The Chinese University of Hong Kong

Surgical Robotics Advance: EndoQuest and Virtuoso Begin First Human Trials for Minimally Invasive Procedures

4 days ago

• EndoQuest Robotics has initiated its pivotal Paradigm trial for an endoluminal robotic system designed to perform endoscopic submucosal dissection for colorectal lesions through natural body openings. • Virtuoso Surgical has successfully completed first-in-human procedures using its robotic endoscopy system with needle-sized manipulators to perform en bloc bladder tumor resections at The Chinese University of Hong Kong. • Both robotic systems aim to address technical challenges in minimally invasive procedures, potentially reducing the need for more invasive surgeries and improving patient outcomes.

New Mainland Chinese Cancer Drug Shows Promising Results in Phase 1 Trial

4 days ago

• A multinational study led by Chinese University of Hong Kong researchers found that D3S-001, a mainland-developed cancer drug, effectively treats tumors driven by KRAS-G12C gene mutations. • The phase 1 trial demonstrated remarkable efficacy with over 70% of the 42 participating patients experiencing significant tumor shrinkage or complete disappearance after treatment. • Researchers noted that D3S-001 inhibits the KRAS-G12C mutation more quickly and potentially for longer durations than existing first-generation inhibitors, showing promise for non-small-cell lung, colorectal, and pancreatic cancers.

Taletrectinib Approved in China for ROS1-Positive NSCLC, Showing Promise in TKI-Pretreated and Naive Patients

6 months ago

• China's NMPA has approved taletrectinib for treating adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with ROS1 TKIs. • The approval was based on the phase 2 TRUST-I trial, which demonstrated a 51.5% ORR in patients pretreated with crizotinib, with a median DOR of 10.6 months. • Taletrectinib has also received priority review for first-line treatment of ROS1-positive NSCLC, supported by data showing a 90.6% ORR in TKI-naive patients. • Clinical trials show taletrectinib's efficacy in CNS penetration and activity against resistance mutations, offering a potential best-in-class safety profile.

Hua Medicine's Dorzagliatin Shows Promise in Restoring β-Cell Glucose Sensitivity in Asian Populations

6 months ago

• Hua Medicine announced positive results from its SENSITIZE study, demonstrating dorzagliatin's ability to improve β-cell glucose sensitivity. • The SENSITIZE 2 study showed a single dose of dorzagliatin restores glucokinase enzyme activity in individuals with impaired glucose tolerance. • Prior SENSITIZE 1 study indicated dorzagliatin enhances insulin secretion in GCK-MODY patients and newly diagnosed type 2 diabetes patients. • Hua Medicine plans further investigations into dorzagliatin's effects on glucose sensitivity and incretin response for personalized diabetes treatment.

FDA Grants Fast Track Designation to Alentis Therapeutics' ALE.P02 for CLDN1+ Squamous Cancers

6 months ago

• The FDA has granted Fast Track designation to Alentis Therapeutics' ALE.P02 for advanced or metastatic CLDN1+ squamous cancers, irrespective of origin. • ALE.P02, a first-in-class antibody-drug conjugate (ADC), targets a unique CLDN1 epitope on cancer cells, potentially offering a less toxic treatment option. • A Phase 1/2 clinical trial is planned to begin in Q1 2025 to assess ALE.P02 in individuals with CLDN1-positive squamous solid tumors. • Alentis is also developing ALE.P03, a similar ADC with a topoisomerase I inhibitor, with ongoing toxicology studies.

Greater Bay Area International Clinical Trial Institute Opens in Hong Kong

6 months ago

• The Greater Bay Area International Clinical Trial Institute (GBAICTI) has officially opened in Hong Kong, aiming to boost biomedical technology development. • The GBAICTI will coordinate clinical trial resources across public and private sectors, streamlining workflows and fostering collaboration within the Greater Bay Area. • The institute plans to establish a Hong Kong Clinical Trial Digital Portal and a Clinical Trial Academy to enhance efficiency and talent development. • Strategic partnerships, including with the Hong Kong Genome Institute, will leverage local data and attract biomedical technology enterprises to the region.

FDA Grants Fast Track Designation to Alentis Therapeutics' ALE.P02 for CLDN1-Positive Solid Tumors

6 months ago

• The FDA has granted Fast Track designation to ALE.P02, an anti-Claudin-1 (CLDN1) antibody-drug conjugate (ADC), for CLDN1-positive squamous solid tumors. • ALE.P02, a first-in-class ADC, targets the CLDN1 epitope on cancer cells and has shown promise in preclinical studies, demonstrating complete tumor regression in xenograft models. • A first-in-human phase 1/2 trial is set to begin in Q1 2025, evaluating ALE.P02 in patients with CLDN1-positive squamous solid tumors, following the FDA's IND clearance in October 2024.

FDA Grants Fast Track Designation to Alentis Therapeutics' ALE.P02 for CLDN1+ Squamous Solid Tumors

6 months ago

• The FDA granted Fast Track designation to ALE.P02, an anti-Claudin-1 (CLDN1) antibody-drug conjugate (ADC), for CLDN1-positive squamous solid tumors. • ALE.P02, a first-in-class ADC with a tubulin inhibitor, targets the CLDN1 epitope on cancer cells, potentially offering a less toxic treatment option. • A phase 1/2 trial for ALE.P02 in patients with CLDN1-positive squamous solid tumors is expected to begin in the first quarter of 2025. • Preclinical data showed that ALE.P02 led to complete tumor regression in patient-derived xenograft models, supporting its clinical development.

CU Medicine Introduces Asia's First Histotripsy 2.0 System for Liver Tumour Treatment

6 months ago

The Chinese University of Hong Kong's Faculty of Medicine has received Asia's first Histotripsy 2.0 system, a donation from the Li Ka Shing Foundation, aimed at treating liver tumours. This advanced system, set to serve patients by early 2025, offers more precise focal therapy and supports continuous upgrades. The Foundation, along with CU Medicine and the Prince of Wales Hospital Charitable Foundation, will sponsor 30 patients to undergo this novel treatment, marking a significant step forward in cancer treatment research.

Alentis' CLDN1-Targeting ADC, ALE.P02, Receives FDA Fast Track for Advanced Squamous Cancers

6 months ago

• Alentis Therapeutics' ALE.P02, a first-in-class antibody-drug conjugate (ADC) targeting Claudin-1 (CLDN1), has been granted FDA Fast Track designation. • The designation aims to expedite the development of ALE.P02 for advanced or metastatic CLDN1+ squamous cancers, irrespective of the origin organ. • ALE.P02 links a tubulin inhibitor to an antibody, potentially offering a more targeted and less toxic approach for treating CLDN1-overexpressing squamous cancers. • A first-in-human clinical trial for ALE.P02 in advanced or metastatic CLDN1+ squamous solid tumors is planned to commence in Q1 2025.

CUHK Study Finds Earlier Endoscopy Did Not Reduce Mortality in Acute Upper GI Bleeding

5 years ago

A study by The Chinese University of Hong Kong reveals that performing endoscopy within 6 hours for acute upper gastrointestinal bleeding does not lower mortality or reduce the risk of further bleeding compared to endoscopy performed between 6 and 24 hours after consultation.