On January 7, 2015 Exelixis reported that it has extended and restructured its agreement with Swedish Orphan Biovitrum AB (Sobi) to support the distribution and commercialization of COMETRIQ (cabozantinib) for progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC) in the European Union (EU), Switzerland, Norway, Russia, and Turkey (Press release Exelixis, JAN 7, 2015, View Source;p=RssLanding&cat=news&id=2004606 [SID:1234501288]). The agreement, which was established in February 2013 and due to expire on December 31, 2015, will now extend to December 31, 2019. Moreover, the payment structure of the partnership will transition from fixed fees paid by Exelixis to Sobi to support initial build out of COMETRIQ European commercial infrastructure to a sales margin-based approach. Exelixis continues to maintain commercial rights for all other potential cabozantinib oncology indications on a global basis.

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"Our amended agreement with Sobi will continue to allow Exelixis to provide COMETRIQ to MTC patients outside the United States," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Over the course of this coming year, we anticipate reaching several key milestones for the company, including receipt of top-line data from the METEOR phase 3 trial of cabozantinib in metastatic renal cell carcinoma in the second quarter, and regulatory progress with our partnered compound cobimetinib for metastatic melanoma in both the United States and European Union."

"We are very pleased to extend the agreement with Exelixis and proud to support access to COMETRIQ in Europe. The evolution of our partnership with Exelixis will continue to bring significant value to patients," said Anders Edvell, Vice President and Head of Sobi Partner Products at Sobi.

Sobi exclusively markets, sells, and distributes COMETRIQ for its MTC indication in the covered territory of the European Union, Switzerland, Norway, Russia, and Turkey. In parts of the territory where COMETRIQ is not approved, Sobi administers a Named Patient Use program. Exelixis is responsible for regulatory approvals in the covered territory, and the company retains the ability to terminate the agreement at will at any time upon payment of certain pre-determined fees.

On January 7, 2015 Nuvilex, Inc. (OTCQB:NVLX) reported that the Company has changed its name to PharmaCyte Biotech, Inc. Shares in PharmaCyte Biotech will trade under the new ticker symbol "PHCB" on the OTCQB electronic platform (Press release, PharmaCyte Biotech, JAN 7, 2015, View Source [SID:1234510563]). The new symbol is expected to become effective at the open of the market on January 8, 2014. The name change is part of the Company’s transformation process to operate solely as a pure biotechnology firm leveraging its Cell-in-a-Box technology, a proprietary cell encapsulation platform being utilized to develop "targeted" treatments for solid cancerous tumors and insulin dependent diabetes.

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"Over the past year, we’ve implemented an aggressive strategy to facilitate the advancement of the treatments we are developing for cancer and diabetes, with our Cell-in-a-Box technology at the core of these treatments. Our new name reflects the tremendous progress we’ve accomplished in terms of clinical development and signifies the structural completion of our transition to becoming a fully dedicated biotechnology company," said Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech.

Some of the highlights in 2014 that have marked this transition include:

Receiving "orphan drug" designation from the U.S. Food and Drug Administration (FDA) for the Company’s pancreatic cancer treatment, with applications filed with the EMA and the TGA for the same status in Europe and Australia.

Development of a clinical protocol for a planned Phase 2b clinical trial with the goal of initiating the clinical trial in 2015.

A preclinical study being completed evaluating the effectiveness of the Company’s pancreatic cancer treatment on the accumulation of malignant ascites fluid often associated with the growth of abdominal cancers with positive results that have led to a follow-up study about to be launched.

The establishment of a world-wide Diabetes Consortium with a number of research agreements now in place with major universities and institutions that will permit the development of a break-through treatment for insulin dependent diabetes that combines Cell-in-a-Box with insulin-producing cells.

Progression at the University of Northern Colorado in the pursuit of treatments for brain and other forms of difficult to treat cancers that will combine cannabinoid or cannabinoid-like compounds with the Cell-in-a-Box technology.
"With exciting developments on the horizon for 2015, our work to develop treatments for both cancer and diabetes will move forward under our new name because it speaks to what we actually do here at PharmaCyte Biotech," concluded Mr. Waggoner.

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 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 5, 2018 Amgen (NASDAQ:AMGN) and Kite Pharma (NASDAQ:KITE) reported that the two companies have entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite’s engineered autologous cell therapy (eACT) platform and Amgen’s extensive array of cancer targets (Press release Amgen, JAN 5, 2015, View Source;p=RssLanding&cat=news&id=2002967 [SID1234501267]). The collaboration brings together Amgen’s commitment to and capabilities in advancing new approaches in immuno-oncology and Kite’s industry-leading presence in CAR T cell therapy.

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Under the terms of the agreement, Amgen will contribute cancer targets, and Kite will leverage its proprietary CAR platform, research and development (R&D) and manufacturing capabilities, and expertise. Kite will be responsible for conducting all preclinical research and cell manufacturing and processing through Investigational New Drug (IND) filing. Each company will then be responsible for clinical development and commercialization of their respective CAR therapeutic candidates, including all related expenses. Kite will receive from Amgen an upfront payment of $60 million, as well as funding for R&D costs through IND filing. Kite will be eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite’s intellectual property for CAR T cell products. Amgen is eligible to receive up to $525 million in milestone payments per Kite program, plus tiered single-digit sales royalties. Further terms of the agreement are not being disclosed.

"The intersection of immunology and oncology represents one of the most promising approaches to delivering significant impact for patients with cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "With our existing immuno-oncology portfolio of cutting-edge technologies and expertise, we believe joining forces with Kite Pharma will leverage our targets and their leading CAR T cell platform to advance another new promising therapeutic approach to fight cancer."

"Amgen is an ideal partner for us, based on their strong presence in oncology and the company’s broad array of cancer targets optimally suited for combining with our CAR technologies. We are proud to announce this unique collaboration and its validation of our R&D expertise, intellectual property position, and therapeutic manufacturing and processing capabilities," stated Arie Belldegrun, M.D., FACS, Kite Pharma’s president and chief executive officer. "We believe that the therapeutic candidates resulting from the collaboration will have the potential to dramatically transform CAR approaches and to become some of the most powerful therapies for the treatment of cancer."

Conference Call / Webcast Information
Kite Pharma will host a live conference call and webcast today at 4 p.m. ET to discuss the transaction. To access the live webcast or replay, please visit Kite Pharma’s Investor Relations website at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

Alternatively, the dial-in number to access the conference call is (844) 856-8656, or from international locations dial (443) 877-4062. The conference ID number for the live call is 59012654. Telephone replay will be available approximately three hours following the call. To access the replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 59012654. The telephone replay will remain available until 11:59 p.m. ET, Jan. 12, 2015.

About CAR T Immunotherapies
Kite Pharma’s broadly enabling eACT technology platform allows a patient’s T cells to be genetically modified to express cancer-targeting receptors. Engineered CAR T cells contain a single chain antibody domain, which recognizes and binds to a cell surface tumor antigen, as well as intracellular T cell-activating domains. CAR T cells are designed to traffic directly to tumor sites and become activated upon engagement with the target tumor antigen, selectively eradicating the tumor cells.