supporting MALT1 inhibition as a novel approach for the treatment of chronic Graft-Versus-Host Disease (cGVHD) and the use of differential metabolic pathway analysis to subset patients in this heterogeneous population. Rheos’s lead product candidate, RHX-317, is a novel, small molecule MALT1 inhibitor initially in development for the treatment of chronic GVHD. The data will be presented at the 63rd Annual Meeting of the American Society of Hematology (ASH), being held in Atlanta and virtually, December 11-14, 2021."

Preclinical • Chronic Graft versus Host Disease • Graft versus Host Disease

Rheos Medicines Forms Research Collaboration With CRYOSTEM to Evaluate MALT1‑Targeted Therapeutics for Graft-versus-Host-Disease (Businesswire) - "Rheos Medicines...today announced a research collaboration with the French non-profit research organization CRYOSTEM. The goal of the research collaboration is to provide biological resources from HSCT (Hematopoietic Stem Cell Transplantation) patients in order to evaluate MALT1-targeted therapeutics, including Rheos’s lead product candidate, RHX-317, for Graft-versus-Host Disease (GvHD), based on functional immunologic profiling of patients and identification of molecular signatures for MALT1 activity....Under the terms of the research collaboration, CRYOSTEM will provide Rheos with biological resources for post-transplant patients in three categories: those who developed acute GvHD, those who developed chronic GVHD, and those who did not develop GvHD."

Licensing / partnership • Chronic Graft versus Host Disease • Graft versus Host Disease