XOMA Earns $25-Million Milestone Payment as Anti-TGFβ Antibody Enters Phase 2 Clinical Study
XOMA Corporation recently announced NIS793, an anti-TGFβ monoclonal antibody licensed from XOMA, has advanced to the Phase 2 development stage, triggering a $25-million milestone payment from Novartis. The Phase 2 trial (NCT04390763) is designed to assess the efficacy and safety of NIS793 in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
“We applaud Novartis for initiating its first Phase 2 study with NIS793 to focus on patients who have one of the highest needs for new treatment options – pancreatic cancer. We are grateful to the patients and their families who have agreed to participate in the NIS793 clinical trials,” said Jim Neal, Chief Executive Officer of XOMA. “This milestone payment further strengthens XOMA’s financial resources as we pursue our royalty aggregation strategy and reduces our Novartis debt obligation to less than $10 million. Importantly, this marks a meaningful clinical advancement of this important asset in our overall portfolio of potential milestones and royalties.”
More information about the NIS793 Phase 2 clinical study, officially titled “A Phase 2, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC),” can be found at ClinicalTrials.gov.
As specified under the terms the agreements between XOMA and Novartis, approximately 30% of the NIS793 milestone will be applied as a partial payment toward XOMA’s debt obligation to Novartis, and the remaining balance will be paid in cash to XOMA.
Under the terms of the 2015 anti-TGFβ development and commercialization agreement with 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.
XOMA has built a significant portfolio of products that are licensed to and being developed by other biotechnology 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 licenses to programs with third-party funding. For more information, visit www.xoma.com.
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