Company News
Steminent Biotherapeutics licenses rights to SCM Lifescience to develop Stemchymal® cell therapy for treating spinocerebellar ataxia (SCA) in South Korea
2020/10/13
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® 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.
About Stemchymal®
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.
仲恩生醫 公開信
2019/2/1
仲恩生醫致力於細胞治療新藥開發，期以科學的技術研究及嚴謹的臨床試驗，一步一步達成轉化細胞治療潛能以協助改善病人生活之願景。
近期出現冒用本公司名義事件，包含販售細胞藥物給有需求之病人及利用本公司相關資訊及商標在社群網路上公開招募捐贈者。本公司特此澄清，公司並未公開對外以不當形式延攬捐贈者或發佈相關之訊息，更無販售細胞藥物給病人之情事。針對此類事件，本公司將委任律師深究，必要時將循法律途徑追究不實消息散播者。
仲恩生醫在過去細胞治療新藥開發的十年間，恪守臨床試驗規範，學習及累積寶貴的經驗，未來也將秉持一貫的態度，保障臨床試驗中的參與者，致力推動各項細胞治療的進步，達成改善病人生活之目標。
亞洲首例！FDA核准仲恩在美執行異體幹細胞臨床二期試驗
2018/7/19
仲恩生醫(Steminent Biotherapeutics)今宣布神經退化小腦萎縮症之幹細胞試驗新藥甫獲得美國FDA核准，將進入臨床二期試驗。執行長張志剛表示，仲恩生醫一直是小腦萎縮症之藥物開發領航者，率全球之先已於2015年取得孤兒藥資格 (orphan drug designation)，核准上市將享有7年市場獨家銷售專屬權。此次再獲得FDA核准進入臨床二期的異體間葉幹細胞藥物試驗，不僅是台灣唯一也是亞洲第一家取得美國臨床二期核可，寫下台灣發展再生醫學的重要里程碑。
推動異體間葉幹細胞治療為核心的再生醫學的仲恩生醫，2009年成立迄今致力脂肪間葉幹細胞的新藥開發。其中在罕見疾病的投入更是領先業界，並於2016年授權日本上市公司ReproCELL，共同合作開發小腦萎縮症治療的日本市場。目前也已向日本PMDA正式遞交臨床試驗申請案，目標著眼在未來試驗完成後，依日本再生醫藥專法取得暫時性藥證許可。
仲恩生醫美國執行董事何慧君醫師表示，美國FDA核准仲恩以異體間葉幹細胞新藥的二期臨床的執行，代表著對仲恩生醫技術、品質管理及產品的肯定。神經退化疾病小腦萎縮症目前並沒有任何有效的治療藥物，我們企盼能藉由仲恩生醫在幹細胞治療的技術發展為病患的未來開啟希望之門。醫學科學的研究最終的目的是促使疾病的治療與轉化，臨床應用發展的結果能對病患有實際的幫助，這也正是仲恩公司的核心價值。
仲恩生醫是幹細胞醫藥產業先驅，擁有世界一流的幹細胞研發團隊與技術，更有堅強的國內外學者及醫師專家共同支持公司在科學、臨床及法規遵循的發展。核心技術平台Stemchymal®以領先全球的幹細胞分離、純化、增生技術，應用於自體及異體的脂肪間葉幹細胞治療。仲恩生醫以最嚴謹的製藥規範與品質管理，不斷累積科學實證，並透過國內外頂尖醫學中心臨床試驗證實仲恩生醫的幹細胞產品的安全與療效。除了小腦萎縮症的臨床二期，仲恩亦執行多項幹細胞藥物臨床試驗包括急性肝衰竭的治療，今年並已完成退化性膝關節炎臨床一期試驗。目前正執行異體間葉幹細胞治療小腦萎縮症的台灣二期人體臨床試驗，力拼在2年內完成。
Steminent Announces FDA Approval of IND for Phase II Clinical Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia
2018/7/18
Steminent Biotherapeutics Inc. (Steminent ) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to initiate its Phase II clinical trial for polyglutamine spinocerebellar ataxia (“PolyQ SCA”) to enroll patients at clinical sites in the United States. This is a key milestone for the Company’s international Stemchymal® SCA Phase II clinical trials program.
