- Bellicum Pharmaceuticals Inc BLCM announced the presentation of early Phase 1 results for BPX-601 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.
- These interim results demonstrated the preliminary efficacy of BPX-601 PSCA-directed GoCAR-T cells in combination with rimiducid in heavily pre-treated patients. These initial data from 2 cohorts consisted of 8 patients.
- Four of eight (50%) patients achieved a PSA50 response, three of whom achieved a PSA90 response.
- Of the six patients with soft tissue disease, two achieved partial responses.
- Of the two patients with the bone-only disease, one patient achieved a PSA90 response with a decreased enhancement of bone lesions observed on the bone scan.
- The most common grade 3+ adverse events were myelosuppression, characteristic of the lymphodepletion chemotherapies used in CAR-T studies.
- Two patients experienced Grade 3 cytokine release syndrome (CRS). One patient experienced Grade 4 immune effector cell neurotoxicity syndrome (ICANS) with concurrent hemophagocytic lymphohistiocytosis (HLH).
- ICANS improved to grade 1 with the standard of care and withholding subsequent doses of rimiducid, the patient died on study day 20 due to sepsis.
- Consistent BPX-601 cell expansion across patients was observed, with the persistence of BPX-601 cells detected in peripheral blood over 200 days.
- BPX-601 cell infiltration in PSCA-positive tumors was observed. The trial continues to enroll patients.
- Price Action: BLCM shares are down 12.70% at $1.07 on the last check Thursday.
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