On December 11, 2022 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported a poster presentation by the University of North Carolina Lineberger Comprehensive Cancer Center (UNC Lineberger) team at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held in New Orleans December 10-13, 2022 (Press release, Bellicum Pharmaceuticals, DEC 11, 2022, View Source [SID1234625011]). The presentation, scheduled for today at 6 p.m. CT, will provide data on four patients who received rimiducid to activate the CaspaCIDe safety switch in an investigator sponsored trial.
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The poster titled "Abrogation of Immune Effector Cell Neurotoxicity Syndrome (ICANS) By Rimiducid (RIM) in Patients Treated with CD19-Specific Chimeric Antigen Receptor Modified T-Cells (CAR-T) Engineered with an Inducible Caspase 9 (iC9 CAR.19)" will also be available on Bellicum’s website.
The UNC Lineberger research team reported the clinical and pharmacodynamic courses of ICANS for four patients treated with rimiducid in an ongoing cell dose expansion cohort of a Phase I/II trial of iC9 CAR.19 cells to treat B-lymphoblastic leukemia (B-ALL). According to the poster, rimiducid administration to these patients experiencing corticosteroid-unresponsive grade 3-4 ICANS was associated with abrupt reduction of circulating iC9 CAR.19 cells and lower ICANS grade within 24 hours. The UNC Lineberger research team concluded that iC9 holds promise as a tool to potentially abrogate the most severe CAR T-cell toxicities.
"There is an unmet need in the management of severe ICANS, and these results suggest that the iC9 switch may mitigate such life-threatening toxicities," commented Natalie Grover, M.D., clinical director of UNC Lineberger’s cellular therapy program. "We look forward to further studies to explore ways to manage adverse reactions and improve patient outcomes for cellular immunotherapy regimens."
"These encouraging findings from UNC reinforce the potential benefit of the CaspaCIDe safety switch and rimiducid in resolving CAR T-cell related adverse events," said Rick Fair, President & CEO of Bellicum Pharmaceuticals. "We continue to support further clinical evaluation of the technology and remain committed to incorporating this important safety feature more broadly in additional cell therapies."
The UNC Lineberger team is exploring lower doses of rimiducid to determine if—by preserving a higher percentage of CAR-T cells—toxicity may be mitigated without diminishing the therapeutic benefit.