Cullinan Therapeutics Touts 2026 “Defining Year” as T-Cell Engager, Zipalertinib Catalysts Near

Key Points

• CLN‑049 (FLT3×CD3) showed promising early AML activity with a ~30% composite CR/CRh rate—including a 50% composite CR rate in TP53‑mutated patients—and Cullinan plans dose escalation to 24 µg/kg, expansion cohorts in Q2 2026 and a registration‑enabling study by end of 2027.
• CLN‑978, a subcutaneously dosed CD19×CD3 T‑cell engager for autoimmune diseases, is being advanced globally in lupus, rheumatoid arthritis and Sjögren’s with first company‑sponsored data expected in 2026 as Cullinan aims to displace current monoclonal antibodies.
• Zipalertinib (EGFR exon 20) has a Taiho rolling NDA nearing completion, and Cullinan’s deal (US 50/50 profit share, $275M upfront, $130M potential U.S. milestones) plus >$430M in cash provides runway into 2029 to support these programs.

Cullinan Therapeutics NASDAQ: CGEM executives highlighted multiple upcoming catalysts across the company’s oncology and autoimmune portfolio during a presentation at Citi’s Virtual Oncology Leadership Summit, with management calling 2026 a “defining year” for the company.

CEO Nadim Ahmed and Chief Medical Officer Jeff Jones outlined progress on Cullinan’s two “high-priority” T-cell engagers—CLN-978 and CLN-049—alongside updates on zipalertinib, its partnered EGFR exon 20 inhibitor in non-small cell lung cancer (NSCLC). Ahmed also emphasized the company’s cash position, saying Cullinan ended December with more than $430 million in cash, providing runway “into 2029.”

Pipeline focus and 2026 catalysts

Ahmed said the company prioritizes programs it believes can be “first-in-class or best-in-class” and have a “transformative impact” for patients. He characterized Cullinan’s targets as clinically and commercially validated across both oncology and autoimmune disease, adding that the company’s programs have shown monotherapy efficacy in the clinic.

While the discussion centered on oncology, management also spent time on CLN-978, Cullinan’s CD19 x CD3 T-cell engager being developed in autoimmune diseases. Ahmed described CLN-978 as a differentiated molecule with “very high binding affinity for CD19,” small molecular size, and subcutaneous administration. He said Cullinan’s goal is to move the therapy earlier in treatment to potentially displace monoclonal antibodies that he said are “very safe, but with marginal efficacy.” The company is pursuing a “global development program” in lupus, rheumatoid arthritis, and Sjögren’s disease, and plans to present first company-sponsored data for a CD19 T-cell engager in 2026.

CLN-049 in AML: design and early clinical observations

In oncology, Cullinan is advancing CLN-049, a FLT3 x CD3 T-cell engager for acute myeloid leukemia (AML). Jones said the company is approaching FLT3 as an immunotherapy target rather than a kinase-inhibition target, noting FLT3 is present on the surface of AML blasts in at least 80% of cases regardless of kinase domain mutation status. He described CLN-049’s design as built on an IgG backbone with two FLT3-binding arms and two CD3-binding single-chain variable fragments at the C-terminus, with only one CD3 binder functionally active.

Jones said Cullinan presented dose-escalation results at the American Society of Hematology (ASH) meeting in December 2025. At doses starting at 6 micrograms per kilogram, the company began to see complete responses (CRs), which he emphasized are critical in AML. By the time of ASH, the study had escalated to 12 micrograms per kilogram, and Jones said eight patients achieved a form of CR (either CR or CR with incomplete hematologic recovery). He described a composite CR rate of about 30%, with the “majority” of those responses durable for at least four months, and said at least five responders had durability in excess of four weeks at the time of the presentation.

Jones also said responses appeared achievable across genetic risk groups and pointed to activity in TP53-mutated AML, which he described as the worst prognostic subtype. He said the composite CR rate in TP53-mutated patients was 50% in the dataset discussed.

Safety, step-up dosing, and development plans

On safety, Jones said cytokine release syndrome (CRS) occurred in about one-third of patients, with one grade 3 CRS case. He said that case occurred in a patient who received only a single step-up prior to the therapeutic dose, and that after implementing a two-step-up regimen the company did not see additional grade 3 CRS, with a trend toward lower overall CRS rates and severity. Jones noted step-up dosing is now standard for approved T-cell engagers.

Looking ahead, Jones said Cullinan plans to continue dose escalation through a target dose of 24 micrograms per kilogram. The company expects to initiate expansion cohorts in the second quarter of 2026 after completing dose escalation and potential backfill for additional pharmacokinetic/pharmacodynamic data. Management said it intends to provide a data update in the second half of 2026, with Ahmed adding the timing is intended to allow sufficient follow-up to better assess durability.

Jones said the company is enrolling backfill cohorts at doses of interest, including 12 micrograms per kilogram, and that expansion will likely include more than one dose in at least the all-comer non-TP53 cohort to support selection of a recommended Phase 2 dose. He also said Cullinan has stated a timeline “to initiate a registration-enabling study in relapsed refractory AML by the end of 2027.”

Ahmed said the company believes its early monotherapy results compare favorably to recent single-arm AML approval precedents, which he characterized as CR/CRh rates around 20%–30% with duration of 4–6 months. He said Cullinan’s goal is to pursue relapsed/refractory approval potentially via a single-arm Phase 2 study, with a frontline trial serving as both confirmatory and label-expansion study.

For frontline development, Jones said Cullinan plans a Phase I/II combination study with venetoclax and azacitidine by the end of 2026, citing emerging evidence supporting venetoclax/azacitidine as a backbone regimen, including what he described as the Paradigm Study presented at ASH.

Zipalertinib: rolling NDA and Taiho partnership economics

Ahmed also discussed zipalertinib, Cullinan’s EGFR exon 20 tyrosine kinase inhibitor partnered with Taiho. He said Taiho began a rolling NDA submission toward the end of 2025 for relapsed EGFR exon 20 NSCLC and expects to complete the rolling submission “this quarter.” Taiho also plans to complete enrollment in the frontline study in the first half of 2026.

Ahmed estimated the U.S. exon 20 NSCLC population at roughly 3,000 to more than 5,000 patients diagnosed annually. He said Cullinan received $275 million upfront in 2022 and is eligible for $130 million in regulatory milestones for U.S. approvals in second-line-plus and frontline settings. Under the deal, Taiho holds ex-U.S. rights, while Cullinan has a 50/50 profit share in the U.S. Ahmed said Taiho’s “lean” commercial structure and focus on precision oncology could make the profit-share arrangement accretive “very, very quickly,” while providing non-dilutive capital to support the broader pipeline.

About Cullinan Therapeutics NASDAQ: CGEM

Cullinan Therapeutics, Inc, a biopharmaceutical company, focuses on developing oncology therapies for cancer patients in the United States. The company's lead program comprises CLN-619, a monoclonal antibody that is in Phase I clinical trial for the treatment of solid tumors. Its development portfolio also includes CLN-049, a humanized bispecific antibody that is in Phase I clinical trial for the treatment of acute myeloid leukemia or myelodysplastic syndrome; CLN-418, a human bispecific immune activator that is in Phase 1 clinical trial for the treatment of multiple solid tumors; and Zipalertinib, a bioavailable small-molecule for treating patients with non-small cell lung cancer.

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