tidutamab (XmAb18087) / Xencor - LARVOL DELTA

Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2 | N=4 | Terminated | Sponsor: Xencor, Inc. | Completed ➔ Terminated; The study has been terminated early by the sponsor due to business decision.

Metastases • Trial termination • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor

Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2 | N=4 | Completed | Sponsor: Xencor, Inc. | Recruiting ➔ Completed | N=142 ➔ 4 | Trial completion date: Mar 2024 ➔ Mar 2022 | Trial primary completion date: Dec 2023 ➔ Mar 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

DUET-1: A Study of XmAb®18087 in Subjects With NET and GIST (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Xencor, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Oct 2021

Trial completion • Trial completion date • Endocrine Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Neuroendocrine Tumor • Oncology • Sarcoma • Solid Tumor

[VIRTUAL] Safety, Pharmacodynamic, and Antitumor Activity of Tidutamab, an SSTR2 x CD3 Bispecific Antibody, in Subjects with Advanced Neuroendocrine Tumors (NANETS 2021) - P1 | "Tidutamab was generally well tolerated with disease control in >50% of evaluable NET subjects. Additional studies in other tumors that express SSTR2 are warranted, and poor outcomes in subjects with higher PD(L)-1 expression suggest combinations with checkpoint inhibitors should be considered."

Clinical • IO biomarker • PK/PD data • Anemia • Endocrine Cancer • Fatigue • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Hematological Disorders • Inflammation • Neuroendocrine Tumor • Oncology • Renal Disease • Sarcoma • Solid Tumor • CD4 • SSTR • SSTR2

Tidutamab Induces Best Overall Response of Stable Disease in Advanced Neuroendocrine Tumors (Oncology Nursing News) - P1, N=42; DUET-1 (NCT03411915); Sponsor: Xencor, Inc.; "'Tidutamab was generally well tolerated,' Bassel El-Rayes,...'Transient cytopenias were observed, which is characteristic of CD3 antibody therapy. No treatment-related deaths were observed,' El-Rayes concluded."

Media quote • P1 data

Tidutamab Shows Early Tolerability, Active Immune Profile in Advanced Neuroendocrine Tumors (OncLive) - "Tidutamab (previously XmAb18087) was found to be well tolerated with a best overall response of stable disease in patients with advanced, well-differentiated neuroendocrine tumors (NETs) of pancreatic, gastrointestinal (GI), lung and undetermined origin, according to preliminary data from a phase 1 trial (NCT03411915)...'Tidutamab was generally well tolerated,' Bassel El-Rayes...'Transient cytopenias were observed, which is characteristic of CD3 antibody therapy. No treatment-related deaths were observed,' El-Rayes concluded."

Media quote

Dr. El-Rayes on the Efficacy of Tidutamab in Advanced NETs (OncLive) - "Bassel El-Rayes, MD...discusses the efficacy of tidutamab in advanced neuroendocrine tumors (NETs)....However, some of the stable disease responses were prolonged, indicating that there may be a signal of activity with the agent in this patient population, El-Rayes concludes."

Video

Xencor Presents Clinical Data from the Phase 1 Study of Tidutamab in Neuroendocrine Tumors at NANETS’ Multidisciplinary NET Medical Virtual Symposium (Businesswire) - P1, N=87; NCT03411915; Sponsor: Xencor, Inc; "Xencor, Inc...announced updated clinical data from a Phase 1 study of tidutamab, an SSTR2 x CD3 bispecific antibody, in patients with neuroendocrine tumors...Tidutamab was generally well tolerated at the 0.3/1.0 mcg/kg dose identified for the expansion portion of the study. All 41 patients treated were included in the safety analysis. The most common treatment-related Grade 3 or Grade 4 adverse events across all doses were lymphopenia (29%), gamma-glutamyl transferase increases (20%), transaminase increases (20%) and vomiting (17%)....Grade 3 CRS was observed in two patients (5%) upon the first dose."

