Bellicum Pharmaceuticals: The FDA Lifted the Clinical Hold on BPX-501 Clinical Trial

Bellicum Pharmaceuticals (BLCM): The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.

Bellicum is a clinical-stage biopharmaceutical company dedicated to the discovery and development of cellular immunotherapies for cancers and orphan inherited blood disorders. Its proprietary Chemical Induction of Dimerization (CID) technology platform aims at engineering and controlling components of the immune system.

Bellicum is developing what it calls next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR-T and TCR cell therapies.  

Bellicum’s clinical product candidates

BPX-501, an adjunct T cell therapy in multiple Phase I/II clinical trials, administered after allogeneic hematopoietic stem cell transplant (HSCT). This adjunct T-cell therapy may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemia activity while minimizing graft versus host disease (GVHD) side effects.

BPX-601, a GoCAR-T product candidate in Phase I clinical trial for treating solid tumors expressing the prostate stem cell antigen.

BPX-701, a T cell receptors (TCR) based therapy in clinical trial for malignant cells expressing the preferentially-expressed antigen in melanoma; and CD19, a chimeric antigen receptor T cell therapy for expressing B cell malignancies setting.

Collaborators

Adaptimmune Therapeutics (ADAP) to evaluate, develop, and commercialize T cell therapies;

Academisch Ziekenhuis Leiden for research to discover and validate high-affinity TCR product candidates targeting various cancer-associated antigens.

Prohost Observations

On January 30, 2018, the U.S. Food and Drug Administration (FDA) placed Bellicum’s product BPX-501 on a clinical hold following three cases of encephalopathy deemed as possibly related to BPX-501.

Prohost had studied this firm and considered it scientifically solid having a formidable technology that enabled creating promising pipeline products. Although the news about the FDA decision to put BPX-501 on clinical hold was painful and caused the stock to lose, we still believed that the outcome of the investigation will be in favor of the firm’s technology.

At the time we recognized the following facts:  

– Encephalopathy occurs in the allogeneic stem cell transplant literature.

– The complications of allogeneic stem cell transplant encephalopathy remain for a long period of time.

– The three cases of encephalopathy had prior failed transplants, prior history of immunodeficiency and infection led us to believe that it might be reasonable considering that Bellicum’s product BPX-501might have nothing to do with the 3 cases of encephalitis.

We decided at the time to put the stock that was cremated by investors following the negative news in the Prohost aggressive investment portfolio.

After the announcement of the FDA lifting the clinical hold put on BPX-501, BLCM Is trading today at around $8.04 UP $1.19.

Could this be the beginning of a stock outperformance on an expected series of upcoming good news?

We believe so.  

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