UNITED STATES
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CURRENT REPORT
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Item 8.01. Other Events.
On November 4, 2021, XOMA Corporation (the “Company” or “XOMA”) announced that NIS793, an anti-TGFb monoclonal antibody licensed from the Company, has advanced to the Phase 3 development stage, triggering a $35 million milestone payment from Novartis International Pharmaceutical Ltd. (“Novartis”), pursuant to that certain License Agreement, dated as of September 30, 2015, by and between XOMA and Novartis, due in 45 days. The Phase 3 trial (NCT04935359) is designed to assess the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). In July 2021, Novartis announced that the U.S. Food and Drug Administration had granted Orphan Drug Designation to NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer. NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
XOMA CORPORATION | ||||||
Date: November 4, 2021 | By: | /s/ THOMAS BURNS | ||||
Thomas Burns | ||||||
Senior Vice President, Finance and Chief Financial Officer |