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

Regulatory News:

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.

About 3BP

3B Pharmaceuticals GmbH (3BP) is a German biotechnology company developing a pipeline of targeted radiopharmaceuticals to serve major unmet therapeutic and diagnostic needs of patients with cancer. All development candidates are exclusively derived from internal discovery efforts and aimed at theranostic combinations based on the same targeting molecule.

As a leader in peptide discovery and optimization, 3B Pharmaceuticals GmbH (3BP) has built a technology platform extending from hit identification to early clinical development. Technologies are applied to both collaborative R&D and in-house projects.

3BP was founded in 2008 by a team of renowned experts in peptide drug discovery and nuclear medicine from Berlin, Berne and Basel. Following a buyout of Jerini AG's R&D assets the company became operative in 2009 and is based in the southeast of Berlin.

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Contact information

For further information :
Ipsen

Media
Ian Weatherhead
Vice President, Corporate External Communications
+44 (0) 1753 627733
ian.weatherhead@ipsen.com

Fanny Allaire
Director, Corporate External Communications
+33 (0) 1 58 33 58 96
Fanny.allaire@ipsen.com

Financial Community
Eugenia Litz
Vice President, Investor Relations
+44 (0) 1753 627721
eugenia.litz@ipsen.com

Myriam Koutchinsky
Investor Relations Manager
+33 (0)1 58 33 51 04
myriam.koutchinsky@ipsen.com

3B Pharmaceuticals

Dr. Jan Michel
Director Finance & Corporate Development
Tel: +49 30 63924317
Mob: +49 176 15151101
E-mail: jan.michel@3b-pharma.com