Nohla Therapeutics is tapping the University of California, Davis (UC Davis) for its expertise in cell therapy GMP and manufacturing so that it can scale up clinical trials manufacture of NLA101, Nohla's Phase IIb-stage off-the-shelf universal donor stem and progenitor cell therapy for hematologic cancers. The firm will also work with UC Davis to further optimize the NLA101 manufacturing process, with a view to future commercial production.
Under terms of the collaboration and manufacturing agreement, UC Davis will carry out manufacturing and quality control testing of NLA101 at the UC Davis Institute of Regenerative Cures (IRC) cGMP Cell Therapy Manufacturing Facility in Sacramento, CA. Nohla has sublicensed office and laboratory space at the Oak Park Research Center next to the IRC, which will act as a warehouse and distribution center for supplying the IRC with raw materials and for storing NLA101 for distribution to the clinical trials sites. The collaboration will enable the production of enough NLA101 to supply clinical trials evaluating NLA101 in hematopoietic cell transplant and for treating chemotherapy-induced neutropenia.
“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 Kathleen Fanning, president and CEO at Nohla.
Lars Berglund, M.D., Ph.D., associate vice chancellor for biomedical research and vice dean for research at UC Davis School of Medicine, added, “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.”
Nohla was established in 2015 to exploit technology developed at the Fred Hutchinson Cancer Research Center, which enables the Notch-mediated ex vivo expansion and directed differentiation of cord blood stem and progenitor cells into off-the-shelf universal donor cell therapies that can be used on demand without human leukocyte antigen (HLA) matching in recipients.
The lead product NLA101 has been evaluated in more than 100 patients at high risk of severe infection and other complications after chemotherapy or cord blood transplantation. A Phase IIb study is ongoing in patients undergoing myeloablative cord blood transplant for leukemia and other blood cancers. Nohla is also planning to start a Phase II study in patients undergoing high-dose chemotherapy for acute myelogenous leukemia (AML).
In November 2016, Nohla raised $43.5 million in a Series A financing round, taking total investment in the company to $64.5 million.
