Adcet Bio Inc. (NASDAQ: ACET) has announced encouraging preliminary results from its phase 1 dose-escalation study evaluating tolerability and safety of ADI-001, the company’s experimental therapy targeting CD20 for the possible B-Cell Non-Hodgkin’s lymphoma treatment.
The study enrolled six patients who received ADI-001
Six patients had been enrolled and given ADI-001 as of the November 22, 2021 data cutoff. The first two patients recruited at the lowest dose level tested did not make it to day 28 and were therefore not evaluable for efficacy. Three out of the four evaluable subjects responded, with two complete responses (CR) and a partial response (PR) that study investigators described as nearly complete. Patients had had a median of five lines of previous systemic therapy, including one who had previously received autologous CD19 CAR T. They obtained complete response after a single infusion of ADI-001 at the lowest dose level.
CEO and President Chen Schor said, “We are extremely excited to see such profound early complete responses in our Phase 1 dose-finding study evaluating ADI-001 as monotherapy among patients with very advanced cancer starting at our first dose level of 30 million CAR+ cells. Data to-date suggest that ADI-001 is highly clinically active. We look forward to reporting additional data in the first half of 2022 and to rapidly progressing our pipeline to realize the full potential of our gamma delta CAR T cell platform for patients.”
ADI-001 produced unequivocal responses in pre-treated patients
Sattva Neelapu, Department of Myeloma/lymphoma professor at the Unversity of Texas MD Anderson Cancer Centre, said, “The unequivocal responses to ADI-001 in this heavily pre-treated patient population at such low dose levels are highly promising. These data suggest that ADI-001 has the potential to be an effective treatment option for B cell malignancies if confirmed in further clinical testing. In addition, ADI-001 does not require gene editing and provides complementary innate, adaptive, and CAR mediated antitumor effects which may improve durability and minimize emergence of tumor resistance.”