Immunovant, HanAll Biopharma's global partner, has begun administering HL161/IMVT-1401, an anti-FcRn monoclonal antibody, to U.S. patients suffering from Graves' ophthalmopathy, as part of its phase 2 clinical trial. Graves' ophthalmopathy is an eye disease resulting in corneal injury and vision loss.
Earlier, the company clinched an out-licensing deal with Roivant Sciences for the new drug candidate HL161. The contract fee alone was $30 million.
HanAll Biopharma will receive separate contract money, research funds, stage-by-stage technological fees, and running royalties by units sold. Fixed royalty stood at $502.5 million (544.4 billion won), research funds at $20 million, and stage-by-stage technological fees at $452.5 million.
Roivant Sciences can exclusively develop, manufacture, receive approval, and sell HL161BKN in the American hemisphere, the European Union, including the U.K. and Switzerland, the Middle East, and North Africa.
After signing the accord, Roivant established Immunovant, a subsidiary specializing in the field of autoimmune diseases, and started conducting global clinical development for HL161/IMVT-1401.
In the phase 2a clinical trial, also known as ASCEND-GO 1, the company plans to give Graves' ophthalmopathy patients a subcutaneous injection of HL161/IMVT-1401 once a week for six weeks to confirm the safety, tolerability and changes in blood autoantibodies.
The company also plans to launch a randomized, dose-ranging phase 2b clinical trial, also known as ASCEND-GO 2, to validate the efficacy of HL161/IMVT-1401.
"Graves' ophthalmopathy is a serious disease accompanied by corneal injury and vision loss," Immunovant COO Sandeep C. Kulkarni, said. "However, there is no treatment approved by the FDA so far, and there are only steroids or surgical treatments with high side effects. IMVT-1401 is expected to have a therapeutic effect for eliminating autoantibodies that cause the disease."
As IMVT-1401 is developed as a self-administering subcutaneous injection method compared with competitive products designed as intravenous products, the company expects it will provide high convenience for patients, Kulkarni added.
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