So near and yet so far for Nordic Nanovector ASA, which has ditched the phase IIb trial of its lead product, Betalutin, just short of completing recruitment, after an independent review cast doubts on the level of efficacy previously reported for the targeted radiopharmaceutical.
To build on its hematology pipeline in treating blood cancers, Astrazeneca plc is acquiring Teneotwo Inc. in a deal that could reach $1.27 billion. Teneotwo is part of Ancora Biotech LLC, which has some other affiliate Tens in the stable, including Teneofour Inc. That company is developing TNB-738, an anti-CD38 enzyme inhibitor. Teneoten Inc. is developing an anti-HBV/CD3 therapy. Both are available for partnering or sale, Ben Buelow, Ancora co-founder, told BioWorld. He co-founded the company with this father, Roland.
After its $247 million acquisition of Epizyme Inc., Ipsen SA will continue to shop for M&A prospects, said Ipsen CEO David Loew, noting that “the [company’s] firepower has not been absorbed in a significant fashion by this deal,” and the firm might undertake a larger transaction next time in oncology, rare diseases, or neurology.
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study.
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. The firms had hoped to win accelerated approval in relapsed/refractory follicular lymphoma and marginal zone lymphoma based on a single-arm phase II study called Tidal.
Novartis AG’s CAR T therapy, Kymriah (tisagenlecleucel), is heading for a third indication after the Basel, Switzerland-based pharma announced supportive results from a pivotal phase II trial, lining it up to compete with Gilead Sciences Inc.’s rival, Yescarta.
Executives of TG Therapeutics Inc. have promised a big year in 2021 and the company got off to strong start with accelerated FDA approval of umbralisib in marginal zone lymphoma and follicular lymphoma. Branded Ukoniq, the drug is the first oral, once-daily inhibitor of PI3K delta and CK1 epsilon and TG’s first commercial product. Pricing for Ukoniq has not yet been disclosed.
About six months after Epizyme Inc. won FDA clearance of Tazverik (tazemetostat) for epithelial sarcoma (ES), the firm scored accelerated approval in the larger indication of relapsed or refractory (r/r) follicular lymphoma (FL). Specifically, U.S. regulators cleared the methyltransferase inhibitor for adults whose tumors test positive for an EZH2 mutation who have received at least two prior systemic therapies and for those with no satisfactory alternative treatment options – language that “gives physicians a lot of flexibility to use their clinical judgement in how to best prescribe” the drug, CEO Robert Bazemore noted.
Arriving at MEI Pharma Inc.’s deal with Kyowa Kirin Co. Ltd., focused on phase II-stage ME-401 for B-cell malignancies, was a competitive process that brought large and midsized pharma bidders to the table, MEI Chief Operating Officer David Urso said, but the terms proposed by suitors tended to “look a lot the same.”
Matthew Ros, chief strategy and business officer for Epizyme Inc., said the company is “not providing specific guidance at the moment” about the sales force that will be deployed to market Tazverik (tazemetostat) in follicular lymphoma (FL), an indication for which U.S. regulators are considering the oral, first-in-class EZH2 inhibitor. “But I can assure you we’ve planned very thoughtfully” about the effort, he said. “That's always been a part of why we thought epithelioid sarcoma [ES] was such a strategically important component of the overall business strategy to get on-the-ground experience.” The sales force numbers 19 for now.
