NEW YORK – Numab Therapeutics on Wednesday said it began testing its tri-specific antibody treatment NM32 as a treatment for solid tumors overexpressing ROR1 in a Phase I trial.
The dose-escalation trial will include up to 60 patients with previously treated ROR1-overexpressing advanced solid tumors. Researchers will characterize the pharmacokinetic properties, pharmacodynamic effects, and safety profile of NM32 and select an optimal dosing regimen for NM32 to take into future studies. They will also measure patients' initial responses, as well as progression-free and overall survival as secondary endpoints.
ROR1 is overexpressed in several solid and hematological cancers including triple-negative breast cancer, lung cancer, ovarian cancer, chronic lymphocytic leukemia, and mantle cell lymphoma. NM32 targets ROR1 on tumor cells, the T-cell receptor-associated antigen CD3, and the protein human serum albumin (HSA). The drug is designed to help a patient's immune system recognize and attack tumor cells. It's also designed to have a long half-life by binding to HSA, which allows for less frequent dosing. In the trial, researchers will explore a biweekly dosing schedule.
"Despite the introduction of checkpoint inhibitors and several commercially available CD3 engagers for the treatment of hematological malignancies, there has been limited success in solid tumors mainly due to the lack of highly tumor-specific antigens allowing selective T-cell activation against tumor cells," Martin Stern, senior VP of clinical science at Numab Therapeutics, said in a statement.
NM32 is Numab's first oncology candidate to enter clinical trials, and the firm has several undisclosed preclinical oncology programs. The company, based in Horgen, Switzerland, has one other clinical-stage therapy it is testing in atopic dermatitis.