Patients with end-stage pancreatic ductal adenocarcinoma achieved unprecedented survival rates after being treated with the Engeneic dream vector nanocells, with 88% of patients doubling the historical survival rates, Engeneic Ltd. co-CEO Jennifer MacDiarmid told BioWorld.
For the second time this week, a contract research organization has come under fire for trial-conduct issues – criticism leveled most recently by Biovie Inc., which saw its shares (NASDAQ:BIVI) tumble $3.03, or 60%, to end Nov. 29 at $1.96 on missed-endpoint data from the phase III trial testing Alzheimer’s disease prospect NE-3107. The data fell short of statistical significance due to site exclusions caused by what Biovie said were “significant good clinical practice violations and protocol deviations.”
Acelyrin Inc. said a vendor used by Fortrea Inc., a CRO the company used for its phase IIb/III study testing interleukin-17A inhibitor izokibep in psoriatic arthritis, incorrectly programmed the study’s protocol and created a dose sequencing error, resulting in some patients in two of the four dosing arms to randomly receive placebo and active treatment instead of the intended alternating pattern. The discovery has prompted a review of other studies involving the CRO, including a study that failed to reach statistical significance in September.
Argenx SE’s surprise phase III blowup with subcutaneous Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in the platelet disorder primary immune thrombocytopenia (ITP) – blamed on a higher-than-expected placebo response – had investors speculating about possible read-throughs to other indications.
Clinical trial updates for the period of January to October 2023 saw an increase of 4.6% compared to the same time period last year. Comparatively, clinical data from January to September 2023 was up 1.79% compared to the same period last year.
GSK plc is looking at a comeback for Blenrep (belantamab mafodotin) as an interim efficacy analysis brought the company good news. Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market for the indication.
Partners Regeneron Pharmaceuticals Inc. and Sanofi SA will file a supplemental BLA by year-end for Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD) after interim data from a second phase III trial confirmed – even bested – data from the first, demonstrating a reduction in exacerbations by 34% and improved lung function in patients with uncontrolled COPD and evidence of type 2 inflammation.
Xenon Pharmaceuticals Inc.’s Kv7 potassium channel opener XEN-1101 remains very much alive despite the primary endpoint miss in top-line data from the phase II proof-of-concept X-Nova trial in moderate to severe major depressive disorder.
Index Pharmaceuticals Holding AB CEO Jenny Sundqvist said liquidation of the company in the wake of phase III data with cobitolimod in moderate to severe ulcerative colitis (UC) is “one of the options that will be on the table.” Shares of the Stockholm-based firm (STO:INDEX) closed Nov. 22 at SEK0.24 (US2 cents), down SEK0.41, or 63%, on word that an independent data monitoring committee (DMC) has completed the planned dose-selection analysis, including safety review and assessment for futility, of induction Study 1 of the phase III program called Conclude, testing the Toll-like receptor 9 agonist cobitolimod. The DMC concluded that Index’s lead compound is unlikely to meet the primary endpoint, and the company said development will be stopped.