XmAb819 / Xencor - LARVOL DELTA

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) (Businesswire) - "The first dose-expansion cohort in the ongoing Phase 1 study is enrolling patients as dose-escalation continues. Xencor plans to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study in advanced ccRCC during 2027."

New P3 trial • Trial status • Clear Cell Renal Cell Carcinoma

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC) (Businesswire) - "Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025."

P1 data • Clear Cell Renal Cell Carcinoma

Xencor Presents Initial Data for XmAb819, a First-in-class ENPP3 x CD3 Bispecific T-Cell Engager, in Development for Clear Cell Renal Cell Carcinoma (Businesswire) - "The results were presented in a poster at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics....As of the September 19, 2025 data cut-off, 69 patients received XmAb819 across 10 intravenous (IV) dose cohorts and 5 subcutaneous (SC) dose cohorts....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 (PR) as best response (n=5, 4 confirmed PRs and 1 unconfirmed PR), with a 70% disease control rate (DCR, 14/20)....Introduction of a low concentration formulation to be implemented during the first half of 2026."

P1 data • Trial status • Clear Cell Renal Cell Carcinoma

Preliminary Phase 1 safety and antitumor activity of XmAb819, a first-in-class ENPP3 x CD3 bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC) (AACR-NCI-EORTC 2025) - "XmAb819 is safe and well-tolerated at IV doses that induce antitumor activity in patients with advanced ccRCC. A recommended Phase 2 dose has not yet been determined. IV dose escalation continues."

Clinical • IO biomarker • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Xencor Announces Presentation of Initial Phase 1 Dose-Escalation Results of XmAb819 in Clear Cell Renal Cell Carcinoma at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - "Presentation of a dataset from an updated data-cut at the conference will include a detailed safety analysis along with efficacy results from the target dose range when the embargo lifts."

P1 data • Clear Cell Renal Cell Carcinoma

Xencor Reports Second Quarter 2025 Financial Results (Businesswire) - "Clinical Program Updates: Oncology:...(i) Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025....; (ii) A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer, germ cell tumors, and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025."

P1 data • Trial status • Clear Cell Renal Cell Carcinoma • Germ Cell Tumors • Ovarian Cancer

XmAb819-01: Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Xencor, Inc. | Trial completion date: Mar 2027 ➔ Nov 2027 | Trial primary completion date: Apr 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Phase 1, multiple-dose study to evaluate the safety and tolerability of first-in-class XmAb819 (ENPP3 x CD3) in subjects with relapsed or refractory clear cell renal cell carcinoma (ccRCC) (NCT05433) (KCRS 2025) - "Initial evidence of anti-tumor activity in ccRCC has been observed, and tolerability supports continued dose escalation. Trial Schema The dosing period consists of priming, step-up, and target doses."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Clinical Program Updates and 2025 Priorities (Businesswire) - "Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial data at a medical conference during the second half of 2025...The 2+1 multivalent format enables greater selectivity for targeting the tumor-associated antigen CLDN6 over similar Claudin family members, and new preclinical data demonstrating this selectivity were presented in January 2025. A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025."

P1 data • Preclinical • Trial status • Clear Cell Renal Cell Carcinoma • Solid Tumor

Xencor Reports Third Quarter 2024 Financial Results (Businesswire) - P1 | N=95 | NCT05433142 | Sponsor: Xencor, Inc. | "Internal Clinical-Stage Program Updates:...XmAb819 (ENPP3 x CD3): In September 2024, Xencor announced that initial evidence of anti-tumor activity was observed in the ongoing Phase 1 dose-escalation study in patients with advanced clear cell renal cell carcinoma, including RECIST responses, and the duration of treatment for several patients in earlier dose cohorts had extended beyond one year. Cytokine release syndrome remained manageable, no maximum tolerated dose had been reached and the tolerability profile from recent dose cohorts supported continued dose escalation toward target dose levels. Xencor continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of the first dose expansion cohort during the first half of 2025."

