Aptevo Therapeutics, a biotechnology company focused on developing novel immuno-oncology and haematology therapeutics, and Alligator Bioscience, a biotechnology company developing antibody-based pharmaceuticals for tumour-directed immunotherapy, announced the companies have initiated chemistry, manufacturing and control (CMC) activities for the manufacturing of clinical material in preparation for a future investigational new drug (IND) submission for the bispecific immunooncology antibody ALG.APV-527.
Per Norlén, CEO of Alligator Bioscience, said: "With CMC and IND enabling activities underway, our partnership with Aptevo is moving ahead rapidly. 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 tumour directed immunotherapy to the next level. By making the immune activation dependent on binding to a tumour antigen we have created a candidate drug with the potential for improved efficacy and fewer side effects.
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 tumour antigen that directs the immune activation to the tumour area.
Through activation of tumour-specific T cells, 4-1BB is known to enhance the immune response to cancer and is believed to be a promising target for new immunotherapeutic approaches.
The bispecific antibody candidate could potentially be used in the treatment of a broad spectrum of cancers over-expressing the tumour antigen, including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers.
Marvin L. White, President and CEO of Aptevo, said: "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.
“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."
