Ipsen and 3BP announce First Patient Dosed in Phase I/II study for first-in-class radionuclide (IPN01087)

Paris (France), 20 Nov 2018 – Ipsen (Euronext: IPN; ADR: IPSEY) and 3BP today announced the first patient has been dosed in a Phase I/II study for the first-in-class radionuclide 177Lu-IPN01087 (formerly known as 3BP-227). IPN01087 is a compound that targets cancer cells in patients with advanced solid tumors which express the Neurotensin Receptor Subtype 1 (NTSR1).

The key objective of the Phase I dose-escalation trial (EUDRACT Number 2017-001263-20) is to evaluate the safety and activity, as well as to identify the optimum systemically-administered dose of radiation to treat patients with any of the following solid tumors expressing NTSR1: pancreatic ductal adenocarcinoma, colorectal cancer, gastric cancer, gastrointestinal stromal tumors, Ewing sarcoma and squamous cell carcinoma of the head and neck. 
 
Alexandre Lebeaut, Executive Vice President, R&D and Chief Scientific Officer, Ipsen, said: “Ipsen is committed to bringing to cancer patients innovative systemic radiation therapy with targeted radiopharmaceuticals. We are pleased to report progress of the development of IPN01087 in this Phase I/II study. Our targeted theranostic approach – which we are advancing in partnership with 3B Pharmaceuticals- provides a novel and exciting potential therapeutic solution for unmet medical needs across a number of solid tumours.” 
 
“This is a great milestone for IPN01087 and for 3B Pharmaceuticals,” said Dr. Ulrich Reineke, Managing Director of 3BP. “We are pleased that the compound is in clinical trials and we remain passionate about systemic radiation therapy and its potential to improve patients' lives.” 
 
 
About IPN01087 IPN01087 is a novel diagnostic and therapeutic (theranostic) product focused on the neurotensin receptor 1 (NTSR1), a protein that is overexpressed in ductal pancreatic adenocarcinoma and potentially other cancers expressing neurotensin receptors, such as colorectal cancer, gastric cancer, gastrointestinal stromal tumors, Ewing sarcoma and squamous cell carcinoma of the head and neck. IPN01087 is a small molecule DOTA-conjugated NTSR1 antagonist (formerly known as 3BP-227) labelled with the radioisotope lutetium-177 (177Lu). A theranostic approach using molecular imaging to identify potential responders will potentially allow more effective treatment of highly underserved patient populations. 
 
About Ipsen Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. Its commitment to Oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €1.9 billion in 2017, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,400 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.