Senti Bio anticipates the launch of a multicenter clinical trial in hematological malignancies this year, with the first patient expected to receive the therapy within 2024’s second quarter.
Senti Biosciences (Senti Bio)’s SENTI-202, an investigational allogeneic chimeric antigen receptor natural killer (CAR-NK) cell therapy candidate intended to treat
In light of the IND clearance, Senti Bio anticipates the launch of a multicenter clinical trial in hematological malignancies this year, with the first patient expected to receive the therapy within 2024’s second quarter. The study, which will take place in both the United States and Australia, will seek to recruit patients with relapsed/refractory hematological malignancies that express either CD33, FLT3, or both CD33 and FLT3. SENTI-202 will be administered at doses of either 1 billion or 1.5 billion CAR-NK cells, depending on a patients’ assigned dose level in the trial. Initially, patients will receive 3 doses weekly after undergoing lymphodepletion; additional cycles of lymphodepletion and doses of the therapy may be administered to patients depending on safety and efficacy outcomes. The company noted that it expects to announce initial clinical efficacy results from the trial by the end of 2024 and durability results in 2025.
SENTI-202 incorporates logic gating based on the company’s proprietary Gene Circuit platform. It targets both CD33 and FLT3 with the company’s “OR” logic gate, while incorporating a “NOT” logic gate to spare cells expressing EMCN.2
“Clearance of our IND application for SENTI-202 is a tremendous milestone and marks an important achievement for Senti as we transition to a clinical-stage therapeutics company,” Timothy Lu, MD, PhD, the chief executive officer and co-founder of Senti Bio, said in a statement.1 “Our team has dedicated immense time and resources to developing our Gene Circuit technology from an initial synthetic biology hypothesis to what is now a tangible product for cancer patients. We look forward to initiating Senti’s first clinical trial and continuing our strong momentum into next year.”
In August 2023, Senti Bio’s manufacturing facility was acquired by private equity firm Celadon Partners, which established GeneFab, a new independent manufacturing company.3 As part of the transaction agreement, GeneFab will carry out clinical manufacturing of SENTI-202 and other CAR-NK products in Senti Bio’s pipeline under a service contract. In December 2023, Senti Bio noted that the majority of manufacturing–related expenses necessary to complete the phase 1 study for SENTI-202 have been prepaid.
“SENTI-202 has been systematically engineered to potentially overcome the key limitations of current AML therapies, namely the need to address AML heterogeneity and to protect healthy marrow cells from on-target and off-tumor killing,” Kanya Rajangam, MD, PhD, the head of Research and Development and the chief medical officer of Senti Bio, added to the statement.1 “Our trial design incorporates lessons learnt from clinical experiences with other AML cell therapies and includes disease-specific lymphodepletion, multiple high doses of CAR-NK cells, as well as multiple treatment cycles. We are excited to begin this trial and deliver a potential treatment to patients who currently have no approved therapies and very poor prognosis.”
The IND clearance follows
