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In Brief This Week: Immunovia, Harpoon Therapeutics, Intellia Therapeutics, and More

NEW YORK – Immunovia said this week that the College of American Pathologists has accredited the company in Marlborough, Massachusetts. According to Immunovia Interim CEO Philipp Mathieu, the accreditation allows the firm to seek licensure in the five remaining states where it doesn't already have a license to offer its IMMray PanCan-d pancreatic cancer test, including California and New York. 

Harpoon Therapeutics said this week that the US Food and Drug Administration has granted orphan drug designation to the firm's DLL3-targeting therapy HPN328 for small-cell lung cancer (SCLC) patients. The firm designed the T-cell engager HPN328 using its tri-specific T-cell activating construct (TriTAC) platform and is studying it in a Phase I/II trial for patients with SCLC and other advanced cancers associated with DLL3 expression. To enroll in the trial, patients must be able to provide a tissue sample or have documented DLL3 expression in a tumor sample from a prior biopsy.

The FDA this week granted orphan drug designation to Intellia Therapeutics' autologous T-cell receptor therapy NTLA-5001 for the treatment of acute myeloid leukemia. Intellia is currently evaluating the therapy, which is designed to target the WT1 antigen expressed in AML, in a Phase I/IIa clinical trial for recurrent AML patients. Intellia uses its CRISPR/Cas9-based platform to generate the TCR therapy from patients' own immune cells ex vivo.

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) this week named its first two designated Radiopharmaceutical Therapy Centers of Excellence, Stanford Health Care and the Dana-Farber Brigham Cancer Center. Both centers earned the designation for their ability to administer multiple radiopharmaceutical therapies and conduct radiopharmaceutical therapy research. The sites meet strict regulatory, training, qualification, and experience performance criteria, according to SNMMI. 

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 Oncology News.