NEW YORK – Arsenal Biosciences on Thursday said the first patient with platinum-resistant ovarian cancer has received its autologous T-cell therapy AB-1015 in a Phase I trial.
The trial will enroll 60 patients with advanced ovarian, fallopian tube, and primary peritoneal cancer who experienced disease recurrence or did not improve on platinum-based treatments. Patients will receive chemotherapy prior to undergoing treatment with AB-1015 in the study.
The trial aims to validate in humans the integrated circuit T-cell (ICT) technology Arsenal deployed in AB-1015. Arsenal's ICT technology engineers a patient's T cells to recognize certain proteins on the surface of ovarian cancer cells so the immune system can better identify and kill the tumor.
The primary endpoints of the study are to determine the incidence of adverse events and the maximum tolerated dose of AB-1015. Investigators will also measure anti-tumor activity, the number of AB-1015 cells present in patients up to one year after treatment, and the co-expression of ALPG and MSLN targets on tumor cells by immunohistochemistry.
"Immunotherapy offers great promise for ovarian cancer patients who have already failed or relapsed following treatment with platinum-based chemotherapies because it uses the patient's own immune cells to kill cancer cells," Arsenal Bio Chief Medical Office Susie Jun said in a statement. "Following our AB-1015 study, we plan to initiate subsequent clinical studies to explore the use of our ICT cell technology in other solid tumor cancers with high unmet medical need including kidney and prostate cancers."
In September, Arsenal Bio raised $220 million in a Series B funding round, which the firm is using to advance its product pipeline and on AB-1015's clinical trials.