miRagen Therapeutics announced an agreement under which miRagen gains exclusive rights to develop and commercialize therapeutic antibodies targeting IGF-1R incorporating Xtend™ Fc technology from Xencor. This clinically validated technology provides for improved antibody half-life, which miRagen intends to leverage in its product candidate VRDN-002 to reduce dose and/or dosing frequency. The Company expects to file an IND for VRDN-002 by the end of 2021.
“We are excited to leverage the Xtend technology in our next-generation IGF1R antibody program VRDN-002.” said Jonathan Violin, Ph.D., President and Chief Operating Officer of miRagen. “We believe that Xtend-enabled half-life extension will facilitate our efforts to reduce dose and/or dose frequency of VRDN-002 to achieve a convenient subcutaneous injection product, and that these features will provide a valuable new option for patients suffering from Thyroid Eye Disease.”
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miRagen is developing multiple product candidates to treat patients who suffer from thyroid eye disease (TED). The Company’s most advanced product candidate is intravenous VRDN-001, which pending feedback from the Food and Drug Administration, may be able to proceed directly to a phase 2 trial. VRDN-002 is a second-generation product candidate, distinct from VRDN-001, which incorporates half-life extension technology and is intended for subcutaneous administration. The Company expects in 2021 to file Investigational New Drug (IND) applications for both VRDN-001 and VRDN-002 and to initiate a Phase 2 clinical trial of VRDN-001.
Under the terms of the exclusive license agreement, miRagen will be solely responsible for the activities and costs related to research, development, and if successful, the potential commercialization of product candidates incorporating technologies licensed from Xencor. Xencor will receive an upfront payment, payable in shares of common stock of miRagen, and is eligible to receive certain development and commercial milestone payments, as well as royalties.