Xencor Reports Q2 2026 Results and Advances XmAb819, XmAb541 and XmAb942 Clinical Programs
核心洞察
Xencor reported second quarter 2026 financial results, including $51.2 million in revenue and a net loss of $21.7 million, while advancing its wholly owned clinical pipeline.
Phase 1 results for XmAb819 in advanced clear cell renal cell carcinoma (搜索) were accepted for a proffered paper oral presentation at ESMO Congress 2026 in Madrid.
XmAb541 monotherapy showed an approximate 14% overall response rate in ovarian cancer (搜索) and 28% in germ cell tumors (搜索), supporting prioritization of its combination with XmAb808.
Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2026, alongside updates across its wholly owned clinical pipeline. The company highlighted an accelerating cadence of anticipated data readouts in 2027 and beyond, anchored by an upcoming presentation of XmAb819 results at the European Society for Medical Oncology (ESMO) Congress 2026.
"We are excited to present XmAb819 results at ESMO this fall and for other fast-approaching key milestones across our wholly owned clinical pipeline," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Xencor's focus on clinical execution and data delivery is setting us up for an accelerating tempo of anticipated readouts in 2027 and beyond."
XmAb819 Advances Toward Registration in Renal Cell Carcinoma
XmAb819 (ENPP3 (搜索) x CD3 (搜索)) is a potential first-in-class, tumor-targeted, T-cell engaging XmAb 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (搜索) (ccRCC) and other tumors with high ENPP3 expression, including colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma.
Phase 1 results for patients with advanced ccRCC were accepted for a proffered paper oral presentation at ESMO Congress 2026, to be held October 23-27 in Madrid, Spain. The presentation will focus on dose levels in intravenous expansion cohorts under evaluation as recommended Phase 3 doses (RP3D). Xencor remains on track to initiate a registration-enabling study of XmAb819 as a monotherapy in advanced ccRCC during 2027.
Dose escalation of subcutaneous administration in advanced ccRCC is ongoing, with evaluation for further development expected prior to a registration-enabling study. A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open for enrollment in the third quarter of 2026. A sub-study evaluating the combination of XmAb819 and anti-PD1 therapy in patients with advanced ccRCC is also being planned. Additionally, a sub-study for patients with ENPP3 (搜索)+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma began enrollment in the second quarter of 2026.
XmAb541 and XmAb808 Combination Prioritized
Xencor has prioritized the ongoing combination study of XmAb541 (CLDN6 (搜索) x CD3 (搜索)) and XmAb808 (B7-H3 (搜索) x CD28 (搜索)), which provides tumor-targeted co-stimulation through CD28 agonism, after observing moderate anti-tumor activity from early monotherapy data of XmAb541.
"Consistent with our focus on efficient clinical decision-making, we have prioritized the ongoing combination study of XmAb541 and XmAb808, which provides tumor-targeted co-stimulation through CD28 (搜索) agonism, after observing moderate anti-tumor activity from early monotherapy data of XmAb541," said Dahiyat. "CLDN6 (搜索) remains a challenging tumor target, and we hope to expand upon an emerging therapeutic window through the orthogonal targeting provided by XmAb808."
Emerging monotherapy data indicate clinical activity at the putative RP3D (60 mg dosed every 3 weeks) in heavily-pretreated patients, with an approximate 14% overall response rate (ORR) in patients with ovarian cancer (搜索) and an approximate 28% ORR in patients with germ cell tumors (搜索). This supports further evaluation in combination with XmAb808 to provide tumor-targeted CD28 (搜索) agonism and additional T-cell stimulation.
Potential additional anti-tumor activity was observed at doses above 60 mg, but reversible hearing impairment limited XmAb541 drug exposure due to the frequency of dose interruptions and dose reductions. Hearing impairment is potentially on target for CLDN6 (搜索), which is expressed on cochlear hair cells. Cytokine release syndrome (CRS) has been low grade, with no cases of Grade ≥3 CRS reported at any dose level. At the putative RP3D, Grade 1 CRS was reported in approximately 14% of patients and Grade 2 CRS in approximately 17%. No other clinically significant safety signals were observed, and the profile is supportive of future outpatient administration.
Based on monotherapy data, in July 2026 the U.S. FDA granted Fast Track designation to XmAb541 for the treatment of patients with germ cell tumors (搜索) who have relapsed following two or more lines of platinum therapy or were refractory to prior platinum therapy.
At the American Association for Cancer Research Annual Meeting in April 2026, Xencor presented data demonstrating co-expression of CLDN6 (搜索) and B7-H3 (搜索) on high-grade serous ovarian carcinoma cells. Preclinical testing demonstrated that XmAb808 promoted durable T-cell-directed killing of cancer cells with XmAb541, enhanced XmAb541-induced killing by exhausted T cells, and enhanced anti-tumor activity of XmAb541. CLDN6 and B7-H3 have low expression overlap on normal tissues, potentially localizing T-cell co-stimulation to tumor cells.
XmAb942 in Inflammatory Bowel Disease
XmAb942 (Xtend anti-TL1A (搜索)) is a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (搜索) (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC whose disease has progressed after at least one conventional or advanced therapy.
Enrollment expectations continue to support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period in 2H27. The primary endpoint is the percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.
Additional Pipeline and Partnership Developments
XmAb412 (搜索) (TL1A (搜索) x IL23p19), a potential best-in-class, extended half-life bispecific antibody for dual targeting of inflammatory pathways, is in Phase 1 development enrolling healthy participants. XmAb412 is Xencor's first novel bispecific antibody developed using the XenLock platform, and the company initiated a first-in-human study in the third quarter of 2026 with plans to present initial data in 1H27.
Plamotamab (CD20 x CD3 (搜索)), a B-cell depleting bispecific T-cell engager in Phase 1 development for rheumatoid arthritis, and XmAb657 (CD19 x CD3), a B-cell depleting bispecific T-cell engager in Phase 1 dose escalation for idiopathic inflammatory myopathies, systemic scleroderma and Sjögren's disease, are both expected to provide updates in 2H26.
In partnership developments, Xencor announced in July 2026 that it will receive $105 million from Alexion pursuant to a settlement agreement resolving a dispute regarding U.S. royalties from sales of Ultomiris. In May 2026, Zenas BioPharma submitted a biologics license application (BLA) to the U.S. FDA for obexelimab in IgG4-related disease, triggering a $10 million regulatory milestone payment to Xencor in June 2026.
Financial Results
Cash, cash equivalents and marketable debt securities totaled $486.4 million as of June 30, 2026, compared to $610.8 million as of December 31, 2025. Revenue for the second quarter was $51.2 million, compared to $43.6 million for the same period in 2025, primarily milestone revenue from Zenas BioPharma and royalty revenue from Alexion and Incyte.
Research and development expenses were $71.9 million, compared to $61.7 million in the prior-year period, driven by increased spending on pipeline programs. General and administrative expenses were $16.4 million, compared to $15.1 million in 2025. Net loss attributable to Xencor was $21.7 million, or $(0.29) per share, compared to a net loss of $30.8 million, or $(0.41) per share, in the second quarter of 2025.
Based on current operating plans, Xencor expects to end 2026 with between $420 million and $440 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028.