News Article | December 5, 2016
STAMFORD, Conn. & SAN DIEGO--(BUSINESS WIRE)--Purdue Pharma L.P. and AnaBios Corporation announced today a collaboration to advance the research of non-opioid, non-NSAID compounds for the treatment of chronic pain. The goal of the collaboration is to accelerate Purdue’s Nav1.7 sodium ion channel drug candidates utilizing AnaBios’ Phase-X® discovery platform to develop treatments for chronic pain. Under the terms of the agreement, Purdue Pharma will license to AnaBios the rights to a suite of patents for Nav1.7 sodium ion channel blockers. AnaBios will employ its Phase-X® technology to de-risk the assets and select a clinical candidate. The two companies will form a joint steering committee to manage pre-clinical as well as clinical development of the lead molecule. In addition, the companies will own any intellectual property (IP) developed jointly. Purdue Pharma has more than 15 years of research history in the sodium channel field that led to multiple patent applications and numerous lead compounds targeting Nav1.7 as well as other sodium channel isoforms that are potentially useful for the treatment of chronic pain. Purdue Pharma also has extensive clinical development experience in advancing new drugs for treating pain. AnaBios has a successful record of accomplishment in employing its Phase-X® platform to support target selection and validation, lead optimization, clinical candidate selection and clinical program de-risking for pharmaceutical drug development programs. The company is also conducting internal preclinical drug discovery programs on proprietary chemical entities and has established a unique and unprecedented capability for studying the human peripheral pain pathway in the laboratory, therefore enabling the identification of novel analgesic drugs with potential efficacy in humans. “The Phase-X® platform enables the discovery of novel drugs directly in normal as well as diseased human tissues, minimizing animal experimentation. This strategy maximizes the chances that preclinical data will successfully translate during clinical development,” said Mark Timney, President and Chief Executive Officer, Purdue Pharma L.P. “This innovative technology can advance this important research and bring value to patients suffering from pain and healthcare providers.” Phase-X ensures that lead optimization truly enhances drug safety and efficacy profiles in humans, not just in animal models. “We will utilize our Phase-X technology to optimize the selection of clinical candidates from the advanced leads that Purdue Pharma has generated,” said Andre Ghetti, Ph.D., Chief Executive Officer, AnaBios Corporation. “Employing human sensory neurons to match the selectivity and properties of sodium channel blockers with specific pain indications, we will maximize the potential success of clinical development of much needed new pain therapeutics.” “Through this unique collaboration we have a tremendous opportunity to quickly advance new treatments into the clinic and potentially serve the many chronic pain patients that cannot find relief with existing medications. Our ability to select clinical candidates based on experiments performed in native human tissues will provide the greatest chance of success," said Don Kyle, Ph.D., Vice President, Discovery Research, Purdue Pharma L.P. Chadbourne & Parke LLP served as lead outside counsel for Purdue Pharma. Reid Adler served as lead outside counsel for AnaBios. Nav1.7 is a sodium ion channel that in humans is encoded by the SCN9A gene. It is usually expressed at high levels in two types of neurons, the nociceptive (pain) neurons at dorsal root ganglion (DRG) and trigeminal ganglion, and sympathetic ganglion neurons, which are part of the involuntary nervous system. Nav1.7 plays a critical role in the generation and conduction of action potentials and is thus important for electrical signaling by most excitable cells. Nav1.7 is present at the endings of pain-sensing nerves, the nociceptors, close to the region where the impulse is initiated. Phase-X® is the proprietary technology developed by AnaBios which enables the investigation of human drug responses in the pre-clinical stage of drug discovery. In the past, access to human cells and tissues for research has relied, almost