Development Pipeline




Overview

OncoMed has five therapeutic candidates currently in clinical development focused on cancer pathways and immuno-oncology targets. All of the therapeutic candidates in our pipeline were discovered by OncoMed scientists using our in-depth knowledge of cancer biology, antibody engineering and a number of proprietary technologies to aid in ongoing drug discovery, candidate validation and predictive biomarker efforts.

 

Navicixizumab (Anti-DLL4/VEGF bispecific, OMP-305B83)

Navicixizumab, OncoMed's anti-DLL4/VEGF bispecific targets both DLL4 in the Notch cancer stem cell pathway and vascular endothelial growth factor (VEGF) receptors. This antibody is intended to have anti-angiogenic plus anti-cancer stem cell and immunomodulatory activity. In a Phase 1a clinical trial, navicixizumab demonstrated single-agent anti-tumor activity and was safe enough to be administered on a continuous basis. We have initiated two Phase Ib clinical trials to assess the safety, preliminary efficacy, immunogenicity and pharmacokinetics of navicixizumab in combination with standard of care chemotherapy in ovarian and colorectal cancers.

Information on Navicixizumab clinical trials is available here: Navicixizumab ClinicalTrials.gov.

This program is part of OncoMed's collaboration with Celgene Corporation.

Public presentations on navicixizumab Anti-DLL4/VEGF bispecific studies include:

 

Rosmantuzumab (Anti-RSPO3, OMP-131R10)

In 2007, we identified that the R-spondin (RSPO) ligands signal through the LGR receptor family and have since identified antibodies to proteins in this family that modulate RSPO-LGR signaling. RSPO appears to be an oncogenic driver in several tumor types, particularly colon cancer, and is associated with the activation of Wnt signaling and tumorigenesis. Anti-RSPO3 Rosmantuzumab (OMP-131R10) is our lead program for RSPO-LGR, and OncoMed has initiated a Phase 1a/1b clinical study for this first candidate targeting the RSPO-LGR pathway. A proprietary biomarker to prospectively screen patients for expression of RSPO is being developed in conjunction with this clinical program. Anti-RSPO3 has demonstrated activity in preclinical models against a variety of major tumor types, including colon, lung and ovarian cancers.

Information on OncoMed's Rosmantuzumab clinical program is available here: Rosmantuzumab ClinicalTrials.gov.

This program is part of OncoMed’s collaboration with Celgene Corporation.

Public presentations on anti-RSPO3 (OMP-131R10) include:

 

Anti-TIGIT (OMP-313M32)

OncoMed's immuno-oncology discovery and preclinical initiatives includes an anti-TIGIT program under developemnt in collaboration with Celgene Corporation. TIGIT (T-cell immunoreceptor with Ig and ITIM domains) blocks T-cells from attacking tumor cells, similar to the inhibitory protein PD-1. Our anti-TIGIT therapeutic is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. A Phase I clinical trial of our anti-TIGIT candidate is currently enrolling patients. (Press release.)

Information on OncoMed's anti-TIGIT clinical program is available here: OMP-313M32 ClinicalTrials.gov.

Public presentations of data from OncoMed's anti-TIGIT pipeline include:

 

GITRL-Fc trimer

OncoMed expects to file an Investigational New Drug Application for its wholly owned GITRL-Fc trimer in the first half of 2017. GITRL is a member of the tumor necrosis factor (TNF) family of ligands and functions to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor) to enhance T-cell modulated immune responses. OncoMed’s GITRL-Fc agent is engineered using a novel single-gene linkerless GITRL trimer which is designed to enable effective GITR activation and robust anti-tumor immune response.

Public presentations of data from OncoMed's GITRL program include:

 

Vantictumab (Anti-Fzd, OMP-18R5)

Vantictumab targets the Wnt cancer stem cell pathway. In preclinical models, vantictumab reduces cancer stem cell frequency and induces differentiation of tumorigenic cells to cell types that are less tumorigenic and more susceptible to conventional chemotherapy. We have seen strong anti-tumor activity using vantictumab in combination with multiple types of approved therapies in patient-derived xenograft models, including pancreatic, breast, lung, melanoma, hepatocellular, ovarian, colorectal and other cancers. We have also observed synergies preclinically when vantictumab is combined with taxane-based chemotherapies. We believe vantictumab is the first monoclonal antibody designed to inhibit Wnt signaling to enter clinical testing.

OncoMed has conducted two Phase 1b clinical trials of vantictumab in combination with standard-of-care chemotherapy: one in HER2-negative breast cancer (vantictumab + paclitaxel) and one in advanced pancreatic cancer (vantictumab + gemcitabine + Abraxane®).

Information about OncoMed's clinical studies of vantictumab is available here: Vantictumab ClinicalTrials.gov.

Public presentations on vantictumab clinical studies include:

 

Ipafricept (FZD8-Fc, OMP-54F28)

Ipafricept selectively binds Wnt ligands that are activators of Wnt signaling. It is a fusion protein that consists of a portion of the Frizzled 8 receptor from the Wnt pathway fused to the Fc domain of a human IgG1. In multiple preclinical models, ipafricept has shown evidence of strong anti-tumor activity in solid tumors including pancreatic, breast, hepatocellular, ovarian, colorectal and other cancers, and reduction of cancer stem cell frequency, either as a single agent or when combined with approved therapies.

OncoMed has conducted two Phase 1b clinical trials of ipafricept in combination with standard-of-care chemotherapy: one in pancreatic cancer (gemcitabine/nab-paclitaxel + ipafricept) and one in ovarian cancer (carboplatin/paclitaxel + ipafricept). In a Phase 1a clinical trial, ipafricept was well tolerated as a single agent and demonstrated evidence of Wnt pathway modulation and potential early single-agent activity manifested by prolonged stable disease.

Information about OncoMed's clinical trials of ipafricept is available here: Ipafricept ClinicalTrials.gov.

Public presentations of ipafricept data include: