Abbott to manufacture TolerRx 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. Financial terms were not disclosed.

“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 Ringler, president and CEO of TolerRx.

TRX4 is a monoclonal antibody that binds to a receptor found on all mature T cells called CD3, which is involved in normal T cell signaling. TRX4 is believed to inhibit the function of autoreactive T cells, which are important in propagating autoimmune diseases, while inducing regulatory T cell pathways that promote immunological tolerance and inhibit autoreactive disease activity.

TolerRx is currently enrolling subjects in a phase Ib/II trial of type 1 diabetes and a phase Ib trial of moderate to severe psoriasis.