invariably, on samples collected employing inconsistent protocols, variable postmortem intervals, and a lack of adequate reagents for ensuring sample viability. As a result of ischemic damage, most available samples were of poor quality and provided inconsistent results. It has also been difficult, if not impossible, to use human tissue samples for functional biochemical and physiological testing of drug effects. At the foundation of Phase-X drug development platform are proprietary methods and reagents for the consistent and reliable procurement of viable human donor samples, the preservation of human sample viability as well as advanced in vitro interrogation methods for obtaining human-relevant data on drug activity. AnaBios Corporation has developed an extensive battery of assays and technologies, Phase-X®, that enable the study of ex-vivo human responses to drugs and the investigation of the molecular and functional basis of human physiology. AnaBios focuses primarily on ex-vivo human tissue and cell-based studies for safety, pain and neurodegeneration. AnaBios generates highly valuable and predictive human data that ensure the selection of the most effective and safest drugs before investing in expensive and time consuming clinical trials. AnaBios is located in San Diego. For more information, please visit https://www.anabios.com/. Purdue Pharma L.P. is a privately-held pharmaceutical company and is part of a global network of independent associated companies that is known for pioneering research in chronic pain and opioids with abuse deterrent properties. The company’s leadership and employees are committed to providing healthcare professionals, patients and caregivers quality products and educational resources to support their proper use. Purdue Pharma is engaged in the development, production and distribution of both prescription and over-the-counter medicines and hospital products. With Purdue Pharma’s expertise in drug development, commercialization and life-cycle management, the company is diversifying in high-need areas to expand through strategic acquisitions and creative partnerships. For more information, please visit www.purduepharma.com or follow the company on Twitter, Instagram and LinkedIn.
Datta-Mannan A.,Eli Lilly and Company |
Chow C.-K.,Biotechnology Discovery Research |
Dickinson C.,Discovery Research |
Driver D.,Discovery Research |
And 3 more authors.
Drug Metabolism and Disposition | Year: 2012
The pH-dependent binding of IgGs to the neonatal Fc receptor (FcRn) plays a critical role in regulating IgG homeostasis in vivo. Enhancing interactions between Fc and FcRn via protein engineering has been successfully used as an approach for improving the pharmacokinetics of monoclonal antibodies (mAbs). Although the quantitative translatability of the in vitro FcRn affinity enhancement to an in vivo pharmacokinetic benefit has been supported by several studies, there are also published reports indicating a disconnect in this relation. The body of literature suggests there are likely additional biochemical and biophysical properties of the mAbs along with their FcRn affinity that influence the in vivo pharmacokinetics. Herein, we more broadly evaluate the in vitro Fc-FcRn interactions and biochemical properties of five humanized IgG4 antibodies each with two Fc variant sequences (T250Q/M428L and V308P) and their corresponding pharmacokinetics in cynomolgus monkeys. Our findings indicate that the FcRn affinity-pharmacokinetic relationship does not show a direct correlation either across different IgGs or between the two variant sequences within a platform. Other parameters that have been suggested to contribute to mAb pharmacokinetic properties, such as the pH-dependent dissociation of the FcRn-IgG complexes, mAb biophysical properties, and nonspecific/charge binding characteristics of the mAbs, also did not independently explain the differing pharmacokinetic behaviors. Our results suggest that there is likely not a single in vitro parameter that readily predicts in vivo pharmacokinetics, but that the relative contribution and interplay of several factors along with the FcRn binding affinity are important determinants of mAb pharmacokinetic properties. Copyright © 2012 by The American Society for Pharmacology and Experimental Therapeutics.
