XmAb662 / Xencor - LARVOL DELTA

A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Xencor, Inc. | N=210 ➔ 7 | Trial completion date: Sep 2030 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2028 ➔ May 2024; The Sponsor made a business decision to end the study.

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor

Xencor Reports Fourth Quarter and Full Year 2023 Financial Results (Businesswire) - "XmAb541 (CLDN6 x CD3):...During the first half of 2024, Xencor plans to dose the first patient in a Phase 1 dose-escalation study....Xencor has been conducting Phase 1 studies evaluating...XmAb662 (IL12-Fc in solid tumors). In the first half of 2024, Xencor plans to conclude studies of...XmAb662, complete internal data packages, and pause further development of both programs until after assessments of future data from competitor programs in this class and safety and biomarker data from Xencor’s studies."

P1 data • Pipeline update • Trial status • Solid Tumor

A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=210 | Recruiting | Sponsor: Xencor, Inc.

Combination therapy • Metastases • Monotherapy • New P1 trial • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor

Xencor Reports Second Quarter 2023 Financial Results (Businesswire) - "XmAb662 is a potency-reduced interleukin-12 Fc (IL12-Fc) fusion protein engineered to increase anti-tumor activity and immunogenicity in the tumor microenvironment by promoting high levels of interferon gamma secretion from T cells and NK cells. In July 2023, Xencor initiated a Phase 1 study in patients with advanced solid tumors."

Trial status • Oncology • Solid Tumor

Xencor Reports First Quarter 2023 Financial Results (Businesswire) - "...'Two new programs are planned to advance into clinical development this year, XmAb662, our engineered IL12-Fc cytokine, on track to start a Phase 1 study mid-year, and XmAb541, our CLDN6 x CD3 bispecific antibody for ovarian cancer, for which we anticipate submitting the IND by year end'."

IND • New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Xencor Reports Fourth Quarter and Full Year 2022 Financial Results (Businesswire) - "XmAb662 (IL12-Fc): A Phase 1 study in patients with advanced solid tumors is expected to start in mid-2023."

New P1 trial • Oncology • Solid Tumor

Xencor Highlights 2023 Corporate Priorities and Provides Portfolio Updates (Businesswire) - "XmAb662: Xencor plans to...Initiate a Phase 1 study in patients with advanced solid tumors in mid-2023; XmAb541: Xencor plans to...Submit an investigational new drug application (IND) in 2023."

IND • New P1 trial • Oncology • Solid Tumor

Potency reduction and half-life extension of cytokines improves therapeutic index for the treatment of cancer: XmAb662 (IL12-Fc) case study (AACR 2022) - "There is no abstract associated with this presentation."

Clinical • Oncology • IL12A

Xencor Highlights 2022 Corporate Priorities and Portfolio Milestones (Businesswire) - "Execute on development plans for mid-stage XmAb® bispecific antibody programs; Vudalimab (PD-1 x CTLA-4), designed to activate intra-tumoral T cells...Present initial data from the Phase 2 study in mCRPC, in the second half of 2022...Plamotamab (CD20 x CD3), for B-cell malignancies...Present data from Phase 1 expansion cohorts, in the second half of 2022...XmAb662...Submit an investigational new drug (IND) application in 2022, and initiate a Phase 1 study in patients with advanced solid tumors in 2023. Xencor plans to present preclinical data from additional cytokine-Fc programs in 2022."

IND • New P1 trial • P1 data • P2 data • Preclinical • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Prostate Cancer • Solid Tumor

Xencor Presents Data from Multiple Preclinical XmAb Bispecific Antibody Programs and IL-12 Cytokine, XmAb662, at the SITC Annual Meeting (Businesswire) - "IL12 Fc-fusions engineered for reduced potency and extended half-life exhibit strong anti-tumor activity and improved therapeutic index compared to wild-type IL12 agents'...Prior clinical studies have demonstrated IL-12 has significant anti-tumor activity; however, its toxicity has limited its potential. Xencor’s IL-12 program follows the same potency reduction design strategy as the Company’s IL15-Fc fusions in oncology, where reduced potency led to improved pharmacokinetics, pharmacodynamics and safety in preclinical studies. In addition, preliminary clinical data from Xencor’s IL15-Fc program, XmAb306, showed generally good tolerability and robust and sustained immune cell expansion...XmAb662 was selected for further development and demonstrated significant anti-tumor activity in vivo...The Company anticipates submitting an IND application for XmAb662 in 2022."

