XOMA Earns $35-Million Milestone Payment as Anti-TGFβ Antibody Enters Phase 3 Clinical Study in Metastatic Pancreatic Cancer
XOMA Corporation recently announced NIS793, an anti-TGFβ monoclonal antibody licensed from the company, has advanced to the Phase 3 development stage, triggering a $35-million milestone payment from Novartis. 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, Novartis announced the US FDA had granted Orphan Drug Designation to NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer.
“Pancreatic cancer claims far too many lives every year, and we appreciate that Novartis chose to pursue it as the first indication for late-stage development with NIS793. We are grateful to the patients and their families who are participating in all of the NIS793 clinical studies,” said Jim Neal, Chief Executive Officer of XOMA. “NIS793 represents one of several important assets in our partner-funded portfolio. This $35-million milestone gives us additional capital to acquire the rights to potential future milestone and royalty economics from biotech companies who can then use the capital to pursue their goal of curing a disease or condition by advancing their clinical development activities.”
More information about the NIS793 Phase 3 clinical study, NCT04935359, titled Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) can be found at ClinicalTrials.gov.
Under the terms of the 2015 anti-TGFβ development and commercialization agreement with Novartis, XOMA has the potential to earn up to $410 million in additional milestone payments. Should Novartis receive regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on net product sales that range from mid-single digit to low double digits. NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.
XOMA has built a significant portfolio of products that are licensed to and being developed by other biotech and pharmaceutical companies. The company’s portfolio of partner-funded programs spans multiple stages of the drug development process and across various therapeutic areas. Many of these licenses are the result of XOMA’s pioneering efforts in the discovery and development of antibody therapeutics. The company’s royalty-aggregator business model includes acquiring additional milestone and royalty rights associated with drug development programs with third-party funding. For more information, visit www.xoma.com.
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