On September 4, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that preclinical data for its first-in-class anti-APRIL antibody BION-1301 was presented at the 5TH European Congress of Immunology in Amsterdam, The Netherlands. Data from the preclinical studies demonstrated that BION-1301 was well-tolerated (Press release, Aduro Biotech, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365988 [SID1234529284]). In addition, pharmacological activity of BION-1301 binding to APRIL (A Proliferation-Inducing Ligand), a ligand for the receptors BCMA (B cell maturation antigen) and TACI (transmembrane activator and cyclophilin ligand interactor), was established in a dose-dependent fashion. The pharmacokinetics (PK) and target engagement biomarkers were used to predict the first-in-human dose. APRIL mediates important B-cell functions including activation, survival and maturation. Serum levels of APRIL are enhanced in patients diagnosed with multiple myeloma (MM) and correlate with a poor prognosis. APRIL in the bone marrow triggers a cascade of events to support human MM to proliferate, survive, induce resistance to standard-of-care drugs in MM cells and provide an immune protective environment.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The pioneering work on the mechanism of action, PK and pharmacodynamics presented today has paved the way for the first clinical evaluation of BION-1301, an ongoing Phase 1/2 trial in patients with multiple myeloma," commented Hans van Eenennaam, Ph.D., executive vice president antibody research and site head, Aduro Biotech Europe.
Aduro is conducting a Phase 1/2 multi-center, open-label study (see www.clinicaltrials.gov, identifier NCT03340883) designed to evaluate the safety and activity of BION-1301 in patients with relapsed or refractory MM whose disease has progressed after at least 3 prior systemic therapies, including immunomodulatory drugs, proteasome inhibitors, chemotherapies, or monoclonal antibodies.
About BION-1301
Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for MM. Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that APRIL plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through BCMA, was shown to be critically involved in the survival, proliferation and chemoresistance of MM, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in MM blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM.