Cullinan Therapeutics, Inc.

Cullinan Therapeutics Advances Velinotamig into Global Clinical Development for Autoimmune Cytopenias Following IND Clearance by the U.S. FDA

Cullinan Therapeutics received FDA and Australian TGA clearance to initiate a global Phase 1b/2a trial of velinotamig in adults with relapsing and refractory ITP and wAIHA. The open-label multicenter study, NCT07738822, evaluates a defined course of four subcutaneous doses of the BCMAxCD3 T cell engager, expanding Cullinan's immunology portfolio into autoimmune cytopenias. Cullinan holds an ex-Greater China, all-indication exclusive license from Genrix Bio, which is separately evaluating the drug in refractory SLE; emerging velinotamig data will be presented at ACR Convergence on November 8, 2026. The company cites a U.S. prevalence of roughly 62,000 chronic ITP adults and 33,300 wAIHA adults, though early-phase safety and activity remain unproven.

•5d ago

Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases

Cullinan Therapeutics and Taiho Oncology announced Phase 2 REZILIENT2 Cohort C results for zipalertinib in NSCLC patients with EGFR exon 20 insertion or uncommon EGFR mutations and active CNS metastases. Among 43 evaluable patients, zipalertinib achieved a 30.2% intracranial objective response rate, a 72.1% intracranial disease control rate, and a median intracranial duration of response of 9.7 months, with the drug well tolerated at 100 mg twice daily. This is the first prospective study of intracranial activity for an EGFR TKI in this population; data will be presented at the ESMO Congress 2026 on October 26 in Madrid. Zipalertinib remains investigational and is being developed with Taiho, so the readout supports the program's continued evaluation rather than a near-term commercial event for CGEM.

•13d ago

Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia

Cullinan Therapeutics dosed the first patient in its pivotal Phase 2 study of CLN-049, an FLT3xCD3 T cell engager, in relapsed/refractory acute myeloid leukemia. The potentially registrational study followed a successful End-of-Phase 1 FDA meeting and includes a brief dose-optimization phase before a single-arm expansion cohort, plus an exploratory cohort in newly diagnosed TP53-mutated AML. In parallel, Cullinan is initiating a Phase 1/2 study of CLN-049 combined with azacitidine and venetoclax in newly diagnosed AML, with a Phase 1 dose-escalation update expected in December.

•24d ago

New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

Cullinan Therapeutics initiated an NDA submission to the FDA for zipalertinib plus platinum chemotherapy in first-line EGFR exon 20 insertion NSCLC under the Real-Time Oncology Review program, with completion expected by year-end 2026. The filing rests on the Phase 3 REZILIENT3 trial, which met its primary endpoint with a statistically significant improvement in median PFS — the longest observed to date in this setting — and was presented at the IASLC 2026 WCLC Presidential Symposium. Separately, an NDA for zipalertinib monotherapy in previously treated EGFR ex20ins NSCLC is under FDA review with a PDUFA date of February 27, 2027, and Cullinan is eligible for $30M and $100M milestones on second- and first-line U.S. approvals.

•1mo ago

Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer

Zipalertinib plus platinum-based chemotherapy extended median progression-free survival to 14.5 months versus 8.5 months with chemotherapy alone (HR=0.50; 95% CI, 0.34-0.73; P=0.00015) in first-line EGFR exon 20 insertion mutation NSCLC, per the Phase 3 REZILIENT3 interim analysis. The combination also raised objective response rates to 65.0% from 40.3% (P<0.0001) and extended median duration of response to 14.2 months versus 9.9 months; the interim overall survival analysis (30% maturity) showed an HR for death of 0.72 (95% CI, 0.42-1.23) with follow-up ongoing. The data were featured in Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer in Seoul; Taiho said it is excited to discuss the results with health authorities to make zipalertinib available to patients in a timely manner. Safety was consistent with the known profiles of the individual agents, though Grade ≥3 AEs were more frequent with the combination (87.1% vs. 54.4%). For Cullinan Therapeutics, which develops zipalertinib in the U.S. in collaboration with Taiho Oncology and Taiho Pharmaceutical, the practice-changing dataset strengthens the asset's path toward a first-line treatment role in the EGFR ex20ins NSCLC niche.

•1mo ago

Cullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer

Cullinan Therapeutics will host a virtual analyst and investor event on Monday, September 14, 2026, at 8:00 a.m. ET to discuss the Phase 3 REZILIENT3 data being presented at the IASLC 2026 World Conference on Lung Cancer in Seoul, South Korea. The zipalertinib plus chemotherapy data will be presented in Presidential Symposium 2 on Sunday, September 13; the trial in first-line EGFR exon 20 insertion mutation-positive NSCLC met its primary endpoint of progression-free survival at a planned interim analysis, as previously announced. CEO Nadim Ahmed and Chief Medical Officer Jeffrey Jones will lead the company's event, with a live webcast and replay available via Cullinan's investor relations website.

