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In Brief This Week: Northwell Health Cancer Institute, Labcorp, AstraZeneca, Cellectis, Artbio

NEW YORK – The Northwell Health Cancer Institute and its Center for Genomic Medicine said this week that they have opened a $3.2 million molecular diagnostics laboratory in Lake Success, New York. The 2,800-square-foot facility is equipped with next-generation sequencing technology for point-of-care tumor and patient genomic profiling to identify appropriate therapies for patients. According to Northwell, the lab will enable improved diagnosis and prognosis for cancer patients and lower costs to them and the health system. Tests offered by the lab in a phased approach include four single gene tests initially — EGFR for non-small cell lung cancer; BRAF for melanoma; KRAS for colorectal, pancreatic, and lung cancers; and BRAF/NRAS for melanoma. In the pipeline is Thermo Fisher Scientific's Oncomine Comprehensive Assay v3, a 161-gene NGS panel for solid malignancies; the Thermo Fisher Scientific Oncomine Myeloid Assay, a 45-gene NGS panel for hematologic malignancies; and MSI-H, a genetic test to evaluate how tumors respond to immunotherapy. 

Laboratory Corporation of American and Invitae said this week that the US Bankruptcy Court has approved the sale of Invitae's assets to Labcorp. The $239 million deal announced in late April follows Invitae's petition for Chapter 11 bankruptcy protection in February. The purchase was contingent on the bankruptcy court approving it and is expected to close in the third quarter. 

AstraZeneca this week said it has completed an equity investment agreement with French biopharma company Cellectis, and now holds about a 44 percent equity stake in Cellectis. As part of the deal, which includes a research collaboration, AstraZeneca will use Cellectis' gene-editing technologies and manufacturing capabilities to develop up to 10 cell and gene therapy products in oncology, immunology, and rare diseases. In the companies' initial announcement of the intended agreement in November, AstraZeneca said the deal included 25 genetic targets. 

Under the terms of the deal, Cellectis is eligible to receive an investigational new drug (IND) option fee, tiered royalties, and payments related to development, regulatory, and sales milestones. AstraZeneca retains an option for worldwide exclusive license for these candidate products, to be exercised before an IND filing. 

Artbio and Nucleus RadioPharma said this week that they have inked a manufacturing and supply deal for Artbio's radioligand therapies. Under the terms of the deal, Nucleus RadioPharma will manufacture Artbio's 212Pb-radiolabeled therapies for Phase I and II clinical trials of AB001, or 212Pb-NG001, which Artbio is studying as treatment for prostate specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer. Nucleus will manufacture and supply the treatment at its facility in Rochester, Minnesota, for patients in the Northern and Midwest US. 

The US Food and Drug Administration has granted fast-track designation to iEcure's ECUR-506, an investigational gene therapy for neonatal onset ornithine transcarbamylase (OTC) deficiency. Precision BioSciences, which is providing its ARCUS nuclease for in vivo insertion of a functional OTC gene for this development program, announced the designation this week. iEcure is studying the activity of ECUR-506 in the Phase I/II OTC-HOPE study. In April, the FDA cleared iEcure to begin enrolling patients within this study in the US. Now that ECUR-506 has fast-track designation, iEcure can meet with the FDA more frequently to discuss development plans and seek accelerated approval and priority review of data it submits for regulatory approval. 

The Australian Research Council hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR) launched this week at the University of Queensland in Australia. AMTAR, which is supported by a A$5 million (US$3.3 million) Australian Research Council grant and more than A$10 million (US$6.6 million) in industry funds, will serve as a central hub so biotech firms and academic scientists can collaborate to develop radiopharmaceuticals. The center is a collaboration between the University of Queensland, University of Sydney, and industry partners including Telix Pharmaceuticals, AdvanCell, Starpharma, Clarity Pharmaceuticals, Cyclowest, and GlyTherix. International partners in Europe, Asia, and the US will also contribute to research and drug development at AMTAR. 

Teal Health said this week that the US Food and Drug Administration has granted breakthrough device designation for the firm's Teal Wand instrument for at-home sample collection for use in cervical cancer screening. The San Francisco-based firm said that it received the designation following an agency review of promising midpoint clinical trial data. The Teal Wand is used to collect vaginal samples that are mailed to a laboratory for primary screening for high-risk human papillomavirus (HPV). 

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.