In the summer of 2020, when Veru Inc. began researching sabizabulin for treating COVID-19 patients, the company’s CEO was cautioned that the virus could be gone by the time a therapy could be developed. Nearly two years later, Veru still has the compound in development and just reported phase III data that could propel it toward an emergency use authorization.
With 11 approved therapeutics in a diversity of targets and indications, antibody-drug conjugates (ADCs) have proved their clinical mettle. But they have not yet reached their full clinical potential, which, in the opinion of Astrazeneca plc’s Kenneth Thress, could transform patient care. The strength of ADCs, he told the audience at an educational session at the 2022 annual meeting of the American Association for Cancer Research (AACR 2022), is that it can turn anything into a targeted therapy.
Fairtility Ltd.’s artificial intelligence (AI)-trained embryo classification system offers patients struggling with infertility and their physicians a better way to maximize the likelihood of implantation following in vitro fertilization (IVF) without the risk of a multiple pregnancy, a study in the Nature portfolio journal Scientific Reports found.
Quanterix Corp.’s Simoa technology helped drive a large, international study to establish reference ranges of serum neurofilament light chain (sNfL) to assess individual disease activity and drug response in multiple sclerosis (MS) patients. The study, published in The Lancet Neurology, utilized Simoa’s ability to precisely detect sNfL protein at ultra-low levels, enabling it to be reliably measured across a broad range of healthy individuals.
C2i Genomics Inc. reported the formal launch of its C2inform minimal residual disease diagnostic across Europe, after obtaining CE marking for the cancer test. The Cambridge, Mass.-based company also has completed several clinical trials it ran with research partners to validate the technology and will be presenting data in different cancers at the American Association for Cancer Research in New Orleans, April 8-13.
Elevated serum creatinine levels in some participants prompted Biocryst Pharmaceuticals Inc. to pause three clinical trials involving BCX-9930, an oral, small-molecule factor D inhibitor for treating rare diseases.
Ark Biopharmaceutical Co. Ltd.’s phase III testing its ziresovir in infants hospitalized with respiratory syncytial virus (RSV) infection produced positive top-line results, meeting both the primary endpoint of reduction in signs and symptoms (S&S) score (p=0.002) and a key secondary endpoint of reduction in viral load (p=0.006) compared with placebo. The company said it is the first oral RSV antiviral to be successful in phase III.
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma.
Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors.
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
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