Clinical Trials

Aduro’s current clinical development programs are focused on potential treatments for a variety of indications including melanoma, head and neck cancer, IgA nephropathy, autoimmune and inflammatory diseases, as well as a variety of other solid tumors and lymphomas.

Concurrently, Aduro works with investigators at leading medical institutions to extend our development efforts through investigator-sponsored trials (ISTs).

Program

Indication

Trial Number

Trial Name

 STING Pathway Activator Programs

ADU-S100/MIW815 Multiple tumors NCT02675439 A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection Alone or in Combination With Ipilimumab to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
ADU-S100/MIW815 Multiple tumors NCT03172936 A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection in Combination with PDR001, an investigational anti-PD-1 checkpoint inhibitor, to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
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
BION-1301 (anti-APRIL) Multiple Myeloma  NCT03340883 A Phase 1/2 Open-Label, Multicenter Study of the safety and efficacy of BION-1301 in patients with relapsed or refractory multiple myeloma.

 Additional Programs

pLADD Colorectal Cancer NCT03189030 A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
ADU-1604 (anti-CTLA-4 antibody) Melanoma NCT03674502 A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma

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 1 clinical trial in cutaneously-accessible tumors, including breast, head-and-neck, and renal cell cancers as well as lymphoma and melanoma. The trial is evaluating the ability of ADU-S100 to activate the immune system and recruit specialized immune cells to attack the injected tumor as well as distant metastases.

BION-1301

Lead Candidate from the APRIL Pathway Technology

BION-1301 is Aduro’s proprietary monoclonal antibody targeting APRIL, which the company is evaluating in healthy volunteers 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.