Dr. Jennifer Ho, Managing Director of Steminent USA, states, “Our Phase II Stemchymal® SCA program includes double blinded, randomized, and placebo-controlled trials to evaluate Stemchymal® SCA for safety and evidence of efficacy for treating PolyQ SCA in three countries. The first of these Phase II trials is currently enrolling patients in Taipei, and now with FDA consent, we are very pleased to initiate this US orphan designated drug trial. ReproCELL, our Japan partner, has also submitted its CTN to the PMDA to assess Stemchymal® SCA in treating PolyQ SCA in Japan.”
“As there are currently no approved treatments for this progressive, irreversible disease, we are encouraged by the possibility that Stemchymal® cell therapy may demonstrate safety and therapeutic benefit in these patients.” said Dr. Susan Perlman, Clinical Director, UCLA Ataxia Center, Professor of Neurology, UCLA, and Medical Director; National Ataxia Foundation, “It is estimated that about 15,000 people in the USA suffer from PolyQ SCA disease.”
The Company manufactures Stemchymal® SCA in Taipei and shipping studies for the US trial have been completed. With this FDA approval, the Company will now focus on preparing the US trial site(s) and starting patient enrollment.
About Stemchymal®
Stemchymal® is the platform technology producing standardized allogeneic stem cells product isolated from human adipose tissues in accordance with regulatory guidelines and stringent quality control criteria for pharmaceutical grade therapeutics. Stemchymal SCA is an orphan designated drug (ODD) candidate for polyQ SCA.
About PolyQ Spinocerebellar Ataxia (PolyQ SCA)
SCAs are rare neurodegenerative diseases that cause progressive difficulty with coordination. In general, the prevalence of SCA is between 2~7/100,000. There are more than 30 subtypes of SCA. PolyQ SCAs including SCA1, SCA2, SCA3, SCA6, SCA7 and SCA17 are caused by an extensive CAG sequence repeat which encodes for expanded polyglutamine residues within the mutated protein.
The age of onset associated with PolyQ SCA disease patients can range from twenty years old to fifty years of age. In addition to being a life-threatening disease for the patient, the patient’s handicap and dependency during the extended disease course also put a heavy burden on the patient’s family and healthcare providers.
About Steminent
Steminent Biotherapeutics Inc. is the leading stem cell clinical development company in Taipei, with subsidiaries in San Diego and Shanghai, dedicated to the development of novel cellular therapeutics 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 for research and clinical development in multiple indications. ReproCELL is Steminent’s partner for developing and commercializing Stemchymal® SCA in Japan.
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.
Stemchymal®技術平台 幹細胞醫藥產業先驅
2018/1/3
仲恩生醫(Steminent Biotherapeutics)成立於2009年，推動以幹細胞治療為核心的再生醫學，致力於脂肪間葉幹細胞的新藥開發。匯集國內外幹細胞科學及新藥開發專家，建立獨特的Stemchymal®幹細胞技術平台。以最嚴謹的製藥規範與品質管理，確保產品的安全與療效。目前正執行異體間葉幹細胞台灣二期人體臨床試驗，計劃於2018年進一步拓展至美國及日本。
