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In Brief This Week: CureMatch, Spesana, Atsena Therapeutics, Pacira BioSciences, COLA, Merck

NEW YORK – CureMatch and Spesana this week announced a partnership to integrate CureMatch's artificial intelligence-driven precision medicine platform into Spesana's clinical workflow system. The precision medicine platform will allow clinicians to see analysis of a patient's genomic data and a ranked list of which treatments are predicted to benefit the patient. Spesana's platform combines clinical, operational, and financial solutions in one medical record. 


Durham, North Carolina-based Atsena Therapeutics this week said it has started dosing the second cohort of its Phase I/II LIGHTHOUSE trial of ATSN-201, a gene therapy for X-linked retinoschisis (XLRS). The investigational gene therapy was well tolerated in the three XLRS patients who received subretinal injections of a lower treatment dose in the first cohort, which kicked off in August, with no serious adverse events reported. In the study, investigators are assessing safety and tolerability of the gene therapy candidate in male patients at least 6 years of age with XLRS due to a pathogenic or likely pathogenic mutation in the RS1 gene. 


The US Food and Drug Administration has granted Tampa, Florida-based Pacira BioSciences regenerative medicine advanced therapy designation for its PCRX-201 (enekinragene inzadenovec) gene therapy candidate, the firm said this week. PCRX-201 specifically codes for interleukin-1 receptor antagonist (IL-1Ra), a cytokine inhibitor involved in blocking inflammation and catabolic processes associated with pain, as an investigational treatment for osteoarthritis of the knee. The FDA's designation decision was supported by encouraging preliminary safety and efficacy data from an open-label Phase I study of 72 patients, in which PCRX-201 was well tolerated, according to Pacira. 


COLA said this week that the Centers for Medicare & Medicaid Services has renewed its deeming approval for six years under the Clinical Laboratory Improvement Amendments of 1988. The nonprofit organization is approved to continue accrediting laboratories as CLIA-compliant through March 6, 2030, according to a Federal Register notice. COLA noted that it has secured approval to accredit CLIA-regulated specialties and subspecialties of microbiology, diagnostic immunology, chemistry, hematology, immunohematology, and pathology. The organization first received deeming authority from CMS in 1993. 


Merck said this week that it has completed its acquisition of Harpoon Therapeutics, bringing Harpoon's T-cell engager candidates, including the DLL3-targeting candidate HPN328, now called MK-6070, into Merck's pipeline. Merck paid $650 million for the acquisition, which it initially announced on Jan. 8


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.