Precision BioSciences backs off-the-shelf cancer cell therapy effort with new manufacturing plant
The field of off-the-shelf cell therapeutics is growing, with the promise of quicker, cheaper, and easier to manufacture therapies than the first generation of autologous CAR-Ts that impressed with their potency but fell short on adoption due to manufacturing wobbles. And Precision BioSciences — which is using its gene editing technology to develop cell based immunotherapies derived from healthy donors instead of the patient — is planning ahead. On Thursday, the company unveiled a new Durham, NC facility dedicated to making its off-the-shelf CAR-T products.
Novartis’ pioneering CAR-T drug — Kymriah — was approved by the FDA amidst great fanfare in 2017, but adoption was hampered by manufacturing woes. Novartis later added capacity, having bought cell and gene therapy manufacturer CellforCure. These products require enormous manufacturing heft — makers first isolate cells from the patient, manipulate them in the lab by adding chimeric antigen receptors to direct T cells to snuff out cancer cells and then re-infuse them back into the patient.
Durham, North Carolina-based Precision is hardly the first drug developer that has taken note of these challenges. Takeda, for instance, which plans to take its off-the-shelf CAR-Ts into the clinic in 2021, is in the final stages of completing its in-house manufacturing facility in the Boston area, which is armed with the capacity to supply a range of clinical trials.
For Precision $DTIL, this new plant is part of a larger investment in its cancer immunotherapy platform and facilities expansions in North Carolina this year.
“(W)e’ve known from the beginning that it was critical for us to address the need for scalable manufacturing of cell-therapy products…” noted co-founder and chief Matt Kane in a statement.
“[The plant] also has the potential to be a commercial launch facility with the capacity to generate up to 10,000 doses of CAR T cell therapies and 4,000 doses of gene therapies per year,” he added.
The drug developer is aiming to have its certifications in place to begin manufacturing in the fourth quarter — and plans to use the facility to create drug ingredients for Phase I/II clinical trials scheduled to begin next year.