The trem-cel+VCAR33 Treatment System is a novel and comprehensive approach that has the potential to transform patient outcomes in AML and establish a new standard of care for patients with high risk of relapse.
We believe trem-cel could unlock the potential of anti-CD33 therapies beyond Mylotarg™ such as VCAR33, which could be a highly potent anticancer therapy that, when combined with trem-cel, is not associated with severe toxicities.
An attractive feature of this Trem-cel+VCAR33 Treatment System is that it uses cells from the same healthy donor for both trem-cel and VCAR33. In this scenario, the apheresis product from the healthy donor would be processed to serve as starting materials for both products. One advantage of this approach is that donor-derived T cells should not recognize CAR-T cells as foreign, potentially prolonging persistence and optimizing CAR-T expansion. In addition, sourcing T cells from healthy donors may provide a healthier, more abundant cell source, allowing for optimizations and efficiencies in the manufacturing process that are not possible with autologous sources. Unlike autologous CAR-T therapies, the manufacturing of the CAR-T cells would not be rate limiting when combined with trem-cel, as we expect the CAR-T therapy would not be needed until 60 days after administration of trem-cel.
Trem-cel+VCAR33 Treatment System—Clinical Development
The Company anticipates initiating a Phase 1 clinical trial with the trem-cel+VCAR33 Treatment System in the second half of 2025.
Patients who have relapsed after a trem-cel transplant are also eligible to receive VCAR33. The ability to treat relapsed trem-cel transplant patients with VCAR33 may provide valuable early insights into the potential of the trem-cel+VCAR33 Treatment System.