根據全球市場研究機構Research and Markets的研究預估，全球再生醫學市場規模由2016年的189億美元成長至2021年的537億美元，年複合成長率超過23.3%。其中幹細胞治療在許多不治之症領域中擁有巨大的應用潛力，吸引許多國家和藥廠相繼投入與佈局。
仲恩生醫的核心技術平台Stemchymal®以領先全球的幹細胞分離、純化、增生技術，應用於自體及異體的脂肪間葉幹細胞治療。在位於內湖科技園區內的生產廠房，將幹細胞科學轉化為高品質、安全及有效的疾病治療藥物。發展標準化的幹細胞藥物的製造過程，能維持細胞的原始幹細胞狀態。使其具有優異的免疫調節能力，並能有效分泌生長因子及細胞激素，進而在人體內產生疾病微環境的調整及受損細胞組織的保護功能。由前臨床動物研究至符合國際藥品優良臨床試驗規範(Good Clinical Practice, GCP)的人體臨床試驗，不斷累積科學實證，並透過國內外頂尖醫學中心臨床試驗證實仲恩生醫的幹細胞產品的安全與療效。
目前仲恩執行多項幹細胞藥物臨床試驗，包括小腦萎縮症、急性肝衰竭的臨床一期試驗，以及退化性膝關節炎的臨床一期試驗。其中，率全球之先的神經退化罕見疾病的小腦萎縮症之治療，是台灣唯一進入臨床二期的異體幹細胞藥物試驗，並於2015年取得美國FDA 孤兒藥資格 (orphan drug designation)。2016年更率先業界，授權日本上市公司ReproCELL，共同合作開發小腦萎縮症治療的日本市場。
仲恩生醫是幹細胞醫藥產業先驅，擁有世界一流的幹細胞研發團隊與技術。並持續與國內外最頂尖的研究單位、醫療機構產學合作。同時積極佈局全球市場，拓展合作夥伴共同開發北美、歐洲及亞洲地區，推動細胞治療再生醫學的長足發展。
リプロセル と台湾 Steminent 社の細胞医薬品に関する共同開発および販売契約の締結による 新たな事業の開始についてのお知らせ
2017/2/8
今回、当社は日本においてStemchymal®を脊髄小脳変性症の治療薬として開発および治験をおこなっていく予定です。 Stemchymal®は、厚生労働省から特定疾患(難病医療)に指定されている脊髄小脳変性症の治療薬として効果が期待されております。脊髄小脳変性症は小脳や脳幹、脊髄の神経細胞が変性してしまう事により徐々に歩行 障害や嚥下障害などの運動失調が現れ、日常の生活が不自由となってしまう原因不明の疾患であり、日本での 患者数は約3万人とされている希少疾患です。さらに、本疾患に対しては、台湾とアメリカにおいて、3段階 ある治験のうち既に第2段階目(第II相)の試験を行っており、アメリカではFDAよりオーファンドラッグ指定 も受けております。ステミネント社は、台湾の国立陽明大学からスピンオフした国際的なバイオ医薬品企業であり、台湾の経済 部から「バイオ新薬会社」として認可されている企業です。開発初期から後期のさまざまな開発段階のパイプ ラインを保有しております。また、原材料調達から最終製品の製造までの特許化技術プラットフォームを自社 で確立しており、未だ有効な治療法のない疾患に向けた治療薬の開発に積極的に取り組んでおります。
当社代表取締役社長の横山周史は「再生医療分野への本格的な参入の開始となる案件として、最先端の技術 を駆使した細胞医薬品Stemchymal®について、ステミネント社との間で独占的な開発および販売に関する契約を 締結できた事を大変喜ばしく思います。本契約によって医薬品の開発を開始することにより、当社は直接的に 患者様のお役に立つ事が出来るようになります。病気に苦しむ方々のためにも細胞医薬品Stemchymal®の開発を 成功させたいと考えております。」と述べるとともに「本開発や治験で得られたノウハウは、当社の次の事業 戦略であるiPS細胞を用いた細胞医薬品に関する事業にも大きく貢献すると確信しており、当社の再生医療分野 への本格的な参入の第一歩として、事業を加速化してまいります。」と述べております。
また、ステミネント社の社長のRyan Chang氏は「成長著しい再生医療領域で確立した地位を持つリプロセル 社と協業して、日本で共に幹細胞医薬品を開発できることを大変嬉しく思います。」と述べるとともに、「特 筆すべきはリプロセル社との協業を通して、当社の幹細胞を用いた治療開発品が脊髄小脳変性症に苦しむ日本 の患者様にも貢献できる可能性が開たことです。」と述べております。
今後は、約1年をかけて当社とステミネント社の両社が協力して日本で製品化するための開発を行い、2017年秋~冬ごろより日本での治験の実施、2020年頃に条件・期限付承認を取得して条件付き販売を開始し、2023年頃の本承認および上市を目指してまいります。
Resource from http://www.fisco.co.jp/uploads/reprocell20170208.pdf
Steminent Biotherapeutics Inc. receives US FDA Orphan Drug Designation for Stemchymal® in the Treatment of Polyglutamine Spinocerebellar Ataxia (PolyQ SCAs)
2016/1/1
In December 2015, Steminent received US FDA Orphan Drug Designation for Stemchymal® in the treatment of PolyQ SCAs. The US FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics intended for both safe and effective treatment of rare indications that affect fewer than 200,000 people in the U.S. The granted designation also allows Steminent to enjoy a 7-year market exclusivity upon approval of Stemchymal® and other development incentives including tax credits for clinical research costs and Prescription Drug User Fee Act (PDUFA) fee exemption. Stemchymal® is the proprietary, allogenic stem cell product developed by Steminent for treatment of selected diseases with unmet or underserved medical needs. The company’s SCA clinical study is now in the Phase II stage.
