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Ipsen enters into a licensing agreement with 3B Pharmaceuticals to develop novel radiopharmaceuticals in oncology

On February 17, 2016 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biotechnological group, and 3B Pharmaceuticals GmbH (3B Pharmaceuticals), a German private life sciences company focusing on targeted radiopharmaceutical drugs and diagnostics for oncology indications, reported the signature of an exclusive license agreement for novel radiopharmaceuticals in oncology (Press release, Ipsen, FEB 17, 2016, View Source [SID:1234509084]).

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Ipsen acquires exclusive worldwide rights to develop and commercialize novel radiopharmaceuticals targeting the neurotensin receptor. Ipsen will focus on the development of the lead program currently in preclinical development for the treatment of pancreatic adenocarcinoma and potentially other oncology indications.

Claude Bertrand, Executive Vice president R&D, Chief Scientific Officer at Ipsen stated: "Ipsen is very pleased to enter into an agreement with 3B Pharmaceuticals. This program is fully aligned with our strategy to strengthen our pipeline in niche oncology indications as well as in the field of radiopharmaceuticals following our recent acquisition of OctreoPharm GmbH."

Ulrich Reineke, Managing Director of 3B Pharmaceuticals, added: "We are very pleased to enter into this agreement with Ipsen, a company with a strong commitment to radiopharmaceuticals. This agreement emphasizes the growing importance of nuclear medicine in targeted cancer therapy, and we hope that the neurotensin receptor-targeting radiopharmaceuticals will improve the lives of seriously ill cancer patients."

Under the financial terms of the agreement 3B Pharmaceuticals will receive a licensing upfront payment and is eligible to receive development and regulatory milestones of up to 82 million Euros for several indications as well as tiered royalties on world-wide annual net sales of products developed and commercialized by Ipsen.

bluebird bio Announces First Patient Treated with bb2121 in CRB-401 Phase 1 Study in Patients with Relapsed/Refractory Multiple Myeloma

On February 17, 2016 bluebird bio, Inc. (Nasdaq:BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported treatment of the first patient in a Phase 1 study of its product candidate bb2121 in patients with relapsed/refractory multiple myeloma (Press release, bluebird bio, FEB 17, 2016, View Source [SID:1234509080]).

bb2121 is a chimeric antigen receptor T cell (CAR T) therapy targeting B cell maturation antigen (BCMA), and bluebird bio is developing bb2121 in collaboration with Celgene Corporation. bluebird bio also announced today that Celgene has exercised its option to exclusively license bb2121, under the terms of the collaboration agreement between the two companies.

"bb2121 is bluebird bio’s first oncology program to enter the clinic, and the treatment of this first patient marks an important milestone for us as we build a broad, fully integrated T cell immunotherapy franchise," said Nick Leschly, chief bluebird. "We are pleased that Celgene has exercised their option to license bb2121. We believe our combined manufacturing, development and commercial expertise will enable us to rapidly advance bb2121 through clinical trials."

"Despite many recent advances in the field, multiple myeloma remains incurable, with almost all patients becoming refractory to therapy eventually," said James N. Kochenderfer, M.D., National Cancer Institute, an investigator for the CRB-401 study. "BCMA is one of the most exciting targets in multiple myeloma, and we are eager to explore the potential of bb2121 to become an important new treatment option for patients living with multiple myeloma."

bluebird bio and Celgene amended and restated their collaboration agreement in June 2015 to focus on developing product candidates targeting BCMA during a three-year collaboration term. By exercising its exclusive option under the terms of the agreement, Celgene will be responsible for worldwide development and commercialization of bb2121 after Phase 1. bluebird bio is responsible for the development of bb2121 through the completion of the CRB-401 Phase 1 study and has an option to share in the development, promotion and profits in the United States. bluebird bio will receive a $10 million option exercise payment from Celgene, and bluebird bio is also eligible to receive specified development, regulatory and commercial milestone payments and royalty payments on net sales.

About the CRB-401 Study

The primary objective of the CRB-401 study is to evaluate the maximum tolerated dose of bb2121 and determine the recommended Phase 2 dose. The secondary objective is patient response, measured using the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma. The first portion of the study includes a dose-escalation phase in which cohorts of patients will receive ascending doses of bb2121 to determine the maximum tolerated dose and establish a recommended Phase 2 dose. The second portion of the study is a dose expansion phase where patients will receive bb2121 to further evaluate the safety, tolerability and clinical activity at the recommended Phase 2 dose.

Durvalumab granted Breakthrough Therapy designation by US FDA for treatment of patients with PD-L1 positive urothelial bladder cancer

On February 17, 2016 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen (Press release, AstraZeneca, FEB 17, 2016, View Source [SID:1234509073]).

Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca said: "Metastatic bladder cancer is an area of enormous unmet medical need. We are encouraged by this Breakthrough Therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible."

The Breakthrough Therapy designation is designed to expedite the development of new drugs which are intended to treat a serious condition and which have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically significant endpoint over available therapies or when there is significant unmet medical need.

The Breakthrough Therapy designation for durvalumab was granted by the FDA on the basis of early clinical data from a Phase I trial (Study 1108) in patients with advanced metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen. This represents the third Breakthrough Therapy designation AstraZeneca has received from the FDA for medicines in Oncology. This designation offers the opportunity for further collaboration with the FDA for the durvalumab development programme. Data from study 1108 have been submitted for presentation at a future medical meeting.

Durvalumab is also being tested in first-line bladder cancer as a monotherapy as well as in combination with tremelimumab as part of the DANUBE Phase III trial which achieved first patient in during the final quarter of 2015.