IND • Preclinical • Oncology

Xencor Reports Third Quarter 2021 Financial Results and Announces Encouraging Preliminary Data from Ongoing Phase 1 Study of Potency-reduced IL15-Fc Cytokine, XmAb306 (Businesswire) - "Preclinical Data Presentations: New data from four preclinical-stage programs, including Xencor’s IL-12-Fc cytokine program, PD-L1 x CD28 bispecific antibody program, TGFβR2 bispecific antibody platform, and bispecific NK cell engager platform, will also be presented at the SITC Annual Meeting."

Preclinical • Oncology

Xencor Reports Third Quarter 2021 Financial Results and Announces Encouraging Preliminary Data from Ongoing Phase 1 Study of Potency-reduced IL15-Fc Cytokine, XmAb306 (Businesswire) - "Portfolio Highlights and Upcoming Data Presentations: The Company plans to submit an IND application for XmAb662, an IL12-Fc cytokine in 2022."

IND • Oncology

[VIRTUAL] IL12 heterodimeric Fc-fusions engineered for reduced potency exhibit strong anti-tumor activity and improved therapeutic index compared to native IL12 agents (AACR 2021) - "Analysis of serum indicated up to 200-fold increases in IFNγ levels. Combined, these data indicate that potency-reduced IL12-Fc retain strong anti-tumor activity, while potentially overcoming safety and tolerability issues related to narrow therapeutic index associated with recombinant native IL12 or IL12-Fc agents."

IO biomarker • Oncology • CD8 • IFNG • IL12A • IL15 • STAT4

Xencor to Present Preclinical Data from Four Preclinical XmAb Bispecific Antibody and Cytokine Programs at the American Association for Cancer Research (AACR) Annual Meeting 2021 (Businesswire) - "Xencor...announced it will present preclinical data on three XmAb® bispecific antibody programs and the IL-12-Fc cytokine program at the American Association for Cancer Research (AACR) Annual Meeting, being held virtually April 10-15, 2021. Abstracts for these poster presentations are now available on AACR’s website."

Preclinical • Oncology

Xencor Reports Third Quarter 2020 Financial Results (Businesswire) - "In the coming weeks, we will present additional clinical data from some of these programs, including updated results from the Phase 1 studies of XmAb20717 at SITC, and vibecotamab at ASH....Tidutamab (SSTR2 x CD3): Xencor plans to initiate an additional clinical study in patients with Merkel cell carcinoma and small cell lung cancer...in early 2021...Xencor plans to initiate additional clinical studies evaluating vibecotamab in 2021....Plamotamab (CD20 x CD3): Patient enrollment continues in the Phase 1 study in non-Hodgkin lymphoma and chronic lymphocytic leukemia, with planned expansion cohorts expected to open in 2021....New data from three preclinical-stage programs, including the IL-12-Fc cytokine program...will also be presented at the SITC Annual Meeting in November 2020....The European Marketing Authorization Application for tafasitamab is currently under review, and MorphoSys expects a decision in the second half of 2021."

Clinical data • European regulatory • New trial • P1 data • Preclinical • Chronic Lymphocytic Leukemia • Lung Cancer • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Small Cell Lung Cancer

[VIRTUAL] Potency-reduced and extended half-life IL12 heterodimeric Fc-fusions exhibit strong anti-tumor activity with potentially improved therapeutic index compared to native IL12 agents (SITC 2020) - "Analysis of serum indicated up to 200-fold increases in IFNγ levels. Conclusions Combined, these data indicate that potency-reduced IL12-Fc retain strong anti-tumor activity, while potentially overcoming safety and tolerability issues related to small therapeutic index associated with recombinant native IL12 or IL12-Fc agents."

IO Biomarker • Oncology • CD8 • IFNG • IL12A • IL15 • IL2RA

[VIRTUAL] Potency-reduced and extended half-life IL12 heterodimeric Fc-fusions exhibit strong anti-tumor activity with potentially improved therapeutic index compared to native IL12 agents (SITC 2020) - "Analysis of serum indicated up to 200-fold increases in IFNγ levels. Conclusions Combined, these data indicate that potency-reduced IL12-Fc retain strong anti-tumor activity, while potentially overcoming safety and tolerability issues related to small therapeutic index associated with recombinant native IL12 or IL12-Fc agents."

IO Biomarker • Oncology • CD8 • IFNG • IL12A • IL15 • IL2RA

Xencor Presents Data from Multiple Preclinical XmAb Bispecific Antibody and Cytokine Programs at the SITC Annual Meeting (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 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).”

Preclinical • Oncology