On July 18, 2023, Novartis International Pharmaceutical Ltd. ("Novartis") reported that based on a benefit-risk assessment, it is discontinuing its Phase 3 trial (the "Trial") investigating NIS793, an anti-TGFb monoclonal antibody, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Xoma, JUL 18, 2023, View Source [SID1234633290]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Trial (NCT04935359) was designed to assess the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo, in mPDAC. Novartis stated it will continue to investigate NIS793 in indications beyond pancreatic ductal adenocarcinoma, including its ongoing Phase 2 study in colorectal cancer.
XOMA Corporation (the "Company") licensed NIS793 to Novartis pursuant to that certain License Agreement dated as of September 30, 2015 by and between XOMA (US) LLC, a wholly owned subsidiary of the Company, and Novartis Institutes for Biomedical Research, Inc., previously filed with the Securities and Exchange Commission as Exhibit 10.2 to its Quarterly Report on Form 10-Q for the period ended September 30, 2015.
NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.