The field of cancer immunotherapies was buoyed last year by the FDA’s approval of the first autologous CAR-T drugs on the market, Novartis’ Kymriah and Gilead’s Yescarta. But, many drug makers are already looking in a new direction — off-the-shelf, or allogeneic, CAR-T therapies.
In autologous therapies, like Kymriah and Yescarta, scientists isolate T cells from the individual’s blood, then genetically engineer them and allow them to multiply before reinfusing them back into the patient. The process can be time-consuming and costly, which has led some drug developers to explore allogeneic CAR-T drugs derived instead from donor cells and could be available to patients “off-the-shelf.”
That approach was in the spotlight in April when it was announced that two former executives of Kite Pharma were launching Allogene Therapeutics to focus specifically on allogeneic CAR-T. The company has licensed 17 CAR-T products from Pfizer, one of which — UCART19 — is already in phase 1 clinical trials for acute lymphoblastic leukemia.
Allogene is among many biotechs exploring allogeneic therapies, most of which are in the preclinical phase of investigating off-the-shelf CAR-T therapies to treat numerous cancers.
Massachusetts gene-editing startup CRISPR Therapeutics is working on an off-the-shelf CAR-T called CTX101. The company hopes to test CTX101 in clinical trials beginning next year and has also presented promising data on allogeneic CAR-Ts targeted toward other antigens.
Meanwhile, New Jersey-based Celularity is looking to use donated placental cells to create several treatments, including allogeneic CAR-T drugs, all of which are still pre-clinical. Belgium-based Celyad licensed some of its allogeneic CAR-T assets to Novartis last year. And in February, Gilead inked a deal with California-based Sangamo Therapeutics to use Sangamo’s gene-editing approaches to create both autologous and allogeneic CAR-T drugs.
With these various allogeneic therapies moving through the pipeline, innovation in CAR-T therapies seems set to blossom in the years ahead — with real benefits for patients.