Aduro Biotech Announces the Initiation of a Phase 1/2 Clinical Trial of BION-1301, a Novel Anti-APRIL Antibody, for the Treatment of Multiple Myeloma
December 18, 2017 at 08:00 AM EST
BERKELEY, Calif., Dec. 18, 2017 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced that the first patient in its Phase 1/2 dose escalation and dose expansion clinical trial (see www.clinicaltrials.gov, identifier NCT03340883) has been dosed at Virginia Cancer Specialists in Fairfax, Virginia, the first site in this multi-center trial. The study is designed to evaluate the safety and activity of BION-1301, a humanized anti-APRIL (A PRoliferation-Inducing Ligand) antibody, for adults with relapsed or refractory multiple myeloma.
“Neutralizing APRIL is a differentiated approach in the treatment of multiple myeloma, and it has been shown to inhibit tumor growth and overcome drug resistance in preclinical studies,” said Natalie Sacks, M.D., chief medical officer of Aduro Biotech. “BION-1301 is our wholly-owned novel antibody that has been shown in non-clinical studies to fully block the APRIL-induced signaling cascade at a critical juncture, and we are eager to further characterize its potential activity in the clinic. Until there is a cure for multiple myeloma which remains a debilitating disease, alternative treatments are needed.”
Recently, two datasets on anti-APRIL were presented at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia. Data presented by Yu-Tzu Tai, Ph.D., of the Dana Farber Cancer Institute in an oral session at ASH demonstrate that BION-1301 and its parental antibody blocked APRIL binding to both its receptors BCMA and TACI. Blocking APRIL with BION-1301 (or its parental antibody) not only inhibited proliferation and survival of multiple myeloma cells but it also alleviated drug resistance and immune suppression in preclinical models and cell culture, leading to enhanced anti-BCMA and daratumumab-mediated myeloma cell killing. Additionally, Dr. Tai and her colleagues demonstrated that regulatory T cells in the blood and bone marrow expressed TACI, and that APRIL blockade inhibited their function. Also, John Dulos, Ph.D., director and project team leader at Aduro Biotech, and his team conducted preclinical pharmacokinetic and pharmacodynamic studies indicating BION-1301 was well tolerated and binding of APRIL in preclinical models resulted in decreased IgA, IgG and IgM production in a dose-dependent fashion.
“We know that APRIL sets off a cascade of events that hinders the immune response to multiple myeloma cells, helping the disease escape immune attack. The data presented at ASH indicate that blocking APRIL by targeting BCMA alone may not be sufficient for the treatment of multiple myeloma, as APRIL critically modulates regulatory T cell function via TACI, not BCMA,” said Dr. Tai. “Importantly, BION-1301, as a fully-blocking monoclonal antibody, may have unique efficacy by inhibiting APRIL-induced proliferation of immune system components linked to multiple myeloma progression.”
About Phase 1/2 Trial
About APRIL and BION-1301
About Multiple Myeloma
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for BION-1301 and our technology platforms, our plans, the timing and availability of results of our clinical trials and those of our collaborators, and the potential for eventual regulatory approval of our product candidates. In some cases, you can identify these statements by forward-looking words such as “may,” “believe,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect,” “targeted” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our quarterly report on Form 10-Q for the quarter ended September 30, 2017, which is on file with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release.