News Article | November 17, 2016
The Human Vaccines Project and Boehringer Ingelheim are pleased to announce a three-year collaboration agreement to support their mutual objective to decode the human immune system with the aim of accelerating understanding and development of immunotherapies overall as well as better vaccines for cancer treatment. Under the terms of the agreement, Boehringer Ingelheim’s contributions to the Project will help catalyze the Project’s expanding programs. “We are tremendously honored that Boehringer Ingelheim has elected to partner with the Project, joining a growing number of leading, global biopharmaceutical companies committed to addressing the key scientific challenges impeding development of next generation vaccines and immunotherapies,” said Wayne C. Koff, Ph.D., President and CEO of the Human Vaccines Project. “Boehringer Ingelheim brings exceptional basic science and clinical research expertise in the areas of oncology and human immunology, and is at the forefront of biopharma innovation in these areas.” A revolution is ongoing in cancer immunotherapy, due to the recent realization of the importance of “checkpoints,” proteins that enable tumors to evade the immune system’s ability to kill the tumor, and novel therapeutics termed “checkpoint inhibitors” that have provided dramatic clinical benefit in managing a subset of cancers in a limited number of patients. “Despite these exciting breakthroughs, our understanding of how the immune system can best be harnessed to attack and eliminate tumors remains limited. A better understanding of the human immune system in healthy individuals as well as patients, and how best to measure and direct the immune system is needed,” said Clive R. Wood, Ph.D., Senior Corporate Vice President, Discovery Research at Boehringer Ingelheim. “We are pleased to become a partner in this groundbreaking project which offers the potential to open a new era in vaccine and immunotherapeutic development. This complements our strong commitment to cancer immunology with a pipeline that includes among others, a therapeutic cancer vaccine and next generation checkpoint inhibitors.” Within the Human Vaccines Project’s scientific network, investigators at leading academic research centers are seeking to determine the central components of the human immune system at the molecular and structural level, as well as the common rules by which the immune system generates specific and durable protective responses against a range of infectious and neoplastic diseases. Successful achievement of these goals should enable accelerated development of new and improved vaccines and therapeutics for major global diseases. “The Human Vaccines Project is one of the more promising projects to help transform the future of vaccine development and cancer immunotherapy. JCVI is pleased to be adding our bioinformatics acumen as part of this effort to help conquer some of the most devastating diseases of the 21st century,” said J. Craig Venter, Founder, Chairman and CEO of the J. Craig Venter Institute which recently joined together with the Scripps Research Institute, La Jolla Institute and UC San Diego to serve as a scientific hub for the Project. About the Human Vaccines Project The Human Vaccines Project is a non-profit public-private partnership with the mission to accelerate the development of vaccines and immunotherapies against major infectious diseases and cancers by decoding the human immune system. The Project has a growing list of partners and financial supporters including: Vanderbilt University Medical Center, the J. Craig Venter Institute, the La Jolla Institute, The Scripps Research Institute, UC San Diego, Aeras, Crucell/Janssen, GSK, Pfizer, MedImmune, Regeneron, Sanofi Pasteur, the Robert Wood Johnson Foundation and the John D. and Catherine T. MacArthur Foundation. The Project brings together leading academic research centers, industrial partners, nonprofits and governments to address the primary scientific barriers to developing new vaccines and immunotherapies, and has been endorsed by 35 of the world’s leading vaccine scientists.
Mathiasen J.R.,Discovery Research |
Dicamillo A.,Discovery Research
Current Protocols in Pharmacology | Year: 2010
The rat novel object recognition (NOR) assay is a relatively high-throughput, robust, and sensitive procedure for evaluating compounds for cognition-enhancing activity. For the test, rats are given the opportunity to explore two identical objects for a predetermined period of time. After a delay, the animals are then presented with two objects to explore, one of which is the same as in the first exploration trial, the other a new object. Depending on the length of the delay between the two trials, the rats will either explore the novel object for a greater time period, indicating memory for the familiar object, or will explore the novel and familiar objects for the same amount of time, indicating a lack of recall or loss of memory for the familiar object presented during the initial trial. The protocol described in this unit can be used to evaluate the effects of a compound on the short-term/working memory of adult male rats following a 24-hr inter-trial interval. Copyright © 2010 John Wiley & Sons, Inc.
