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Taiho Oncology and Cullinan Announce REZILIENT3 Trial Results
The company states: "Taiho Oncology Taiho Pharmaceutical Co, and Cullinan Therapeutics announced that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer - NSCLC - harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations, met its primary endpoint of progression-free survival (PFS) at a planned interim analysis. In this analysis, the study demonstrated a statistically significant and clinically meaningful improvement in PFS in the zipalertinib containing arm. Observed safety for the zipalertinib containing arm was manageable. Based on these data, the Independent Data Monitoring Committee recommended unblinding the study. The trial will continue to monitor efficacy and safety. Full results from REZILIENT3 will be submitted for presentation at an upcoming international medical conference. Based on these results, pending discussions with the U.S. Food and Drug Administration, Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics plan to pursue U.S. regulatory approval for this combination regimen in the first-line setting."
Cullinan Therapeutics Shares Clinical Data for CLN-978 and Velinotamig
"At our recent Immunology Day event, we shared compelling initial clinical data for CLN-978 and velinotamig, two T cell engagers with potential to achieve immune reset and transform outcomes for people living with autoimmune diseases. We look forward to sharing additional clinical data throughout the remainder of 2026 as we rapidly advance these programs towards Phase 2 studies," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.
Cullinan Therapeutics to Initiate Phase 2 Study of CLN-049 in 2026
Cullinan Therapeutics announced feedback from the FDA following an End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 T cell engager being evaluated in patients with acute myeloid leukemia. The EOP1 meeting focused on the planned Phase 2 development strategy for CLN-049. Based on discussions with the FDA, Cullinan will initiate a potentially registrational Phase 2 study of CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026. The study design agreed with the FDA incorporates a short dose-optimization phase with seamless progression to a single-arm cohort at the recommended Phase 2 dose. As presented at the 2025 American Society of Hematology annual meeting, CLN-049 demonstrated clinical activity and a favorable safety profile in patients with relapsed/refractory AML. The company plans to share an update from the dose escalation portion of this study in Q4. Following the positive feedback from the FDA, the company plans to initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3. The company will also initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML.
Cullinan Therapeutics CLN-049 Receives FDA Orphan Drug Designation
Cullinan Therapeutics announced that the FDA has granted orphan drug designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory acute myeloid leukemia.
Cullinan Therapeutics Looks Forward to Initial Clinical Data for CLN-978 and Velinotamig
"T cell engagers have the potential to transform outcomes for people living with autoimmune diseases and cancer, and emerging clinical data underscore their promise as a compelling therapeutic modality. We look forward to sharing initial clinical data for CLN-978 and velinotamig throughout 2026. CD19 and BCMA are now well-validated autoimmune targets, and by addressing both, we aim to comprehensively treat more diseases and redefine standards of care for more patients with these two clinical-stage programs. Similarly, the early success of CLN-049 in AML further reinforces the remarkable promise of T cell engagers in many high unmet need disease settings across immunology and oncology," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.
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