Clinical Trials

Aduro’s current clinical development programs are focused on potential treatments for a variety of cancers, including metastatic colorectal and multiple myeloma cancers, 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 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

 B-Select Program

Anti-April/BION-1301 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.

 Personalized LADD® 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-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.

pLADD

Lead Candidate from LADD Technology

Personalized LADD is a second-generation LADD strain exploring the use of neoantigens, or the tumor markers specific to an individual’s cancer and derived from the patient’s own tumor cells. To create a patient-specific pLADD therapy, a physician begins by removing tumor cells from the patient. These cells are analyzed in order to molecularly characterize (sequence) the tumor, including any mutations that are unique to the patient’s own tumor cells. Predictive algorithms for antigen processing are run to identify pertinent tumor antigens. Aduro then creates a LADD strain that includes the patient-specific neoantigens for administration. In pre-clinical models, pLADD has been shown to induce anti-tumor immune responses specific to tumor neoantigens which correlated with longer survival.  pLADD is being investigated in a Phase 1 study in adults with metastatic colorectal cancer that is microsatellite stable (MSS).