Adicet Bio, Inc. (NASDAQ: ACET) has announced positive interim data from its dose escalation Phase 1 study that evaluates the safety and tolerability of ADI-001, the company’s investigational therapy that targets CD20 for potential treatment of B-cell Non-Hodgkin’s Lymphoma. Since November 22nd’s cutoff, six patients have been enrolled and received the ADI-001. The initial two patients enrolled in the lowest dose level tested did not reach its day 28 assessment and were not evaluable for efficacy per protocol. Three out of the four evaluable patients have achieved responses that include two complete responses and one partial response in investigators that are characterized as nearly complete. Patients have been heavily pre-treated with a median of five lines of prior systemic therapy. This includes a patient who received prior autologous CD19 CAR T and achieved complete response that follow a single infusion of ADI-001 administered at the lowest dose level.
“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,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “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.”
“The unequivocal responses to ADI-001 in this heavily pre-treated patient population at such low dose levels are highly promising,” said Sattva Neelapu M.D., Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. “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. 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.”