Samsung Medical Center

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.

Korea launched the National Bio Big Data Initiative to establish a comprehensive bio big data platform for precision and personalized medicine, aiming to collect data from one million participants by 2032. The initiative integrates clinical, public health, and genomic data through voluntary participation, with data to be available for research from 2026.

Chang Gung Memorial Hospital, Linkou validated for Stage 7 of HIMSS INFRAM and Stage 6 of DIAM, focusing on cybersecurity, infrastructure maturity, and digital imaging. The hospital plans to invest in data analytics and medical imaging management, aiming for Stage 7 DIAM and adopting AI, big data, and FHIR standards for telemedicine interoperability.

Clinical trials of AST-201, a liver cancer drug using Aptamer-Drug Conjugate technology, will start soon at four Korean institutions. The phase 1 trial aims to assess safety and tolerability in 36 GPC3-positive advanced solid tumor patients, with efficacy exploration planned. The first dose is expected in January 2025.

Korean researchers identified preoperative topical glaucoma medication exposure, quantified by the Glaucoma Medication Intensity Index (GMII), as a significant risk factor for trabeculectomy failure in primary open-angle glaucoma (POAG) patients. Advanced age at surgery and subsequent cataract surgery also increased failure risk. A GMII threshold of ≥4.35 was linked to poorer long-term intraocular pressure (IOP) control. The study suggests optimizing surgery timing to minimize GMII exposure could improve outcomes.

GC Biopharma and Novel Pharma dosed the first US patient in a multinational Phase I clinical trial for ‘GC1130A’, an innovative drug for Sanfillippo syndrome type A (MPS IIIA). The trial, spanning the US, Korea, and Japan, aims to assess safety, tolerability, and efficacy over two years for children aged 2-6. ‘GC1130A’, a first-in-class treatment, uses an ICV injection to bypass the blood-brain barrier, addressing a significant unmet medical need.

Blood tests for Alzheimer’s are ready, with many plasma p-tau217 assays meeting triage criteria and several vendors filing for FDA approval. CMS may reimburse, but rates are uncertain. Vendors like Fujirebio and Roche have filed for IVD approval, and leaders in AD drug development await regulatory approval. The CEOi panel recommends tests with 90% sensitivity and 85% specificity, prompting vendors to optimize their tests. The p-tau217/Aβ1-42 ratio outperforms p-tau217 alone in identifying amyloid-positive individuals, with fewer indeterminate results. Post-approval, integration into clinical practice and appropriate-use recommendations are crucial.

Methods for keloid spheroid formation, viability, composition, and propagation assays are detailed, involving fibroblasts and endothelial cells. Fibroblasts from commercial lines and keloid patients, and HUVECs, were cultured and mixed to form spheroids. Viability, composition, and propagation of spheroids were assessed using fluorescent staining and microscopy. Gene expression analysis by RT-PCR and drug assays with triamcinolone, fluorouracil, and bleomycin were conducted. Statistical analysis was performed using Prism 9.3.1, with significance set at p < 0.05.

In a phase 1 study of PHI-101 for AML, 50% of evaluable patients achieved an overall complete response. PHI-101 targets FLT3 gene mutation in AML patients, presenting at ASH 2024. Pharos iBio plans to complete phase 1 and proceed with early commercialization.

A research team led by Ho Sang Jung has developed a non-invasive cancer diagnostic method using a specialized sensor material that amplifies optical signals of cancer metabolites in biofluids like saliva. This technology has shown diagnostic capability for colorectal and lung cancers, and has potential for other diseases with poorly understood diagnostics. The team also achieved high sensitivity and specificity in urine diagnostics for multiple cancers.