China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, AlaMab Therapeutics Inc., will present preliminary positive data from a Phase I clinical study of its pipeline candidate ALMB-0168 at the American Society of Clinical Oncology (ASCO) annual meeting. ALMB-0168 is a monoclonal antibody (mAb) that targets connexin 43 (Cx43) for the treatment of osteosarcoma.
Pre-Clinical Studies and Drug Designation
Pre-clinical studies have demonstrated that ALMB-0168 can inhibit the growth and metastasis of bone in bone and breast cancer patients by activating the Cx43 protein to release tumor suppressor substances. The drug has previously obtained orphan drug designation (ODD) and rare pediatric disease status, highlighting its potential impact on treating rare diseases.
Phase I Study Design and Results
The multi-center, open-label, single-arm Phase I study aimed to assess the safety, tolerability, and preliminary efficacy of ALMB-0168 in osteosarcoma. It enrolled bone cancer patients aged 16 and above who had developed disease progression after standard chemotherapy and were histologically confirmed. A total of 13 patients were eligible for response assessment. The overall response rate (ORR) from the study was 15.4%, including two cases of partial response (PR). The disease control rate (DCR) reached 53.8%. Patients who received a 6mg/kg dose of ALMB-0168 and had undergone three or more previous treatments, as well as those with lung metastasis, achieved 33 weeks of stable disease (SD) and more than 8 weeks of PR, demonstrating sustained disease control. No dose-limiting toxicity and no cardiac or severe liver events related to Cx43 were observed.
Conclusion of Phase I Dose Escalation Trial
In summary, the Phase I dose escalation trial of ALMB-0168 showed encouraging efficacy and tolerable safety in patients with metastatic or unresectable bone cancer after standard chemotherapy, positioning it as a potential new treatment option for this patient population.-Fineline Info & Tech
