Xencor (XNCR) investor relations material

Key pipeline updates and clinical data outlook

• Anticipates a rapid flow of clinical data starting in the second half of this year, including a pivotal phase I readout for XmAb819 with recommended phase III dose and robust efficacy and tolerability data, followed by additional oncology and autoimmune program updates through 2027.

• XmAb819 is positioned as a potential first commercial product, with dose expansion cohorts in clear cell renal cell carcinoma (CCRCC) and parallel studies in other ENPP3-positive tumors, aiming for pivotal studies as early as next year.

• XmAb541 (Claudin-6) is being evaluated in germ cell and gynecologic tumors, with independent data sets expected by year-end to determine future investment and strategy.

• XmAb942 (TL1A) phase IIb readout is expected in late 2027, targeting best-in-class efficacy and dosing convenience in ulcerative colitis, with a focus on exceeding current placebo-adjusted remission rates.

• XmAb412, a novel bispecific for autoimmune diseases, will enter the clinic in Q3 with first-in-human results anticipated in the first half of 2027, leveraging new XenLock technology for high potency and convenient dosing.

Strategic focus and development approach

• Shift towards advancing wholly owned assets to commercial stage, while maintaining a strong partnering model for technological validation and revenue.

• Parallel development strategy in oncology, rapidly advancing lead indications while exploring additional tumor types for broader market opportunities and potential tumor-agnostic labels.

• Emphasis on monotherapy efficacy before pursuing combination regimens, with flexibility to combine agents when both are internally owned.

• Investment decisions and program prioritization will be driven by near-term clinical data, with a disciplined approach to capital allocation.

• Platform engineering enables bespoke molecule design for specific indications, focusing on safety, potency, and patient convenience, especially in chronic autoimmune settings.

Innovation in bispecifics and combination strategies

• Pursuing AND gate CD28/CD3 T-cell engager combinations to enhance selectivity and therapeutic index, aiming to minimize off-tumor toxicity and broaden efficacy.

• XmAb808 (B7H3/CD28) and XmAb541 (Claudin-6/CD3) combination leverages co-expression on tumor cells for more selective targeting, with dose escalation ongoing.

• XenLock technology enables high-potency, stable bispecifics suitable for subcutaneous administration, supporting expansion into autoimmune and allergic diseases.

• Ongoing partnerships in CD28 and T-cell engager space provide insights and support continued leadership in the field.

• Future pipeline includes preclinical programs using modular toolkit for rapid candidate selection and potential partnering.