U.S. Food and Drug Administration has Granted Orphan Drug Designation to XOMA’s Licensed anti-TGFβ Asset NIS793

On July 28, 2021 XOMA Corporation (NASDAQ: XOMA), reported NIS793 in combination with standard of care chemotherapy has been granted Orphan Drug Designation in pancreatic cancer by the U.S. Food and Drug Administration (Press release, Xoma, JUL 28, 2021, View Source [SID1234585306]). NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ). An Orphan Drug Designation grants special status to a drug that treats a rare disease or condition and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these severe diseases1.

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!

"Pancreatic cancer is a particularly difficult diagnosis for a patient to receive. The statistics clearly demonstrate pancreatic cancer is an unmet medical need, and we are highly supportive of Novartis’ efforts to bring NIS793 to this patient population," said Jim Neal, Chief Executive Officer at XOMA.

Under the terms of the 2015 agreement between XOMA and Novartis, XOMA has the potential to earn up to $445 million in additional milestone payments. Upon receipt of regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on any net product sales that range from the mid-single digits to the 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.