Hanyang Securities reported on the 24th that in the ongoing clinical trial of the CAR-T therapy by SCM Lifescience, 6 out of 7 patients achieved complete remission (CR), and Phase 2 data is expected to be released in the second quarter.
SCM Lifescience is a cell therapy development company. It is developing treatments for acute pancreatitis, atopic dermatitis, and chronic graft-versus-host disease. Its affiliate (majority shareholder) ‘CoImmune’ is developing a CAR-T therapy targeting acute lymphoblastic leukemia.
Byungyong Oh, a researcher at Hanyang Securities, stated in the report, “Among these, the CAR-T therapy for acute lymphoblastic leukemia is the most highly anticipated by the market,” adding, “This is because it is an allogeneic CAR-T therapy with low production costs, and in a previous Phase 1 clinical trial, an impressive 18 out of 27 patients (66.7%) achieved complete remission (CR).”
Researcher Oh added, “The time has come to focus on the ongoing Phase 2 clinical trial of the CAR-T therapy,” and said, “According to the latest data from CoImmune, a total of 10 patients have been dosed in Phase 2, 7 are evaluable, and 6 out of those 7 (85.8%) are in complete remission (CR). The interim results of this Phase 2 trial are scheduled to be disclosed in the second quarter.”
He predicted, “Since Phase 2 involves high-dose repeated administration, it is expected to be more effective than Phase 1, and approximately data from more than 10 patients will be announced.”
The second anticipated milestone is the Phase 2 clinical trial results of the atopic dermatitis treatment. SCM Lifescience began patient recruitment in February 2021 and completed the trial in October last year, about two years later. Data is currently being compiled, and the final results are expected to be announced by the end of May this year.
He explained, “Since 13 out of 19 patients showed improvement in atopic symptoms in Phase 1, this data release is also highly anticipated,” adding, “Although the atopic dermatitis market is dominated by Sanofi’s Dupixent, the company’s treatment is affordable and aims for a fundamental cure with just a single administration. Handok is contracted to conduct Phase 3 trials.”
Additionally, there are two more upcoming catalysts in May. SCM Lifescience submitted a paper on the results of the Phase 1/2a clinical trial for acute pancreatitis, announced last year, to ‘Gastroenterology’ (impact factor 33.9), one of the world’s top academic journals. It is scheduled to be published in Gastroenterology in May.
He added, “Moreover, the Phase 1/2a acute pancreatitis paper will be presented at the Digestive Disease Week (DDW) held in the United States from May 6 to 9,” and noted, “For reference, the Phase 1/2a acute pancreatitis paper was presented at the Korean Digestive Disease Week (KDDW 2022) held in Korea last December, where it was selected as the best abstract, leading to a sharp rise in the stock price.”
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