Tiragolumab

Roche is acquiring its cell therapy and genomic medicines partner Poseida Therapeutics, the companies said Tuesday morning. The Basel-based pharma giant will pay $9 per share in upfront cash, giving Poseida an equity value of about $1 billion. If certain therapies enter pivotal studies and get commercialized, Poseida’s shareholders could get up to an additional $4 per share. Poseida’s shares $PSTX skyrocketed 224% after the opening bell, rising slightly above the $9 buyout price. Roche also said Tuesday morning that its drug tiragolumab failed a late-stage cancer study, dealing another blow to the TIGIT field. The Swiss drugmaker appears to have wanted to scoop up Poseida well in advance of having to dish out more money. The duo linked arms in August 2022 in a partnership that could have been worth up to $6 billion . That’s if all milestones were met, a rare feat in drug R&D. Roche had already delivered $80 million in milestones so far this year, but it dropped an option for one of Poseida’s CAR-Ts in September. “We do really think this is only the beginning. And when you think about it this way, then the answer becomes almost a foregone conclusion that there is so much complementarity, there is so much potential, we should become one,” Aviv Regev, head of research and early development at Genentech, said in an interview with Endpoints News . Regev said Poseida will continue its partnership with Astellas, which had done a $50 million equity investment in the company and paid $50 million upfront, with more than $500 million in additional payments on the line. Another Tokyo-based drugmaker, Takeda, had dropped its alliance with Poseida in the summer of 2023. Poseida has about 350 employees , Roche said. The teams have been working together for about two years, so “the relationships are all in place,” Regev said. “We plan to keep the site in San Diego for the foreseeable future,” she added. “There will be a large team there” that does both research and clinical manufacturing. Roche is getting access to a pipeline of off-the-shelf CAR-T therapies, meaning they derive from donors rather than the patient themselves, unlike most of the approved cell therapies. The biotech is working on blood cancers, solid tumors, autoimmune diseases and neurology. Poseida has presented some clinical data in multiple myeloma. It will also move into multiple sclerosis and systemic lupus erythematosus, Regev said, with IND filings recently submitted. Poseida focuses on stem cell memory T cells, which are the “ideal type for allogeneic cell therapies,” former CEO Mark Gergen previously said. “Roche’s global capabilities in late-stage development and commercialization will enable patients worldwide to benefit from the transformative potential of allo CAR-T,” Poseida CEO Kristin Yarema said in a press release. Beyond its multiple cell therapies already being tested in humans, the San Diego biotech is also working on preclinical non-viral genomic medicines for hereditary angioedema and hemophilia A. Roche adjusted its work in the cell therapy field earlier this year. Its Genentech unit had broken off a different off-the-shelf pact, saying goodbye to Adaptimmune and their work on αβ T cell therapies and αβ T cell receptors. Meanwhile, Roche ended development of an autologous TCR-based T cell therapy with partner Adaptive Biotechnologies in April, a Roche spokesperson said in an email, but it “will continue to work with Adaptive on T cell therapies.” Roche’s broad cell therapy work also touches ophthalmology, where it’s in Phase 2 with partner Lineage Cell Therapeutics . The Poseida deal marks a trio of acquisitions for Roche this fall. It bought Regor’s CDK inhibitors for $850 million upfront and paid an undisclosed amount for Wnt agonism-focused AntlerA and the startup’s suite of preclinical candidates in ophthalmology. It also completed its multibillion-dollar acquisition of obesity biotech Carmot Therapeutics at the beginning of the year. Will Roche buy more of its partners? “Every particular partnership is its own special snowflake, so then you can’t generalize,” Regev said. Roche and Poseida anticipate their deal will close in the first quarter. Editor’s note: This story was updated to include details from an interview with Genentech executive Aviv Regev.

Roche’s TIGIT drug has failed to clear the final hurdle in a late-stage cancer trial in what’s proving to be a mostly disappointing year for a drug class that was once seen as the next big thing in immuno-oncology. The Swiss pharma’s tiragolumab plus Tecentriq missed the overall survival endpoint in the final analysis of the Phase 3 SKYSCRAPER-01 study in previously untreated PD-L1-high locally advanced unresectable or metastatic non-small cell lung cancer, according to a Tuesday release . The trial had missed its other primary endpoint of progression-free survival two years ago, but Roche was hoping to bounce back with OS data. Ten minutes after disclosing its TIGIT miss on Tuesday, Roche said it was buying its cell therapy partner Poseida Therapeutics for $1 billion upfront. It’s been a bad year for tiragolumab. In July, the TIGIT drug combined with Tecentriq and chemotherapy missed both the PFS and OS endpoints in a separate Phase 3 trial in patients with previously untreated, locally advanced unresectable or metastatic nonsquamous NSCLC. That failure prompted the drugmaker to shutter two other studies in different forms of NSCLC as part of a broader pipeline reshuffle. Tiragolumab did score one Phase 3 win in January, when it met both survival endpoints in the SKYSCRAPER-08 study in Asian patients with certain forms of esophageal squamous cell carcinoma. However, the trial’s comparator arm tested chemotherapy and placebo, which didn’t stack up with the latest standard of care that includes checkpoint inhibitors. Elsewhere, there was some hope for the TIGIT space in September, when GSK and iTeos reported that belrestotug combined with Jemperli improved overall response rates by more than 30 percentage points compared with Jemperli alone in a Phase 3 trial in people with previously untreated PD-L1-high locally-advanced or metastatic NSCLC. But in May, Merck was forced to wind down a late-stage test of its anti-TIGIT drug vibostolimab in skin cancer after a high number of patient dropouts due to immune side effects.