Local biotech partners with Pfizer and Merck

Biotech News: A clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, Immutep, has signed a Clinical Trial Collaboration and Supply Agreement with Merck and Pfizer for a new clinical study in patients with urothelial cancer, called INSIGHT-005.

An emerging and exciting category of novel medicines, LAG-3 became the third validated checkpoint in March 2022 with the approval of Bristol Myers Squibb’s (BMS) Opdualag (nivolumab/relatlimab combination therapy) by the US FDA for the treatment of metastatic melanoma – with US$84 million in sales in the three months to September 2022 – outstripping expectations for early sales. This approval was quickly followed by European Commission approval in September 2022.

Immutep CEO, Marc Voigt, said “We are very pleased to be deepening our collaboration with Merck and Pfizer through this new [Phase I] study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options.

“INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of efti (eftilagimod alpha) and Bavencio (avelumab) in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy.”

Bavencio, co-developed and co-commercialised by Merck and Pfizer, is a checkpoint inhibitor that works by targeting and blocking a protein called PD-L1 on the surface of certain immune cells, activating the cells to find and kill cancer cells. It is approved in more than 60 countries around the world as a monotherapy for first-line maintenance treatment for adult patients with advanced urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

Efti was previously evaluated in combination with Bavencio via the INSIGHT-004 study in patients with advanced solid cancers, including colorectal, pleural mesothelioma, squamous anal cell, cervical, and gastroesophageal carcinomas. Immutep announced final data from INSIGHT-004 in June 2021, reporting encouraging efficacy signals from the combination with a response rate of 41.7% according to RECIST 1.1.

Under the new Agreement, Immutep and Merck will jointly fund the INSIGHT-005 study. It will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.

Immutep designed the first anti-LAG-3 antibody and licensed it to CoStim Pharmaceuticals in 2012, which was acquired by Novartis in 2014.

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