Bellicum Reports FDA Lifted Clinical Hold on BPX-601 Phase 1/2 Clinical Trial

Rhea-AI Summary

Bellicum Pharmaceuticals (NASDAQ:BLCM) announced that the FDA has lifted the clinical hold on its Phase 1/2 trial assessing BPX-601 and rimiducid for metastatic pancreatic and prostate cancer. The hold was addressed satisfactorily, allowing the company to resume patient enrollment without protocol changes. CEO Rick Fair expressed optimism about BPX-601's safety and clinical potential. BPX-601 is designed to enhance T cell efficacy against tumors expressing prostate stem cell antigen (PSCA). This marks a significant step forward for Bellicum in developing controllable cell therapies.

Positive

• FDA lifted clinical hold on BPX-601 trial, allowing patient enrollment to resume.
• No modifications to current study protocol, simplifying the resumption process.
• CEO expressed optimism regarding BPX-601's safety and potential benefits for patients.

Negative

• None.

HOUSTON, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.

Bellicum worked diligently with the FDA over the past two months to respond to the clinical hold and has been informed by FDA that the company has satisfactorily addressed all clinical hold issues. Bellicum may now resume enrollment without modification to the current study protocol. The company plans to work with clinical investigators to resume patient enrollment.

“I am pleased that our team was able to address the FDA’s clinical hold questions in a timely manner, enabling us to evaluate BPX-601 in a cohort of patients with previously treated metastatic prostate cancer,” said Rick Fair, President and CEO of Bellicum Pharmaceuticals. “I remain optimistic about the safety and potential clinical benefit of our BPX-601 product candidate in these patients.”

About BPX-601

BPX-601, the company’s first GoCAR-T^® product candidate, incorporates iMC, Bellicum’s inducible co-activation domain. iMC (inducible MyD88/CD40) is designed to provide a powerful boost to T cell proliferation and persistence, production of immunomodulatory cytokines and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for pancreatic and prostate tumors expressing prostate stem cell antigen (PSCA).

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.

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 plans to work with clinical investigators to resume patient enrollment in the clinical trial; and the safety and potential clinical benefit of our BPX-601 product candidates in these patients. 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

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

FAQ

What does the FDA lifting the clinical hold mean for BLCM?

It allows Bellicum Pharmaceuticals to resume patient enrollment in their trial for BPX-601 without any changes to the study protocol.

What is BPX-601 being tested for?

BPX-601 is being evaluated as a treatment for metastatic pancreatic and prostate cancer.

How did Bellicum Pharmaceuticals address the FDA's clinical hold?

Bellicum worked diligently with the FDA over two months, satisfactorily addressing all clinical hold concerns.

What is the significance of the Phase 1/2 trial for BLCM?

The Phase 1/2 trial is crucial for assessing the safety and efficacy of BPX-601 in treating aggressive cancers.