Cytokine release syndrome • P1 data • Trial status • Clear Cell Renal Cell Carcinoma

XmAb819, a 2+1 bispecific antibody targeting ENPP3 X CD3 in development for RCC (DAVAGU 2024) - No abstract available.

Clinical Progress Updates in Early-Stage Oncology Programs: XmAb819 (ENPP3 x CD3) and XmAb808 (B7-H3 x CD28) (Businesswire) - "XmAb819: ENPP3 x CD3 bispecific T-cell engager in Phase 1 dose escalation for patients with advanced clear-cell renal cell carcinoma (ccRCC)....The Company continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of the first dose expansion cohort during the first half of 2025. XmAb808: B7-H3 x CD28 bispecific T-cell engager in Phase 1 dose escalation in advanced solid tumors....The Company continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of dose expansion cohorts during the first half of 2025."

P1 data • Trial status • Castration-Resistant Prostate Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

Xencor to Host Research & Development Webcast and Conference Call on Monday, September 9, 2024 (Businesswire) - "Xencor, Inc...announced that management will host a webcast and conference call at 8:00 a.m. ET (5:00 a.m. PT) on Monday, September 9, 2024 to introduce new XmAb programs in development for the treatment of patients with autoimmune diseases and to provide updates on continued progress in dose escalation with 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."

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor Reports Second Quarter 2024 Financial Results (Businesswire) - "Bispecific Antibody Programs Advancing in Internal Clinical Development: XmAb819 (ENPP3 x CD3):...Xencor is advancing through dose-escalation cohorts in an ongoing Phase 1 study, and the Company anticipates reaching target dose levels by year end; XmAb808 (B7-H3 x CD28):...Xencor is advancing through dose-escalation cohorts in an ongoing Phase 1 study, and the Company anticipates reaching target dose levels by year end."

Trial status • Clear Cell Renal Cell Carcinoma • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Xencor, Inc. | Trial completion date: Apr 2026 ➔ Mar 2027

Metastases • Trial completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor Highlights 2023 Corporate Priorities and Provides Portfolio Updates (Businesswire) - "Plamotamab: Xencor plans to...Continue enrolling patients into the Phase 1 subcutaneous dose escalation study; Vudalima: Xencor plans to...Continue enrolling patients into the two Phase 2 clinical studies of vudalimab; XmAb104: Xencor plans to: Continue enrolling patients into the expansion portion of the Phase 1 clinical study; XmAb819: . Xencor plans to...Continue enrolling patients into the Phase 1 dose-escalation study in patients with RCC."

Enrollment status • Genito-urinary Cancer • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

A Phase 1, multiple-dose study to evaluate the safety and tolerability of XmAb819 (ENPP3 x CD3) in subjects with relapsed or refractory clear cell renal cell carcinoma (RCC) (SITC 2022) - P1 | "Research Sponsor: Xencor, Inc. Ethics Approval This study was approved wcg IRB; IRB Tracking Number 20221085."

Clinical • IO biomarker • P1 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor to Present Seven Posters on Multiple Clinical Trials and Research-stage Programs at the SITC Annual Meeting (Businesswire) - "Xencor, Inc... today announced seven poster presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, being held in Boston, November 10-12, 2022....Data from the first patients enrolled in a Phase 2 study of vudalimab, Xencor’s selective PD-1 x CTLA-4 bispecific antibody, plus chemotherapy in patients with metastatic castration-resistant prostate cancer, will be presented in abstract 668."

P1 data • P2 data • Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Xencor, Inc.

New P1 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor Highlights 2022 Corporate Priorities and Portfolio Milestones (Businesswire) - "Expand the Company’s portfolio with the first internally developed XmAb® 2+1 CD3 and XmAb® CD28 bispecific antibodies advancing into Phase 1 clinical studies; XmAb819 (ENPP3 x CD3)...Initiate a Phase 1 study evaluating XmAb819 in patients with RCC in the first half of 2022. XmAb808 (B7-H3 x CD28)...Submit an IND application in the first half of 2022, and initiate a Phase 1 study in patients with advanced solid tumors in the second half of 2022."

