SEATTLE, March 28, 2017 (GLOBE NEWSWIRE) -- Nohla Therapeutics Inc. (Nohla), a leading innovator in the development of off-the-shelf universal donor cellular therapies, announced today the initiation of a collaboration with the University of California, Davis (UC Davis). Manufacturing and sublease agreements will enable Nohla to utilize UC Davis’ expertise in cell therapy Good Manufacturing Practices (GMP) and state-of-the-art infrastructure to facilitate the further development and commercialization of NLA101, the Company’s expanded off-the-shelf universal donor stem and progenitor cell therapy for treatment of patients with blood cancers.
“This collaboration allows Nohla to capitalize on the expertise at UC Davis to scale manufacturing for NLA101 and increase our ability to supply product for multiple clinical trials,” commented Katie Fanning, President and Chief Executive Officer of Nohla.
Under a manufacturing agreement, UC Davis will perform clinical manufacturing and quality control testing of NLA101 on behalf of Nohla in the cGMP Cell Therapy Manufacturing Facility at the UC Davis Institute of Regenerative Cures (IRC) in Sacramento, California. Nohla will contribute additional infrastructure to support increased manufacturing capacity at the IRC. This collaboration will allow the Company to manufacture sufficient quantities of NLA101 to supply its clinical trials for Hematopoietic Cell Transplant (HCT) and Chemotherapy Induced Neutropenia (CIN). Further collaborative efforts will refine and optimize the NLA101 manufacturing processes, a key step in achieving commercial viability.
In addition, Nohla has signed a sublease agreement with UC Davis for approximately 2800 sq. ft. of office and laboratory space in the Oak Park Research Center, located adjacent to the IRC. The new facility, staffed by Nohla, will serve as a warehouse and distribution center to supply raw materials to the IRC to be used in GMP manufacturing, and will function as a depot to store and deliver NLA101 to clinical trial sites.
“We are particularly excited to partner with Nohla for the development of this groundbreaking technology as it demonstrates our commitment to work with innovative companies developing lifesaving therapies,” commented Lars Berglund, Associate Vice Chancellor for Biomedical Research and Vice Dean for Research at UC Davis School of Medicine.
NLA101, Nohla’s lead off-the-shelf universal donor product (which does not require any HLA matching), has been used safely across multiple clinical studies in over 100 patients at risk of severe infection and other complications after intensive chemotherapy or cord blood transplantation. This product is currently being evaluated in a multicenter, randomized Phase 2b study in the setting of myeloablative cord blood transplant for leukemia and other blood cancers. The Company also plans to initiate a Phase 2 randomized study in the setting of high dose chemotherapy for acute myelogenous leukemia (AML).
About Nohla Therapeutics
Nohla Therapeutics Inc. (Nohla) is a clinical stage biopharmaceutical company dedicated to the development of universal donor cellular therapies for the treatment of patients with blood cancers and other life threatening conditions. The Company is leveraging a platform developed over the past two decades at Fred Hutchinson Cancer Research Center which enables the ex vivo expansion and directed differentiation of stem/progenitor cells resulting in “off-the-shelf” universal donor cellular therapies (which can be used on demand without the need for HLA matching). Nohla is evaluating the ability of the first of these “off-the-shelf” products to reduce infection and other complications of neutropenia in two lead programs involving multi-center, randomized clinical trials: a Phase 2b study in the setting of cord blood transplant and a global Phase 2 study in the setting of high dose chemotherapy for acute myelogenous leukemia (AML). Nohla is supported by top-tier healthcare dedicated institutional investors including ARCH Venture Partners, 5AM Ventures, and Jagen Group.