Immunotherapy company Immutep (ASX:IMM) has announced a new collaboration and supply agreement with German company Merck for a Phase 1/2a clinical trial in patients with solid tumours.
The trial, called INSIGHT-005, will evaluate the feasibility, safety and efficacy of Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), when given in combination with bintrafusp alfa (M7824).
M7824 is an investigational bifunctional fusion protein immunotherapy being jointly developed by Merck and GSK.
Bintrafusp alfa aims to block two immunosuppressive pathways, TGF-β and PD-L1, while efti activates antigen-presenting cell via the LAG-3 – MHC II pathway.
“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," said Immutep CEO Marc Voigt.
"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.”
INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research, at Krankenhaus Nordwest in Frankfurt as an investigator-initiated trial with Professor Salah-Eddin Al-Batran as lead investigator.
The study will be run as an amendment to the protocol of the ongoing Phase I INSIGHT trial as the fifth arm (Stratum E). Professor Al-Batran is also the lead investigator of INSIGHT and INSIGHT-004 and a member of Immutep’s clinical advisory board.
“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.
Immutep is financially supporting the trial to be run by IKF. 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 the first data in early 2022.