Bellicum’s GoCAR-Ts crash out of clinic over safety signal, sparking search for strategic alternatives
15 Mar 2023
Cell TherapyImmunotherapyClinical Study
Preview
Source: FierceBiotech
Bellicum was running phase 1/2 clinical trials of two GoCAR-T candidates.
Bellicum Pharmaceuticals’ GoCAR-T cell therapies have skidded out, with the biotech halting trials of the two candidates over dose-limiting toxicities. The evaporation of Bellicum’s pipeline prompted the CAR-T cell therapy specialist to start an evaluation of strategic alternatives.
Houston-based Bellicum was running phase 1/2 clinical trials of two CAR-T candidates, namely the PSCA prospect BPX-601 and the HER2 candidate BPX-603. Both assets use the biotech’s GoCAR-T technology. BPX-601 expresses a rimiducid-inducible co-activation switch to enhance T cell potency and persistence. And BPX-603 features both the co-activation switch and a CaspaCIDe safety switch.
Bellicum pitched the switches as ways to boost effector cell proliferation, enhance functional persistence and empower physicians to wipe out the CAR-T cells in the event of a serious side effect such as cytokine release syndrome. Yet, the early data on the candidates have discouraged Bellicum.
The most recent metastatic castration-resistant prostate cancer patient to receive BPX-601 experienced serious immune-mediated adverse events including grade 4 cytokine release syndrome. The adverse events marked the second time Bellicum has seen a dose-limiting toxicity in that dose escalation cohort.
In response, the biotech paused enrollment and reviewed the data. The review showed four of the nine prostate cancer patients experienced a 90% or greater reduction in the PSA biomarker. But also revealed the need to optimize either the clinical dose and schedule of BPX-601 and the activating agent rimiducid, or the design of the BPX-601 cell construct to make the benefits outweigh the risks.
Bellicum, which ended September with $28.8 million to its name, lacks the cash to pull off the BPX-601 rescue mission, leading it to stop clinical trials of the candidate and its other pipeline prospect BPX-603. With all clinical development winding down, the biotech is now evaluating strategic alternatives.
The initiation of the evaluation suggests Bellicum’s drawn-out demise is now nearing the end. Back in 2014, the biotech was one of three CAR-T cell therapy developers to arrive on Nasdaq. The other two cell therapy developers—Kite Pharma and Juno Therapeutics—went on to land multi-billion dollar buyouts and deliver commercial products.
Bellicum has looked unlikely to follow in the footsteps of the other members of the CAR-T class of 2014 for several years. In 2020, the company laid off 79% of its employees after BPX-601 delivered lackluster safety and efficacy data.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.