MEN1112 / Menarini, Oxford BioTherapeutics - LARVOL DELTA

Phase 1b Dose Escalation of 212Pb-ADVC001 and novel 212Pb PET Imaging (TAT-Alpha 2026) - P1/2 | "212Pb-ADCV001 point sources in glass capillary tubes in a water phantom were imaged to determine the system spatial resolution, full width at half maximum (FWHM). Clinical 212Pb-ADVC001 PET imaging of 208Tl gamma pair production confirmed the alpha emission from 212Pb-ADVC001 within PSMA-avid lesions. Phase 2 expansion will assess 212Pb-ADVC001 with novel dosing strategies to optimize clinical outcomes in 3 indications across mCRPC and metastatic hormone-sensitive prostate cancer."

P1 data • Castration-Resistant Prostate Cancer • Dental Disorders • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Xerostomia

[VIRTUAL] MEN1112/OBT357, a first-in-class humanized de-fucosylated monoclonal antibody targeting CD157 positive cells in acute myeloid leukemia and myelodysplastic syndrome (AACR 2021) - P1 | "Importantly, we confirmed in ex vivo experiments, the depletion of these immunosuppressive cells by MEN1112/OBT357. Overall, our data demonstrate that MEN1112/OBT357 is a novel antibody with potent ex vivo activity against blast cells in AML and MDS patients, suggesting a potential contribution of MEN1112/OBT357 in altering the immunosuppressive environment in the bone marrow niche."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FCGR3A

ARMY: Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=71; Terminated; Sponsor: Menarini Group; Trial completion date: Dec 2021 ➔ Apr 2021; Active, not recruiting ➔ Terminated; The Sponsor accepted the iDSMB recommendation to terminate the study due to evidence of unpredictable liver toxicity and meaningful target engagement not translating into any clinical objective response.

Trial completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

ARMY: Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=71; Active, not recruiting; Sponsor: Menarini Group; Recruiting ➔ Active, not recruiting; Trial primary completion date: Mar 2021 ➔ Jun 2021

Enrollment closed • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

ARMY: Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Menarini Group; N=50 ➔ 100; Trial completion date: May 2020 ➔ Dec 2021; Trial primary completion date: Jun 2019 ➔ Mar 2021

Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

CD157: From Myeloid Cell Differentiation Marker to Therapeutic Target in Acute Myeloid Leukemia. (PubMed, Cells) - "The aim of this review is to provide an overview of the immunoregulatory functions of human CD157/BST-1 in physiological and pathological conditions. We then focus on CD157 expression in hematological tumors highlighting its emerging role in the interaction between acute myeloid leukemia and extracellular matrix proteins and its potential utility for monoclonal antibody targeted therapy in this disease."

IO Biomarker • Journal • Review • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology