Xencor Unveils Preliminary Findings for XmAb819, a Novel ENPP3 x CD3 Bispecific T-Cell Engager Targeting Clear Cell Renal Cell Carcinoma
XmAb819 Clinical Trial Results: XmAb819, a bispecific antibody for advanced clear cell renal cell carcinoma (ccRCC), shows a 25% overall response rate and a well-tolerated safety profile in heavily pretreated patients during a Phase 1 study.
Dose Expansion and Future Plans: The first dose-expansion cohort has been selected, with ongoing dose escalation to determine the recommended Phase 3 dose, aiming to initiate a pivotal study in 2027.
Safety Profile and Adverse Events: The most common treatment-emergent adverse events were mild to moderate, including cytokine release syndrome and rash, with a few cases of Grade 3 events; no Grade 5 events were reported.
Webcast Announcement: Xencor will host a webcast to discuss the initial results, accessible through their website, with a recording available for 30 days.
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Incyte reveals EU authorization for lymphoma treatment developed in partnership with Xencor
Approval of Minjuvi: The European Commission has approved Incyte's drug Minjuvi, in combination with lenalidomide and rituximab, as a late-line treatment for adults with relapsed or refractory follicular lymphoma.
Second Indication: This approval marks the second indication for Minjuvi in the EU, following its conditional approval for use in relapsed or refractory diffuse large B-cell lymphoma.
Xencor Extends Ultomiris Patent to 2028, Anticipates $100M to $120M in Additional Revenue
- Patent Extension: Xencor has been granted U.S. Patent 12,492,253 covering its Xtend™ Fc domain, extending the patent term to December 2028, which is approximately three years longer than the previous patent, ensuring low-single digit royalty income from Ultomiris.
- Potential Revenue Growth: Based on consensus sales forecasts, Xencor anticipates receiving an additional $100 million to $120 million in royalties during the extended patent term, which will support funding for its internal pipeline as it advances in clinical development.
- Strategic Partnership: OMERS has acquired royalties due to Xencor on global Ultomiris sales starting in 2026, with potential annual revenues of up to $35 million, enhancing the company's financial stability as excess royalties revert to Xencor.
- Technological Advantage: Xencor's Xtend antibody half-life extension technology provides new therapeutic mechanisms for its XmAb medicines, driving innovation in cancer and autoimmune disease treatments, aligning with its long-term value creation strategy.