“Our newest findings from the data presented at ASH indicate that combining an anti-APRIL antibody such as BION-1301, which inhibits APRIL binding to TACI and BCMA, with a BCMA-targeted therapy may have the potential to augment anti-myeloma activity,” commented Dr.
Moreover, studies showed patient serum levels of APRIL were elevated at all stages of MM investigated, suggesting a role for APRIL in early development and pathogenesis. In addition, APRIL was found to induce production of key chemokines with osteolytic capacity. Blocking APRIL could modulate the tumor microenvironment more broadly, illustrating the potential of BION-1301 as a therapeutic agent for MM, particularly in combination therapies.
“We are encouraged by the data we presented at ASH, which support our ongoing clinical evaluation of BION-1301,” said
Aduro is currently 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.
The abstract, “APRIL Is Significantly Elevated at All Stages of Multiple Myeloma (MM) and Interferes with Anti-BCMA Monoclonal Antibody-Mediated Cytolysis, Supporting the Clinical Evaluation of BION-1301 As a Novel Therapeutic Approach in MM,” was presented in a poster session titled “652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II” and is available online at the ASH Annual Meeting Website.
The abstract, “BION-1301 Blocks APRIL-Induced Anti-Apoptotic Signaling, Immune Suppressive Phenotype, and Chemokine Production Associated with Multiple Myeloma,” was presented in a poster session titled “651. Myeloma: Biology and Pathophysiology, excluding Therapy: Poster I” and is available online at the ASH Annual Meeting Website.
APRIL is a member of the tumor necrosis factor superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with MM and binds to BCMA and TACI to stimulate a wide variety of responses that promote MM growth and survival and suppress the immune system so that the tumor cells are protected and sustained in the bone marrow.
BION-1301 is currently being evaluated in a Phase 1/2 clinical study in patients with relapsed or refractory MM. Aduro also plans to explore BION-1301 as a potential treatment for IgA nephropathy (IgAN). Despite new treatments recently approved in MM, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In prior preclinical studies, Aduro established 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.
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 for the treatment of MM and our ability to advance our drug development programs. In some cases you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” 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, early or preliminary clinical trial results may not be predictive of future results, 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 technologies 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
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