Cell Therapy Archives | Page 53 of 64

Cesca Partners with Healthbank Biotech (Stem Cell Bank) to Provide Immune Cell Banking

November 18, 2019 By Cade Hildreth, Founder & President Leave a Comment

ImmuneCyte to Begin Operations in Fourth Quarter of 2019

RANCHO CORDOVA, Calif., Oct. 22, 2019 — Cesca Therapeutics Inc. (Nasdaq: KOOL), a market leader in automated cell processing and autologous cell therapies for regenerative medicine, and ThermoGenesis, its wholly owned device subsidiary, today announced that the company has entered into a definitive joint venture agreement with HealthBanks Biotech (USA) Inc., one of the world’s leading stem cell bank networks, to commercialize its proprietary cell processing platform, CAR-TXpress™, for use in immune cell banking as well as for cell-based contract development and manufacturing services (CMO/CDMO). The joint venture will be named ImmuneCyte Life Sciences Inc. (“ImmuneCyte”) and is expected to officially launch during the fourth quarter of 2019. [Read more…]

CARsgen’s CAR-T Therapy CT053 for R/R Multiple Myeloma is 37th Publicly Announced RMAT

October 28, 2019 By Cade Hildreth, Founder & President Leave a Comment

SHANGHAI, Oct. 28, 2019 — CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM). [Read more…]

Anemocyte to expand its plasmid manufacturing capabilities

September 29, 2019 By Cade Hildreth, Founder & President 1 Comment

A new state-of-the-art facility dedicated to plasmid manufacturing is now operational in Gerenzano, Italy. The new site will couple with the existing GMP facility active in the Cell and Gene (C&G) therapy space. With 800m2 (8,000 square feet) of cleanrooms, the two facilities of Anemocyte, the first Biotech Manufacturing Organisation (BMO), will address manufacturing needs of Somatic Cells, Non-Viral Modified Cells, Vesicles and Plasmids for Viral Vectors. [Read more…]

First iPSC-Derived CAR-T Therapy by CiRA and Takeda Nears Clinical Testing

July 23, 2019 By Cade Hildreth, Founder & President Leave a Comment

− iCART Program Advances the Potential for a Highly Scalable, Lower Cost, Off-the-Shelf CAR T-Cell Therapy to Treat Cancer

KYOTO and OSAKA, Japan I July 16,2019 – The Center for iPS Cell Research and Application (CiRA) at Kyoto University and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that a novel induced pluripotent stem (iPS) cell-derived chimeric antigen receptor (CAR) T-cell therapy (iCART) has been transferred from their T-CiRA research collaboration to Takeda as the program begins process development toward clinical testing. Under the terms of the T-CiRA agreement, Takeda has the global rights to develop and commercialize the iCART product and CiRA will receive development and approval milestones. The teams will continue to collaborate as they prepare the iCART program for a clinical trial in 2021. [Read more…]

U.S. FDA Approved RMATs on the Rise

July 13, 2019 By Cade Hildreth, Founder & President Leave a Comment

With recent news from Sangamo Therapeutics and Krystal Biotech, the count of announced RMAT (“Regenerative Medicine Advanced Therapy”) designations has risen to 30.

Krystal Biotech received an RMAT designation for its gene therapy KB103 on June 24, 2019. KB103 is being studied for its wound closure capacity in patients with severe generalized recessive dystrophic epidermolysis bullosa (“RDEB”). The FDA also granted a RMAT designation for Sangamo Therapeutics’ SB-525, an investigational gene therapy being developed in collaboration with Pfizer to treat severe hemophilia A. SB-525 is the first hemophilia A gene therapy to receive RMAT designation. [Read more…]