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…]
First iPSC-Derived CAR-T Therapy by CiRA and Takeda Nears Clinical Testing
− 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…]
Why is Healthy Donor Tissue So Important for Cell and Gene Therapies?
Brad Taylor, PhD and Dominic Clarke, PhD
HemaCare Corporation 8500 Balboa Boulevard Suite 130 Northridge CA 91325
INTRODUCTION
Public discourse on cell and gene therapy is focused on novel approaches to long-established procedures such as bone marrow transplants, as well as on truly innovative treatments such as cancer immunotherapy and stem cell therapy for autoimmune disorders and other serious ailments. Positive clinical trial results and the demonstrated success of advanced therapies such as Kymriah® and Yescarta® are fueling a sense of excitement on what could be accomplished with these medicines—and driving a significant increase in the number of cell therapies in the clinical trial pipeline. As of last year, there were nearly 300 different cell and gene therapies in development, and that number is on target to grow.[1] [Read more…]
New Frontiers in Gene-Editing and Stem Cell Innovation – Interview with Dr. Chen-Tsai of Applied StemCell
I had the honor of interviewing Dr. Ruby Yanru Chen-Tsai, Chief Scientific Officer and Co-founder of Applied StemCell Inc. (ASC), a fast growing biotechnology company in Milpitas, California. Specializing in gene-editing technologies and stem cell innovation, ASC offers an optimized series of tools for basic research study, drug discovery, bio-processing, bio-production and preclinical applications.
In this fascinating interview, we discuss Dr. Yanru Chen-Tsai’s impressive background, ASC’s unique product portfolio, its TARGATT™ gene editing technology, and the company’s future trajectory. [Read more…]
Cellectis Secures 82,000 Sq Ft Manufacturing Facility in Raleigh to Compliment Paris Facility
Cellectis, a leading French biopharmaceutic company, has signed a lease agreement for an 82,000 sq. ft. manufacturing facility in Raleigh, North Carolina, to complement its existing 14,000 sq. ft. manufacturing facility in Paris, France.
Located at 2500 – 2540 Sumner Boulevard in Raleigh, NC, the new USA facility is owned by Equus Capital Partners and will be used for clinical and commercial production of Cellectis’ leading allogeneic UCART products.
Importantly, the decision will combine the capabilities of Cellectis’ two facilities to advance its manufacturing processes and prepare for potential commercialization of its UCART products in the future. [Read more…]