News Article | December 1, 2016
Ingelheim, Germany and Nanjing China, 01-Dec-2016 — /EuropaWire/ — Boehringer Ingelheim and China Southeast University Institute of Life Sciences today announced the start of a joint research project to develop new treatment approaches for hearing loss through regeneration of hair cells from inner ear stem cells. The new collaboration combines the expertise of Professor Renjie Chai, one of the worldwide leaders in the field of hearing loss, with Boehringer Ingelheim’s expertise in drug discovery and clinical development to pave the way for the development of much needed new treatment options for this condition. According to WHO data, over 360 million people live with disabling hearing loss, of which 32 million are children under15 years old. The prevalence of hearing loss increases with age and has a serious impact on the elderly by diminishing their ability to communicate and affecting their daily quality of life. A dramatic increase in frequency of the condition is predicted as a result of worldwide aging populations. Patients with hearing loss usually have degeneration of inner ear hair cells. There is no effective treatment that could restore hearing loss. “Professor Renjie Chai and his team are among the world leaders in this emerging research area. We are excited about initiating this collaboration, which is an important next step towards a new focus area for our research and development and our first human pharma research collaboration in China,” said Clive R. Wood, Ph.D., Senior Corporate Vice President, Discovery Research at Boehringer Ingelheim. “This is our second collaboration in hearing loss, one of the focus areas of our Research Beyond Borders initiative. It is an outstanding example of how this unique initiative will boost our R&D by partnering with the most innovative scientists working at the forefront of biomedical research.” The new research collaboration in hearing loss is an initiative of Boehringer Ingelheim’s newly established organisation Research Beyond Borders (RBB). It complements a research collaboration with Kyoto University initiated earlier this year that focuses on utilising findings on hair cell regeneration in birds. Through the collaboration with China Southeast University, Boehringer Ingelheim will investigate key signaling pathways and proteins involved in regeneration in the inner ear to develop a drug discovery strategy to target hair cell regeneration and ultimately address the unmet medical need in hearing loss via regenerative medicine approaches. Dr. Wei Xie, Dean of China Southeast University Institute of Life Sciences commented: “Through this joint project with Boehringer Ingelheim, a world leading innovative pharmaceutical company, we wish to further promote scientific development in the field of hair cell regeneration, and to accelerate the translation of basic science to clinical applications. The current collaboration will demonstrate the regulation mechanism of inner ear stem cells, and we hope to develop insights for targeting the key pathways via small molecule compounds together with Boehringer Ingelheim.” RBB is one of the pillars of Boehringer Ingelheim’s R&D strategy. It complements the company’s five core therapeutic areas (cardiometabolic, respiratory, immunology, oncology and central nervous system) by exploring emerging science, disease areas and technology. It will contribute new innovation opportunities within and beyond the core therapeutic areas and ensure early entry for Boehringer Ingelheim in the next big innovation waves in in biomedical research. RBB is currently focusing on the areas of regenerative medicine, the microbiome and new technologies such as gene therapy. Asia is rapidly becoming an innovation a hot spot in biomedical research and has gained a leading position in regenerative medicine research. Boehringer Ingelheim is thus expanding its activities in this region and looking for more partnering opportunities. By combining a focus on cutting-edge science with a long-term view the company aspires to develop the next generation of medical breakthroughs to improve the lives of patients with high unmet medical needs. About Research Beyond Borders (RBB) RBB is a global research division newly established within Boehringer Ingelheim’s discovery research organization. RBB supports discovery research activities for the development of pharmaceutical products in Boehringer Ingelheim’s key therapeutic areas (cardiometabolic, respiratory, immunology, oncology, central nervous system) as well as disease areas with considerable unmet needs, such as sensorineural hearing loss, by identifying cutting edge medical and scientific fields and technologies in a timely and efficient manner through the discovery of new scientific results and technologies. Boehringer Ingelheim Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine. Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does. In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales. For more information please visit www.boehringer-ingelheim.com About China Southeast University Southeast University (SEU) is one of the national key universities administered directly under the Central Government and the Ministry of Education of China. Southeast University has become a comprehensive and research-oriented university featuring the coordinated development of such multi-disciplines as science, engineering, medicine, literature, law, philosophy, education, economics, management, art, etc., with engineering as its focus. The university boasts a high-level faculty of over 2,700 full-time teachers, including 1800 full or associate professors, 835 doctoral supervisors, 1,889 supervisors for masters, 13 academicians of the Chinese Academy of Sciences and Academy of Engineering. At present, it has an enrollment of over 30,000 full-time students, including 14,440 postgraduate students; it also has over 3,300 on-the-job master’s degree candidates. The university now comprises 29 schools or departments with 75 undergraduate disciplines in all.
