Bellicum’s GoCAR-Ts crash out of clinic over safety signal, sparking search for strategic alternatives

15 Mar 2023
www.fiercebiotech.com
Cell TherapyImmunotherapyClinical Study
Bellicum was running phase 1/2 clinical trials of two GoCAR-T candidates.
Bellicum Pharmaceuticals’ GoCAR-T cell therapies have GoCAR-T 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.
Bellicum Pharmaceuticalsas 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 Bellicums 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 pitchBellicumwitches as ways to boost effector cell proliferation, enhance functional pePSCAtence  andBPX-601r physiciHER2to wipe outBPX-603R-T cells in the event of a serious side effect suchBPX-601okine release syndrome. Yet, the early data on the candidates have discouraged Bellicum.BPX-603CaspaCIDe
Bellicum 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 eventscytokine release syndromeellicum has seen a dose-limiting toxicity in that dose esBellicum cohort.
In response, themetastatic castration-resistant prostate cancera. The review showedBPX-601f the nine prostate cancer patients experienced a 90% or greatgrade 4 cytokine release syndrome. 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-60prostate cancern, leading it to stop clinical trials of the candidate aPSAits other pipeline prospect BPX-603. With all clinical development winding down, the biotechBPX-601 evaluating strategic alterimiducidBPX-601
Bellicumiation of the evaluation suggests Bellicum’s drawn-out demise is now nearing the end. BBPX-6012014, the biotech was one of three CAR-T cell therapy developers to arrive on Nasdaq. The other two cBPX-603rapy 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 Bellicumsteps of the other members of the CAR-T class of 2014 for several years. In 2020, the cCAR-T celld off 79% of its employees after BPX-601 delivered lackluster safety and efficaKite PharmaJuno Therapeutics
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