Bellicum Receives FDA IND Clearance to Initiate a Phase 1/2 Clinical Trial for BPX-603, a Dual-Switch GoCAR-T® for HER2+ Solid Tumors

HOUSTON, June 15, 2020 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for BPX-603. BPX-603 is a GoCAR-T^® product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2). BPX-603 is the company’s first dual-switch GoCAR-T^® product candidate, which incorporates both the company’s iMC activation and CaspaCIDe^® safety switch technologies.

“The FDA’s clearance of our IND for BPX-603 marks a significant milestone for Bellicum, adding a second clinical program to further evaluate our novel GoCAR-T technology’s ability to enhance CAR-T and host immune cell activity against solid tumors,” said Rick Fair, President and Chief Executive Officer of Bellicum. “We look forward to initiating our Phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year.”

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 and CAR-NK 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.

Source: Bellicum Pharmaceuticals

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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 “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: our research and development activities and expectations regarding generating and presenting data for our BPX-601, BPX-603 and other cell therapy programs, our ability to recruit investigational sites and initiate the planned clinical trial for BPX-603; our ability to enroll patients and generate meaningful clinical data in the BPX-603 clinical program; whether the activity of other HER2-directed therapeutics predicts activity for BPX-603; whether the dual switch configuration containing both iMC and CaspaCIDe will provide safety or efficacy benefits in patients; and whether we will be able to manufacture BPX-603 in compliance with cGMPs for use in the planned clinical trials. 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 March 31, 2020 and our annual report on Form 10-K for 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.