Neostem Licenses UCSF Patents Covering Methods For "Tregs"

NeoStem said today it licensed three families of patents from the University of California, San Francisco (UCSF), collectively covering methods to isolate, expand, and use the company's human regulatory T cell ("Treg") platform with therapeutic potential for autoimmune disorders.

The value of the license agreement was not disclosed.

Patents covered by the license include U.S. Patent 7,722,862, which claims a cellular immunotherapy for the treatment of type 1 diabetes. As a result of the license, NeoStem's patent estate for its Treg program now includes exclusive rights to 22 issued patents in United States and major international commercial geographies. Those rights cover isolation, activation, expansion, and methods of treating or preventing certain conditions and/or diseases using Tregs, NeoStem said.

"This collaboration advances that program toward a Phase II trial to evaluate the efficacy of autologous Tregs in type 1 diabetes, effectively accelerating the company's pipeline more quickly than had it developed a program for this clinical indication independently," Robin L. Smith, M.D., M.B.A., NeoStem's chairman and CEO, said in a statement.

NeoStem said its worldwide exclusive license to the patents provided incremental protection for Tregs, and complemented a collaboration announced July 15 with UCSF and the laboratories of two investigators based there to develop Tregs for type 1 diabetes, as well as for steroid-resistant asthma and for organ transplant rejection.

The two investigators are Jeffrey A. Bluestone, Ph.D., UCSF's executive vice chancellor and provost and A.W. and Mary Margaret Clausen distinguished professor of medicine, pathology, microbiology and immunology, and Qizhi Tang, Ph.D., director of the transplantation research laboratory at UCSF's diabetes center and an associate professor in the department of surgery.

Under its UCSF collaboration, NeoStem said it will manufacture a Treg product consisting of polyclonally expanded Tregs for the planned Phase II trial to treat patients newly diagnosed with type 1 diabetes, and will collaborate with Dr. Bluestone on allospecific Tregs for organ transplant tolerance in another Phase II study.  NeoStem also said it plans to sponsor a Phase Ia/IIb study on the use of Tregs for the treatment of steroid-resistant asthma.

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