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Immutep : GlaxoSmithKline Discontinues Phase II Study On Ulcerative Colitis

Immutep Limited (IMMP) said that its licensing partner GlaxoSmithKline plc. (GSK.L,GSK) has discontinued its Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody, GSK2831781, in patients with active ulcerative colitis.

GlaxoSmithKline stopped the trial based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial's Data Review Committee.

However, GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

Meanwhile, Immutep said that its collaboration with GSK remains in place and GSK2831781 continues to be under an exclusive license with GSK.

Immutep noted that GSK2831781 has also been explored in another autoimmune disease beyond ulcerative colitis. It was previously evaluated in a phase I study in patients with psoriasis which showed preliminary evidence of clinical efficacy.

As per the terms of its collaboration agreement with GSK, Immutep is eligible to receive up to a total of 54 million pounds in remaining developmental milestone payments as well as single-digit tiered royalties, if GSK2831781 is commercialised.

Further milestone payments are subject to the continuation of the program, while GSK is responsible for all costs associated with the clinical development and commercialization of GSK2831781.

Immutep stated that the discontinuation of the GSK trial has no impact on the company's three other product candidates all of which have different mechanisms of action, including its lead product candidate eftilagimod alpha. In addition, there is no impact to Immutep's funding capacity for the development of its in-house programs.
Immutep said it remains in a robust operational and financial position with a cash runway beyond the end of calendar year 2022.

GSK2831781 is a depleting anti-LAG antibody that was derived from IMP731 and was licensed to GSK in 2010.

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