On January 6, 2015 Argos Therapeutics reported a collaboration with Saint-Gobain’s Performance Plastics division, a leader in high-performance components and solutions using engineered polymers (Filing 8-K , Argos Therapeutics, JAN 7, 2015, View Source [SID:1234501282]). Under the terms of the agreement, Saint-Gobain will partner with Argos to design, integrate and scale production of a range of disposables for use in the automated manufacturing of Argos’ lead product candidate, AGS-003, currently being tested in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

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"We believe Saint-Gobain is the ideal partner to provide us with disposables that meet the technical specifications we need in the manufacturing of our personalized immunotherapies," says Jeff Abbey, president and CEO of Argos. "Their commitment to this development program and to Argos is a critical step in our effort to bring together all of the high quality resources and expertise we need to support the potential future commercialization of AGS-003. The utilization of their disposables with our automated production technology positions us to maximize throughput while processing biomaterials from multiple patients simultaneously in the same automated manufacturing suite."

"Argos’ Arcelis technology platform shows clear potential to support development of a range of autologous cell therapies that could change the future of patient care in cancer and infectious diseases. We are excited about the opportunity to partner with the Argos team to develop and supply the essential range of disposables that will be required to advance AGS-003 through late stage development and on to commercialization," says Steve Maddox, General Manager of Saint-Gobain Performance Plastics’ Life Sciences business unit.

On January 7, 2015 Intellia Therapeutics, a leader in the development of therapeutic products using CRISPR/Cas9 technology for gene editing and repair, reported a five-year research and development collaboration with Novartis to accelerate the ex vivo development of new CRISPR/Cas9-based therapies using chimeric antigen receptor T cells (CARTs) and hematopoetic stem cells (HSCs) (Press release, Intellia Therapeutics, JAN 7, 2015, View Source [SID1234533042]). This collaboration comes only three months after Intellia was launched by Atlas Venture and Caribou Biosciences, providing an important validation of Intellia’s team and capabilities.

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CRISPR/Cas9-based gene editing holds promise across a range of gene therapy applications, including blood disorders, cancer and other genetic based diseases. It has been shown to be an efficient and precise method for gene editing across multiple cell and tissue types, making it an ideal platform for ex vivo applications, such as CART- and HSC-based therapies, as well as in vivo applications.

Under the terms of the agreement, Novartis receives exclusive rights to develop all collaboration programs focused on engineered CARTs. Within HSCs, Novartis and Intellia will jointly advance multiple programs, and have agreed to a process for assigning development and ownership rights, which will enable Intellia to develop its own proprietary internal HSC pipeline.

In addition to increasing its equity holding in Intellia, Novartis is making an upfront payment, and providing technology access fees and funding for R&D programs during the five-year term of the collaboration. Intellia is also eligible to receive downstream success-based milestones and royalties. Intellia will gain access to certain Novartis intellectual property and technology for the development of its own product pipeline. Intellia also reserves the right to pursue additional enabling partnerships in other areas of therapeutic interest.

"Our collaboration with Novartis is an important building block for Intellia that will greatly accelerate our effort to translate the promise of CRISPR/Cas9 into meaningful advances for 2 patients," said Nessan Bermingham, Ph.D., Chief Executive Officer and co-founder of Intellia. "CARTs and HSCs represent two of the most immediate opportunities for CRISPR therapeutic development, and Novartis, as a leader in this space, is the ideal partner with which to develop strong product pipelines in these areas."

On January 06, 2015 Gilead Sciences, Inc. (Nasdaq:GILD) and Phenex Pharmaceuticals AG, a privately-held biotechnology company, reported the signing of a definitive agreement under which Gilead will acquire Phenex’s Farnesoid X Receptor (FXR) program comprising small molecule FXR agonists for the treatment of liver diseases including nonalcoholic steatohepatitis (NASH) (Press release, Gilead Sciences, JAN 6, 2015, View Source [SID1234639733]). Under the terms of the agreement, Gilead will pay Phenex an upfront payment plus additional payments based upon achievement of certain development milestones that may potentially be worth up to $470 million.

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NASH is a common, serious chronic liver disease characterized by inflammation and excessive fat accumulation in the liver and may lead to progressive fibrosis, cirrhosis and liver failure. NASH is estimated to affect 10 to 20 percent of people in the developed world. There are currently no approved therapies to treat NASH. FXR is a nuclear hormone receptor that regulates bile acid, lipid and glucose homeostasis, which can help reduce liver steatosis and inflammation, and may help prevent liver fibrosis.

"This agreement represents a significant milestone for our company and for the field of liver disease research," said Dr. Claus Kremoser, CEO of Phenex Pharmaceuticals AG. "After 15 years of research, FXR is now one of the few clinically validated targets for NASH and we are delighted that Gilead will be continuing the research necessary to more fully realize its potential for advanced liver disease."

"The acquisition of Phenex’s FXR program represents an important opportunity to accelerate Gilead’s efforts to develop new treatment options that address fibrotic liver diseases," said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to working closely with Phenex’s research and development team to advance the FXR program into clinical development as quickly as possible to explore its potential in areas of significant unmet need."

