On June 4, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported that it has entered into an agreement with Genrix Bio for a global (ex-Greater China), all indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T cell engager. Velinotamig has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory (r/r) multiple myeloma (MM) (Press release, Cullinan Oncology, JUN 4, 2025, View Source [SID1234653706]). Cullinan will develop velinotamig in autoimmune diseases.

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"We believe T cell engagers represent the next wave of innovation in autoimmune diseases, and we are excited to build upon our core T cell engager expertise and extensive KOL relationships to develop another potential best-in-class, clinical-stage program. Accumulated data supports BCMA as a promising target in autoimmune diseases, offering a precise and potentially disease-modifying approach by eliminating the entirety of the self-reactive plasma cells that result in certain autoimmune diseases, especially those diseases driven by long-lived plasma cells," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "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."

Genrix plans to initiate a Phase 1 study in China by the end of this year in patients with autoimmune diseases. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.

"With our planned Phase 1 study of velinotamig in autoimmune diseases, we will be able to quickly leverage our experience in autoimmune diseases to complete the study in China expeditiously," said Dr. Liu Zhigang, Chairman, Chief Executive Officer, and Chief Science Officer of Genrix Biopharmaceutical "Cullinan is a proven leader in developing T cell engagers and we are confident in the company’s ability to carry the program forward to address the needs of patients with autoimmune diseases."

Under the agreement, Cullinan will pay Genrix Bio an upfront license fee of $20 million for exclusive rights to develop and commercialize velinotamig in all disease areas globally outside of Greater China. In the future, Genrix will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400M in sales-based milestones, as well as tiered royalties from mid-single digits up to the mid- teens on potential ex-Greater China net sales.

Importantly, with refinement of the clinical oncology pipeline, Cullinan reiterates its existing guidance to have cash resources into 2028 based on its current operating plan.