Navicixizumab (OMP-305B83) is an anti-DLL4/VEGF bispecific antibody designed to inhibit both Delta-like ligand 4 (“DLL4”) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (“VEGF”) and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities.
On January 13, 2020 Mereo BioPharma Group plc (Mereo) and Oncologie, Inc. announced a global licensing agreement under which Oncologie has received an exclusive worldwide licence to develop and commercialize navicixizumab. Oncologie will be responsible for all future research, development and commercialization of navicixizumab. Mereo has received an upfront payment of $4 million with an additional payment of $2 million conditional on a CMC (Chemistry, Manufacturing and Controls) milestone. Additionally, Mereo will be eligible to receive up to $300 million in future clinical, regulatory and commercial milestones, tiered royalties ranging from the mid-single-digit to sub-teen percentages on global annual net sales of navicixizumab, as well as a negotiated percentage of sublicensing revenues from certain sublicensees.
In a Phase 1a clinical trial in 66 patients, navicixizumab demonstrated single-agent anti-tumor activity and was safe enough to be administered on a continuous basis.
We are currently completing a Phase 1b clinical trial with navicixizumab in combination with paclitaxel in patients with heavily pre-treated platinum-resistant ovarian cancer. Ovarian cancer remains a deadly malignancy because most patients develop recurrent disease that is resistant to chemotherapy, including platinum.
Public presentations of studies on navicixizumab include:
- A Phase 1b Study of Navicixizumab & Weekly Paclitaxel in Heavily Pre-Treated Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer - ESMO 2018
- A first-in-human phase 1a study of the bispecific anti-DLL4/anti-VEGF antibody navicixizumab (OMP-305B83) in patients with previously treated solid tumors - Investigational New Drugs, Sep 19 2018
- A First-in-Man Phase 1a Study of the Bispecific Anti-DLL4/Anti-VEGF Antibody OMP-305B83 in Patients with Previously Treated Solid Tumors - EORTC-NCI-AACR 2016
- Co-Targeting of Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF) with Programmed Death 1 (PD1) blockade inhibits tumor growth and facilitates anti-tumor immune responses - SITC 2015
- Dual targeting of the DLL4 and VEGF pathways with a bi-specific monoclonal antibody inhibits tumor growth and reduces cancer stem cell frequency - AACR-NCI-EORTC 2015