Allele Biotechnology and SCM Lifescience Sign a Joint Research and Development Agreement to Develop iPSC-based Diabetes Treatment


2019-04-15 18:45:11 BioSpace


San Diego-based Allele Biotechnology and Pharmaceuticals, Inc., officially announced a joint research and development agreement with South Korea’s SCM Lifescience Co., Ltd., for the development of diabetes therapies using pancreatic beta cells derived from induced pluripotent stem cells . iPSCs can be derived from adult human tissue cells yet share the developmental potentials of embryonic stem cells. Currently Japan has 6 ongoing clinical trials utilizing this technology, but the rest of the world is now joining the movement with 4 clinical trials initiated outside of Japan in the past year. Since 2009, Allele Biotechnology has been developing clinically compatible technologies to produce high quality iPSCs and tissue-specific cells from iPSCs. The pancreatic beta-cell program is powered by Allele’s core capabilities, including proprietary methods utilizing mRNA for generation and differentiation of iPSCs, and a state-of-art, commercialization-ready cGMP facility in San Diego, California. Dr. Jiwu Wang, Founder and CEO of Allele Biotechnology, said, “We are excited to have a partnership with SCM Lifescience, which has years of experience in cell therapy clinical trials. This collaborative project will help us quickly generate first-in-human results in the fast-moving field of iPSC-based therapies.” The purpose of the collaboration is to confirm the therapeutic applicability of Allele’s iPSC-derived pancreatic beta cells for diabetes and related indications. The initial efforts will be focused on developing an autologous product for certain forms of Type 3c Diabetes (T3cDM), that are inherently non-autoimmune in nature. Allele Biotechnology also envisages alternative, off-the-shelf allogeneic therapeutic products for other types of diabetes, taking advantage of its growing bank of cGMP-grade footprint-free iPSCs, and gene editing technologies. SCM Lifescience currently has a number of allogeneic mesenchymal stem cell therapies in its pipeline, indications include chronic graft versus host disease, acute pancreatitis, severe atopic dermatitis, and liver cirrhosis. The new collaboration will expand its capabilities by exploring the iPSC-based market. "We are pleased to collaborate with Allele Biotechnology for the development of diabetes treatment which will be a valuable addition to our current pipeline. Knowing Allele’s cGMP manufacturing experience, we are expecting a great synergy with our recent acquisition of CoImmune with its production site in North Carolina,” stated Dr. BG Rhee, CEO of SCM Lifescience.
总部位于圣地亚哥的 Allele Biotechnology and Pharmaceuticals , Inc .正式宣布与韩国 SCM Lifescience Co ., Ltd .签订合作研发协议,用于利用诱导多能干细胞衍生的胰腺β细胞开发糖尿病治疗方法。 iPSCs 可从成人组织细胞中提取,但与胚胎干细胞具有共同的发育潜力。目前,日本有6个正在进行的临床试验利用这一技术,但世界其他地区现在加入运动与4个临床试验开始在日本以外的去年。 自2009年以来, Allele Biotechnology 一直在开发临床兼容的技术,从 iPSCs 生产高质量的 iPSCs 和组织特异性细胞。胰腺β细胞项目由 Allele 的核心能力提供动力,包括利用 mRNA 生成和分化 iPSCs 的专有方法,以及加利福尼亚州圣迭戈先进的商业化的 cGMP 设施。 Allele Biotechnology 创始人兼首席执行官 Jiwu Wang 博士说:“我们很高兴与 SCM 生命科学公司建立合作关系, SCM 生命科学公司拥有多年的细胞治疗临床试验经验。这个合作项目将帮助我们在快速移动的基于 iPSC 的治疗领域快速产生人类第一成果。” 该合作的目的是确认 Allele 公司的 iPSC 衍生胰腺β细胞对糖尿病和相关适应症的治疗适用性。最初的努力将集中在为某些形式的3c 型糖尿病( T3cDM )开发一种自身产品,这些糖尿病本质上是非自身免疫的。Allele Biotechnology 还设想为其他类型的糖尿病提供替代、现成的同种治疗产品,利用其不断增长的 cGMP 级无足迹 iPSCs 和基因编辑技术。 SCM 生命科学目前已有多个异基因间充质干细胞疗法在其管道,迹象包括慢性移植物抗宿主病,急性胰腺炎,严重的特应性皮炎和肝硬化。新的合作将通过探索基于 iPSC 的市场扩大其能力。 “我们很高兴与 Allele Biotechnology 合作开发糖尿病治疗,这将是我们目前管道的宝贵补充。了解 Allele 的 cGMP 制造经验,我们期待着与我们最近收购 CoImmune 及其在北卡罗莱纳州的生产基地有巨大的协同效应,” SCM 生命科学首席执行官 BG Rhee 博士说。