Ipsen and 3BP announce First Patient Dosed in Phase I/II study for first-in-class radionuclide (IPN01087)
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.”
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.
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.
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.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words "believes", "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2017 Registration Document available on its website (www.ipsen.com).
For further information :
Vice President, Corporate External Communications
+44 (0) 1753 627733
Director, Corporate External Communications
+33 (0) 1 58 33 58 96
Vice President, Investor Relations
+44 (0) 1753 627721
Investor Relations Manager
+33 (0)1 58 33 51 04
Dr. Jan Michel
Director Finance & Corporate Development
Tel: +49 30 63924317
Mob: +49 176 15151101
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
The Current RPA Approach is Broken, It’s Time for a People1st Approach13.12.2018 09:42 | Pressemelding
Businesses are still struggling to understand where and how to start Robotic Process Automation (RPA). This was also a key finding of the first-of-a-kind global research by Softomotive into RPA for Growth Companies conducted by KS&R. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181213005261/en/ The Softomotive People1st Approach puts People before Robots. (Photo: Business Wire) “Despite uncertainty about which are the best processes to start automating, conventional wisdom is still typically to start with a big bang approach with high upfront investments associated with software, hardware and consulting, which carries more project risk, is more rigid and is less innovative, “said Marios Stavropoulos, CEO and co-founder of Softomotive, “In whichever currency you work in, it simply does not add up any longer. This has led some of our customers to say that there must be a better way to RPA rather than doing the same old thing
Adnuntius Enriches Geotargeting Capabilities With Digital Element’s IP Intelligence Solution13.12.2018 09:02 | Pressemelding
Digital Element, the global IP geolocation data and services provider, has today announced that specialist online advertising and marketing platform, Adnuntius, has chosen its NetAcuity PulseTM technology to improve targeting capabilities for its global publishing and marketing clients. Adnuntius provides a holistic solution for data utilisation, programmatic buying and selling, and effective ad serving to clients internationally. By deploying Digital Element’s NetAcuity Pulse IP intelligence, Adnuntius will achieve the highest level of geotargeting available for its clients, right down to a hyper-local postcode level. The identification of connection type and speed, mobile carrier and internet service provider also helps Adnuntius’ clients to effectively build highly accurate targeting profiles. “We enable publishers and marketers to reach the right audience with the right ad in the right context,” commented Stian Remaad, CEO and Co-Founder Adnuntius. “When a user goes to a webpage us
Entersekt Gains Early Certification for E-Commerce Authentication Solution13.12.2018 08:00 | Pressemelding
Entersekt, an innovator in mobile-first fintech solutions, today announced that it has gained EMVCo certification for its 3-D Secure 2 access control server. EMVCo is a payments industry consortium managing global specifications for secure card-based e-commerce transactions. Entersekt has offered a 3-D Secure access control server (ACS) for many years. Its mobile-optimized solution was among the first to be accredited by Visa, Mastercard, and American Express. It has proved popular among consumers in Europe and South Africa, who continue to enjoy the password-free, one-touch experience it makes possible. “Several years ago, Entersekt was the first company in Africa to earn accreditation for its ACS from all three of the big card networks,” recalled Entersekt’s SVP products Niel Bester of an early milestone in the company’s history. “This time around, with 3-D Secure 2, I’m pleased to see we are not only the first in Africa but fifteenth in the world. Congratulations, team, this yet aga
Traxens Trials Internet-of–Things (IoT) Network in a Port Environment for the First Time at MSC Terminal Valencia13.12.2018 08:00 | Pressemelding
Traxens, a company providing high-value data and services for the supply chain industry, today announces that it is collaborating with MSC Mediterranean Shipping Company, a global leader in transportation and logistics, on a pilot IoT project in the Port of Valencia, Spain, aimed at improving the operational efficiency of the port. Specifically, Traxens co-operates on this project with MSC Terminal Valencia and the Port Authority at the Port of Valencia, and Fundacion Valenciaport (FVP). The trial started in September 2018. As part of the pilot project, MSC Spain trucks have been equipped with Traxens’ dedicated IoT devices, allowing for near real-time tracking of movement of vehicles. This can help port authorities to predict and manage potential congestions, as well as to anticipate truck arrivals at the gates. Overall operational efficiency is therefore expected to significantly improve due to easy monitoring of on-site road activity, improved fleet management as well as pre- and po
Energy Observer Vessel Fitted with Oceanwings® Wingsails, the Solution Devised by VPLP and CNIM to Decarbonize Maritime Transport13.12.2018 07:52 | Pressemelding
Energy Observer , the first hydrogen-powered vessel aiming to achieve energy self-sufficiency, with zero greenhouse gas and fine particle emissions, has been equipped with Oceanwings ® wingsails. This hybrid propulsion system consisting of a composite mast 12m high and two sails of 32m², will reduce the craft's energy spending. Designed by VPLP Design, Oceanwings ® wingsails are jointly developed and manufactured in CNIM's industrial facilities in La Seyne-sur-Mer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181212005969/en/ (Photo: Business Wire) Installation of Oceanwings® on board Energy Observer is a first step towards reducing the environmental impact of global shipping. Inspired by the rigid sails of the America's Cup, this technology allows energy savings of between 18 and 42% depending on the vessel. A significant figure when it is recalled that 90% of all world trade transits by sea. Some 50,000 ships are therefo
c-LEcta: Successful Transformation into a Product Company in 2018 with a Promising Outlook for 201913.12.2018 07:00 | Pressemelding
c-LEcta, a globally active biotechnology company with technology leadership in enzyme engineering and bioprocess development for regulated markets such as the food and pharmaceutical industries, continued its successful development towards becoming a product company in fiscal year 2018. Successful products marketed by c-LEcta itself such as DENARASE ® contributed to this development. The company also actively advanced the expansion of its corporate structures to support its current growth course and successfully exploit future market potentials. For c-LEcta, the end of fiscal year 2018 has been marked by successful transformation. The company is going through a development process from a project company into a product company to better exploit existing market potentials in the food and pharmaceutical industries, and to continue its strong growth. Project business activities as a service business in contract research were completely discontinued last year on strategic grounds. This step