On January 8, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported corporate priorities and 2026 pipeline advancement milestones for its clinical-stage portfolio of novel XmAb drug candidates.
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"Xencor designs proteins that enable potential first-in-class and best-in-class medicines for patients, and we are building on momentum from 2025, when we presented encouraging clinical data from our portfolio of T-cell engagers and TL1A antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "We are excited to be evaluating a pipeline of five wholly owned clinical-stage XmAb drug candidates and have plans this year to begin the first-in-human study of our TL1A x IL23p19 bispecific antibody for development in inflammatory bowel disease."
"Throughout 2026, we plan to present key clinical data and program updates as we advance our oncology programs toward late-stage development and present clinical proof-of-concept data for our autoimmune programs. We are also starting the year with a strong balance sheet to execute our plans, and we look forward to several updates, potential regulatory achievements and milestones across multiple partner programs."
Four Novel XmAb T-Cell Engagers in Solid Tumor Oncology and B-Cell Depletion for Autoimmune Disease
XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). Initial results from an ongoing Phase 1 study in advanced ccRCC indicated that XmAb819 demonstrated evidence of anti-tumor activity and an acceptable safety profile that was generally well tolerated. Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (RECIST v1.1) as best response with a 70% disease control rate. The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-escalation continues. We plan to:
Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) during 2026
Initiate a pivotal study of XmAb819 in ccRCC during 2027
XmAb541 (CLDN6 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced gynecologic and germ cell tumors. In 2025, Xencor presented early efficacy data from a cohort in the ongoing Phase 1 dose-escalation study of XmAb541. Nine patients had received XmAb541 in the most recently completed escalation cohort. Confirmed partial responses (RECIST v1.1) were observed in three patients: one patient with ovarian cancer and two patients with germ cell tumors. We plan to:
Present new clinical data to support a recommended Phase 3 dose in 2H26
Initiate a pivotal study of XmAb541 during 2027
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in development for patients with rheumatoid arthritis (RA). Xencor is evaluating plamotamab in an ongoing Phase 1b proof-of-concept study, for patients with RA who have progressed through prior standard-of-care treatment. We plan to:
Provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in development for patients with idiopathic inflammatory myopathies (IIM). In the fourth quarter of 2025, Xencor initiated a Phase 1 proof-of-concept study of XmAb657 for patients with IIM. We plan to:
Provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26
Two Differentiated, Potentially Best-in-Class Therapeutic Options for Inflammatory Bowel Disease
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Patient enrollment in the study is ongoing. We plan to:
Present final results from the Phase 1 study of XmAb942 in healthy volunteers in 1H26
Provide an update on progress achieved in the XENITH-UC study near year-end 2026
XmAb412 (TL1A x IL23p19), a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. XmAb412 was selected as the lead candidate in 2025. We plan to:
Present preclinical characterization of XmAb412 in 1H26
Initiate a first-in-human study of XmAb412 in 2H26
Preliminary Cash Position and Financial Guidance
Xencor’s broad development portfolio is supported by a strong financial position. Xencor ended the fourth quarter of 2025 with unaudited cash, cash equivalents and marketable debt securities expected to be approximately $611 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2028.
(Press release, Xencor, JAN 8, 2026, View Source [SID1234661856])