CLN-978

Cullinan Therapeutics has nabbed an exclusive license to an experimental treatment from China's Genrix Bio, marking the latest in a series of lucrative ties between US and Chinese biotechs.Announced Wednesday, the agreement could be worth up to $712 million and gives Cullinan exclusive rights, everywhere except China, to develop and potentially commercialise velinotamig, a bispecific T-cell engager that targets BCMA and CD3.Genrix gets $20 million upfront, with up to $292 million tied to development and regulatory milestones plus an additional $400 million based on sales performance. The Chinese company could also collect tiered royalties ranging from mid-single digits to mid-teens on net sales outside China.Cullinan plans to develop velinotamig for autoimmune indications. "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," said Nadim Ahmed, Cullinan's chief executive.Velinotamig "complements our rapid global clinical development of [bispecific CD19 T-cell engager] CLN-978, enabling us to address the needs of more patients across a broader range of autoimmune diseases," Ahmed added.The drug has already shown promise. In a Phase II trial for relapsed or refractory multiple myeloma, it demonstrated what Cullinan described as "potential best-in-class efficacy" at its Phase II target dose in nearly 50 patients. Genrix plans to initiate a Phase I study in China by year-end in patients with autoimmune diseases, with Cullinan using that data to accelerate global development.The transaction reflects a trend of Western pharmaceutical companies turning to Chinese assets to bolster their pipelines. Bristol Myers Squibb this week agreed to pay $1.5 billion upfront for a PD-L1/VEGF bispecific originally developed by Chinese company Biotheus, mirroring similar moves by Pfizer and Merck & Co. for candidates in the same class, while Regeneron Pharmaceuticals struck a deal for a China-developed obesity candidate. Sanofi also recently launched new funds specifically targeting Chinese clinical-stage innovations.Moreover, Chinese biotech continues to draw investment despite volatility in the broader market. At least four out of the 15 larger venture capital rounds announced in the first quarter – those raising at least $100 million – involved assets sourced from China, totaling more than a third of all funds raised, and nearly triple last year's total for the same time period. See – Vital Signs: China's footprint grows in US biotech, but lands in regulator crosshairs.At the same time, these cross-border deals are attracting scrutiny. A US government-backed report released in April warned that the country is at risk of falling behind China in biotechnology, urging a $15-billion investment to maintain US leadership in the sector.

iStock, Veronika Oliinyk Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases. Like its Big Pharma peers, Cullinan Therapeutics is turning to China for novel drug candidates. The company on Wednesday inked a licensing deal with Genrix Bio, gaining global rights to the Chongqing-based biotech’s velinotamig, a bispecific T cell engager being studied for autoimmune diseases. In a note to investors on Wednesday evening, analysts at William Blair said velinotamig “complements” Cullinan’s autoimmune portfolio well, particularly CLN-978, which the company is developing for systemic lupus erythematosus (SLE), rheumatoid arthritis and Sjögren’s disease. Under the terms of Wednesday’s agreement, Cullinan will pay $20 million upfront for the exclusive rights to develop and commercialize velinotamig outside the Greater China area. Though this initial investment is relatively small, the agreement puts Cullinan on the hook for up to $292 million in development and regulatory milestones and up to $400 million in sales-based milestones. Like CLN-978, velinotamig is a bispecific antibody that binds to both BCMA and CD3, proteins found on the surface of various immune cells. For velinotamig in particular, this mechanism of action allows cytotoxic T cells to target and destroy BCMA-expressing cells, which are often abnormally activated in autoimmune conditions. As per Cullinan’s announcement, velinotamig has a higher affinity for BCMA than it does CD3, which William Blair said will help “drive specific recruitment and activation of T cells while minimizing safety liabilities from non-specific T-cell activation.” Along with CLN-978, Cullinan can “target the treatment of both B-cell and plasma-cell mediated autoimmune indications,” the analysts added. Genrix has also previously tested the drug in multiple myeloma. According to a Thursday morning note from Leerink, in a Phase II trial, it showed “superior overall response rate (85%) vs. approved agents (58-71%). Genrix is planning to run a Phase I autoimmune study in China later this year, after which Cullinan will take charge of all of velinotamig’s subsequent clinical development. Cullinan will focus its efforts on autoimmune diseases, though it has not yet specified with specific indications it intends to prioritize. Cullinan on Wednesday also reiterated that its cash runway will be enough to keep the lights on through 2028, though William Blair noted that the company might “require additional capital in the future for continued development and potential commercialization.” The deal with Genrix does not affect Cullinan’s runway projection. With the Genrix deal, Cullinan joins the growing group of biopharma companies looking to China to boost their pipelines. Most recently, Astellas last week pledged more than $1.5 billion for Evopoint’s Claudin18.2-targeting antibody-drug conjugate, which the pharma will leverage for solid tumors. Novo Nordisk and AstraZeneca have also turned eastward in recent months, each with their own multibillion-dollar contracts.