Immutep enters into a new collaboration with Merck KGaA,
- Collaboration with Merck KGaA, Darmstadt, Germany to evaluate eftilagimod alpha in combination with bintrafusp alfa
- New investigator-initiated, multicenter, open-label, exploratory phase I / IIa trial in 12 patients previously treated with different solid tumors, called INSIGHT-005
- The first patient is expected to be recruited and dosed for H2 in calendar year 2021
SYDNEY, AUSTRALIA, June 01, 2021 (GLOBE NEWSWIRE) – Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, announces a new collaboration agreement and procurement with Merck KGaA, Darmstadt, Germany for a Phase I / IIa clinical trial in patients with solid tumors, called INSIGHT-005.
The trial will assess the feasibility, safety and efficacy of Immutep’s lead product candidate, eftilagimod alpha (efti or IMP321), when co-administered with bintrafusp alfa (M7824), an investigational immunotherapy based on bifunctional fusion proteins jointly developed by Merck, Darmstadt, Germany and GlaxoSmithKline. Bintrafusp alfa aims to block two immunosuppressive pathways, TGF-β 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 body’s immune system accelerator into three different positions of the cancer immunity cycle. The new trial builds on our knowledge and encouraging data from the INSIGHT trial of efi, also in solid tumors. We are delighted with this new clinical collaboration which allows us to expand and strengthen our relationship with an existing partner in a new and exciting setting, especially at a time when there is increasing awareness and validation of the LAG-3 MHC class II interaction, ”said Marc Voigt, CEO of Immutep.
INSIGHT-005 will be conducted by the Institute for Clinical Cancer Research, at the Krankenhaus Nordwest in Frankfurt, Germany (IKF) as a researcher-initiated trial, with Professor Salah-Eddin Al-Batran as the principal investigator. The study will be conducted 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 Principal Investigator of INSIGHT and INSIGHT-004 and a member of the Clinical Advisory Board of Immutep.
“We are very happy to extend our involvement with Immutep to explore efti in a new combination with bintrafusp alfa. Our experience and knowledge of efti, combined with our extensive national network of more than 500 German clinical facilities, means that we are well equipped to lead the INSIGHT-005 study, ”said Prof. Al-Batran, Principal Investigator of ‘INSIGHT-005.
INSIGHT-005 is expected to take place at 2 clinical sites in Germany. Immutep is financially supporting the trial to be conducted by IKF, and Merck, Darmstadt, Germany is contributing financially to the work related to biomarkers. Subject to regulatory and ethics committee approval, the first patient is expected to be recruited in mid-2021 and the trial is expected to provide the first data in early 2022.
Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutics related to LAG-3 for the treatment of cancer and autoimmune diseases. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and maximize shareholder value. Immutep is listed on the Australian Securities Exchange (IMM) and NASDAQ (IMMP) in the United States.
Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a soluble LAG-3 fusion protein (LAG-3Ig), which is an antigen presenting cell (APC) activator of first order being explored in cancer. and infectious diseases. Immutep is also developing a LAG-3 agonist (IMP761) for autoimmune diseases. Other LAG-3 products, including antibodies for modulating the immune response, are under development by Immutep’s major pharmaceutical partners.
Further information can be found on the company’s website www.immutep.com or by contacting:
Australian Investors / Media:
Catherine Strong, Citadelle-MAGNUS
+61 (0) 406 759 268; [email protected]
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; [email protected]