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Hematopoietic Stem Cells (HSCs)

Gamida Cell Announces $40 Million Private Financing

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Financing provides strong base to complete Phase 3 clinical trial and commercialization of lead product candidate NiCord® for blood cancers

Gamida CellJerusalem, 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…]

Pluristem Announces Promising Results from Non-Human Primate Pilot Study of PLX-R18 in Acute Radiation Syndrome

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  • All PLX-treated groups showed improvements in survival rates compared to untreated groups
  • PLX-R18 cells did not increase leukocyte levels in non-irradiated NHPs, indicating no requirement to determine levels of radiation exposure prior to administration
  • Data will inform a pivotal trial that could support marketing authorization under the FDA’s Animal Rule regulatory pathway

[Read more…]

Governments on Alert and Stockpiling Antidotes for Nuclear Accidents and Attacks

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Many governments, including the U.S. and Japan, are well aware of the dangers to their populations of exposure to high levels of radiation from nuclear accidents or dirty bomb  attacks. Whereas Japan’s population was recently exposed at Fukushima following the tsunami of 2011, the U.S. Department of Defense has been stockpiling acute radiation syndrome (ARS) countermeasures as a precaution for many years.

The recent escalation of tensions between North Korea and the U.S. may give the American government cause to up its investment in ARS antidotes. During a military parade on April 15th, North Korea displayed weapons including an intercontinental ballistic missile (ICBM) that could be capable of reaching the U.S. ARS may have just become a larger threat to health than it was just a few weeks ago. [Read more…]

Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord® in HSCT

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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…]

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