Merck & Co. Inc.'s $1.05 billion acquisition of Peloton Therapeutics Inc. in 2019, a big bet on the hypoxia inducible factor-2 alpha inhibitor belzutifan, has paid off with an earlier-than-anticipated FDA approval of the drug for cancers associated with von Hippel-Lindau disease. The therapy will be marketed as Welireg.
An unexpected complete response letter (CRL) from the FDA has thrown a wrench into Sesen Bio Inc.’s commercial launch plans for Vicineum (oportuzumab monatox) in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The company, which has spent the past few months completing its commercial build phase and hiring sales reps ahead of the Aug. 18 PDUFA date, instead must now address outstanding clinical and statistical data and analyses, in addition to CMC issues, cited in the CRL.
Contrary to the broader markets, BioWorld’s Cancer Index is down by 22% this year, losing more than 7% throughout the month of July, despite oncology driving several high-money deals and accounting for 38%, the lion’s share, of financings. Both the Nasdaq Biotech Index and the Dow Jones Industrial Average are tracking similarly for the year, and are up by 13.2% and 15.2%, respectively, as of Aug. 10.
Hutchmed Ltd. has struck a deal for Epizyme Inc.’s anticancer therapy Tazverik (tazemetostat) that could bring the latter up to $310 million. The agreement gives Hutchmed rights to research, develop, manufacture and commercialize Tazverik in greater China, which covers mainland China, Hong Kong, Macau and Taiwan.
Cell therapy company Zhuhai Grit Biotechnology Inc. completed a series A+ financing of undisclosed value to advance its lead tumor-infiltrating lymphocyte (TIL) program, GT-101 for advanced solid tumors, into the clinic by year end while also developing other TIL candidates in its pipeline.
The new case of myelodysplastic syndrome (MDS) that overshadowed Bluebird Bio Inc.’s earnings and resulted in a clinical hold by the FDA will be addressed similarly to an earlier hitch in the sickle cell disease program, said Andrew Obenshain, the company’s head of severe genetic diseases. “Essentially, we will try and do the same thing,” and exonerate the lentiviral vector, he said during a conference call with investors. “At this point, we don't have tumor cells or leukemia to analyze,” he noted.
Astrazeneca plc and Daiichi Sankyo Co. Ltd. are pushing forward with a challenge to Roche Holding AG with breast cancer drug Enhertu (trastuzumab deruxtecan) after it demonstrated superiority over the Swiss firm’s Kadcyla (trastuzumab emtansine) in a head-to-head trial.
LONDON – Newco Macomics Ltd. has closed its first financing round at £7.4 million (US$10.3 million), enabling it to lay the ground for a new approach to addressing immunosuppression in the tumor microenvironment by modulating disease-specific macrophages.
Seagen Inc. and Remegen Co. Ltd. will collaborate to exclusively develop and commercialize disitamab vedotin, a humanized antibody-drug conjugate (ADC) targeting HER2, giving Remegen the chance to earn up to $2.4 billion in total milestone payments.
While Aprea Therapeutics Inc.’s data disclosed July 21 from the phase II trial with eprenetapopt – also known as APR-246, a reactivator of mutant tumor suppressor protein p53 – plus azacitidine (AZA) whetted interest in taking aim at the “guardian of the genome,” the company’s fortune took an unexpected turn when the FDA smacked a partial clinical hold on work with the duo.
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