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April 2019

USCGF is in cancer immunotherapy clinical trials with Torque Therapeutics

University of Rochester, NY, April 16, 2019the Upstate Stem Cell cGMP Facility (USCGF), a Good Manufacturing Practice Laboratory at the University of Rochester, founded by Vice-Dean Steve Dewhurst and directed by Luisa Caetano Davies, is working in coordination with Torque Therapeutics (Cambridge, Massachusetts) to produce autologous TRQ-1501 Deep IL-15 Primed T cells for Phase 1-2 clinical trials in patients with selected, relapsed or refractory, solid tumors and lymphomas.The clinical trial started on February 20th.

At the USCGF, the manufacture of TRQ-1501 is taking place in 2 state-of-the-art (ISO class 6) manufacturing suites with highlyUSCGF skilled technicians and scientists experienced in the production of cell-based therapies, cell culture, immunotherapy and quality control/assurance. Important partners in this endeavor are UR Flow Core, UR Microbiology Clinical lab and UR Immunology Center Core.

This is a significant milestone for the USCGF as this is the first time that a cancer immunotherapy product produced in our GMP laboratory will be administered to a human subject, and approximately 80 patients are to be enrolled in the trial. TRQ-1501 is an investigational immune cell therapy produced from a patient’s own T cells, which are primed to target multiple tumor-associated antigens and loaded with Deep IL-15 (a multimer of IL-15 cytokine) anchored to the T cells’ surface.

This immunotherapy has the capability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive microenvironment that shuts down T cell function, and only requires outpatient treatment, with a high margin of safety. 

Additional details about Torque’s Phase 1 study may be found at www.clinicaltrials.gov (study identifier NCT03815682): “A Phase 1/1b Open-Label Multi-Center Study to Characterize the Safety and Tolerability of TRQ-1501 in Patients with Relapsed/Refractory Solid Tumors and Lymphomas

 

Research Roundup: Stephen Dewhurst Explores the Newest Bench-to-Bedside Projects

Endorsements:

Sally TempleTherapy for macular degeneration using stem cell-derived human retinal pigment epithelium
“We selected the USCGF to create clinical grade Retinal Pigment Epithelial Stem Cell Lines for future clinical applications. The staff is highly experienced and knowledgeable and respond rapidly to our questions—they are part of our team!”
- Sally Temple, Ph.D. New York Neural Stem Cell Institute, AMC

Steve GoldmanTransplantation of human glial progenitor cells as a treatment for multiple sclerosis
“This facility is a boon to researchers across the state. It will specifically help accelerate our lab’s work in multiple sclerosis and other neurological disorders be enabling us to generate cell lines suitable for early phase clinical studies.”
- Steve Goldman , M.D. Ph.D., University of Rochester

Eddie SchwartzTissue engineered massive allografts for healing large segmental long bone defects
“The Upstate Stem Cell cGMP Facility has become an essential asset to the progression of our tissue engineering research programs from the lab to the clinic.”
- Hani Awad  Ph.D., University of Rochester

Eddie SchwartzMonoclonal antibody passive immunization for MRSA
"We chose the Upstate Stem Cell cGMP Facility to manufacture our monoclonal antibody for large animal testing of our passive immunization for S. aureus implant-associated osteomyelitis due to its great team, and ability to readily generate drug through our Phase 1 clinical trial.  Given the great demand for first-in-man mAb, I highly recommend this facility for early stage clinical trials.”
- Eddie Schwarz  Ph.D., University of Rochester

Rick Lawless

"The Upstate Stem Cell cGMP Facility is a model for contract development and manufacturing organizations looking to provide maximum flexibility for its clients. The skilled operations team can utilize three separate processing areas with validated equipment and a comprehensive quality system to process a variety of mammalian cell lines simultaneously." 
- Rick Lawless, BTEC, North Carolina

Eddie Schwartz
“We are very impressed with the GMP facility at URMC, and consider it as one of the top academic GMP facilities within biologics manufacturers”
- Gerhard Bauer, UC Davis

Eddie Schwartz
"Dr. Luisa Davies and her USCGF colleagues provide a superb biomanufacturing curriculum and hands-on practicum experiences to develop next generation leaders and skilled professionals for the biomanufacturing industry. USCGF leads the fall semester MBI406 course and ensures trainees have a strong technical background and real-world opportunities to meet and learn from experts within the cGMP community".
- Tracey Baas, PhD University of Rochester

Mark NobleGMP astrocytes produced from embryonic glial progenitor cells for spinal cord repair
“This facility represents the key bridge to early stage trials in humans and will enable us to move forward with studies in a wide range of conditions, including efforts to repair CNS damage, regrow bone and cartilage, and even target cancer stem cells.”
- Mark Nobel Ph.D., University of Rochester


Contact

Luisa Caetano DaviesLuisa Caetano-Davies
Executive Director, Upstate Stem Cell cGMP Facility
585.276.6208
E-mail