ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patients have been dosed in a Phase I/II clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-602 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The trial is being led by The University of Texas MD Anderson Cancer Center.
ADCT-602 is an ADC that incorporates a pyrrolobenzodiazepine (PBD) drug linker and targets CD22, which is a clinically validated ADC target. Preclinical studies have demonstrated that ADCT-602 has significant anti-tumor activity in a number of animal models.
Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia, and Nitin Jain, MD, Associate Professor in the Department of Leukemia, at MD Anderson, are leading the Phase I/II clinical trial of ADCT-602. The open-label trial will enroll up to 65 patients.
Dr. Kantarjian said, "There is a significant unmet need for new treatment options for adult patients with B-cell ALL who have not responded to initial treatment or whose cancer has returned after treatment. We are excited to evaluate the safety and anti-tumor activity of a CD22-targeted ADC in these patients."
Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President at ADC Therapeutics, said, "We are delighted to be partnered with MD Anderson on this important clinical trial in adult patients with relapsed or refractory B-cell ALL, who have limited therapeutic options and for whom the prognosis is typically poor. We are hopeful that the response rates seen in our ADCT-402 and ADCT-301 lymphoma clinical trials can be replicated in the ALL patient population with ADCT-602, and that our growing portfolio of hematology-focused ADCs targeting CD19, CD25 and now CD22 can make a positive impact on patient outcomes."
For more information about this clinical trial, please visit www.clinicaltrials.gov (identifier NCT03698552).
ADCT-602 is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD22 conjugated to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD22-expresing cell, ADCT-602 is internalized into the cell where enzymes release the PBD-based warhead. CD22 is an attractive and clinically validated ADC target. CD22 is highly expressed on most malignant B-cells, including expression in greater than 90% of patients with B-cell acute lymphoblastic leukemia.