Biotechnology company Immutep (ASX: IMM) has announced a trial collaboration and supply agreement with Merck KGaA and Pfizer Inc.
The agreement allows the emergent biotech company to evaluate a combination of its own lead immunotherapy product candidate “eftilagimod alpha”, also known as “efti” with Avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies.
Merck and Pfizer first announced a strategic alliance to co-develop and co-commercialise Avelumab way back in November 2014, with the antibody undergoing over 30 different clinical programs and seven separate phase 3 trials over the past few years.
According to information obtained from clinicaltrials.gov, a national register of clinical studies operated by the National Library of Medicine, Avelumab is currently being evaluated in the JAVELIN clinical development program and has racked up more than 8,600 patients across more than 15 different tumour types prior to Immutep’s collaboration announced today.
Immutep’s efti is a first-in-class antigen presenting cell (APC) activator which stimulates cancer-fighting T cells, while Avelumab is an anti-PD-L1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells.
According to Immutep, Avelumab has received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC). The antibody treatment is being clinically evaluated across a range of tumour types under a global strategic alliance between Merck and Pfizer.
The collaboration between an emergent biotech company and two of the world’s largest pharmaceutical giants is rather unprecedented and exemplifies the strong commercial interest currently vying to tap into Immutep’s efti product candidate.
Immutep has said that it intends to evaluate the clinical benefits of combining its immune stimulator, eftilagimod alpha, with Avelumab, a PD-L1 blocking mechanism of action.
The medical company is now expected to initiate its clinical trial later this year and has also confirmed that it will carry out further clinical investigations in the foreseeable future.
“We are delighted to have the opportunity to collaborate with Merck KGaA, Darmstadt, Germany, and Pfizer on this Phase 1 clinical trial. We feel that this new collaboration, with these industry leaders, further supports our hypothesis that there is a potentially meaningful therapeutic benefit in combining eftilagimod alpha with a checkpoint inhibitor in the treatment of cancer,” said Marc Voigt, CEO of Immutep.
“This novel combination regimen adds to our clinical development program to further evaluate the potential in different challenging cancers,” said Alise Reicin, Head of Global Clinical Development at EMD Serono, a biopharma business operated by Merck.
From phase 1 to phase 2
The planned clinical evaluation will be an amendment to the existing INSIGHT Phase 1 clinical trial and will evaluate the safety, tolerability and recommended Phase 2 dose of efti when combined with Avelumab.
Immutep’s clinical trial intends to evaluate the clinical benefits of “releasing the brakes and pushing the accelerator of the body’s immune system” at two different positions in the cancer immunity cycle, the company said.
The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany will sponsor the clinical trial within the remit of the existing protocol of the ongoing INSIGHT clinical study.
Furthermore, Immutep has said that Professor Dr Salah-Eddin Al-Batran, will be the lead investigator of the trial, thereby supplementing his existing role as lead investigator of INSIGHT and serving on Immutep’s clinical advisory board.
“This clinical trial will be conducted through an amendment to our existing protocol which will hopefully allow us to commence the clinical trial before the end of the year,” said Dr Al-Batran.