Cullinan Therapeutics Expands Autoimmune Pipeline with $700M+ Deal for Chinese Bispecific

Cullinan Therapeutics has inked a licensing agreement with China-based Genrix Bio for velinotamig, a bispecific T cell engager targeting BCMA and CD3, in a deal potentially worth over $700 million. The acquisition bolsters Cullinan's growing autoimmune disease portfolio and marks another significant partnership between Western pharmaceutical companies and Chinese biotechs.

Deal Structure and Financial Terms

Under the terms of the agreement, Cullinan will pay Genrix Bio $20 million upfront for the exclusive rights to develop and commercialize velinotamig outside of Greater China. The deal includes potential payments of up to $292 million in development and regulatory milestones, and up to $400 million in sales-based milestones, along with tiered royalties.

Cullinan's cash runway, which extends through 2028, remains unaffected by this transaction. However, analysts at William Blair note that the company may require additional capital in the future for continued development and potential commercialization efforts.

Strategic Fit and Pipeline Synergies

Velinotamig complements Cullinan's existing autoimmune portfolio, particularly CLN-978, a CD19xCD3 bispecific T cell engager being developed for systemic lupus erythematosus (SLE), rheumatoid arthritis, and Sjögren's disease. The addition of velinotamig allows Cullinan to target both B-cell and plasma-cell mediated autoimmune indications.

Nadim Ahmed, CEO of Cullinan, emphasized the strategic importance of the acquisition, stating, "Adding a BCMAxCD3 bispecific T cell engager to our pipeline complements our rapid global clinical development of CLN-978, enabling us to address the needs of more patients across a broader range of autoimmune diseases than with either molecule alone."

Clinical Development and Mechanism of Action

Velinotamig has shown promise in multiple myeloma, demonstrating an 85% overall response rate in a Phase II trial, outperforming approved agents. Genrix plans to initiate a Phase I autoimmune study in China later this year, after which Cullinan will take charge of subsequent clinical development, focusing on autoimmune diseases.

The bispecific antibody binds to both BCMA and CD3, proteins found on various immune cells. Its higher affinity for BCMA is expected to drive specific recruitment and activation of T cells while minimizing safety concerns from non-specific T-cell activation. This mechanism allows cytotoxic T cells to target and destroy BCMA-expressing cells, which are often abnormally activated in autoimmune conditions.

Industry Trends and Competition

Cullinan's deal with Genrix reflects a growing trend of pharmaceutical companies looking to China for novel drug candidates. Recent examples include Astellas' $1.5 billion agreement with Evopoint for a Claudin18.2-targeting antibody-drug conjugate, as well as significant deals by Novo Nordisk and AstraZeneca.

The acquisition also highlights the increasing interest in bispecific antibodies and T cell engagers as potential treatments for autoimmune diseases. This approach offers a more convenient alternative to CAR-T cell therapies, which have shown promise but face challenges related to manufacturing costs, potential side effects, and the need for chemotherapy pre-treatment.

As the field of autoimmune disease treatment evolves, Cullinan's expanded pipeline positions the company to compete with other major players, including GSK and Merck & Co., in the development of innovative therapies for inflammatory conditions.