Quris Technologies Ltd. has inked an agreement with Merck KGaA to assess its BioAI safety prediction platform. The partnership will compare the Quris’ artificial intelligence (AI)-based platform with traditional in vivo and in vitro approaches of evaluating drug safety concerns.
Blue Note Therapeutics Inc. took a new approach to expanding its pipeline of prescription digital therapeutics (PDT) with an exclusive licensing agreement with the University of Sydney for Conquerfear, a metacognitive intervention that helps cancer survivors cope with the fear of disease recurrence. Blue Note has developed its PDTs internally to date but hopes to convert Conquerfear’s elements, which are typically delivered face-to-face, into a PDT for the U.S. and Canada. As a digital therapy, the program could potentially reach many more patients.
Inivata Ltd. published new data from a prospective clinical study assessing its Radar diagnostic test in head and neck squamous cell carcinoma (HNSCC). Results from the Liquid Biopsy for Minimal Disease Detection in HNSCC (LIONESS) study suggest the assay demonstrated 100% specificity in patients with no recurrence and 100% sensitivity in patients with clinical recurrence. The personalized assay can track up to 48 tumor-specific variants in a patient using a blood sample. Last year the test was granted breakthrough device designation by the FDA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics, Motus GI, Sequana Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocardia, Lungpacer Medical, Magnus Medical, Mainz Biomed, Nexstim, Precision Biomonitoring, Sqi Diagnostics, Trinity Biotech.
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.”
Mica Biosystems Ltd. is linking up with U.K. innovation center Cell and Gene Therapy Catapult (CGT Catapult) to accelerate commercialization of its regenerative technology platform. CGT Catapult is supporting the Birmingham, U.K.-based startup as it engages in conversations with the U.K.’s Medicines and Healthcare Products Regulatory Agency for clinical trials testing its remote-controlled stem cell therapy platform.