On June 1, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported a new collaboration and supply agreement with Merck KGaA , Darmstadt, Germany for a Phase I/IIa clinical trial in patients with solid tumours, called INSIGHT-005 (Press release, Immutep, JUN 1, 2021, View Source [SID1234583365]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The trial 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), an investigational bifunctional fusion protein immunotherapy being jointly developed by Merck, Darmstadt, Germany and GlaxoSmithKline. Bintrafusp alfa aims to block two immunosuppressive pathways, TGF-ß and PD-L1, while efti activates antigen presenting cells, 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. 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.
INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research, at Krankenhaus Nordwest in Frankfurt, Germany (IKF) as an investigator-initiated trial, with Prof. Dr. 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). Prof. 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 Prof. Al-Batran, lead investigator of INSIGHT-005.
INSIGHT-005 is planned to take place in 2 clinical sites in Germany. Immutep is financially supporting the trial to be run by IKF, and Merck, Darmstadt, Germany 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.