US-based OncoMed Pharmaceuticals has dosed the first patient in a Phase Ia clinical trial of its anti-DLL4 / VEGF bispecific antibody (OMP-305B83), which is designed to undertake anti-cancer stem cell and anti-angiogenic activity.
Patients with advanced refractory solid tumours are being enrolled in the single-agent Phase Ia open-label dose-escalation trial.
Being conducted at four sites in the US, the trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-DLL4 / VEGF bispecific antibody.
OncoMed chairman Paul Hastings said: "This is the sixth novel product candidate discovered by OncoMed researchers and the second product from our multi-billion dollar collaboration with Celgene to be advanced to the clinic by our development team.
"This antibody leverages the clinical experience gained with our anti-DLL4 antibody, demcizumab, which has demonstrated encouraging early signs of clinical activity in Phase Ib clinical trials."
The bispecific antibody was discovered using the company’s MAbTrap antibody display technology, which helps in the rapid identification of monoclonal antibodies that bind targets with high affinity and specificity.
OncoMed chief medical officer Dr Jakob Dupont said: "The combined inhibition of DLL4 and VEGF with this bispecific has demonstrated robust preclinical activity against a number of solid tumour types.
"In this trial, we look forward to establishing a suitable dose and exploring this antibody’s safety and initial efficacy.
"We also plan to advance this bispecific antibody to Phase Ib trials, in combination with standard of care in select solid tumours."
The antibody is the first programme based on the company’s BiMAb bispecific platform technology, which allows bispecific antibodies with a traditional antibody shape to enter clinical testing.
OncoMed Pharmaceuticals said in preclinical studies its anti-DLL4 / VEGF bispecific antibody showed robust in-vivo anti-tumour efficacy across a range of solid tumour xenografts, including colon, lung and pancreatic cancers, among others.
The trials showed the bispecific antibody delayed tumour recurrence following termination of chemotherapy, and decreased frequency of cancer stem cells.