P1 data • Neuroendocrine Tumor • Oncology

Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P1b/2; N=142; Recruiting; Sponsor: Xencor, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • MRI

DUET-1: A Study of XmAb®18087 in Subjects With NET and GIST (clinicaltrials.gov) - P1; N=87; Active, not recruiting; Sponsor: Xencor, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Mar 2021 ➔ Oct 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Endocrine Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Neuroendocrine Tumor • Oncology • Sarcoma • Solid Tumor • MRI

Xencor Reports First Quarter 2021 Financial Results (Businesswire) - "XmAb717 (PD-1 x CTLA-4): The Company plans to initiate a Phase 2 study in patients with certain molecular subtypes of castration-resistant prostate cancer (CRPC) in mid-2021; Tidutamab (SSTR2 x CD3): The Company plans to initiate a clinical study in patients with Merkel cell carcinoma and small cell lung cancer...in mid-2021; Plamotamab (CD20 x CD3)...The Company plans to initiate the first of these studies, in patients with r/r DLBCL, an aggressive type of non-Hodgkin lymphoma (NHL), in late 2021 or early 2022; XmAb698 (CD38 x CD3): The Company plans to support investigator-initiated studies of XmAb698 (formerly AMG 424), and a new study is currently being planned to start later in 2021...Xencor earned $12.5 million for the development milestone and recognized royalty revenue of $1.4 million on net sales of Monjuvi® during the first quarter of 2021."

New P2 trial • New trial • Sales • Diffuse Large B Cell Lymphoma • Genito-urinary Cancer • Hematological Malignancies • Merkel Cell Carcinoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer

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

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] Preliminary Safety, PK/PD, and Antitumor Activity of XmAb18087, an SSTR2 x CD3 Bispecific Antibody, in Patients with Advanced Neuroendocrine Tumors (NANETS 2020) - P1 | "Preliminary data indicate XmAb18087 was well-tolerated in NET patients, with dose-dependent T-cell proliferation and disease control in almost half of evaluable patients. Updated data from the expansion cohort will be presented."

Clinical • PK/PD data • Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Neuroendocrine Tumor • Oncology • Sarcoma • Solid Tumor

Clinical Investigation Into Antibody With Activity Against SSTR2 and CD3 Moves Forward (Targeted Oncology) - P1, N=27; DUET-1 (NCT03411915); Sponsor: Xencor, Inc.; "'XmAb18087 induced acute and sustained T-cell activation and proliferation...in peripheral blood and was generally well tolerated at the [0.3 to 1.0 μg/kg] expansion dose,' said Bassel El-Rayes, MD, during a presentation at the North American Neuroendocrine Tumor Society (NANETS) 2020 Multidisciplinary NET Medical Virtual Symposium....'These events may be related to engagement of the somatostatin receptor 2 that has been identified in the gastrointestinal tract,' said El-Rayes..."

Media quote • P1 data

[VIRTUAL] Succinate Dehydrogenase–Deficient GIST: Raising Awareness of an Exceptionally Rare Entity With Unique Treatment and Genetic Implications (CAP 2020) - "No mutations in KIT or PDGFRA genes were identified, which prompted discontinuation of imatinib and initiation of a new clinical trial drug, Xmab18087. While these distinct clinical, gross, and histologic features are often misdiagnosed, they should prompt the GI pathologist and moreover the general surgical pathologist to consider the uncommon diagnosis of SDH-deficient GIST. Furthermore, pathologists should be aware of their unique biologic behavior and possible association with genetic syndromes (ie, Carney triad or Carney-Stratakis syndrome)."

Gastrointestinal Cancer • Gastrointestinal Disorder • Gastrointestinal Stromal Tumor • Hepatology • Oncology • Sarcoma • KIT • PDGFRA

Xencor Presents Initial Data From the Phase 1 Study of Tidutamab in Neuroendocrine Tumors at NANETS’ Multidisciplinary NET Medical Virtual Symposium (Businesswire) - P1, N=87; DUET-1 (NCT03411915); Sponsor: Xencor, Inc; "Tidutamab was generally well tolerated at the recommended dose identified for the expansion portion of the study, a 0.3 mcg/kg priming dose and subsequent 1.0 mcg/kg repeated doses (the 0.3/1.0 mcg/kg dose). All 27 patients treated were included in the safety analysis...CRS was observed in 41% of patients and was limited to Grade 1 and Grade 2 and also to the first two doses....Xencor plans to initiate an additional clinical study in patients with Merkel cell carcinoma and small cell lung cancer, SSTR2-expressing tumor types known to be responsive to immunotherapy, in early 2021."

