ontuxizumab (MORAb-004) / Eisai - LARVOL DELTA

TEM1/endosialin/CD248 promotes pathologic scarring and TGF-β activity through its receptor stability in dermal fibroblasts. (PubMed, J Biomed Sci) - "Our data indicate that TEM1 plays a role in pathologic scarring, with its synergistic effect on the TGF-β signaling contributing to dermal fibroblast activation. Targeting TEM1 may represent a novel therapeutic approach in reducing the morbidity of pathologic scars."

Journal • Fibrosis • Inflammation • TGFB1

An individualized stemness-related signature to predict prognosis and immunotherapy responses for gastric cancer using single-cell and bulk tissue transcriptomes. (PubMed, Cancer Med) - "We developed an individualized stemness-related signature, which can accurately predict the prognosis and efficacy of immunotherapy for each GC sample."

IO biomarker • Journal • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Morphotek Investigation in Colorectal Cancer: Research of MORAb-004 (MICRO) (clinicaltrials.gov) - P2 | N=154 | Terminated | Sponsor: Morphotek | Completed ➔ Terminated; By the sponsor at the end of Stage 1 due to futility.

Monotherapy • Trial termination • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Endosialin/CD248 may be a potential therapeutic target to prevent the invasion and metastasis in osteosarcoma. (PubMed, Oncol Lett) - "Taken together, these results suggest that endosialin may play a role in migration, and may be involved in the metastatic process of OSs. Furthermore, MORAb-004 reduces the motility of OS cells, and suppresses invasion and the development of metastatic lesions."

Journal • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • FN1

Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation. (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: Morphotek; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Oncology • Sarcoma

Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation. (SOURCE) (clinicaltrials.gov) - P2; N=209; Active, not recruiting; Sponsor: Morphotek; Trial primary completion date: Sep 2015 ➔ Dec 2015

Trial primary completion date • Biosimilar • Oncology • Sarcoma

Efficacy study of pharmacokinetic(PK)/pharmacodynamic(PD) relationship of monotherapy MORAb-004 in metastatic melanoma (clinicaltrials.gov) - P2, N=80

Melanoma

Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma (clinicaltrials.gov) - P2; N=81; Active, not recruiting; Sponsor: Morphotek; Trial completion date: Dec 2017 ➔ Jan 2019

Clinical • Monotherapy • Trial completion date • Melanoma • Oncology • Solid Tumor

A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. (PubMed, Cancer) - "Ontuxizumab plus G/D showed no enhanced activity over chemotherapy alone in soft-tissue sarcomas, whereas the safety profile of the combination was consistent with G/D alone."

Clinical • Journal • P1 data • P2 data • Oncology • Sarcoma • Solid Tumor

Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma (clinicaltrials.gov) - P2; N=76; Completed; Sponsor: Eisai Inc.; Active, not recruiting ➔ Completed

Clinical • Monotherapy • Trial completion

A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Ontuxizumab (MORAb-004) in Patients with Chemorefractory Metastatic Colorectal Cancer. (PubMed, Clin Cancer Res) - "No benefit with ontuxizumab monotherapy compared with placebo for clinical response parameters of PFS, OS, or ORR was demonstrated. Ontuxizumab was well tolerated."

Biomarker • Clinical • Journal • Monotherapy • P2 data

Phase 1 trial of ontuxizumab (MORAb-004) in children with relapsed or refractory solid tumors: A report from the Children's Oncology Group Phase 1 Pilot Consortium (ADVL1213). (PubMed, Pediatr Blood Cancer) - "Ontuxizumab administered weekly at 12 mg/kg appears to be well tolerated in children with relapsed or refractory solid tumors. The PK of ontuxizumab does not appear to be significantly different in children compared to adults."

Clinical • Journal • P1 data

Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma (clinicaltrials.gov) - P2; N=76; Active, not recruiting; Sponsor: Eisai Inc.; Trial completion date: Jan 2019 ➔ Jan 2020

Clinical • Monotherapy • Trial completion date