TolerRx has announced that it has entered into an agreement with Abbott for the manufacturing of TolerRx's TRX4 monoclonal antibody.
Under the terms of the agreement, Abbott will perform scale-up and GMP manufacturing of TRX4 for use in clinical trials, as well as supply commercial-grade material to support regulatory submissions and potential commercial launch.
"With the recent efficacy data with TRX4 in type 1 diabetes and our ongoing clinical trials in subjects with type 1 diabetes and psoriasis, this agreement positions TolerRx to ensure adequate supply of TRX4 for pivotal clinical studies and, if approved, for commercial sale," stated Douglas J. Ringler, V.M.D., President and CEO of TolerRx.
"In this regard, we are delighted to have Abbott, a company with demonstrated experience and expertise in the manufacturing of monoclonal antibody products, as our manufacturer."
"There is synergy between Abbott's experience, capacity, and technical expertise and TolerRx's manufacturing needs," stated Mark O' Mahony, Director of Process Development, Manufacturing and Quality Control for TolerRx.
"We look forward to working with one of the world's leading health care companies as our manufacturer of TRX4."