China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its antibody-drug conjugate (ADC) BA1301. The drug is indicated for use in Claudin18.2 (CLDN18.2)-positive advanced solid tumors, including advanced gastric cancer, adenocarcinoma of the gastroesophageal junction, and pancreatic cancer. This marks a significant step forward in the development of innovative treatments for these challenging conditions.
Mechanism and Technology
BA1301 features Luye’s partner Levena Biopharma’s C-Lock fixed-point coupling technology, which pairs a small-molecule cytotoxin with a CLDN18.2 monoclonal antibody. This innovative approach guides the small-molecule toxin to the tumor site, enhancing anti-tumor activity while reducing toxicity and side effects, thereby improving the treatment window.
Preclinical Efficacy and Safety
Preclinical efficacy studies have shown that BA1301 demonstrates excellent internalization activity and bystander effect, with significant tumor growth inhibition observed both in vitro and in vivo across tumor cell models with varying CLDN18.2 expression levels. Pharmacokinetic and toxicological studies have revealed enduring activity for the molecule’s toxin, with the drug exhibiting a favorable safety and tolerability profile in animal models.
Future Outlook
The approval for clinical trials of BA1301 underscores Luye Pharma Group’s commitment to advancing innovative cancer therapies. With its demonstrated preclinical efficacy and safety, BA1301 has the potential to address significant unmet needs in the treatment of CLDN18.2-positive advanced solid tumors. Luye’s ongoing efforts in clinical development highlight its dedication to improving patient outcomes in oncology.-Fineline Info & Tech
