NeoStem, Inc., a leader in the emerging cellular therapy market, has executed agreements with the University of California, San Francisco (UCSF) and the laboratories of Jeffrey Bluestone, PhD, and Qizhi Tang, PhD, to collaborate on the development of human Regulatory T cells (Tregs) for the treatment of type 1 diabetes (T1D), steroid resistant asthma, and organ transplant rejection. This collaboration advances NeoStem’s role in the development and commercialisation of immunomodulatory cellular therapeutic products for the treatment of intractable diseases involving the immune system.
“Worldwide, type 1 diabetes affects over 340 million people, and has an economic cost of over $174 billion in the US alone. Severe asthma affects another 60 million people,” said Dr Robin L Smith, chairman and CEO of NeoStem. “Our collaboration with Dr Bluestone and Dr Tang, industry leaders in Treg research, and UCSF represents a significant advance in the development of our Athelos technology platform.”
Dr Bluestone is the AW and Mary Margaret Clausen distinguished professor and executive vice chancellor and Provost, UCSF and is a leader in the field of Tregs and immunotherapy of autoimmune and inflammatory diseases. He has also published over 400 articles on T cell biology and activation, and regulation and control of normal and pathogenic immune responses. Dr Tang is an associate professor in the Department of Surgery and has been working with Dr Bluestone for over a decade on the clinical application of Tregs in autoimmunity and organ transplantation.
This collaboration advances NeoStem’s Treg programme towards a clinical phase II trial to evaluate the efficacy of autologous Tregs in T1D. Under the agreements NeoStem will manufacture a Treg product consisting of polyclonally expanded Tregs for the planned phase II trial to treat patients newly diagnosed with T1D and will collaborate with Dr Bluestone on allo-specific Tregs for organ transplant tolerance in another phase II study. Additionally, NeoStem plans to sponsor a phase Ia/IIb study on the use of Tregs for the treatment of steroid resistant asthma. The collaboration includes the research effort to develop the next generation of Treg products for therapeutic use.
“I am excited to begin this collaboration with NeoStem,” said Dr Bluestone. “Their in-house expertise in development and manufacturing will serve as a complement to my team at UCSF and, through this partnership, I look forward to building on a strong existing foundation, moving these products through clinical development to treat diseases which have long been a focus of my own clinical research.”
“NeoStem has core expertise in the development and conduct of cell therapy based trials,” said Dr Andrew L Pecora, chief medical officer of NeoStem. “This collaboration accelerates the development of our immunomodulatory therapeutic portfolio, enabling the initiation of a phase II trial in type 1diabetes and a phase Ib/IIa trial in steroid resistant asthma. This development significantly diversifies and augments NeoStem’s cell therapy pipeline, which includes a phase II cardiovascular clinical trial which is expected to complete enrollment in 2013.”