BioWorld International Correspondent

ZICHRON YA'AKOV, Israel - Gamida-Cell Ltd., which focuses on stem cell expansion therapeutics for cancer and autoimmune diseases, said it is earmarking more than US$10 million for research and development of its lead product, Stem-Ex.

The Office of the Chief Scientist (OCS) of the Israel Ministry of Industry and Trade (MoIT) will contribute US$1.4 million of an overall approved budget of $3.2 million to the effort.

"We decided to award Gamida-Cell's team close to the top 50 percent allocation, given the highly encouraging nature of stem cell therapeutics and the pioneering efforts of Gamida-Cell," said Eli Opper, chief scientist of the MoIT.

Ehud Marom, CEO of Gamida-Cell, told BioWorld International, "In approving our application for funding, the OCS recognized the special value of our unique small-molecule-based product, StemEx, and the collaborations that we initiated here and overseas."

StemEx expands ex vivo cord blood stem/progenitor cells. The first application is aimed at replacing bone marrow transplantation in the treatment of hematological malignancies.

The OCS news marks the third investment in Gamida-Cell in the past four months. On March 12, the company announced an equity investment of $3 million by Teva Pharmaceuticals Ltd. in Jerusalem. On March 27, Gamida-Cell announced a leadership role in the newly established Israel Stem Cell Therapy Consortium, a body predominantly funded by the MoIT's Magnet Program. Gamida-Cell was approved to get 40 percent of the $15 million the MoIT is contributing to the overall $25 million consortium budget, or $6 million over three years. Collaborators include 10 universities and hospitals, Teva, and Rehovot-based Proneuron Ltd. and Prochon Ltd.

Marom said, "This is the fourth consortium I am participating in. The consortium formalizes and integrates academic advances in a step-by-step manner into industry with a long-term perspective that benefits all parties involved. There is an enormous value in combining research efforts toward a common goal."

Gamida-Cell was co-founded in 1998 by Toni Peled based on her key patents being licensed from the Hadassah University Medical Center in Jerusalem. She heads Gamida-Cell's New Technologies.

Frida Grynspan, Gamida's vice president of research and development, told BioWorld International, "Our novel technology uses a simple copper chelator in combination with off-the-shelf cytokines to rapidly expand early progenitor, or undifferentiated, stem cells ex vivo. This method enables generation of a cell graft highly enriched with the early undifferentiated cells, which are widely believed to be critical for successful engraftment.

"Gamida-Cell is the only company that has an ex vivo expansion technology of cord blood progenitor cells currently engaged in an FDA IND clinical trial," she said. Nagler is the Israeli principal investigator on the first Phase I trial, currently in progress in the U.S. at M.D. Anderson Cancer Center.

Marom added that this lead-time is significant, and that Gamida anticipates expanding its collaborations with other companies, expecting a first commercial product in 2006 or even 2005.