BMS announced data from three studies evaluating Breyanzi (liso-cel), including long-term data with three-year follow-up from the Phase 3 TRANSFORM trial of Breyanzi as a second-line treatment in patients with relapsed or refractory LBCL, results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results from a subgroup analysis assessing the efficacy and safety of Breyanzi based on use of bridging therapy in the TRANSCEND FL trial in relapsed or refractory follicular lymphoma (FL).
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Breyanzi demonstrated clinically meaningful outcomes in broad range of B-cell cancers
CLINICAL AND REGULATORY
Breayanzi demonstrated clinically meaningful outcomes in broad range of B-cell malignancies
Three-year follow-up results from TRANSFORM show ongoing event-free survival and durable responses with Breyanzi compared to standard of care. Results from a subgroup analysis from mantle cell lymphoma cohort of TRANSCEND NHL 001 show Breyanzi demonstrated consistent clinical benefit regardless of number of prior lines of therapy, supporting use of Breyanzi in earlier lines of treatment. Data from bridging therapy subgroup analysis of TRANSCEND FL show consistent efficacy with high response rates and a consistent safety profile regardless of receiving prior bridging therapy, supporting Breyanzi’s differentiated profile in relapsed or refractory follicular lymphoma.
Galapagos presented encouraging data for its CAR-T candidate in NHL
Galapagos presented new data from the ongoing Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101, in relapsed or refractory NHL at the annual EHA congress. Galapagos’ product candidate GLPG5101 is produced using the company’s innovative, decentralized T-cell manufacturing platform. GLPG5101 was administered as a fresh product in 94% of patients with a median vein-to-vein time of seven days, eliminating the need for bridging therapy. T-cell subsets were assessed in the apheresis starting material and final CAR-T product. There was a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells (naive/stem cell memory and central memory T cells) in the final product compared with starting material, indicating an increase of those populations during the manufacturing process. This demonstrates the feasibility of Galapagos’ decentralized manufacturing platform to deliver a high-quality CAR T-cell product to patients. A total of 14 of 16 efficacy-evaluable patients responded to treatment (ORR 87.5%), with 12 patients achieving a complete response (CR rate 75%). In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), and all responders achieved a complete response (CRR 93.3%). Durable responses were observed in the majority of responding patients – 71% of patients in Phase 1 had an ongoing response at data cut-off with median follow-up of 13.1 months; and 100% of patients in Phase 2 had an ongoing response at data cut-off with median follow-up of 4.2 months.
CARsgen presented first-in-human GPRC5D targeting CAR-T at EHA 2024
CARsgen Therapeutics presented the initial results from the ongoing first-in-human study of CT071 in a poster presentation at EHA congress. The preliminary results of Phase 1 of CT071 in patients with relapsed or refractory multiple myeloma demonstrated overall response rate of 90%, including 5 patients (50%) with stringent complete response (sCR), 2 patients (20%) with very good partial response (VGPR), and 2 patients (20%) with partial response (PR). No adverse events of special interest or dose limiting toxicity occurred.
Cellectis received Orphan drug designation for UCART22 for patients with ALL
Cellectis announced that the European Commission has granted an Orphan Drug Designation to its product candidate UCART22, for the treatment of ALL. UCART22 is an allogeneic CAR T-cell product candidate targeting CD22 and evaluated in BALLI-01, a Phase 1/2 open-label dose-escalation and dose-expansion study, designed to evaluate the safety, expansion, persistence and clinical activity of UCART22 in patients with relapse/refractory ALL.
DEALS AND FINANCING
Cargo Therapeutics raised $110 million in private placement
Cargo has entered into a securities purchase agreement for a private investment in public equity financing that is expected to result in gross proceeds of approximately $110 million. The private placement included participation from both new and existing investors including EcoR1 Capital, Woodline Partners, Saturn V Capital, Opaleye Management, T. Rowe Price Associates, Novo Holdings, Perceptive Advisors, RTW Investments, Samsara BioCapital, Wellington Management, Ally Bridge Group, Third Rock Ventures, and a large investment manager. Cargo sold 6,471,000 shares of its common stock at a price of $17 per share.