On March 4, 2021 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported the publication of a case report using the company’s CaspaCIDe (inducible caspase-9, or iC9) safety switch (Press release, Bellicum Pharmaceuticals, MAR 4, 2021, View Source [SID1234576102]). The letter to the editor titled "Utility of Safety Switch to Abrogate CD 19 CAR T Cell-Associated Neurotoxicity" appeared as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper). Link to article.

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The publication detailed a case report from an investigator-sponsored trial (IST) at the University of North Carolina Lineberger Comprehensive Cancer Center, where a Phase 1/2 trial is ongoing to test the safety and efficacy of autologous T lymphocytes genetically modified to express a CD19 chimeric antigen receptor (CAR) and iC9. A patient in the dose expansion cohort of this trial experienced a high grade neurologic adverse event with persistence of grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) for 72 hours despite standard care, and rimiducid was subsequently given per protocol to activate iC9.

Within twelve hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days. This publication marked the first reported clinical use of the iC9 safety switch to mitigate a severe CAR-T-mediated adverse event refractory to standard of care treatment.

"Given the risks of ICANS and other CAR-T cell-mediated adverse events, the inclusion of the iC9 switch has the potential to dramatically improve the safety of cellular immunotherapies," said Matthew Foster, M.D., University of North Carolina Lineberger Comprehensive Cancer Center. "We are also encouraged by the anti-leukemic response we observed in this patient even with the use of the iC9 switch."

"We remain enthusiastic about our switch technology, which as shown in this case report and in the extensive CaspaCIDe experience from the rivo-cel program, can improve the overall benefit/risk profile of cell therapy," said Rick Fair, President and CEO of Bellicum Pharmaceuticals. "We believe this clinical experience validates our continued efforts to incorporate this technology into a growing number of internal and collaborator programs."

About CaspaCIDe

CaspaCIDe (inducible caspase-9, or iC9) is Bellicum’s chemical induction of dimerization (CID) safety switch technology designated to eliminate cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. Infusion of rimiducid is designed to trigger activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. Because CaspaCIDe is designed to be permanently incorporated into Bellicum’s cellular therapies, the safety switch has the potential to be available for use long after the initial therapy is delivered.