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In Brief This Week: Immatics, Cordance Medical, Life Molecular Imaging, Yale School of Medicine

NEW YORK – Immatics this week said that IMA203 has received regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration as a potential treatment for multiple HLA-A*02:01-positive and PRAME-expressing relapsed or refractory cancers, including cutaneous melanoma, uveal melanoma, endometrial carcinoma, synovial sarcoma, and ovarian cancer. IMA203 is a T-cell receptor T-cell (TCR-T) therapy designed to target the PRAME protein, which is often expressed in various solid tumors. With RMAT designation, IMA203 is on an expedited development and review pathway, and Immatics can benefit from all the advantages of the fast-track and breakthrough designation programs, such as having early meetings with the FDA to discuss potential surrogate or intermediate endpoints for accelerated approval and strategies for satisfying post-approval requirements. 

Cordance Medical said this week that its NeuroAccess device has received breakthrough device designation from the US Food and Drug Administration. The device employs focused ultrasound and microbubbles to open the blood brain barrier temporarily and noninvasively. This allows cell-free DNA from the brain to enter the blood circulation, where it can be analyzed by existing cancer liquid biopsy tests. The so-called "SonoBiopsy" technology was developed by researchers at Washington University in St. Louis, who demonstrated it earlier this year in brain cancer patients. Cordance Medical licensed patents related to the technology from WashU last month. 

Berlin-based Life Molecular Imaging this week said its beta-amyloid PET imaging radiotracer Neuraceq, a florbetaben F-18 injection, has received regulatory approval from the National Medical Products Administration in China. Neuraceq, which will be manufactured and distributed by Beijing-based Sinotau Pharmaceutical Group, is the first radiopharmaceutical approved in China to assess beta-amyloid accumulation to support Alzheimer's diagnosis. The presence of beta-amyloid accumulation is required to prescribe new Alzheimer's disease drugs like Eisai and Biogen's Leqembi (lecanemab). Such drugs have been approved in the US and could soon be approved in China, according to the companies. 

Neuraceq is already approved for use in the US, UK, and EU. 

Yale School of Medicine this week announced it will launch the Stephen and Denise Adams Center for Parkinson's Disease Research, in which researchers will work to develop precision diagnostics and treatments for the neurodegenerative disorder. Researchers at the center also plan to create a biobank of data for research and create analytic tools that use genetics and other health data to predict patients' likelihood of developing the disease and what therapeutics might help to prevent debilitating symptoms. The center will bring together scientists and engineers from neurology, neuroscience, cell biology, genetics, bioinformatics, and computer science.   

Nucleix said this week its CE-marked Bladder EpiCheck liquid biopsy test for detection of primary or recurrent bladder cancer is available in France through the firm's participation in the Association Francaise d'Urologie Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer. The registry is evaluating the diagnostic performance of urine biomarkers and comparing them with bladder endoscopy results performed during two years of follow-up testing. The Bladder EpiCheck test, which is used to detect disease-specific changes across 15 methylation markers, is also US Food and Drug Administration 510(k)-cleared for detection of bladder cancer recurrence. 

AGC Biologics this week said it signed a service agreement with Medigene AG to provide autologous cell therapy production supporting an investigational new drug application filing and clinical trials for Medigene's TCR-T therapy MDG1015. The product combines a T-cell receptor targeting NY-ESO-1/LAGE-1a with a PD1-41BB costimulatory switch protein.  

Fapon said this week that it has been granted an exclusive license by Swiss biotech firms Lascco and Abionic for use of the pancreatic stone protein (PSP) biomarker for sepsis diagnosis in China. Fapon will research, develop, manufacture, and commercialize PSP raw materials and chemiluminescent immunoassay-based reagents within China. According to China-based Fapon, the PSP immunoassay received CE marking under the IVDR and Australian registration, and 510(k) clearance from the US Food and Drug Administration is anticipated in 2024. 

Caris Life Sciences said this week that Sarah Cannon Research Institute (SCRI) has joined the Caris Precision Oncology Alliance. The alliance is a network of almost 90 cancer centers, academic institutions, research consortia, and healthcare systems that collaborate to advance precision oncology and biomarker-driven research. They have access to Caris' database and artificial intelligence platform to establish standards for cancer profiling and molecular testing in oncology. 

New York state is making newborn screening for Duchenne muscular dystrophy mandatory for all babies born in the state, advocacy group Parent Project Muscular Dystrophy said this week. Starting in 2024, all newborns in the state will undergo screening for the inherited disease, and at least 21 infants are expected to be diagnosed with Duchenne. The state's decision was based on a pilot program that ran from 2019 to 2021 and identified four infants with Duchenne or Becker muscular dystrophy. New York is the second state, after Ohio, to make newborn screening for Duchenne mandatory. 

Digital pathology firm Paige said this week that the US Food and Drug Administration has granted breakthrough device designation for its Paige Lymph Node artificial intelligence software for detection of breast cancer metastases in lymph node tissue. The medical device software is used to highlight areas of concern for further review by pathologists. Paige said it trained Paige Lymph Node on more than 32,000 digitized hematoxylin and eosin lymph node slides and, in an investigational study, it detected the presence of metastases with near perfect sensitivity. 

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.