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 multiple myeloma. We are evaluating this therapy both as a monotherapy and in combination with standard therapies.
AO-176 Clinical Development for Patients with Solid Tumors
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 and pharmacodynamics, and preliminary efficacy of AO-176.
In Phase 1, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity 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.
Additional information about this trial is available at www.clinicaltrials.gov using the trial identification number NCT03834948.
AO-176 Clinical Development for Patients with Multiple Myeloma
We are advancing AO-176 for the treatment of patients with multiple myeloma in the first dedicated clinical trial of an anti-CD47 antibody for this disease indication. We are expanding into this indication based on the promising preclinical data on AO-176 in myeloma models in large tumors as well as the encouraging Phase 1 data demonstrating safety and evidence of anti-tumor activity when AO-176 is 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. 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.
Additional information about this trial is available at www.clinicaltrials.gov using the trial identification or NCT04445701.
Our next-generation anti-CD47 antibody AO-176 is highly differentiated with a best-in-class profile
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.