Bellicum Announces Presentation by UNC at ASH 2022 on Potential Abrogation of iC9 CAR T-Cell Toxicities with Rimiducid

Rhea-AI Summary

Bellicum Pharmaceuticals (BLCM) announced a poster presentation at the 64th ASH Annual Meeting, highlighting findings from the University of North Carolina Lineberger Cancer Center. The study involved four patients treated with rimiducid to manage ICANS related to CD19-specific CAR-T therapy. The results indicated that rimiducid could significantly reduce severe ICANS symptoms within 24 hours. Bellicum's leadership expressed optimism about the technology's potential in improving patient outcomes and reducing toxicities associated with CAR-T therapies.

Positive

• Rimiducid demonstrated a quick reduction in ICANS symptoms within 24 hours.
• Potential for the iC9 safety switch to mitigate severe CAR-T toxicities.
• Support for further clinical evaluation of the CaspaCIDe safety switch.

Negative

• Clinical trial results are preliminary and based on a small patient cohort.
• Future studies may not confirm the effectiveness of rimiducid as indicated.

HOUSTON, Dec. 11, 2022 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced a poster presentation by the University of North Carolina Lineberger Comprehensive Cancer Center (UNC Lineberger) team at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition being held in New Orleans December 10-13, 2022. 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.

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.

About Bellicum Pharmaceuticals

Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company’s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum’s GoCAR-T^® product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at www.bellicum.com or follow us on Twitter or LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as “continue,” “designed,” “may,” “will,” “potential” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding Bellicum’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the applications and benefits of, as well as additional clinical support for, the CaspaCIDe safety switch and rimiducid in resolving CAR T-cell related adverse events, and incorporation of the CaspaCIDe safety switch and rimiducid into additional cell therapies. Various factors may cause differences between Bellicum’s expectations and actual results, including, among others, the impact of the COVID-19 pandemic and the fludarabine shortage on Bellicum’s clinical trial sites and trial enrollment, future study results, including those conducted with larger patient populations, may demonstrate that CaspaCIDe and rimiducid are not be as effective in resolving adverse events associated with cell therapies as reported by the UNC Lineberger research team, interest in CaspaCIDe and rimiducid may not be as expected, alternative or competitor products and technologies may be introduced, other factors, such as safety issues, may impact Bellicum’s clinical progress, actual expenses incurred may be higher than anticipated, and trial results may be different than anticipated, as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the Securities and Exchange Commission, including without limitation Bellicum’s quarterly report on Form 10- Q for the three months ended September 30, 2022 and Bellicum’s annual report on Form 10-K for the year ended December 31, 2021. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update Bellicum’s forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Source: Bellicum Pharmaceuticals

Investors:
Robert H. Uhl
Managing Director
ICR Westwicke
858-356-5932
Robert.uhl@westwicke.com

 

FAQ

What was presented at the ASH Annual Meeting related to BLCM?

Bellicum Pharmaceuticals presented data on rimiducid's effectiveness in reducing ICANS in CAR-T therapy patients.

What are the implications of rimiducid for CAR-T cell therapies?

Rimiducid may help mitigate life-threatening adverse effects associated with CAR-T cell therapies.

When was the poster presentation for BLCM made?

The poster presentation occurred on December 11, 2022, during the ASH Annual Meeting.

What is the focus of the ongoing trial mentioned in the BLCM press release?

The trial focuses on the effectiveness of iC9 CAR.19 cells in treating B-lymphoblastic leukemia.