This section highlights FDA-related milestones and regulatory updates for drugs developed by Xencor (XNCR).
Over the past two years, Xencor has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XmAb and XmAb942. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
XmAb - FDA Regulatory Timeline and Events
XmAb is a drug developed by Xencor for the following indication: For the treatment of patients with autoimmune diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XmAb
- Announced Date:
- September 9, 2024
- Indication:
- For the treatment of patients with autoimmune diseases
Announcement
Xencor, Inc. announced four new XmAb® programs in development for the treatment of patients with autoimmune diseases and provided updates from dose-escalation studies evaluating its first-in-class oncology programs, including XmAb819 (ENPP3 x CD3) in patients with advanced clear cell renal cell carcinoma and XmAb808 (B7-H3 x CD28) in patients with advanced solid tumors.
AI Summary
Xencor, Inc. announced exciting updates on its XmAb® programs in development for autoimmune diseases, as well as progress in its first-in-class oncology studies. The company is evaluating XmAb819 (ENPP3 x CD3) in a Phase 1 dose-escalation study for patients with advanced clear cell renal cell carcinoma. Early data from this study shows encouraging antitumor activity with RECIST responses and manageable cytokine release syndrome, suggesting promise for reaching target dose levels later this year.
Additionally, XmAb808 (B7-H3 x CD28) is being tested in a Phase 1 study for patients with advanced solid tumors, including many with metastatic castration-resistant prostate cancer. Preliminary observations include declines in PSA levels during a monotherapy safety run-in phase, and the treatment has been well tolerated. Xencor plans further clinical updates as these oncology programs progress in coming months.
Read Announcement
XmAb942 - FDA Regulatory Timeline and Events
XmAb942 is a drug developed by Xencor for the following indication: For the treatment of cancer and other serious diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XmAb942
- Announced Date:
- April 29, 2025
- Indication:
- For the treatment of cancer and other serious diseases
Announcement
Xencor, Inc announced positive interim results from its first-in-human study of XmAb942, a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD).
AI Summary
Xencor, Inc. announced encouraging interim results from its first-in-human study of XmAb942, an investigational anti-TL1A antibody designed for patients with inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). The Phase 1 study in healthy volunteers showed that single and multiple doses of XmAb942 are well tolerated, with no serious side effects. Pharmacokinetic analysis revealed a human half-life of over 71 days, supporting a 12-week dosing schedule during maintenance treatment. Based on these promising findings, Xencor plans to begin the Phase 2b trial, XENITH-UC, in patients with moderate-to-severe UC in the second half of 2025. These results validate the design goals for a high-potency drug that may improve clinical outcomes and convenience for patients, marking an important step forward in the treatment of IBD.
Read Announcement- Drug:
- XmAb942
- Announced Date:
- October 10, 2024
- Indication:
- For the treatment of cancer and other serious diseases
Announcement
Xencor, Inc. announced that preclinical data on XmAb942 were published in a poster to be presented during United European Gastroenterology (UEG) Week on Tuesday, October 15 in Vienna, Austria.
AI Summary
Xencor, Inc. recently announced that its preclinical data for XmAb942, an investigational anti-TL1A antibody, has been published in a poster. This poster is set to be presented at United European Gastroenterology (UEG) Week in Vienna, Austria, on Tuesday, October 15. XmAb942 is designed to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease by blocking TL1A, a molecule linked to inflammation.
The company highlighted that XmAb942 shows promising in vitro potency and an extended half-life, suggesting that patients could benefit from less frequent dosing compared to older treatments. Xencor expects to begin dosing the first subject in a Phase 1 healthy volunteer study during the fourth quarter of 2024, with early clinical data anticipated in the first half of 2025.
Read Announcement- Drug:
- XmAb942
- Announced Date:
- October 10, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- For the treatment of cancer and other serious diseases
Announcement
Xencor, Inc. announced that XmAb942 on track for first subject dosing in Phase 1 healthy volunteer study in Q4 2024 -
AI Summary
Xencor, Inc. announced that its investigational antibody XmAb942 is on track for first subject dosing in a Phase 1 study with healthy volunteers in the fourth quarter of 2024. XmAb942 is designed to treat inflammatory bowel diseases, such as ulcerative colitis and Crohn’s disease, by blocking TL1A interactions. The antibody shows high potency and an extended half-life, with preclinical studies suggesting superior in vitro activity and pharmacokinetics. In non-human primates, XmAb942 demonstrated a half-life of 23 days, potentially allowing for an eight- to twelve-week dosing schedule. This dosing regimen could improve treatment convenience and patient compliance. The strong early results have increased confidence in XmAb942’s potential to become a next-generation anti-TL1A therapy that offers both improved potency and reduced dosing frequency.
Read Announcement
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