AO-176 is a humanized anti-CD47 IgG2 monoclonal antibody with a potential best-in-class profile among agents in this class. We are advancing the development of AO-176 in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and hematologic malignancies. We are evaluating this therapy both as a monotherapy and in combination with standard therapies.
We are conducting a Phase 1/2 trial for AO-176 in patients with select solid tumors. In this open-label, multi-center, dose escalation trial, we are evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AO-176.
In Phase 1, AO-176 demonstrated encouraging early clinical activity and was well tolerated when administered as a single agent. In this initial clinical trial, we established the recommended dose for Phase 2 development.
Next, we expanded into a Phase 1/2 chemotherapy combination trial. We have begun dosing patients with AO-176 in combination with paclitaxel.
We recently established a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United States and Canada. Under this collaboration, we are expanding our ongoing Phase 1/2 clinical trial further to evaluate AO-176 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. This part of the study will include patients with relapsed, platinum-resistant ovarian cancer, endometrial cancer, and gastroesophageal cancer.
We are advancing AO-176 for the treatment of patients with hematologic malignancies. This is based on the promising preclinical data on AO-176 in myeloma, including models with large tumor burden and hematologic malignancies as well as the encouraging Phase 1 data for AO-176 administered as a single agent for patients with solid tumors.
In our Phase 1/2 clinical trial, we are evaluating AO-176 for patients with relapsed/refractory multiple myeloma. We believe this is the first dedicated clinical trial of a CD47 targeted agent for this disease indication. This open-label, multi-center, dose-escalation Phase 1/2 trial is evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AO-176.
Up to 100 patients whose disease has progressed following at least three prior lines of treatment will be enrolled. In Phase 1, patients enrolled in up to four dose-escalation cohorts will receive AO-176 monotherapy. Next, patients will receive AO-176 in combination with dexamethasone and bortezomib. Then, in Phase 2, patients will receive a recommended dose of AO-176 in combination with dexamethasone and bortezomib to evaluate the safety and preliminary efficacy of this combination.
We understand that patients and caregivers are interested in accessing our investigational therapies prior to approval and outside of the clinical trial setting. We believe that advancing our clinical trials to support regulatory approvals is the best approach in support of patients.
For this reason, we do not offer access to AO-176 outside of a clinical trial and we do not have an Expanded Access Program, which is sometimes also referred to as a compassionate use program.