Severance Hospital

Hudson Therapeutics' Nugel Shows Promise in Phase 2b Trial for Atopic Dermatitis

4 months ago

• Hudson Therapeutics announced positive results from Part 1 of its Phase 2b trial of Nugel for atopic dermatitis, with the Safety Monitoring Committee recommending advancement to Part 2. • The trial assessed safety across multiple doses, revealing no significant drug-related side effects and demonstrating exceptional tolerability compared to the placebo group. • Nugel achieved the EASI 50 index in efficacy assessments, with 100% of patients reaching EASI 50 at an optimized dose, compared to 44% in the placebo group. • Part 2 of the trial will involve a larger cohort across multiple U.S. and South Korean clinical sites to further evaluate Nugel's efficacy and safety profile.

Aptamer Sciences' Liver Cancer Drug, AST-201, Enters Phase 1 Trials in Korea

6 months ago

• Aptamer Sciences initiates Phase 1 clinical trials for AST-201, a novel aptamer-based drug for liver cancer, across four Korean medical institutions. • The trial will assess the safety and tolerability of AST-201 in up to 36 patients with GPC3-positive advanced solid tumors, with potential efficacy exploration. • AST-201 utilizes Aptamer-Drug Conjugate (ApDC) technology, offering targeted drug delivery to cancer cells with reduced side effects. • First dosing is anticipated in January, with initial data expected in the first half of the following year, according to Aptamer Sciences.

TiCARos Unveils Switchable CAR-T Therapy Demonstrating Enhanced Safety and Efficacy in Solid Tumors

6 months ago

• TiCARos' switchable CAR-T technology overcomes on-target off-tumor toxicity, a major limitation in existing CAR-T therapies, particularly for solid cancers. • The novel approach uses a chemically tagged cotinine adapter to indirectly target cancer cells, sparing normal tissues and reducing toxicity in animal studies. • A suicidal switch mechanism provides an added layer of safety, allowing for the removal of CAR-T cells if necessary, enhancing the therapeutic control. • Human T-cell trials confirmed the efficacy and safety of the switchable CAR-T system, suggesting its potential for treating both solid tumors and hematologic cancers.

Vyloy Approval in Korea Faces Reimbursement Hurdles Despite Clinical Promise

6 months ago

• Vyloy (zolbetuximab), the first Claudin 18.2-targeted gastric cancer drug, has been approved in Korea for advanced gastric cancer treatment. • Concerns arise that Korea's reimbursement system may impede patient access to Vyloy, despite its potential to significantly improve survival rates. • The Health Insurance Review and Assessment Service (HIRA) is reviewing the companion diagnostic device (CDx) for Claudin 18.2, potentially delaying Vyloy's launch. • Experts advocate for policy improvements to support the synchronized introduction of targeted drugs and their companion diagnostics in Korea.

J INTS BIO's JIN-A02 Shows Promise in EGFR-TKI Resistant NSCLC

7 months ago

• J INTS BIO presented interim Phase 1/2 data for JIN-A02, a 4th-generation EGFR-TKI, at the ENA Symposium, targeting resistant NSCLC. • The trial showed JIN-A02 has a favorable safety profile with no dose-limiting toxicities up to 150mg daily in EGFR-mutated NSCLC patients. • Early efficacy signals included tumor control and partial responses in lung lesions, along with activity against brain metastases, were observed. • JIN-A02 could address a critical unmet need in NSCLC patients who have developed resistance to 3rd-generation EGFR-TKIs.

Amlodipine and Candesartan Combination Therapy Shows Superior Efficacy in Treating Hypertension

8 months ago

• A Phase III clinical trial demonstrates that a combination of amlodipine and candesartan is more effective than amlodipine alone in reducing diastolic blood pressure in hypertensive patients. • The study, involving Korean patients with essential hypertension, showed significant reductions in both diastolic and systolic blood pressure with the combination therapy. • The fixed-dose combination of amlodipine and candesartan was well-tolerated, with adverse events comparable to those observed with amlodipine monotherapy. • These findings support the use of amlodipine and candesartan combination therapy as an effective treatment option for patients whose hypertension is not adequately controlled by amlodipine alone.