(CAR-NK) Takeda and MD Anderson Partner to Develop Allogeneic CAR-NK Cell Therapy — Phase 3 Pivotal Study Planned for 2021

Takeda announced an exclusive licensing and research collaboration with MD Anderson Cancer Center to co-develop cord blood-derived chimeric antigen receptor natural killer (CAR-NK) cell therapy with interleukin-15 (IL-15) treatment for relapsed or refractory B-cell malignancies, with an allogeneic (off-the-shelf) application as the goal.

Under this agreement, Takeda will collaborate with MD Anderson on research, obtain exclusive licensing rights to use the MD Anderson CAR-NK platform, and acquire development and commercialization rights for four programs.

This development program utilizes natural killer (NK) cells isolated from cord blood, which are genetically engineered to express chimeric antigen receptors (CAR) targeting two specific cancer markers — CD19 and BCMA — and supplemented with IL-15 to enhance cell persistence and proliferation.

Key features of the platform:

1. MD Anderson's allogeneic CAR-NK platform isolates NK cells from cord blood and engineers them to express CARs targeting specific cancer targets.

2. CAR-NK cells are modified using retroviral vectors to deliver genes and enhance their efficacy against specific tumors.

3. The CD19 CAR increases cell specificity for B-cell malignancies, while the immune cytokine IL-15 enhances CAR-NK cell proliferation and survival in the body.

4. In contrast to current CAR-T cell therapies, which use patient-specific genetically modified T cells requiring a production process of several weeks, CAR-NK cells are designed to be manufactured from unrelated donor sources and stored for ready use. This off-the-shelf approach enables faster administration.

CD19 CAR-NK cell therapy is expected to be administrable in outpatient settings. In an ongoing Phase 1/2a clinical study, patients with relapsed or refractory B-cell malignancies who received CD19 CAR-NK therapy did not experience the severe cytokine release syndrome (CRS) or neurotoxicity observed with current CAR-T therapies.

In addition to CAR-NK, Takeda and its partners are investigating multiple approaches to improve the safety, efficacy, and accessibility of first-generation CAR-T therapies, including gamma-delta CAR-T, iPSC-derived CAR-T, CAR-T targeting solid tumors, and other next-generation approaches. Takeda plans to advance 5 oncology cell therapies to clinical stages by the end of fiscal year 2020. Among the better-known collaborative programs is GammaDelta, the first iPSC-derived CAR-T cell therapy, invented at Kyoto University in Japan, in collaboration with CAR-T pioneer Michel Sadelain of Memorial Sloan Kettering Cancer Center.

Source: https://www.businesswire.com/news/home/20191105005250/en/Takeda-MD-Anderson-Announce-Collaboration-Accelerate-Development

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