NEW YORK – Quest Diagnostics this week announced it has received breakthrough device designation from the US Food and Drug Administration for its AAVrh74 ELISA assay (CDx). The enzyme-linked immunosorbent in vitro diagnostic assay is for semi-quantitative detection of IgG antibodies to AAVrh74 capsid in human serum. It is intended to be used alongside other clinical information to identify patients eligible for treatment with Sarepta Therapeutics' Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for Duchenne muscular dystrophy the FDA approved in June.
Exact Sciences this week said it has been chosen by the National Cancer Institute to participate in its recently launched precision medicine platform trial, called ComboMATCH. As a ComboMATCH-designated lab, Exact will use its recently launched OncoExTra test, a comprehensive next-generation sequencing assay, to analyze tumor tissue and paired normal blood samples from patients. Funded by the NCI, ComboMATCH involves an initial registration trial, which serves as the gateway to a set of clinical trials evaluating new anti-cancer treatment combinations directed by NGS testing in select groups of adults and children with advanced cancer.
Daiichi Sankyo and AstraZeneca this week said that the US Food and Drug Administration has granted Enhertu (trastuzumab deruxtecan) breakthrough therapy designation as a treatment for patients with unresectable or metastatic HER2-positive solid tumors who have progressed on prior therapy and have no other treatment options, and as a treatment for patients with HER2-positive metastatic colorectal cancer who progressed on two or more regimens.
Lantern Pharma said this week that it is expanding the functionality of its RADR AI platform to increase speed, scalability, and precision in identifying new combination therapies that overcome the shortcomings of immune checkpoint inhibitors. In a recent study, the RADR platform had an 88 percent accuracy rate for predicting which melanoma patients with resistance to anti-PD-1 therapy would respond to Actuate Therapeutics' GSK-3B inhibitor elraglusib. Lantern will apply the new RADR immune checkpoint inhibitor predictive module to explore combination strategies with two of its drug candidates.
NorthStar Medical Radioisotopes said this week it will supply the therapeutic radioisotope actinium-225 to support Curadh MTR's development of targeted radiopharmaceuticals. NorthStar anticipates it will begin producing radiochemical grade actinium-225 in the second half of 2024.
Separately this week, NorthStar said the first neuroblastoma patient has received Clarity Pharmaceuticals' theranostic 64Cu/67Cu SARTATE containing NorthStar's electron accelerator-produced copper-67 in a Phase I/II trial. To be eligible for the therapeutic version of the trial with copper-67, patients need to have somatostatin receptor 2-expressing tumors that take up the diagnostic copper-64 labeled version of the theranostic.
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.