•1mo ago

Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer

Cullinan Therapeutics and Taiho Oncology announced that the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy met its primary endpoint of progression-free survival in first-line EGFR exon 20 insertion mutation-positive NSCLC. The trial data was selected for presentation in the Presidential Symposium at the IASLC 2026 World Conference on Lung Cancer, a premier session featuring research with potential to change clinical practice. The multicenter trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.

•2mo ago

Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results

Cullinan Therapeutics reported Q2 net loss of $53.7 million, narrowing from $70.1 million year-over-year, with cash and investments of $356 million providing a runway into 2029. The company achieved key regulatory milestones, including a positive FDA End-of-Phase 1 meeting for CLN-049 initiating a registrational Phase 2 study, and the FDA acceptance of the NDA for zipalertinib with a PDUFA target date of February 27, 2027. Pipeline updates include planned data readouts for CLN-978 and velinotamig in late 2026 and Phase 2 expansion studies across immunology and oncology programs slated for early 2027.

•2mo ago

Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML

Cullinan Therapeutics received positive FDA feedback following an End-of-Phase 1 meeting for its lead asset CLN-049, clearing the way for a potentially registrational Phase 2 study in relapsed/refractory AML. The company plans to initiate the single-arm Phase 2 study with seamless dose optimization in the third quarter of 2026, with a data update expected in the fourth quarter. Additionally, Cullinan will launch a Phase 1/2 combination study evaluating CLN-049 with venetoclax and azacitidine in previously untreated AML patients.

•3mo ago

Cullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune Diseases

Cullinan Therapeutics reported positive Phase 1 clinical data for its CD19 T-cell engager CLN-978 in rheumatoid arthritis, including clinical remission in a poly-refractory patient with a DAS28-ESR score dropping from 4.0 to 2.2. Data for its BCMA T-cell engager velinotamig showed complete renal responses and rapid reductions in disease activity scores in two patients with refractory systemic lupus erythematosus. The company plans to report additional multi-dose data for CLN-978 in Q3 and Q4 2026, and expects to share further velinotamig data before year-end, supporting a path toward Phase 2 expansion.

•4mo ago

Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress

Cullinan Therapeutics presented initial Phase 1 data for CLN-978 at EULAR 2026, showing clinical benefit and remissions in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). In the SLE cohort, 71% of patients with sufficient follow-up saw a significant reduction in disease activity scores, and half of those achieved remission. Deep, dose-dependent B-cell depletion was observed in both blood and tissue. The RA cohort showed 71% improvement in disease activity, with one patient achieving remission after a single dose. The safety profile was favorable, with no neurotoxicity observed and only one case of Grade 3 cytokine release syndrome at the highest dose tested. Cullinan will host an Immunology Day on June 10 to discuss these results and present initial data for its second asset, velinotamig.

•4mo ago

Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager

Cullinan Therapeutics will host an in-person Immunology Day on June 10, 2026, in New York City to present new clinical data for its autoimmune pipeline. The event will feature initial data from the first multi-dose cohort of CLN-978 in rheumatoid arthritis and single-dose escalation data in systemic lupus erythematosus, building on data previously reported at EULAR 2026. Velinotamig, a BCMA T-cell engager, will also see initial multi-dose cohort data presented from a study conducted by partner Genrix Bio in China.

•5mo ago

Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress

Cullinan Therapeutics will present initial Phase 1 clinical data for CLN-978, a subcutaneous CD19xCD3 bispecific T-cell engager, at the EULAR 2026 Congress in London. The data covers two ongoing studies, OUTRACE RA and OUTRACE SLE, evaluating the drug in treatment-refractory rheumatoid arthritis and systemic lupus erythematosus, respectively. The abstract reports a favorable safety profile, robust B-cell depletion in blood and tissue, and early signals of clinical activity in both indications.

•5mo ago

Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results

Cullinan reported Q1 2026 net loss of $49.7 million, or $0.75 per share, with cash and investments of $393.3 million providing runway into 2029. The FDA accepted the NDA for zipalertinib in relapsed EGFR ex20ins NSCLC, setting a PDUFA target action date of February 27, 2027, while partner Taiho completed enrollment in the pivotal REZILIENT3 study. Pipeline updates include initial CLN-978 data in SLE and RA scheduled for presentation at the EULAR 2026 Congress in June, with multi-dose regimen data in RA expected in Q3 2026.

•5mo ago

U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

The FDA accepted the New Drug Application for zipalertinib for the treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The submission is supported by data from the Phase 2b REZILIENT1 trial, which demonstrated a confirmed objective response rate of 35% and a median duration of response of 8.8 months in the primary efficacy population. The Prescription Drug User Fee Act target action date is set for February 27, 2027, marking a significant step toward potential commercialization for Cullinan and its partner Taiho Oncology.

•6mo ago