Chongqing Genrix Biopharmaceutical Co., Ltd.

Plus, news about Novartis, Signify Bio, Ocugen, Dynavax and ViGeneron: Cullinan Therapeutics gets rights to T cell engager developed in China: The company made a deal with Chongqing-based Genrix Bio for velinotamig, a BCMAxCD3 bispecific T cell engager. It’s paying $20 million upfront and up to $692 million in milestones for the rights outside of Greater China. “We believe T cell engagers represent the next wave of innovation in autoimmune diseases,” Cullinan CEO Nadim Ahmed said in a release. Once a Genrix-run Phase 1 trial in China wraps up, Cullinan will handle further development of the asset in autoimmune diseases. — Jaimy Lee Kardigan acquires another drug: The cardiology startup , which unveiled with $300 million in January, acquired the rights to ataciguat, a spokesperson told Endpoints News . The drug was developed by Sanofi and the Mayo Clinic and had been licensed by Rancho Santa Fe Bio . The once-daily oral drug is a guanylate cyclase activator. Kardigan has now taken it into a Phase 3 trial in moderate calcific aortic valve stenosis. The spokesperson said the company hopes ataciguat can delay the need for valve replacement surgery. The biotech also licensed a mid-stage Ionis drug earlier this year. It has “multiple late-stage candidates,” per the spokesperson. — Kyle LaHucik Novartis’ 100-week data for kidney disease drug: The Swiss drugmaker’s APRIL targeting monoclonal antibody, dubbed zigakibart, achieved an average 60% reduction in proteinuria at 100 weeks in a Phase 1/2 trial in people with IgA nephropathy, according to results presented this week at the European Renal Association’s annual meeting in Vienna. Zigakibart is being evaluated in the Phase 3 BEYOND study, which is measuring the primary endpoint of change in proteinuria at 40 weeks. — Ayisha Sharma Signify Bio launches with $15M: The company counts several well-known biotech entrepreneurs as its leaders, including Taysha Gene Therapies founder RA Session II and ReCode Therapeutics co-founder Daniel Siegwart. It’s also being financed by blue-chip backers like Eli Lilly and the Gates Foundation Strategic Investment Fund. Signify is developing what it calls in situ protein therapeutics from research out of Siegwart’s lab at the UT Southwestern Medical Center. — Jaimy Lee Ocugen inks gene therapy deal with unnamed company: Ocugen is getting $11 million in upfront and near-term milestone payments, plus $150 million in sales milestones, for the rights to OCU400 in South Korea. It’s developing OCU400 to treat retinitis pigmentosa. — Jaimy Lee Dynavax responds to Glass Lewis claims: The company continues to push back against putting Deep Track Capital executives on its board. — Jaimy Lee ViGeneron’s name change: Its new name is VeonGen Therapeutics, and it’s working on gene therapies for patients with Stargardt disease and a form of retinitis pigmentosa. — Jaimy Lee

William Blair analysts agreed that the acquisition of velinotamig “complements” Cullinan Therapeutics’ CLN-978.\n Cullinan Therapeutics is paying $20 million upfront for a BCMAxCD3 bispecific T-cell engager that the biotech plans to pair with its existing CD19 candidate.In return for the ex-China rights to its new addition, called velinotamig, Cullinan has agreed to pay Genrix Bio the upfront fee followed by up to $292 million in development and regulatory milestones, up to an additional $400 million in sales-based milestones and potential tiered royalties.Genrix has already tested velinotamig in almost 50 patients with multiple myeloma, where the drug has demonstrated “potential best-in-class efficacy,” Cullinan explained in a June 4 release. The next step is for Chongqing-based Genrix to launch a phase 1 study of velinotamig in its home territory of China in autoimmune disease, before passing the drug to Cullinan for further clinical development.Cullinan CEO Nadim Ahmed suggested that as a BCMAxCD3 bispecific T-cell engager, velinotamig could complement the company’s CD19xCD3 T-cell engager CLN-978, which is being evaluated in systemic lupus erythematosus.“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,” Ahmed said in Wednesday\'s release.“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,” the CEO added. Speaking to Fierce back in February, Ahmed didn’t directly answer whether the biotech was looking for a BCMA candidate to complement CLN-978, but the CEO did say at the time that the company was “thinking about continued opportunities in the autoimmune disease space.”William Blair analysts agreed that the acquisition of velinotamig complements Cullinan’s CLN-978.“While we generally believe a CD19xCD3 TCE will have a more approachable side effect profile, we believe there will be autoimmune indications that will require more potent depletion of plasma cells, and therefore see opportunity for velinotamig,” the analysts said in a June 4 note. “The key will be indication selection and dosing frequency, given chronic dosing with BCMAxCD3 TCEs could result in increased risk of infections and loss of vaccine response.”Cullinan was known as Cullinan Oncology until last year, when the biotech followed a hot trend among cell therapy biotechs of pivoting from cancer to an autoimmune focus. This included switching the direction of CLN-978 from blood cancer to lupus.

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.