Cullinan Therapeutics Licenses BCMA-Targeted Bispecific T Cell Engager for Autoimmune Disease Development
核心洞察
Cullinan Therapeutics has licensed velinotamig (搜索), a BCMAxCD3 bispecific T cell engager from Genrix Bio (搜索) for $20 million upfront, with potential milestone payments totaling up to $692 million.
Velinotamig (搜索) demonstrated potential best-in-class efficacy at Phase 2 target dose in nearly 50 patients with relapsed/refractory multiple myeloma (搜索) and will now be developed for autoimmune diseases (搜索).
The licensing agreement advances Cullinan's T cell engager portfolio for autoimmune diseases (搜索), complementing their existing CD19 (搜索) TCE program CLN-978.
Cullinan Therapeutics has entered into a global licensing agreement with Genrix Bio (搜索) to acquire exclusive rights to velinotamig (搜索), a BCMAxCD3 bispecific T cell engager that has shown promising efficacy in multiple myeloma (搜索) patients. The Cambridge-based biopharmaceutical company will now pivot the clinical-stage asset toward autoimmune disease development, marking a significant expansion of its T cell engager portfolio.
Strategic Licensing Deal Worth Up to $712 Million
Under the agreement announced June 4, 2025, Cullinan will pay Genrix Bio (搜索) an upfront license fee of $20 million for exclusive rights to develop and commercialize velinotamig (搜索) in all disease areas globally outside of Greater China. The deal structure includes substantial milestone payments, with Genrix eligible to receive up to $292 million in development and regulatory milestones plus an additional $400 million in sales-based milestones, along with tiered royalties ranging from mid-single digits to mid-teens on potential ex-Greater China net sales.
"We believe T cell engagers represent the next wave of innovation in autoimmune diseases (搜索), 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," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.
Clinical Validation in Multiple Myeloma
Velinotamig (搜索) has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory multiple myeloma (搜索). The bispecific antibody received Breakthrough Therapy Designation from China's Center for Drug Evaluation for the treatment of relapsed and refractory multiple myeloma (搜索), following regulatory approval from the National Medical Products Administration in January 2022 to conduct clinical trials.
The therapeutic's design features high affinity for BCMA (搜索) and lower affinity for CD3 (搜索), with affinity for BCMA being two orders of magnitude higher than for CD3. This differential binding ensures the bispecific antibody recruits and activates T cells while minimizing non-specific T cell activation and reducing CD3-mediated toxicity.
Targeting Autoimmune Disease Applications
Ahmed emphasized the strategic rationale for developing velinotamig (搜索) in autoimmune diseases (搜索), noting that "accumulated data supports BCMA (搜索) 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."
The addition of a BCMAxCD3 bispecific T cell engager complements Cullinan's existing autoimmune pipeline, which includes CLN-978, a CD19 (搜索)-targeted T cell engager currently in rapid global clinical development. This dual approach enables the company to address a broader range of autoimmune diseases (搜索) than either molecule could target alone.
Development Timeline and Strategy
Genrix Bio (搜索) plans to initiate a Phase 1 study in China by the end of 2025 in patients with autoimmune diseases (搜索). Cullinan intends to leverage the data generated from this study to accelerate global clinical development of the program. Following completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig (搜索) in autoimmune diseases.
"With our planned Phase 1 study of velinotamig (搜索) in autoimmune diseases (搜索), 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."
Financial Position and Portfolio Refinement
The licensing deal strengthens Cullinan's autoimmune portfolio while maintaining financial sustainability. With refinement of its clinical oncology pipeline, Cullinan reiterates its existing guidance to have cash resources into 2028 based on its current operating plan. This strategic approach allows the company to advance both CD19 (搜索) and BCMA (搜索) T cell engagers in autoimmune diseases (搜索) while preserving its financial runway.