News Article | December 21, 2016
Crystal Bioscience today announced an expansion of its agreement to collaborate with Boehringer Ingelheim on the discovery and development of therapeutic antibodies. Crystal Bioscience will continue to apply its proprietary gel encapsulated microenvironment (GEM) technology to identify antibodies meeting the design goals set by Boehringer Ingelheim. Under the expanded agreement, Boehringer Ingelheim will now have access to Crystal’s HuMab chickens, which are genetically engineered to yield human sequence antibodies. Today’s announcement builds on an initial collaboration, which started in January 2014. Boehringer Ingelheim is the fourth collaborator to access Crystal’s HuMab chickens since the antibody discovery platform was launched earlier this year. Boehringer Ingelheim will have the option to conduct further development and commercialization of the antibodies. Under the terms of the agreement, Crystal will receive an upfront technology access fee and research funding for each program, and may receive technical success fees, option exercise fees and downstream payments. "We are pleased to expand our relationship with Boehringer Ingelheim to include the HuMab discovery platform,” said Robert J Etches, President & CEO of Crystal Bioscience. “The human platform retains the broad epitope coverage and access to pan-mammalian antibodies that is characteristic of our original wild type platform. In addition, the HuMab platform facilitates advancement into clinical studies by obviating the need to humanize candidate mAbs.” Crystal is the leader in discovery of avian antibodies for use as therapeutics, and its platform can access new binding epitopes, which are unavailable by other more traditional approaches. Most importantly, this platform provides Boehringer Ingelheim the opportunity to discover cross-species reactive antibodies that complement its approach to biotherapeutics research and will ideally streamline and accelerate the drug discovery process. “Boehringer Ingelheim looks forward to expanding our relationship with Crystal Bioscience as this technology enhances our ability to accelerate development of new therapies,” said Clive R. Wood, Ph.D., Senior Corporate Vice President, Discovery Research at Boehringer Ingelheim. “This alliance is yet another example of Boehringer Ingelheim’s strategic approach to collaborations that speed the research and development of vital treatments for unmet patient needs,” added Wood. Crystal Bioscience is a privately held company that was founded in 2008 to develop a world-class therapeutic antibody discovery engine using chickens. Its platform is "powered by evolution," exploiting the large phylogenetic distance between mammals and birds to generate a diverse array of antibodies to human targets that have proven intractable in mammalian and other discovery platforms. Crystal’s patented platform provides the unique ability to isolate monoclonal antibodies from immunized chickens, and can screen simultaneously for specificity and biological activity. It has led to the discovery of bioactive monoclonals directed against difficult targets, including GPCRs and ion channels. Chicken antibodies often recognize both human and mouse orthologs, which can simplify early stages of drug development where mouse disease models are used. The depth of screening provided by the GEM assay in combination with the breadth of the antibody repertoire in immunized birds provides access to an unparalleled source of affinity matured antibodies with therapeutic potential. Crystal’s HuMab chickens, which are genetically engineered to yield fully human sequence mAbs, capture the attributes of the chicken repertoire in a therapeutic format.
