World News: 22:05 GMT Wednesday 15th May 2019. [Aduro Biotech, Inc. via Globe Newswire via SPi World News]
BERKELEY, Calif., May 15, 2019 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today provided an update on its clinical development programs for BION-1301, a first-in-class humanized IgG4 monoclonal antibody that fully blocks APRIL binding to both the BCMA and TACI receptors. “We believe the clinical potential for BION-1301 is rooted in scientific rationale and we will pursue the development of BION-1301 in the IgAN indication, where we believe there is significant opportunity to address unmet patient need. We are pleased to initiate this study as a first step in evaluating BION-1301’s ability to reduce the autoimmune deposition of immune complexes affecting kidney function, and its potential to become a meaningful treatment option for this progressive kidney disease,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “However, with the emergence of transformative therapeutic options for multiple myeloma, we have determined not to continue the current Phase 1/2 study as designed in this setting. Although no objective responses were observed, we believe there is potential for investigator-sponsored trials of BION-1301 in combination with other approved agents, given the excellent tolerability profile and PK-PD data.”
The first cohort of healthy volunteers has been cleared in a Phase 1 multicenter study (see , identifier: NCT03945318) designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BION-1301 in healthy volunteers and adults with IgAN. The study, which will enroll up to 63 healthy subjects and up to 10 subjects with IgAN, will be conducted in three parts: Part 1 is a double-blind, randomized, placebo-controlled, single ascending dose in healthy volunteers; Part 2 is a double-blind, randomized, placebo-controlled multiple ascending dose in healthy volunteers; and Part 3 is an open-label, multiple dose in subjects with IgAN.
“There are currently no approved therapeutic options for IgAN patients. We believe BION-1301’s mode of action may target the production of galactose-deficient IgA as well as the autoantibody response to IgA, two key steps in the disease etiology preceding the formation of immune complexes in the kidney and subsequent loss of renal function,” said Andrea van Elsas, Ph.D., chief scientific officer of Aduro. “In addition to assessing the safety profile and PK-PD relationship of BION-1301 in healthy volunteers and IgAN patients in this study, we are looking to establish proof-of-mechanism.”
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.
Aduro completed the dose escalation portion of its Phase 1/2 study evaluating safety and tolerability in patients with relapsed or refractory MM whose disease had progressed after at least three prior systemic therapies. Results demonstrated that BION-1301 was well tolerated in patients with relapsed or refractory MM across a wide dose range and no DLTs were observed at any dose levels. While 95% target engagement was achieved at peak exposure levels and levels of free APRIL decreased dose-dependently, no objective responses were observed.
Aduro does not intend to proceed to the Phase 2 portion of the ongoing Phase 1/2 study or initiate further company-sponsored studies in the MM patient setting. Aduro is working closely with thought leaders to assess the direction of the BION-1301 MM program, including through potential investigator-sponsored studies.
Two abstracts highlighting data from the Phase 1/2 study will be presented on Monday, June 3 at the 2019 ASCO Annual Meeting in Chicago, IL. Details of the poster presentations are as follows:
To view these and other Aduro abstracts, please visit the ASCO website at .
Globe Newswire: 22:05 GMT Wednesday 15th May 2019
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