Collaboration to evaluate immunotherapy and antibody combination

Biotechnology company Immutep has entered into a clinical trial collaboration and supply agreement with Merck and Pfizer to evaluate the combination of Immutep’s lead immunotherapy product candidate, eftilagimod alpha (‘efti’ or ‘IMP321’), with avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies.

The Phase I clinical trial will 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. 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.

Avelumab has received accelerated approval by the US FDA for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC). It is under further clinical evaluation across a range of tumour types under a global strategic alliance between Merck and Pfizer.

“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 the biopharma business of Merck. “We are eager to assess the opportunity of combining eftilagimod alpha with avelumab to improve patient outcomes.”

“We continue to focus on opportunities to advance combination trials with avelumab, as we believe the pathway to progress in immuno-oncology lies in combination approaches,” said Chris Boshoff, Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. “We look forward to collaborating with Immutep on this clinical trial collaboration, which will help us accelerate and advance treatment options that will potentially benefit more patients.”

The planned clinical evaluation will be an amendment to the existing INSIGHT Phase I clinical trial and will evaluate the safety, tolerability and recommended Phase II dose of efti when combined with avelumab in patients with advanced solid malignancies. Professor Dr Salah-Eddin Al-Batran, the lead investigator of INSIGHT and member of Immutep’s clinical advisory board, will be the lead investigator of the trial.

“We are excited to have the opportunity to sponsor this clinical trial of two complementary mechanisms of action and build upon the existing relationship between IFK and Immutep,” Prof Dr Al-Batran said. “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.”

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