Trial to Evaluate Drug Combination for treating Solid Tumours

Sydney-based biotech Immutep is collaborating in a Phase I/IIa clinical trial that will be evaluating its lead candidate eftilagimod alpha (efti or IMP321), when given in combination with bintrafusp alfa (M7824), an investigational bifunctional fusion protein immunotherapy being jointly developed by Merck, Darmstadt, Germany and GlaxoSmithKline, for patients with solid tumours. Bintrafusp alfa aims to block two immunosuppressive pathways, TGF-β and PD-L1, while the Australian biotech’s efti activates antigen presenting cells, via the LAG-3 – MHC II pathway.

To be conducted by The Institute of Clinical Cancer Research, at Krankenhaus Nordwest (IKF) in Frankfurt, Germany, INSIGHT-005 will be run as an amendment to the protocol of the ongoing Phase I INSIGHT trial being led by Principle Investigator Professor Dr Salah-Eddin Al-Batran, a member of Immutep’s clinical advisory board.
“Through INSIGHT-005, we plan to explore the effect of releasing the brakes and pushing the accelerator of the body’s immune system in three different positions of the cancer immunity cycle. The new trial builds on our knowledge and the encouraging data from the INSIGHT trial of efti, also in solid tumours. We are excited about this new clinical collaboration which allows us to extend and strengthen our relationship with an existing partner in a new and exciting setting, particularly at a time when there is growing awareness and validation of the LAG-3 MHC class II interaction,” said Immutep CEO Marc Voigt.
“We are very pleased to be expanding our involvement with Immutep to explore efti in a new combination with bintrafusp alfa. Our experience and knowledge of efti, combined with our extensive nationwide network of more than 500 German clinical facilities, means we are well equipped to lead the INSIGHT-005 study,” said Professor Al-Batran, lead investigator of INSIGHT-005.

Immutep is financially supporting the two-centre trial to be run by IKF; and Merck is financially contributing to the biomarker-related work. Subject to regulatory and ethics committee approval, the first patient is expected to be enrolled in mid-2021 and the trial is expected to deliver first data in early 2022.

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