Cytokine release syndrome • New trial • P1 data • Lung Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer

XmAb18087 Shows Encouraging Preliminary Activity in NETs (OncLive) - P1, N=27; Duet-1 (NCT03411915); Sponsor: Xencor, Inc.; "Preliminary data from the phase 1 Duet-1 study of XmAb18087 (tidutamab), a humanized, anti-somatostatin receptor 2 (SSTR2), anti-CD3 bispecific antibody, demonstrated a disease control rate (DCR) of 43% across dose levels in patients with neuroendocrine tumors (NETs) and a favorable safety profile, supporting further study of the agent, according to Bassel El-Rayes, MD....which will enroll a maximum of 20 patients, and longer follow-up are required to evaluate PFS and the clinical utility of XmAb18087 in this patient population,' El-Rayes concluded."

Media quote • P1 data

Xencor to Present Initial Data from the Phase 1 Study of Tidutamab in Neuroendocrine Tumors at NANETS’ Multidisciplinary NET Medical Virtual Symposium (Businesswire) - P1, N=NA;Sponsor: Xencor, Inc.; "Xencor, Inc…announced that initial data from its ongoing Phase 1 dose-escalation study of tidutamab (XmAb®18087), an SSTR2 x CD3 bispecific antibody, in patients with neuroendocrine tumors (NETs) will be presented during the upcoming North American Neuroendocrine Tumor Society's 2020 Multidisciplinary NET Medical Virtual Symposium....The abstract was also selected to be presented in an oral session...Presenter: Bassel El-Rayes..."

P1 data • Neuroendocrine Tumor • Oncology

Xencor Reports Second Quarter 2020 Financial Results (Businesswire) - "Dr. Dahiyat continued, 'Looking forward to the second half of 2020, we plan to present additional clinical data from our portfolio, including initial data from the Phase 1 dose-escalation study evaluating tidutamab, our SSTR2 x CD3 bispecific antibody in patients with neuroendocrine tumors (NETs). In 2021, subject to potential COVID-19 impacts, we also look forward to initiating additional studies evaluating vibecotamab and plamotamab, as well as new Phase 1 studies for XmAb27564, our IL-2-Fc cytokine candidate for autoimmune disease, and XmAb30819, our ENPP3 x CD3 XmAb 2+1 bispecific antibody for renal cell carcinoma.'"

New trial • P1 data • Neuroendocrine Tumor • Oncology • Renal Cell Carcinoma

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 reports first quarter 2020 financial results (Businesswire) - "...'we continue to anticipate initial clinical results for our first two solid tumor programs in 2020, including initial Phase 1 data from XmAb20717, for which an abstract was accepted to the ASCO20 Virtual Scientific Program, and initial Phase 1 data from XmAb18087 later this year. Across our portfolio, we also look forward to initiating, subject to potential COVID-19 impacts, additional studies evaluating vibecotamab (XmAb14045) and plamotamab (XmAb13676), and we continue to enroll patients in the ongoing Phase 1 studies evaluating these programs'."

Enrollment status • New trial • P1 data • Oncology • Solid Tumor

Xencor reports third quarter 2019 financial results (Businesswire) - "Recent business and clinical highlights and anticipated upcoming milestones: (i) XmAb14045 (CD123 x CD3): A Phase 1 study in patients with relapsed or refractory acute myeloid leukemia is enrolling patients into dose-escalation cohorts. The Company is planning to initiate additional clinical studies evaluating XmAb14045 in 2020; (ii) XmAb13676 (CD20 x CD3): A Phase 1 study in patients with B-cell malignancies is enrolling patients into dose-escalation cohorts. Initial data from the study will be presented at the American Society of Hematology Annual Meeting in December 2019; (iii) XmAb18087 (SSTR2 x CD3): A Phase 1 study in patients with neuroendocrine tumors or gastrointestinal stromal tumors is enrolling patients into dose-escalation cohorts, and initial data are expected in the first half of 2020."

Enrollment status • New trial • P1 data

Xencor reports second quarter 2019 financial results (Businesswire) - "Enrollment in dose-escalation cohorts...[in the] phase 1 dose-escalation study...of XmAb13676 in patients with B-cell malignancies is ongoing, and initial data are expected in the fourth quarter of 2019; Enrollment in dose-escalation cohorts...[in the] phase 1 dose-escalation study...of XmAb18087 in patients with neuroendocrine tumors or gastrointestinal stromal tumors is ongoing, and initial data are expected in the first half of 2020; Enrollment in dose-escalation cohorts...[in the] phase 1 dose-escalation study... of XmAb20717...in patients with advanced solid tumors is ongoing, and initial data are expected in the first half of 2020."

Enrollment status • P1 data

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