Dive Brief:
- UK-based Adaptimmune Therapeutics has signed a manufacturing agreement with the contract development and manufacturing organization PCT, a subsidiary and manufacturing arm of Caladrius Biosciences, for development, clinical and commercial scale manufacturing.
- PCT will produce Adaptimmune's SPEAR cancer immunotherapies exclusively at its FDA and EU-compliant unit in Allendale, NJ.
- The five-year agreement extends an existing relationship between the two companies. The pair have worked together for the last three years.
Dive Insight:
Manufacturing personalized T-cell cancer therapies is more complex that synthesizing small molecule therapeutics. T-cells are extracted from the blood of cancer patients, and combined with enhanced affinity T-cell receptors that target cancer cells. These altered T-cells are then activated, expanded and reinfused into the patient, where they target and destroy the cancer cells. Because patient-specific cell therapies must be manufactured individually, one of the major challenges is keeping cost of goods sold under control, as Brian Hampson of PCT explains in a Life Science Leader piece.
One approach, as taken by Adaptimmune, is to collaborate with a specialist company that has appropriate technologies and expertise. Adaptimmune and PCT have worked together for three years already.
"We are pleased to significantly advance our relationship with Adaptimmune, which began with earlier-phase clinical trials,” said Robert A. Preti, president of PCT and senior vice president, Manufacturing and Technical Operations of Caladrius Biosciences.
Adaptimmune is also developing in-house manufacturing capabilities, building a new plant in Philadelphia.
Adaptimmune's SPEAR (Specific Peptide Enhanced Affinity Receptor) T cell therapy targets the NY-ESO cancer antigen. This is in Phase 1/2 trials in solid tumors and blood cancers, and is in development in collaboration with GlaxoSmithKline. The company also has therapies targeting the MAGE-A10 and AFP cancer antigens that are awaiting Phase I and another targeting MAGE-A4 cancer antigen that is in preclinical studies.