Taipei, Taiwan, October 13, 2020 — Steminent Biotherapeutics Inc. (President & CEO; Dr. Ling-Mei Wang) and SCM Lifescience Co., Ltd. (KOSDAQ: 298060, hereinafter SCM Lifescience, CEO: BG Rhee) today announced they have signed an exclusive license agreement for clinical development and commercialization of Steminent’s allogeneic cell therapy candidate; Stemchymal® for the treatment of Polyglutamine Spinocerebellar Ataxia (PolyQ SCAs) in South Korea.
Under the agreement, Steminent Biotherapeutics will receive an undisclosed up-front payment, regulatory milestone payments, and a double-digit royalty on annual sales. Stemchymal® for treating PolyQ SCA (ODD in the US and Japan) is in Phase II clinical development within the US, Taiwan and Japan (partner REPROCELL). Steminent will continue to pursue partnering plans for Stemchymal® PolyQ SCA advanced development and commercialization for the US, Europe and rest of world.
It is estimated that approximately 4,000 patients are suffering from SCA in South Korea, with global prevalence estimated at 300,000; however, no effective treatment has been developed so far. A medical petition to the Blue House of South Korea in 2018 stated; ‘we desperately need medicine and infrastructure for cerebellar atrophy and multiple system atrophy’, underscoring this unmet medical need.
“Steminent Biotherapeutics is very pleased to partner with SCM Lifescience; one of the leading cell therapy and regenerative medicine development companies in South Korea, for the purpose of advancing our Stemchymal® cell therapy for treating SCA patients in the Korean market.” said Dr. Ling-Mei Wang, President & CEO. “Patients suffering from spinocerebellar ataxia, a debilitating neurodegenerative disease, currently have no effective treatment options.”
“We are excited to partner with Steminent Biotherapeutics Inc. for the development of this US and Japan acknowledged ODD cell therapy candidate for PolyQ SCA, and to add Stemchymal® into our pipeline,” said BG Rhee, Chief Executive Officer of SCM Lifescience. He continued that, “We hope to bring this therapy to market in the near future to benefit those patients in need.”
As the Advanced Regenerative Biopharmaceutical Act was implemented and activated last August, 2020 in South Korea, Stemchymal® for SCA, with an orphan drug designation, may be eligible for conditional marketing approval by 2023 after the completion of a Phase II clinical trial and thereby potentially offer a new treatment option for SCA patients sooner.
About SCM Lifescience
SCM Lifescience Co., Ltd. (KOSDAQ: 298060) is a publicly listed, clinical-stage biopharmaceutical company specializing in the development of innovative stem cell and immune cell therapeutics. The company is using its proprietary subfractionation culturing method to isolate homogeneous population of clonal mesenchymal stem cells, serving as basis to its stem cell pipelines: SCM-CGH for treatment of chronic graft-versus-host disease, and SCM-AGH for treatment of atopic dermatitis and acute pancreatitis. It has recently expanded into the immuno-oncology sector through its U.S.-based subsidiary, CoImmune, incorporating allogeneic, non-viral use CAR-CIK, and dendritic cell cancer vaccine into its pipeline. With strong capabilities around cell therapy research and development and the US-based cGMP manufacturing facility, SCM Lifescience is focused on accelerating product candidates through clinical trials to provide benefits to patients in high unmet medical needs.
About Steminent Biotherapeutics Inc.
Steminent Biotherapeutics Inc. is the leading stem cell clinical development company in Taiwan; with subsidiaries in San Diego and Shanghai, dedicated to the development of their novel cellular therapeutic platform for the treatment of diseases with unmet or under-served medical needs. Steminent utilizes advanced, proprietary processes and know how to isolate, purify, amplify and manufacture standardized stem cell products of the highest quality, which have been approved for research and clinical development by the USFDA, Taiwan FDA and Japan PMDA.
Steminent’s Stemchymal® allogeneic cell therapy R&D program has generated a portfolio of clinical stage therapeutic candidates for multiple diseases including: Phase II; Spinocerebellar Ataxia (PolyQ SCA), Phase I; Osteoarthritis of the Knee, and Phase I: Acute Liver Failure, and rationale for treating SARS-CoV-2 related indications.
Stemchymal® is Steminent’s platform technology produced standardized allogeneic stem cells isolated from human adipose tissues in accordance with regulatory guidelines and stringent quality control criteria for pharmaceutical clinical grade therapeutics. Stemchymal® SCA is an FDA and PMDA orphan designated drug (ODD) candidate for polyQ SCA.
Dr. Kevin Ho
Steminent Biotherapeutics Inc., Taipei, Taiwan
Steminent USA, San Diego, CA
E-Mail: [email protected]