Bellicum Enrolls First Patient in Phase 1/2 Clinical Trial for BPX-603
HOUSTON, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with tumors that express human epidermal growth factor 2 (HER2). BPX-603 is Bellicum’s first dual switch GoCAR-T® product candidate that incorporates the company’s iMC activation and CaspaCIDe® safety switch technologies.
“Initiation of this Phase 1/2 dose escalation clinical trial for BPX-603 denotes an important achievement for Bellicum and represents our second GoCAR-T program to enter the clinic,” stated Rick Fair, President and CEO. “This program may provide further validation of our technology’s ability to enhance both the efficacy and safety of immune cell therapy against solid tumors. We are excited to advance this potentially life-saving treatment approach into the clinic.”
BPX-603 Phase 1/2 Clinical Trial Design
This Phase 1/2, open-label, multicenter, non-randomized study will investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid. The trial will enroll patients with previously treated, locally advanced or metastatic solid tumors with HER2 amplification or overexpression. The initial dose escalation phase of the trial is designed to evaluate safety and identify the Phase 2 dose of BPX-603 administered with rimiducid at a fixed dose of 0.4 mg/kg per infusion. The Phase 2 portion of the trial will assess the safety, pharmacodynamics, and clinical activity of BPX-603 in various HER2+ solid tumors. Tumor types that may be studied include gastric, breast, ovarian, endometrial, and colorectal.
HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or “iMC”. MC signaling is believed to boost effector cell proliferation and survival, enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment, and stimulate the cancer patient’s own immune system. Additionally, Bellicum’s dual-switch technology—which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules—is designed to enhance real-time control of both efficacy and safety.
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.
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 “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential further validation of our technology’s ability to enhance both the efficacy and safety of immune cell therapy against solid tumors; the potential for this treatment approach to save lives; and the tumor types to be evaluated in the Phase 2 portion of the trial. Various factors may cause differences between Bellicum’s expectations and actual results as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the Securities and Exchange Commission, including without limitation our quarterly report on Form 10-Q for the three months ended September 30, 2020 and our annual report on Form 10-K the year ended December 31, 2019. 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 our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Bellicum Pharmaceuticals
Robert H. Uhl