On August 17, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, and Alligator Bioscience (Nasdaq Stockholm:ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that the companies have initiated CMC activities for the manufacturing of clinical material in preparation for a future investigational new drug (IND) submission for the bispecific immuno-oncology antibody ALG.APV-527 (Press release, Aptevo Therapeutics, AUG 17, 2017, View Source [SID1234520276]).
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ALG.APV-527 was the subject of a collaboration agreement announced by the companies in July 2017. It targets the co-stimulatory receptor 4-1BB and an undisclosed tumor antigen that directs the immune activation to the tumor area. 4-1BB is known to enhance the immune response to cancer through activation of tumor-specific T cells and is believed to be a promising target for new immunotherapeutic approaches. The bispecific antibody candidate could potentially have utility in the treatment of a broad spectrum of cancers over-expressing the tumor antigen, including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers.
"With CMC and IND enabling activities underway, our partnership with Aptevo is moving ahead rapidly," said Per Norlén, Chief Executive Officer of Alligator Bioscience. "Having worked collaboratively to design and engineer ALG.APV-527, we are pleased to now announce its advancement into preclinical development. This bispecific antibody brings tumor directed immunotherapy to the next level. By making the immune activation dependent on binding to a tumor antigen we have created a candidate drug with potential for improved efficacy and fewer side effects."
"The timely progress we are making underscores our respective companies’ expertise in bispecific antibody engineering and we are very excited to begin the next phase of development of ALG.APV-527 and further demonstrate the elegance of our ADAPTIR technology platform," said Marvin L. White, President and Chief Executive Officer of Aptevo. "The robust and flexible nature of our ADAPTIR platform permits the development of bispecific antibodies with different mechanisms of immune system engagement. Because ADAPTIR bispecifics are based on an IgG backbone, they have excellent stability and manufacturing characteristics, with traditional monoclonal antibody-like manufacturing properties – a key differentiator from other bispecific constructs. As an emerging class of new therapeutics, bispecific antibodies may offer important technological advancements over traditional monoclonal antibodies, including the potential for more precise targeted therapy through enhanced functionality, potency and efficacy. We look forward to advancing ALG.APV-527 towards IND submission and to further validating the utility of our ADAPTIR protein therapeutic platform."