bavunalimab (XmAb22841) / Xencor - LARVOL DELTA

XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov) - P1 | N=6 | Terminated | Sponsor: University of California, San Francisco | Trial completion date: Dec 2025 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Apr 2024; Sponsor decision

Checkpoint inhibition • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Melanoma • Oncology • Solid Tumor • BRAF • LAG3 • PD-L1

XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: University of California, San Francisco | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1 | N=46 ➔ 6

Checkpoint inhibition • Enrollment change • Enrollment closed • Metastases • Phase classification • CNS Disorders • Melanoma • Oncology • Solid Tumor • BRAF • LAG3 • PD-L1

Phase Ib/II Study of XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) combination in metastatic melanoma refractory to prior immune checkpoint Inhibitor therapy with and without CNS disease (SITC 2023) - P1/2 | "1. At the time of this abstract submission, Cohort 1 of dose escalation has begun with the first few patients still within the DLT observation window."

Checkpoint inhibition • Metastases • P1/2 data • Melanoma • Oncology • Solid Tumor • CTLA4 • ICOS • LAG3 • PD-1

Phase Ib/II study of XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) combination in metastatic melanoma refractory to prior immune checkpoint inhibitor therapy with and without CNS disease. (ASCO 2023) - P1, P1/2 | "At the time of this abstract submission, Cohort 1 of dose escalation has begun with the first few patients still within the DLT observation window. Clinical trial information: NCT05695898."

Checkpoint inhibition • Metastases • P1/2 data • CNS Disorders • Immune Modulation • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • CTLA4 • ICOS • LAG3 • PD-1

DUET-4: A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Xencor, Inc. | Active, not recruiting ➔ Completed | N=242 ➔ 78 | Trial completion date: Nov 2025 ➔ Feb 2023 | Trial primary completion date: Jun 2024 ➔ Feb 2023

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Anal Carcinoma • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Penile Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Vulvar Cancer • ER • HER-2 • PD-L1 • PGR

XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov) - P1/2 | N=46 | Recruiting | Sponsor: University of California, San Francisco | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Metastases • CNS Disorders • Immune Modulation • Melanoma • Oncology • Solid Tumor • BRAF • LAG3 • PD-L1

XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy (clinicaltrials.gov) - P1/2 | N=46 | Not yet recruiting | Sponsor: University of California, San Francisco

Checkpoint inhibition • Metastases • New P1/2 trial • CNS Disorders • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • BRAF • LAG3 • PD-L1

DUET-4: A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=242 | Active, not recruiting | Sponsor: Xencor, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Monotherapy • Anal Carcinoma • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Penile Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Vulvar Cancer • ER • HER-2 • PD-L1 • PGR

DUET-4: A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors (clinicaltrials.gov) - P1; N=242; Recruiting; Sponsor: Xencor, Inc.; Trial completion date: Mar 2027 ➔ Nov 2025; Trial primary completion date: Sep 2026 ➔ Jun 2024

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Anal Carcinoma • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Penile Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Vulvar Cancer • ER • HER-2 • MSI • PD-L1 • PGR

DUET-4: A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors (clinicaltrials.gov) - P1; N=242; Recruiting; Sponsor: Xencor, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Anal Carcinoma • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Penile Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Vulvar Cancer • ER • HER-2 • MSI • PD-L1 • PGR

DUET-4: A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors (clinicaltrials.gov) - P1; N=230; Not yet recruiting; Sponsor: Xencor, Inc.

Clinical • Combination therapy • Monotherapy • New P1 trial • Anal Carcinoma • Biliary Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Fallopian Tube Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Penile Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer • Vulvar Cancer • ER • HER-2 • MSI • PD-L1 • PGR

Xencor and MD Anderson Enter Strategic Collaboration to Advance Investigational XmAb Drug Candidates (Businesswire) - "Xencor, Inc…and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration to study investigational treatments for patients with a variety of cancer types. The parties will collaborate to design and execute additional clinical studies with Xencor’s portfolio of XmAb® drug candidates, including novel bispecific antibodies and engineered cytokines. Xencor is committing to funding and supporting these studies over an initial five-year term."

Licensing / partnership • Oncology

Simultaneous checkpoint-checkpoint or checkpoint-costimulatory receptor targeting with bispecific antibodies promotes enhanced human T cell activation (AACR 2018) - "We developed optimized bispecific antibody candidates that simultaneously engage PD1 and CTLA4 (XmAb20717), CTLA4 and LAG3 (XmAb22841), and PD1 and ICOS (XmAb23104), that preferentially bind to cells co-expressing the targeted receptors. Each bispecific antibody promoted a unique RNA gene signature suggesting distinct mechanisms of action. These bispecific antibodies demonstrate compelling immune modulatory activity suggesting clinical development is warranted for the treatment of human malignancies."

IO Biomarker • PD(L)-1 Biomarker • Oncology

Xencor reports second quarter 2018 financial results (PRNewswire) - "Initial data from Phase 1 study of XmAb14045 for the treatment of AML and other CD123-expressing hematologic malignancies expected in 2018....Initial data from Phase 1 study of XmAb®13676 for the treatment of B-cell malignancies expected in 2019....Initial data from Phase 1 study of XmAb®18087 for the treatment of neuroendocrine tumors and gastrointestinal stromal tumors expected in 2019...IND filing for XmAb22841...for the treatment of multiple oncology indications, expected in 2018 and initiation of Phase 1 trial expected in 2019."

IND • P1 data • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Gastric Cancer • Hematological Malignancies • Neuroendocrine Tumor • Non-Hodgkin’s Lymphoma • Oncology

Xencor doses first patient in phase 1 study of XmAb22841 for the treatment of patients with advanced solid tumors (Businesswire) - “Xencor, Inc….announced that the first patient has been dosed in a Phase 1 clinical study to evaluate the safety and tolerability of XmAb22841, both as a monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors."

Enrollment open

Xencor reports first quarter 2019 financial results (Businesswire) - P1, N=87; DUET-2 (NCT03517488); Sponsor: Xencor, Inc.; "Initial data from the Phase 1 studies of XmAb13676 (CD20 x CD3) in patients with B-cell malignancies and XmAb18087 (SSTR2 x CD3) in patients with neuroendocrine tumors or gastrointestinal stromal tumors are expected in the second half of 2019...Initiation of a Phase 1 study of XmAb22841 (CTLA-4 x LAG-3) as a monotherapy and in combination with pembrolizumab in patients with select advanced solid tumors is expected in the second quarter of 2019. Initial data from DUET-2, a Phase 1 study of XmAb20717 (PD-1 x CTLA-4) in patients with advanced solid tumors, are expected in the second half of 2019."

P1 data • Trial initiation date