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Aptevo Therapeutics' Novel Bispecific Antibody Therapeutic APVO436 Shows Broad Activity in Primary Human AML SamplesNew APVO436 Preclinical Data Show Robust T-Cell Engagement and Cytotoxicity in AML Patient Specimens SEATTLE, Dec. 11, 2017 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, today announced that new preclinical data on the Company’s next generation bispecific antibody candidate, APVO436, were presented at the American Society of Hematology (ASH) 59th Annual Meeting in Atlanta, GA, December 9-12, 2017. Aptevo is developing APVO436 for the treatment of acute myeloid leukemia (AML), a form of blood and bone marrow cancer that is characterized by rapid disease progression. While treatments for AML are available, there remains a high unmet medical need for targeted immunotherapies like APVO436, that can potentially treat patients with relapsed or refractory disease, or patients who cannot tolerate traditional chemotherapy. “CD123 is an attractive target for bispecific antibody-based therapies in AML due to its prevalence on AML myeloblasts and leukemic stem cells. With an extended half-life, enhanced potency, and desirable manufacturing properties, APVO436 holds promise as a novel immunotherapeutic molecule in the treatment of AML,” said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. “We have generated a compelling body of preclinical data demonstrating robust T-cell mediated cytotoxic activity with APVO436 in various in vivo and in vitro models, including these latest data showing robust T-cell activation and proliferation accompanied by CD123 cell depletion in AML subject samples. We are excited about the opportunity to advance this next generation of precision-targeted, antibody therapeutic and look forward to commencing Phase 1 development of APVO436 next year.” Aptevo has previously shown APVO436’s ability to induce tumor-specific immune responses and T-cell mediated cytotoxicity in vitro and in vivo through the simultaneous targeting of CD123 (a cell surface receptor highly expressed in several hematological malignancies) and CD3 (a T-cell co-receptor that promotes cytotoxicity). The latest data presented at the ASH annual meeting build on these earlier findings, showing that APVO436 has broad immunotherapeutic activity against primary human AML cells in vitro, suggesting its utility as a potent and selective immunotherapeutic candidate in the treatment of AML. In a series of experiments sponsored by Aptevo and conducted in collaboration with scientists at the Fred Hutchinson Cancer Research Center in Seattle, Washington, APVO436 was shown to:
ADAPTIR Clinical and Preclinical Portfolio:
APVO436 is a bispecific antibody candidate designed to simultaneously target CD123 and CD3 and redirect T-cell cytotoxicity. It was developed based on Aptevo’s proprietary next generation ADAPTIR platform. Focused on generating novel, targeted bispecific antibody-based immunotherapies for cancer and autoimmune diseases, the ADAPTIR platform offers key advantages over other bispecific formats, derived in part from the flexible and modular nature of the ADAPTIR structure. These advantages include: (i) potent biological activity and extended half-life in preclinical studies; (ii) traditional antibody-like manufacturing processes with the potential for extended dosing regimens; (iii) unique properties for redirecting T-cell cytotoxicity (RTCC), including a favorable cytokine release profile and the ability to achieve target-dependent induction of RTCC at low drug concentrations. If these data are confirmed in clinical studies, it could suggest the potential for enhanced safety and tolerability compared to other immuno-oncology approaches. About Aptevo Therapeutics Inc. Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo has a commercial product, IXINITY® coagulation factor IX (recombinant), approved and marketed in the United States for the treatment of Hemophilia B, and a versatile core technology – the ADAPTIR™ modular protein technology platform capable of generating highly-differentiated bispecific antibodies with unique mechanisms of action to treat cancer or autoimmune diseases. Aptevo has two ADAPTIR antibody candidates currently in clinical development and a broad pipeline of novel investigational-stage bispecific antibody candidates focused in immuno-oncology and autoimmune disease and inflammation. For more information, please visit www.aptevotherapeutics.com Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential milestone payments, Aptevo’s outlook, financial performance or financial condition, Aptevo’s technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo’s business or prospects; adverse developments in research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 31, 2017, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo’s expectations in any forward-looking statement. Source: |