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In Brief This Week: Kyverna Therapeutics, LianBio, Orgenesis, Telix Pharmaceuticals

NEW YORK – The US Food and Drug Administration granted Kyverna Therapeutics fast-track designation for KYV-101, the cell therapy developer said last week. KYV-101 is an autologous therapy designed to treat refractory lupus nephritis, a serious complication of lupus. The treatment is a CAR T-cell therapy that aims to deplete a patient's B cells. 

LianBio said this week that China's National Medical Products Administration (NMPA) granted breakthrough therapy designation to its FGFR inhibitor infigratinib for the treatment of gastric cancer. The firm also reported positive data from a Phase II trial of infigratinib in patients with FGFR2-mutant advanced gastric cancer and gastroesophageal junction cancer, demonstrating a 25 percent response rate. Drugs with this designation from the NMPA can access additional communication channels and technical guidance from the regulator's Center for Drug Evaluation, along with access to accelerated approval pathways. 

Orgenesis and the University of California Davis said this week that they plan to set up Orgenesis Mobile Processing Units and Labs, or OMPULs, at medical and academic institutions in the University of California system. Under the terms of the collaboration, Orgenesis will install and operate its OMPULs to allow their point-of-care (POCare) Service Platform to manufacture cell therapies for clinical trials at hospitals throughout California. The first OMPUL will be installed and validated at UC Davis, after which Orgenesis will follow a decentralized model to install OMPULs at other sites in California. 

Telix Pharmaceuticals this week opened Telix Manufacturing Solutions, a radiopharmaceutical facility located south of Brussels, Belgium, which will be the company’s main manufacturing site for radioisotopes, including commercial and clinical products, for patients in Europe, the Middle East, and Africa. The facility is part of the Melbourne, Australia-based firm’s €14.1 million ($15.2 million) investment in radiopharmaceutical manufacturing capabilities. 

The College of American Pathologists and the American Society of Clinical Oncology said this week that they have reaffirmed the Human Epidermal Growth Factor Receptor 2 (HER2) Breast Cancer Testing Guidelines following a review of the recent DESTINY-Breast04 clinical trial for metastatic breast cancer patients that found a treatment traditionally used in HER2-positive patients was also effective in patients considered HER2-negative. CAP and ASCO did not recommend changes in HER2 reporting terminology, but the updated guidelines emphasize awareness of the new clinical significance of specific HER2 protein levels reported and include a reporting comment footnote to clarify that significance. 

The US Food and Drug Administration has granted Rocket Pharmaceuticals both fast track and orphan drug designations for RP-A601, the gene therapy developer said this week. RP-A601 is an adeno-associated virus (AAV)-based gene therapy designed to treat arrhythmogenic cardiomyopathy, a rare heart disease caused by mutations in the PKP2 gene. Rocket Pharmaceuticals in May announced receiving clearance of its investigational new drug application for RP-A601 and plans for a Phase I trial to study the therapy. 

Eisai this week said it filed a marketing authorization application for lecanemab, which it codeveloped with Cambridge, Massachusetts-based Biogen as a treatment for early Alzheimer's disease, with South Korea's Ministry of Food and Drug Safety. Lecanemab, branded as Leqembi in the US, received accelerated approval from the US Food and Drug Administration in January based on its ability to clear amyloid plaque in the brain. Tokyo-based Eisai leads development and regulatory submissions for lecanemab globally and has submitted applications for approval in Japan, Europe, China, Canada, and Great Britain, and has submitted to the FDA to convert its accelerated approval into a traditional approval. Eisai said it plans to submit additional applications in other Asian countries. 

DermTech said this week that it has signed an agreement with a Blues plan payor in Hawaii, enhancing access to its melanoma test for this plan's nearly 800,000 members. The move brings DermTech's total covered lives in the US to approximately 126 million, including 68 million under Medicare and another 58 million served by commercial and governmental payors. 

The DermTech Melanoma Test is designed to assess pigmented lesions, using RT-PCR to detect expression of the LINC and PRAME genes and, optionally, DNA sequencing to identify mutations in the TERT promoter region. Positive results for any of those biomarkers are correlated with a higher risk of melanoma. If none are detected, it indicates a greater than 99 percent probability that the mole being tested is not a melanoma. 

Bristol Myers Squibb this week said the US Food and Drug Administration approved its cell manufacturing facility in Devens, Massachusetts for commercial production for its autologous cell therapies. The 244,000 square foot facility has been expanded twice to accommodate BMS' cell therapy production needs around the world. 

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.