MAYO CLINIC

GI Innovation dosed the first patient in a phase 1 trial of GI-102, an immune-oncology drug in SC formulation, marking the first Korean firm to do so. The SC formulation aims to enhance efficacy over IV administration and is expected to improve ease of administration and therapeutic outcomes for melanoma. The trial is conducted at 14 institutions in Korea and the U.S., with Samsung Biologics handling GMP production. The phase 1 trial is expected to conclude by February 2025.

Victor Ortega, M.D., Ph.D., discusses how genome-wide technologies enable personal health forecasts, predicting disease risks like heart disease and cancer. Polygenic risk scores, compiled from DNA sequence variants, estimate overall disease risk, aiding informed lifestyle choices and enhanced screenings. Dr. Ortega's mission includes advancing precision medicine and expanding genomic testing for rare diseases.

Dr. Huang's lab studies prostate cancer genetics, focusing on African Americans. The Hollander Foundation awarded him $25,000 for research. Dr. Robert Hollander, a prostate cancer survivor and winemaker, funds the foundation to support prostate cancer research.

FDA expands Zepbound approval for obstructive sleep apnea in obese adults, making it the first drug treatment for the disorder affecting 39M U.S. adults. Zepbound, sharing active ingredient with Lilly's diabetes drug Mounjaro, aids weight loss, potentially improving symptoms. Current treatments like CPAP machines face issues, prompting interest in drug options. Zepbound showed significant reduction in sleep apnea events in trials, though head-to-head trials against CPAP are needed.

FDA approved Zepbound as the first prescription medicine for sleep apnea, marking a significant win for Eli Lilly. Zepbound, already approved for weight loss, can now be prescribed for adults with moderate-to-severe obstructive sleep apnea and obesity, improving sleep quality and reducing weight.

Kenton R. Kaufman, Ph.D., emphasizes the importance of real-world evidence from wearable sensors over lab settings and questionnaires for patient outcomes. His lab focuses on developing algorithms for sensor data, aiding in orthopedic patient care and therapeutic monitoring. The shift to value-based care and real-world evidence in healthcare supports these advancements, aiming for optimal patient outcomes at lower costs. Remote therapeutic monitoring benefits include joint goal setting, adherence tracking, and reimbursement, fostering patient-physician partnerships.

Jennifer J. Westendorf, Ph.D., studies osteoarthritis progression reversal, focusing on Phlpp1 and 2 proteins. Her research shows Phlpp1 regulates cartilage health, protecting against injury-induced osteoarthritis. Phlpp inhibitors could reboot chondrocytes, reduce pain, and promote cartilage preservation, potentially delaying joint replacement in younger populations.

Dr. Doug Flora, Executive Medical Director of Oncology Services at St. Elizabeth Cancer Center, discusses the growth of the program, attracting top providers, CMS 5-star rating, unique blend of local talent and renowned specialists, clinical trials, personalized medicine, nurse navigation, and whole-person care.

Mayo Clinic researchers use AI and multiplatform molecular data to personalize brain tumor care, focusing on meningioma, glioma, brain metastasis, and neurofibromatosis. Their studies, published in Nature Medicine and Acta Neuropathologica, highlight the importance of molecular classification and DNA methylation profiling in treatment decisions and clinical trial design.

Envoy Medical selects seven sites for its pivotal Acclaim® cochlear implant study, with initial enrollment expected Q1 2025. The fully implanted device, FDA-approved with Breakthrough Device Designation, aims to address severe hearing loss without external components.