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Gamida Cell is an Israeli company specializing in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company is developing a diverse clinical pipeline based on its proprietary NAM technology platform. It lead program, NiCord®, is now in Phase 3 development for allogeneic bone marrow transplantation.
NiCord® was granted Breakthrough Therapy Designation by the FDA, as well orphan drug designation by the European Medicines Agency (EMA). [Read more…]
Jerusalem, Israel, June 19, 2017 — Gamida Cell Ltd., a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, today announced the signing of a $40 million financing to support the ongoing Phase 3 trial of the Company’s FDA Breakthrough Designated clinical-stage product, NiCord, to facilitate bone marrow transplantation. The financing is being led by new investor Shavit Capital. Additional primary participants include new investors VMS Investment Group and Israel Biotech Fund, as well as existing investor and major shareholder, Novartis. Current shareholders Clal Biotechnology Industries (CBI) and Israel HealthCare Ventures (IHCV) also participated in the financing.
“We are very pleased to have the strong support from both new and current investors as we continue to advance our lead product NiCord through late stage development and toward commercialization,” said Gamida Cell President and CEO Yael Margolin, Ph.D. “With this financing, we are well-positioned to complete the Phase 3 clinical trial of NiCord with the goal of bringing this lead product candidate to market and filling an important unmet need in bone marrow transplantation for blood cancer patients who cannot rapidly find a fully matched donor.” [Read more…]
Jerusalem, Israel and New York, New York, July 10, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that Ronit Simantov, M.D. will join the Company as its new Chief Medical Officer (CMO) based in the U.S. [Read more…]
Phase 3 study of NiCord commenced last month in blood cancer patients
Jerusalem, Israel, March 23, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT).
“We are very encouraged that the EMA has widened NiCord’s orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications,” said Gamida Cell president and CEO Dr. Yael Margolin. “This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase 3 study and prepare for commercialization.” [Read more…]
Jerusalem, Israel, Tuesday, December 6, 2016 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, today announced results from its Phase 1/2 study of NiCord® for Sickle Cell Disease (SCD). The data were presented during a poster session at the 58th American Society of Hematology (ASH) Annual Meeting & Exposition, December 3-5, 2016 in San Diego, CA. [Read more…]
