Clinical Trials

Date: 2017-02-13

Type of information: Treatment of the first patient

phase: 1b-2

Announcement: treatment of the first patient

Company: OncoMed Pharmaceuticals (USA - CA)

Product: navicixizumab - anti-DLL4/VEGF bispecific antibody (OMP-305B83)

Action mechanism: bispecific antibody. OncoMed's anti-DLL4/VEGF bispecific antibody is designed to inhibit the function of both DLL4 and VEGF and thereby induce potent anti-tumor responses while mitigating certain angiogenic-related toxicities. It was developed utilizing OncoMed's BiMAb™ bispecific platform technology, which enables the design of bispecific antibodies comparable to traditional monoclonal antibodies but possessing dual target-binding specificity. In preclinical studies OncoMed's anti-DLL4/VEGF bispecific antibody demonstrated robust in vivo anti-tumor efficacy across a range of solid tumor xenografts, including colon, ovarian, lung and pancreatic cancers, among others. Further, in preclinical studies dual inhibition of DLL4 and VEGF appears to exhibit synergistic anti-tumor activity at doses where blockade of either target alone elicited sub-optimal activity.

Disease: ovarian cancer

Therapeutic area: Cancer - Oncology

Country: USA

Trial details: The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread. (NCT03030287)

Latest news:

• • On February 13, 2017, OncoMed Pharmaceuticals announced it has enrolled and dosed the first patient in a Phase 1b clinical trial of its anti-DLL4/VEGF bispecific antibody (OMP-305B83) in combination with paclitaxel in patients with platinum-resistant ovarian cancer. OncoMed's anti-DLL4/VEGF bispecific antibody is designed to have anti-angiogenic, anti-cancer stem cell and immuno-modulatory activity. The Phase 1b multicenter, open-label, dose-escalation and expansion trial is designed to assess the safety, preliminary efficacy, immunogenicity, pharmacokinetics and biomarker effects of the anti-DLL4/VEGF bispecific antibody plus paclitaxel. OncoMed expects to enroll approximately 30 patients with platinum-resistant ovarian cancer (including fallopian tube or primary peritoneal cancers) who have previously received bevacizumab (Avastin®, anti-VEGF) and/or have failed at least two prior therapies. The trial is being conducted at five clinical sites in the United States. In an ongoing Phase 1a dose escalation and expansion study of 51 patients with previously treated advanced solid tumors, OncoMed's anti-DLL4/VEGF bispecific antibody was generally well tolerated with hypertension, headache and pulmonary hypertension being the most common drug related toxicities. Single-agent anti-tumor activity was observed. Two of 46 evaluable patients had a partial response and 12 other patients had a reduction in tumor volume. In the Phase 1a trial, five of eight evaluable patients with ovarian cancer had a reduction in tumor volume and remained on therapy for 129-357+ days. Four of these five patients had previously received bevacizumab.

Is general: Yes