Cullinan Therapeutics Refocuses Pipeline, Discontinues Oncology Programs Amid Autoimmune Push

Cullinan Therapeutics, formerly known as Cullinan Oncology, has announced a significant shift in its research and development strategy, discontinuing two oncology programs while reinforcing its commitment to autoimmune diseases and T cell engagers. The move marks a pivotal moment in the company's evolution, balancing its pipeline between autoimmune and cancer indications.

Pipeline Restructuring and Strategic Focus

Cullinan has decided to halt the development of two cancer programs: CLN-619, an anti-MICA/B antibody in phase 1 for multiple myeloma and solid tumors, and CLN-617, an IL-12 cytokine fusion protein in early-stage trials for solid tumors. CEO Nadim Ahmed explained that the decision was based on a review of emerging clinical data, emphasizing the company's new focus on "T cell engagers applied to well-validated targets with transformative potential in immunology and oncology."

This strategic realignment is expected to extend Cullinan's cash runway into 2029, demonstrating the company's commitment to long-term sustainability and focused resource allocation. The restructured pipeline now comprises four named assets equally distributed between autoimmune and cancer indications.

Autoimmune Disease Expansion and Asset Redirection

In a notable pivot, Cullinan has redirected the development of its CD19xCD3 T-cell engager CLN-978 from B-cell non-Hodgkin lymphoma to autoimmune conditions. The asset is currently undergoing phase 1 testing in rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease, reflecting the company's expanded focus on immunology.

This shift aligns with Cullinan's rebranding from Cullinan Oncology to Cullinan Therapeutics in April, signaling a broader therapeutic scope. CEO Ahmed described the company's approach as "modality-agnostic," exploring potential applications across hematology, solid tumors, and autoimmune diseases.

Zipalertinib Progress and Regulatory Plans

Despite the oncology program discontinuations, Cullinan continues to advance its most developed asset, zipalertinib, an EGFR ex20ins inhibitor. The drug is currently being evaluated in three non-small cell lung cancer (NSCLC) trials, including a phase 3 study. Cullinan's partner, Taiho Pharmaceutical, plans to initiate a rolling FDA submission for zipalertinib in NSCLC by the end of the year, marking a significant milestone for the company's oncology efforts.