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.
Former JHL Biotech Inc. CEO Racho Jordanov and former Chief Operating Officer Rose Lin were sentenced for their respective roles in conspiring to commit trade secret theft and wire fraud exceeding $101 million. The pair last summer admitted to obtaining confidential, proprietary, and trade-secret information from Roche Holding AG’s Genentech Inc. unit and using what they stole to reduce expenses and hasten the timeline of JHL’s efforts to develop biosimilars.
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
Wall Street was not as pleased as some might have expected by Immunogen Inc.’s full results from the pivotal study called Soraya testing mirvetuximab soravtansine (mirv) monotherapy in patients with folate receptor (FR) alpha-high, platinum-resistant ovarian cancer (PROC) who have been previously treated with Avastin (bevacizumab, Roche Holding AG). Analysts hailed the results as positive but shares (NASDAQ:IMGN) closed at $4.30, down 96 cents, or 18.25%.
Volastra Therapeutics Inc., dedicated to taking aim at chromosomal instability (CIN) to design cancer drugs by way of its CINtech platform,, scored a potential $1 billion-plus agreement with Bristol Myers Squibb Co. (BMS) to find synthetic lethal targets as drug candidates.
Former JHL Biotech Inc. CEO Racho Jordanov and former Chief Operating Officer Rose Lin were sentenced for their respective roles in conspiring to commit trade secret theft and wire fraud exceeding $101 million.
The recent start of Neurogene Inc.’s first-in-human trial testing NG-101 in ceroid lipofuscinosis type 5 (CLN5) Batten disease (BD) drew investor attention to the space, where a handful of developers vie for new therapies against the challenging indication.
Tiziana Life Sciences Inc.’s intranasal, fully human anti-CD3 monoclonal antibody will need testing in 10 or 20 more patients to confirm the signal in secondary progressive multiple sclerosis (SPMS), but key opinion leaders on a conference call March 14 sounded optimistic as they checked out the prospect’s early efficacy.
In top-line data from the Pathway phase III trial with Transcon PTH in hypoparathyroidism, Ascendis Pharma A/S provided “what many have been waiting for: a way of therapy to not only boost serum calcium into the normal range, but to make sure that the kidney issues [are] also handled,” said Aimee Shu, vice president of clinical development in endocrinology and co-director of the study, during a conference call with investors.
Tyra Biosciences Inc.’s recent deal with Xcures Inc. drew more attention to the already popular FGFR inhibitor space in oncology, as the pair made known a collaboration on a real-world biomarker study involving patients with FGFR-mutant bladder cancer who are given once-daily, oral Balversa (erdafitinib, Johnson & Johnson), a pan-FGFR blocker approved in April 2019.
