It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
Sumitovant to acquire Myovant Sciences for women’s health powerhouse worth $2.9B
Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd. agreed to acquire Myovant Sciences Ltd. for $27 per share, up from its earlier offer of $22.75 per share, which Myovant had rebuffed. The deal is worth $1.7 billion on a fully diluted basis and a total company value of $2.9 billion on a fully diluted basis.
Alpine stops davoceticept studies after another patient death
A second death in the study of davoceticept (ALPN-202) has prompted Alpine Immune Sciences Inc. to stop enrolling participants in two phase I studies of the CD28 co-stimulator and dual checkpoint inhibitor. The death in the Neon-2 study is being attributed to cardiogenic shock. In May, the U.S. FDA removed the partial clinical hold it had placed in February on the Neon-2 study combining davoceticept with Keytruda (pembrolizumab, Merck & Co. Inc.) after a patient death that also was blamed on cardiogenic shock. The phase I Neon-1 study of davoceticept as a monotherapy for treating advanced malignancies is also halted. Alpine stock (NASDAQ:ALPN) had climbed out of the deeper trough it began the morning in to only being down about 3.5% at midday.
Mirum’s Livmarli hits endpoints in PFIC study
The decision to increase the dosage of oral ileal bile acid transporter inhibitor Livmarli (maralixibat) in patients with progressive familial intrahepatic cholestasis (PFIC) proved a good one, as the drug showed statistically significant improvement in pruritis severity across a range of PFIC subtypes in the phase III March study. Developer Mirum Pharmaceuticals Inc.’s next steps will involve discussions with regulators about expanding the use of Livmarli, which gained a first U.S. FDA approval in 2021 for Alagille syndrome, another rare liver disease.
Tricida shipwrecked after phase III miss with veverimer in CKD acidosis
Shares of Tricida Inc. (NASDAQ:TCDA) plummeted 94.58% or $10.29 to trade midday at 59 cents after the firm unveiled top-line data in chronic kidney disease (CKD) from the phase III Valor-CKD renal outcomes trial. The study, designed to evaluate the ability of veverimer, a non-absorbed, oral polymer, to slow CKD in patients with metabolic acidosis, missed its composite primary endpoint related to kidney health. South San Francisco-based Tricida said it is “evaluating next steps.”
GSK looking to escape fate of other HIF-PHIs
Hoping its drug, daprodustat, can succeed in the U.S. where two other oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Wednesday to the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for daprodustat as a treatment for anemia in patients with chronic kidney disease whether they’re on or off dialysis. GSK’s briefing document for the meeting seeks to differentiate daprodustat from Fibrogen Inc.’s roxadustat and Akebia Therapeutics Inc.’s vadadustat, both of which received complete response letters from the FDA. The roxadustat CRL followed last year’s negative CRDAC vote – 13-1 against approval for the non-dialysis population and 12-2 against approval for the dialysis-dependent population.
Zelgen’s donafenib garners positive phase III data in differentiated thyroid cancer
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative, donafenib, in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free survival vs. a placebo.
Maxinovel raises ¥100M to support pipeline development
Maxinovel Pharmaceuticals Inc. raised ¥100 million (US$13.8 million) in a series C+ round to develop its candidates for acute myeloid leukemia, solid tumors, and autoimmune diseases. The latest financing included investments by Lapam Capital and Suzhou Zhongxin Innovation Capital Management Co. Ltd. and built on a ¥200 million series C round the company completed in January 2021.
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