IND • New P1 trial • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor Reports Second Quarter 2021 Financial Results (Businesswire) - "Later this year, the Company anticipates initiating new studies of XmAb717 in additional tumor types and plans to announce additional data from the Phase 1 expansion cohorts for prostate cancer and renal cell carcinoma, as well as a cohort with multiple tumor types....XmAb819 is in development for patients with renal cell carcinoma, and the Company plans to submit an investigational new drug (IND) application in 2021 and initiate a Phase 1 study in early 2022."

IND • New P1 trial • P1 data • Oncology • Prostate Cancer • Renal Cell Carcinoma

Xencor Presents Data from Multiple Preclinical XmAb Bispecific Antibody and Cytokine Programs at the AACR Annual Meeting 2021 (Businesswire) - "XmAb Engineered Cytokine Platform; Abstract 1743, 'IL12 heterodimeric Fc-fusions engineered for reduced potency exhibit strong anti-tumor activity and improved therapeutic index compared to native IL12 agents'...Abstract: 1880, 'PDL1-targeted CD28 costimulatory bispecific antibodies enhance T cell activation in solid tumors'...PD-L1 x CD28 was well tolerated in non-human primates and exhibited favorable pharmacokinetics...Abstract: 1860, 'Bispecific claudin-6 x CD3 antibodies in a 2+1 format demonstrate selectivity and activity on human ovarian cancer cells'...data from non-human primate studies demonstrated the candidates were well-tolerated with favorable pharmacokinetic profiles...Abstract: 1831, 'Affinity tuned XmAb® 2+1 GPC3 x CD3 bispecific antibodies demonstrate selective activity in liver cancer models.'"

Preclinical • Oncology

Xencor Presents Data from Multiple Preclinical XmAb Bispecific Antibody and Cytokine Programs at the AACR Annual Meeting 2021 (Businesswire) - "Xencor, Inc...announced the presentation of new data from multiple preclinical XmAb® bispecific antibody programs and its preclinical IL-12-Fc cytokine program at the American Association for Cancer Research (AACR) Annual Meeting, being held virtually April 10-15, 2021...'In 2021, we anticipate submitting an IND for XmAb819, our lead XmAb 2+1 CD3 bispecific antibody targeting ENPP3, and initiating a Phase 1 study in early 2022.'"

IND • New P1 trial • Preclinical • Oncology

Xencor Reports Fourth Quarter and Full Year 2020 Financial Results (Businesswire) - "Internally, early-stage clinical data have guided our decisions to advance several candidates into new studies scheduled for 2021. These include a potentially registrational study to evaluate the chemotherapy-free, triple combination of plamotamab, tafasitamab and lenalidomide for patients with relapsed or refractory DLBCL…'we plan to submit an IND by year-end for XmAb819, an ENPP3 x CD3 bispecific antibody for renal cell carcinoma…In the first half of 2021, the Company plans to initiate a Phase 1b study of XmAb717 for patients with certain molecular subtypes of CRPC, as a monotherapy or in combination depending on the subtype, as these patients represent a high unmet medical need.’"

IND • New P1 trial • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Renal Cell Carcinoma

Arcus Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Operational Highlights (Businesswire) - "Continued to advance our clinical collaboration with AstraZeneca for the conduct of PACIFIC-8, a registrational trial designed to evaluate domvanalimab and durvalumab in Stage 3 non-small cell lung cancer (NSCLC). We expect this trial to start in the second half of 2021...Received IND clearance for AB308...Our Phase 1/1b dose-escalation study for AB308...is designed to quickly establish the safety, pharmacokinetics and pharmacodynamics of AB308 in combination with zimberelimab and could enable the advancement of AB308 into a registrational trial by year-end 2021."

IND • New P1/2 trial • New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology