NEW YORK – Biovica this week said it is partnering with Axlab to commercialize Biovica's DiviTum TKa assay in the Nordic region. The deal will make the test available to oncology departments and cancer centers in the area. Financial and other terms of the agreement were not disclosed. The blood-based DiviTum TKa assay is used to monitor and predict treatment response in hormone-receptor-positive metastatic breast cancer by measuring thymidine kinase activity. Based in Denmark, Axlab supplies equipment to hospitals and laboratories.
Atsena Therapeutics this week said it has received regenerative medicine advanced therapy designation from the US Food and Drug Administration for ATSN-101, its lead gene therapy candidate and an investigational treatment for Leber congenital amaurosis caused by biallelic mutations in the GUCY2D gene (LCA1). The gene therapy is currently being studied in an ongoing Phase I/II clinical trial. The firm said it plans to report 12-month data from the trial by year-end and is exploring options to advance ATSN-101 into a pivotal trial.
SIRPant Immunotherapeutics this week said the US Food and Drug Administration granted orphan drug designation for its autologous activated macrophage therapy SIRPant-M for treatment of T-cell lymphoma. SIRPant-M is designed to train the patient's own macrophages to recognize and eliminate cancer cells. The company is developing the product as a monotherapy and in combination with other immuno-stimulatory therapies such as radiotherapy and immune checkpoint inhibitors. The FDA grants orphan designation to drugs for rare diseases, which provides sponsors tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug after regulatory approval.
Natera said this week that it has inked a deal with Merck focused on real-world data for oncology research and drug development. For its part of the deal, Natera will bring its de-identified real-world database, which contains both clinical and genomic data from 100,000 patients with early- and late-stage cancers. These patients have all undergone testing with Natera's personalized molecular residual disease (MRD) test, Signatera. Most patients included in the database also have longitudinal monitoring data, which offers Merck insight on how these patients respond to treatment over time on the molecular level.
Gilead Sciences and Arcellx said this week that they have expanded their cell therapy collaboration, which was originally inked in late 2022. The firms will now evaluate Arcellx's CART-ddBCMA for lymphoma patients as well as multiple myeloma patients. Gilead subsidiary Kite has exercised its option to negotiate a license for Arcellx's ARC-SparX cell therapy program, ACLX-001, in multiple myeloma. When the expanded deal closes, Gilead will own 13 percent of Arcellx. Arcellx will receive a $200 million equity investment to purchase 3,242,542 shares of its common stock as well as an upfront payment of $85 million.
Bayer and Ionetix this week announced a supply agreement focused on the therapeutic radioisotope actinium-225. Under the terms of the agreement, Ionetix will provide Bayer with actinium-225 from its production facility in Lansing, Michigan, for use developing radiopharmaceutical treatments.
Fusion Pharmaceuticals said this week that it has partnered with BWXT Medical to provide the supply of generators to produce actinium-225, a medical isotope used in radiopharmaceuticals. BWXT will provide the actinium-225 that Fusion will use to manufacture its targeted alpha therapies for clinical trials. Fusion is developing several actinium-225-based radiopharmaceutical therapies, with ongoing clinical trials in EGFR- and cMET-expressing solid tumors, NTSR1-expressing tumors, and FGFR3-positive tumors.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.