SCM-CGH / SCM Lifescience - LARVOL DELTA

SCM Life Sciences: “GVHD Phase 2 failed to prove efficacy…significant” [Google translation] (Nate) - P2 | N=84 | NCT04189432 | Sponsor: SCM Lifescience Co., LTD. | "SCM Life Science has confirmed partial efficacy and safety in phase 2 clinical trials for the treatment of graft-versus-host disease (GVHD). However, it failed to demonstrate statistical significance in the overall response rate. It plans to continue research to shed light on the efficacy of SCM-CGH based on the key data and experience acquired in phase 2 clinical trials....SCM Life Science announced on the 7th that it has completed phase 2 clinical trials for 'SCM-CGH', a stem cell treatment for chronic graft-versus-host disease, and confirmed the safety and efficacy results....As a result of the efficacy evaluation, the overall response rate at 12 weeks, which was the primary efficacy evaluation variable, did not show a statistically significant difference (p>0.05), failing to prove clinical efficacy."

P2 data • Chronic Graft versus Host Disease

SCM Life Science, expectations for commercialization of stem cell source technology next year [Google translation] (Money Today) - "SCM Life Science announced on the 28th that the phase 2 clinical trial of 'SCM-CGH', a stem cell treatment candidate for chronic graft-versus-host disease, is progressing smoothly and that it plans to announce clinical results as early as the second half of 2024."

P2 data • Chronic Graft versus Host Disease

Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: SCM Lifescience Co., LTD. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Sep 2024 | Trial primary completion date: Mar 2022 ➔ Mar 2024

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

SCM Life Sciences completes patient registration for phase 2 clinical trial of graft-versus-host disease treatment candidate [Google translation] (The Economist) - "SCM Life Science announced on the 21st that it has recruited all patients to participate in the phase 2 clinical trial of 'SCM-CGH', a stem cell treatment candidate for chronic graft-versus-host disease (cGvHD). The company said, 'We have secured 84 clinical participants and recently completed the first administration for the last patient'....SCM Life Sciences plans to obtain product approval for SCM-CGH and sell it within 2025."

Enrollment closed • Launch non-US • Non-US regulatory • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - P2; N=77; Recruiting; Sponsor: SCM Lifescience Co., LTD.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Mar 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

CHA Biotech to make SCM Lifescience’s advanced cell therapies [Google translation] (Korea Biomedical Review) - "CHA Biotech said Tuesday that it has agreed to manufacture SCM Lifescience’s cell therapies using bone marrow. Under the accord, CHA Biotech will make its partner’s...SCM-CGH, for chronic graft versus host disease through subsidiary CHA BioLab....The two partners believe the two drugs to receive conditional use authorization from the regulators after completing the phase 2 studies....'Although we have a GMP-certified facility licensed to manufacture advanced biopharmaceuticals, we hope to accelerate commercialization after receiving conditional approval by completing the studies with CHA Biotech'."

Licensing / partnership • Graft versus Host Disease