Seoul National University Hospital

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.

Curacle presented phase 2a trial results of CU06 for diabetic macular edema at the 4th Asia Retina Congress. The oral medication improved best corrected visual acuity in 67 US DME patients, with a 5.8-letter improvement in the 300 mg group. No serious adverse events were reported, and a phase 2b trial is planned. Curacle aims to finalize its development strategy with the US FDA in February 2025.

Curacle presented phase 2a trial results of CU06 for diabetic macular edema (DME) at the 4th Asia Retina Congress, showing improvements in visual acuity across all dosing groups (100, 200, 300 mg), with the 300 mg group experiencing a 5.8-letter improvement. Central subfield thickness remained stable, and dose-dependent improvements in anatomical markers were observed. No serious adverse events were reported. A phase 2b trial is planned, and a Type C meeting with the US FDA in February 2025 will finalize the development strategy.

Sanofi Korea announced Beyfortus (nirsevimab) availability in Korea, an RSV preventive antibody injection for infants and children under 24 months. Clinical trials showed significant reductions in RSV-related hospitalizations, emphasizing the need for RSV prevention in all infants.

TiCARos' “Switchable CAR-T” technology, developed by Seoul National University and Sungkyunkwan University, was published in Nature Communications on Nov. 18. The study shows switchable CAR-T's efficacy in treating various cancers, including solid tumors, by selectively targeting cancer cells while sparing normal tissues. TiCARos is conducting phase 1 clinical trials and collaborating with Cartherics to expand into the CAR-NK field.

Vyloy, the first Claudin 18.2-targeted gastric cancer drug, was approved in Korea, but its complex reimbursement system may limit patient access. The Korean Cancer Association plans to address policy issues, as the approval of Roche Diagnostics' companion diagnostic device for Claudin 18.2 is under review by HIRA, potentially delaying the drug's use.

Global pharmaceutical companies invested 872.9 billion won in Korean clinical research in 2023, up 6.7% from 2022. Clinical trials grew 7.7% to 1,723, with phase 3 trials up 12.8% to 644. Cancer research accounted for 69.0% of trials, while rare disease research grew 35.3%.

Mounjaro (tirzepatide) is highly effective for glycemic control and weight loss, dubbed a 'super GLP-1 RA'. It activates GIP and GLP-1 receptors, leading to significant HbA1c reduction and weight loss, comparable to bariatric surgery. However, rebound effects and high cost are concerns, necessitating lifestyle modifications and potential reimbursement discussions.

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.