Patients

Aduro’s current clinical development programs are focused on potential treatments for head and neck cancer and IgA nephropathy.

If you are interested in our ongoing studies in head and neck cancer and/or IgA nephropathy and to find out more, please visit ClinicalTrials.gov for your nearest site contact and location information.

Program

Indication

Trial Number

Trial Name

STING Pathway Activator Programs

ADU-S100/MIW815 Head & Neck Cancer NCT03937141 A Phase 2, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of ADU-S100 (MIW815) Administered Intratumorally in Combination with Pembrolizumab in a First-line Setting to Adults with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

APRIL Pathway Programs

BION-1301 (anti-APRIL) IgA nephropathy NCT03945318 A Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy

ADU-S100

Lead Candidate from the STING Pathway Activator Technology

Aduro is developing ADU-S100, a novel synthetic molecule that activates human STING (Stimulator of INterferon Genes), in collaboration with Novartis. ADU-S100 is being evaluated in a Phase 2 clinical trial in adults with PD-L1 positive recurrent or metastatic head and neck cancer. The trial is evaluating the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting.

BION-1301

Lead Candidate from the APRIL Pathway Technology

BION-1301 is Aduro’s proprietary monoclonal antibody targeting APRIL, which the company is evaluating for the treatment of IgA nephropathy. Preclinical studies have demonstrated that BION-1301 binds to a specifically defined epitope on APRIL, resulting in complete blockade of APRIL-induced receptor activation. Dosing of BION-1301 in non-human primates led to a significant reduction of blood IgA levels and established a favorable safety profile. Preclinical studies demonstrated that hAPRIL transgenic mice produce rising levels of IgA as well as IgA deposits in the kidney. Administration of mouse anti-human APRIL was shown to reduce levels of IgA in both the serum and the kidney. BION-1301 is currently being evaluated in a Phase 1 clinical trial in healthy volunteers and patients with IgA nephropathy.