The trem-cel + VCAR33 Treatment System is a novel and comprehensive approach that has the potential to transform clinical outcomes and establish a new standard of care for patients suffering with AML.
We believe trem-cel could unlock the potential of anti-CD33 therapies beyond Mylotarg™ such as VCAR33ALLO, 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 Treatment System is that it uses the same allogeneic source of cells for both the shielded transplant and CAR-T. In this scenario, the apheresis product from the healthy donor can 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. 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.
Trem-cel + VCAR33 Treatment System—Clinical Development
We intend to submit an IND application with the FDA and conduct a clinical trial of the trem-cel + VCAR33 Treatment System after we obtain the initial results from our trem-cel Phase 1/2a clinical trial and our planned VCAR33ALLO Phase 1/2 monotherapy clinical trial. We believe demonstration of disease clearance activity by VCAR33ALLO would provide a fundamental rationale for further development in a non-relapse/refractory population which is still high risk, including patients with poor prognostic molecular markers and/or MRD positivity.
Patients who have relapsed after a trem-cel transplant are also eligible to receive VCAR33ALLO. The ability to treat relapsed trem-cel transplant patients with VCAR33ALLO may provide valuable early insights into the potential of the trem-cel + VCAR33 Treatment System.