Zolbetuximab, a first-in-class investigational monoclonal antibody (mAb) targeting tumor-associated antigen CLDN18.2 which is highly expressed on gastric cancer cells, was recently reported to meet the primary endpoint in Phase III trial as first-line treatment in CLDN18.2 positive and HER2-negative gastric cancers. Furthermore, PM1032 was generally well tolerated, with no significant abnormalities observed in toxicity studies, including the liver and stomach. In summary, PM1032 demonstrated good PK and an exceptional safety profile in rhesus monkeys supporting further investigation in clinical studies.

5 months ago

PK/PD data • Journal

HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)

HER-2 negative • CLDN18.2 positive • CLDN18.2 positive + HER-2 negative

Vyloy (zolbetuximab) • PM1032

1year

Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov)

P1/2, N=200, Recruiting, Biotheus Inc.

1 year ago

New P1/2 trial

CLDN18 (Claudin 18)

CLDN18.2 positive

PM1032