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Aptevo Therapeutics Receives Orphan Drug Designation for APVO436 for the Treatment of Acute Myelogenous Leukemia
SEATTLE, Dec. 06, 2019 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel oncology and
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"SEATTLE, Dec. 06, 2019 (GLOBE NEWSWIRE) -- Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, announced today that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to APVO436, a bispecific antibody candidate intended for the treatment of acute myelogenous leukemia (AML). APVO436 is currently being evaluated in a Phase 1/1b clinical trial in patients with AML and myelodysplastic syndrome (MDS).\n The U.S. Orphan Drug Act is intended to encourage companies to develop safe and effective therapies for the treatment of rare diseases and conditions, specifically those expected to affect fewer than 200,000 people in the United States. Orphan drug designation provides important benefits to companies such as eligibility for a special seven-year period of market exclusivity upon approval, potential tax credits for research, potential grant funding for research and development, reduced filing fees for marketing applications, and assistance with clinical trial protocol review. “We are making steady progress in our ongoing Phase 1/1b clinical trial of APVO436 and are pleased to have been granted orphan drug designation for APVO436, as this designation affords important benefits as we continue to advance APVO436 through clinical development,” said Marvin L. White, President and Chief Executive Officer of Aptevo. “We look forward to providing future updates on the APVO436 clinical development program as additional data from the Phase 1/1b clinical trial becomes available.” About APVO436 APVO436 is an optimized bispecific antibody candidate designed to simultaneously target CD123 and CD3 and redirect T-cell cytotoxicity to the tumor. It is currently being evaluated in a Phase 1/1b open-label, dose-escalation study evaluating safety and pharmacokinetics. APVO436 was built on Aptevo’s proprietary ADAPTIR™ protein therapeutic platform. Focused on generating novel, targeted bispecific antibody-based immunotherapies for cancer 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) achieving potent biological activity and extended half-life while retaining desirable manufacturing characteristics; (ii) abili...