NEW YORK – BioNexus Gene Lab (BGLC) of Kuala Lumpur, Malaysia, said this week that it has invested RM 1 million ($228,000) in Malaysian healthcare technology firm Ascension Innovation (AISB) through its wholly owned subsidiary MRNA Scientific. AISB's aiCMS platform uses predictive analytics and AI tools for clinical management and patient care. BGLC plans to integrate its blood-based genomic screening services with AISB's platform to enable more accurate diagnostics and tailored treatments for patients.
AC Immune this week said its partner Life Molecular Imaging (LMI) has received fast-track designation for [18F] PI-2620, a tau positron emission tomography (PET) diagnostic, from the US Food and Drug Administration. The designation covers LMI's development programs for the tau diagnostic in three neurodegenerative conditions: Alzheimer's disease, progressive supranuclear palsy, and corticobasal degeneration. LMI is testing the PET imaging agent's ability to detect tau pathology in Alzheimer's patients in Phase III studies, and researchers are also assessing the diagnostic in other neurodegenerative settings. With fast-track designation, LMI can meet more frequently with the FDA about the development program for PI-2620, can submit data on a rolling basis for regulatory approval, and may be eligible for priority review and accelerated approval of regulatory applications.
AC Immune is developing ACI-35.030, an immunotherapy that targets phosphorylated tau, in a Phase II study in Alzheimer's patients and is using tau PET imaging to measure the accumulation of the biomarker in those receiving its drug versus a placebo. "The designation for PI-2620 is a further recognition of AC Immune's drug discovery and development platform and of how we, together with our partners, continue to drive innovation," AC Immune CEO Andrea Pfeifer said in a statement.
Nuvectis Pharma this week said the US Food and Drug Administration granted orphan drug designation to its SRC kinase inhibitor NXP800 as a potential treatment for AT-rich interactive domain-containing protein 1a (ARID1a)-deficient ovarian, fallopian tube, and primary peritoneal cancers. Nuvectis is conducting a Phase Ib trial of the drug in patients with platinum resistant ARID1a-mutated ovarian cancer. The FDA grants orphan designation to drugs for rare diseases, which makes sponsors eligible for tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug if it achieves regulatory approval.
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