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Antibody potential a 'SIMPLE' fact
ROTTERDAM, The Netherlands—You can never have too many friends, and the same seems to go for business partners, as Shire recently announced yet another partnership in the area of rare genetic diseases.
Shire and biopharmaceutical company arGEN-X, which specializes in discovering and developing human monoclonal antibodies, have entered into an alliance to create novel therapeutic antibody products against multiple targets. The alliance represents the first time the two companies have worked together.
"We are delighted to pioneer human antibodies as novel, first-in-class therapies for rare diseases with a partner of Shire's caliber. Shire's depth of experience in protein-based therapies is the perfect complement to our own discovery capabilities," Tim Van Hauwermeiren, CEO of arGEN-X, said in a press release. "We are confident that our SIMPLE Antibody platform, which consistently delivers antibodies of therapeutic quality against complex targets often intractable with other technologies, will bring significant value to this alliance. We believe this alliance represents an industry first and we are looking forward to an exciting and productive collaboration with Shire."
Per the terms of the agreement, arGEN-X will receive an upfront technology access fee, research funding and preclinical success payments, and will be responsible for the discovery work, as well as preclinical support and providing antibody development candidates for Shire. Shire will gain an option to license promising leads for additional preclinical and clinical development as well as commercialization worldwide, and will also pay arGEN-X fees, milestones and royalties on future product sales. Specific financial details were not disclosed, and no details were released as to how many targets the alliance would focus on, or in which indications.
"As a leader in innovative therapies for rare diseases, Shire is continuing to apply new technologies to address the needs of patients," Philip J. Vickers, senior vice president of research and development at Shire Human Genetic Therapies (HGT), said in a press release. "Monoclonal antibody therapy is an underutilized approach to the treatment of rare diseases, and this novel platform has the potential to bring multiple drug candidates into our early- stage pipeline. Partnerships such as this one with arGEN-X are an important part of our strategy to bring new therapies to those suffering from rare diseases worldwide."
arGEN-X's Superior Immunodiversity with Minimal Protein Lead Engineering (SIMPLE) Antibody platform is based on the active immunization of Camelids—specifically llamas—with target antigens in order to deliver antibody variable regions that are essentially identical to those of human antibodies. According to arGEN-X's site, "active immunization of outbred llamas with human proteins elicits strong, unrestricted IgG responses. The variable regions of such IgGs reveals an extraordinary degree of similarity to their human antibody counterparts." The end result is SIMPLE Antibodies that display "extremely high binding affinities for their targets, translating into high potencies in functional bioassays." With the platform, arGEN-X can generate full-size, human therapeutic antibodies by combining the variable regions with human constant domains.
"arGEN-X's SIMPLE Antibody platform is a rapid, efficient way of identifying multiple different, high-potency human antibodies, even against very complex targets," says Dr. Debbie Allen, senior director of business development for arGEN-X. "Multiple discovery candidates enable you to choose only the best possible lead for development as a therapeutic antibody product. The majority of existing antibody platforms do not give this high degree of lead choice."
Jessica Cotrone, senior director of corporate communications for Shire HGT, says the company has not seen widespread use of such monoclonal antibody technology, which was "very attractive to us."
"There are many possibilities that are aligned with Shire's focus on the orphan disease space, meeting the needs of the specialist physician and pursuing innovative treatment options in areas of high unmet need that deliver value for physicians, patients and the healthcare community," says Cotrone.
Allen adds that arGEN-X expects to see the rare disease market gain more attention as time goes on, "both from antibody companies and from other platform technology players."
"We believe this deal between arGEN-X and Shire is an industry first, but we would not anticipate it being the last, since antibodies have been widely accepted as a valuable class of drug across the entire biopharmaceuticals industry," she says.