On January 6, 2015 Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of cell therapies, reported the acquisition of OnCyte, the oncology division of privately-held U.S. biotechnology company Celdara Medical, and its portfolio of immuno-oncology product candidates (Press release, Celyad, JAN 6, 2015, View Source [SID1234516407]). The acquisition marks Cardio3 Biosciences’ entry into the rapidly growing and very promising field of immuno-oncology, positioning the Company at the forefront of the CAR T-Cell space and represents a significant step towards the Company’s strategic objective of developing into a world leader in cell therapy.

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Cardio3 BioSciences acquires OnCyte for an upfront payment of USD 10 million, of which USD 4 million will be paid in C3BS shares. For the successful development of the most advanced product CM-CS1, Celdara could receive up to USD 50 million in development and regulatory milestones until market approval. Celdara will be eligible to additional payments on the other products upon achievement of development and regulatory milestones totalling up to USD 21 million per product. In addition, Celdara will receive up to USD 80 million in sales milestones when net sales will exceed USD 1 billion and royalties ranging from 5 to 8%.

The Chimeric Antigen Receptor (CAR) technology developed by OnCyte uses human Natural Killer cell (NK cell) receptors which, unlike traditional CAR technologies, have the potential to target a broad range of liquid and solid cancers via a human natural receptor that targets ligands present on most tumor types. The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology, Cancer Research and Blood.

OnCyte’s most advanced autologous CAR T-Cell drug candidate, CM-CS1, uses a specific human Natural Killer cell receptor, NKG2D, that targets tumor antigens expressed in most liquid and solid cancers. CM-CS1 has an active Investigational New Drug (IND) clearance with the U.S. Food and Drug Administration (FDA) for a Phase I clinical trial in hematologic malignancies and the Company plans to begin enrolling patients in Q1 2015. The CM-CS1 Phase I study is expected to be completed in the second quarter of 2016. The Company expects to report interim data from this trial throughout the enrolment period. In addition to CM-CS1, OnCyte has two CAR T-Cell programs targeting other cancer cell ligands in pre-clinical development, as well as an allogeneic T-Cell platform, which enables almost any CAR T-Cell therapy to be made into an "off-the-shelf" product.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented: "We are thrilled to add the OnCyte clinical development program and CAR T-Cell platform to our portfolio of world-class assets. Building on the strong foundation of our lead cardiac product, C-Cure, this acquisition positions us in a second therapeutic area characterized by significant unmet medical need, while allowing us to leverage our leading cell therapy capabilities to drive the development of this potentially gamechanging immuno-oncology technology. We look forward to initiating the Phase I trial of CM-CS1 and advancing the other OnCyte assets to create value for patients, the medical community and other key Cardio3 BioSciences stakeholders."

Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, added: "We are extremely proud of everything that the OnCyte team has accomplished to date. The product candidates they have developed could have a tremendous impact on the field of immuno-oncology, and we believe that Cardio3 BioSciences is the optimal partner to lead the further advancement of this groundbreaking technology. Cardio3 BioSciences possesses the right scientific, manufacturing, and clinical expertise to continue developing these therapies and to realize their full potential."

Recognized by experts as one of the most exciting fields in the treatment of cancer, immunooncology, and more specifically CAR T-Cell therapies, represents an innovative approach to treat cancers by leveraging the body’s own immune system.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, further added: "Like our cardiopoietic platform for C-Cure, the OnCyte CAR T-Cell portfolio and development platform represent potential breakthroughs in cancer therapy that could offer transformational treatment options for patients. We believe that this new technology will become a strong asset of Cardio3 BioSciences’ product portfolio as we develop it further."

Cardio3 BioSciences intends to progress the various candidate products acquired from current preclinical stage to human clinical trials over the next months and years. Further information on CAR T-Cell therapies and OnCyte’s technology platform is available at www.c3bs.com/immuno-oncology

On January 15, 2015 Cyclenium Pharma Inc., an emerging pharmaceutical company specializing in the discovery and development of novel drug candidates based on proprietary macrocyclic chemistry and the Institute for Research in Immunology and Cancer — Commercialization of Research (IRICoR) along with Université de Montréal and its Institute for Research in Immunology and Cancer (IRIC) announced today the signing of a collaborative research agreement (Press release, Universite de Montreal, JAN 5/, 2015, View Source [SID1234517247]). The collaboration intends to utilize Cyclenium’s proprietary QUEST Library of next generation macrocyclic molecules and associated hit-to-lead optimization expertise in concert with IRIC’s state-of the-art capabilities in biological target identification, characterization and screening, as well as medicinal chemistry. The objective of the collaboration is to discover and develop new drug candidates in cutting-edge target areas for the treatment of cancer and immunological disorders.

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"We are delighted to have forged this collaboration with IRICoR and the team of leading investigators at IRIC in two of our therapeutic focus areas," stated Helmut Thomas, Ph.D., President & Chief Executive Officerof Cyclenium. "Combining IRIC’s exquisite research expertise in the understanding of novel pharmacological targets with our CMRT drug discovery technology and our joint experience in the medicinal application of macrocyclic compounds and proven development success in the macrocycle arena offers superb potential for success in the search for new pharmaceuticals in oncology and immunology indications."

"We are extremely pleased to be working with Cyclenium," said Michel Bouvier, Chief Executive Officer of both IRIC and IRICoR. "We clearly see multiple areas of synergy between IRIC’s drug discovery, screening, and medicinal chemistry expertise with Cyclenium’s leadership position in macrocycle-based drug development."