Clinical Trials

Aduro’s current clinical development programs are focused on potential treatments for a variety of indications within and outside of oncology, including melanoma, head and neck cancer, multiple myeloma, 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

APRIL Pathway Programs

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 B-select Technology

BION-1301 is Aduro’s proprietary monoclonal antibody targeting APRIL, which the company is evaluating in patients with multiple myeloma. Preclinical studies demonstrated that BION-1301 halts tumor growth, overcomes drug resistance to standard-of-care agents such as lenalidomide and bortezomib, and relieves immunosuppression. BION-1301 is currently being evaluated in a Phase 1/2 clinical trial.