NOTES TO EDITORS

About bladder cancer

Urothelial bladder cancers arise from the epithelium of the bladder and are the 9th most common form of cancer worldwide. Based on the Global Burden of Disease Cancer Collaboration, it is estimated that there were 400,000 incidents of bladder cancer and 173,000 deaths worldwide for the year 2013. Metastatic bladder cancer remains an area of great unmet medical need with 5-year overall survival rates of less than 15%.

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumours to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the tumour’s immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, bladder, gastric, pancreatic, HCC and blood cancers.

BIND Therapeutics and Synergy Pharmaceuticals Announce Collaboration to Develop ACCURINS® with Proprietary Uroguanylin Analogs for Targeting Gastrointestinal Receptors on Tumors

On February 16, 2016 BIND Therapeutics, Inc. and Synergy Pharmaceuticals Inc. reported they have entered into a research collaboration to engineer ACCURINS incorporating Synergy’s proprietary uroguanylin analogs to explore the potential targeting of guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies (Press release, BIND Therapeutics, FEB 16, 2016, View Source [SID:1234513873]). Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to enhance the potential effect of uroguanylin-based ACCURINS by incorporating therapeutic payloads.

"This collaboration represents another important advance as we develop ACCURINS with the potential to target a broad range of cells with novel therapeutic payloads," said Jonathan Yingling, Ph.D., chief scientific officer, BIND Therapeutics. "The versatility of our platform is demonstrated by our wide range of collaborations and the ability to leverage our technology platform in a wide variety of applications. We believe the complementary technologies of Synergy and BIND have the potential to generate novel uroguanylin-based therapies that could have a profound impact on the treatment of diseases."

Uroguanylin is a naturally occurring GI peptide and activator of the intestinal GC-C receptor, which is a known target for stimulating a variety of physiological responses. Plecanatide, Synergy’s lead uroguanylin analog for functional GI disorders, successfully completed phase 3 clinical trials for chronic idiopathic constipation (CIC) in 2015, and the Company recently filed a new drug application (NDA) for plecanatide to treat CIC. Synergy also recently announced positive data on its second uroguanylin analog, dolcanatide, in a phase 1b proof-of-concept study in ulcerative colitis patients.

"We are pleased to collaborate with BIND Therapeutics on this project, which we believe can broaden the potential therapeutic applications of our proprietary uroguanylin-based platform," said Kunwar Shailubhai, Ph.D., M.B.A., chief scientific officer and executive vice president of Synergy Pharmaceuticals. "BIND’s ACCURIN technology has been shown to target diseased tissues with a wide variety of therapeutic payloads. We have separately presented data showing that uroguanylin analogs specifically bind to different types of colorectal polyps and tumor in mice. Together, we believe that we can create uroguanylin-based ACCURINS that have the potential to provide new treatment options in GI cancer."

This early research collaboration is not expected to have a material financial impact on Synergy Pharmaceuticals or BIND Therapeutics.

About ACCURINS
ACCURINS, a new class of targeted therapeutics developed using BIND’s Medicinal Nanoengineering platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of ACCURINS allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.

ACCURINS can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables ACCURINS to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

Varian Medical Systems ARIA Oncology Information System and Eclipse Treatment Planning Software Named 2015/2016 Category Leaders in the 2015/2016 Best in KLAS: Software and Services Report

On February 16, 2016 Varian Medical Systems (NYSE: VAR) reported its ARIA oncology information system and Eclipse treatment planning software have been named "2015/2016 Category Leader" in the "Best in KLAS: Software and Services Report" by KLAS, an independent research firm specializing in monitoring and reporting on the performance of healthcare vendors (Press release, InfiMed, FEB 16, 2016, View Source [SID:1234509075]).

In use in some 3,200 cancer treatment centers around the world, ARIA was named the "2015/2016 Category Leader" for Oncology software. ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology. The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up.

ARIA users shared these comments posted on KLASresearch.com: a director stated, "ARIA is a great solution. It works well for both medical and radiation oncology." While a CIO shared these comments about the ARIA solution: "ARIA is tightly linked with the functionality of our linear accelerator, and that is incredible. That connection is what makes ARIA very valuable to our oncologists and radiologists. The linear accelerator is controlled through the software, so the charting and things we do with patients become almost invisible. All the documentation we have to do is automatically put in to the system. On the oncology side, all the formulas are streamlined. Doctors don’t have to look for a lot of things. There are a lot of customized fields doctors can set up."

For more information on ARIA, visit View Source

Named a "2015/2016 Category Leader" for Treatment Planning software for the third year in a row, the market and technology-leading Eclipse software is in use at some 3,400 cancer treatment centers around the world. The software creates an optimized radiotherapy treatment plan based on a physician’s dose instructions, and information about the size, shape and location of the tumor to be treated with radiation. The Eclipse software incorporates unique features such as RapidPlan knowledge-based planning, which makes it easier and faster to plan sophisticated cancer treatments like intensity-modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and RapidArc radiotherapy.

In comments posted on KLASresearch.com, a vice president who uses Eclipse said: "We really like Eclipse and feel it is the very best treatment planning software out there." A physicist using Eclipse stated: "We find it very easy to create good, efficient dose management using the system."

For more information on Eclipse, visit View Source

"These rankings acknowledge the hard work the Varian team has done. Working closely with oncology clinicians and administrators has allowed us to understand their needs, enhance the ARIA information system and Eclipse software, and provide the best-in-class tools for fighting cancer," said Kolleen Kennedy, president of Varian’s Oncology Systems business.

The 2015/2016 Best in KLAS report, published at the end of January, ranks healthcare vendors and their solutions by the professionals who use them—healthcare providers. For a full list of Best in KLAS winners, Global (Non-U.S.) Best in KLAS winners, and Category Leaders, visit View Source