News Article | February 21, 2017
ARDSLEY, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that Catherine D. Strader, Ph.D., has joined its board of directors, effective February 17. Dr. Strader is currently a founding partner at Synergy Partners R&D Solutions. “I am delighted to welcome Dr. Strader to Acorda’s board of directors,” said Ron Cohen, M.D., Acorda's President and CEO. “Catherine brings decades of experience as both a drug developer and biopharmaceutical business executive with an outstanding track record of achievement. I expect her to add significant value to the Board and the Company as we continue to develop our pipeline and grow our business.” “I am excited to be joining Acorda’s board of directors,” said Dr. Strader. “The Company has a promising pipeline of innovative neurological therapies. I’m looking forward to working with Ron, the Board and the management team to help advance these programs.” Dr. Strader will be filling a newly-added Board seat and will be up for re-election in 2018. Prior to founding Synergy Partners R&D Solutions, Dr. Strader held executive leadership positions at both Merck, where she was Vice President and Site Head, and Schering-Plough, where she was Executive Vice President of Discovery Research and Chief Scientific Officer. She has guided more than 50 compounds through drug discovery and development during her career. At Merck, she led an external research initiative, with responsibility for developing and implementing an integrated strategy for building Merck's early pipeline using external sources of innovation. At Schering-Plough, Dr. Strader had both strategic and operational responsibility for the company’s global small molecule and biologics discovery research portfolio, when she and her team initiated many of the programs that currently populate the Merck portfolio. Dr. Strader received her B.S. in Chemistry from the University of Virginia and her Ph.D. in Chemistry from the California Institute of Technology. She did her postdoctoral training as a Howard Hughes Fellow in Robert Lefkowitz’s laboratory at Duke University and is the author of more than 150 scientific publications. Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has an industry leading pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease, migraine and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. For more information, please visit the Company’s website at: www.acorda.com. This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from the Biotie and Civitas transactions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the ability to successfully integrate Biotie’s operations and Civitas’ operations, respectively, into our operations; we may need to raise additional funds to finance our expanded operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including CVT-301 or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market CVT-301, any other products under development, or the products that we will acquire when we complete the Biotie transaction; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain and maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies. These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
News Article | December 19, 2016
SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc. (Nasdaq:KITE) today announced several updates to its broad intellectual property portfolio relating to the use of chimeric antigen receptors (CARs) to harness the power of a patient’s immune cells. These updates include a recent U.S. Patent and Trademark Office (USPTO) decision concerning one narrow patent related to CAR products containing a pre-specified CD28 costimulatory domain, and a recent favorable result in a challenge at the USPTO to one of Kite’s important CAR-T patents, U.S. Patent Number 6,319,494. In August 2015, Kite preemptively filed a petition with the U.S. Patent and Trademark Office (USPTO) to institute an inter partes review (IPR) of U.S. Patent No. 7,446,190 owned by Sloan Kettering Institute for Cancer Research and licensed by Juno Therapeutics, Inc. The IPR was aimed at invalidating the ‘190 patent, which has a narrow scope directed to CAR products containing a pre-specified CD28 costimulatory domain. The USPTO’s recent ruling in this matter did not revoke the patent. However, Kite continues to believe the patent to be invalid and plans to appeal the USPTO decision to the U.S. Court of Appeals for the Federal Circuit. This patent does not have any counterpart patents outside of the United States. The USPTO’s decision will have no impact on the timing of the rolling submission or review of the Biologics License Application for Kite’s lead product candidate, axicabtagene ciloleucel (KTE-C19), a potentially lifesaving investigational therapy that has demonstrated the most advanced utilization of the CD28 costimulatory domain in a CAR-T therapy to date. Axicabtagene ciloleucel is currently being developed for the treatment of CD19 positive B cell malignancies, including non-Hodgkin lymphoma and acute lymphoblastic leukemia. Separately, Kite recently defeated an anonymous challenge filed against U.S. Patent Number 6,319,494, developed by Kite’s Senior Vice President of Discovery Research, Margo Roberts, Ph.D. and colleagues. This patent, which covers methods for treating a viral disease or malignancy using modified T cells that contain single-chain variable fragment (scFv) binding elements and other key CAR-T features, impacts multiple competitor CAR-T cell product candidates under development. In addition to the Roberts patent, Kite’s growing intellectual property portfolio encompasses more than 150 patent assets including an exclusive license to U.S. Patent No. 7,741,465, a leading and widely significant patent directed to CAR-T constructs, developed by Dr. Zelig Eshhar and colleagues. This patent, currently under reexam by the USPTO, potentially impacts CAR-T products under development by multiple Kite competitors. About Kite Pharma Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Kite’s ability to successfully appeal the USPTO decision not to revoke the ‘190 patent, Kite’s ability to enforce its patents and Kite’s expectations regarding its ability to obtain and maintain intellectual property protection for its product candidates. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2016. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
News Article | February 15, 2017
INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced a collaboration with Weill Cornell Medicine to identify new treatment approaches for chronic obstructive pulmonary disease (COPD) in order to develop novel treatments that could possibly halt or even reverse the progression of the disease process. The new, three-year collaboration combines Weill Cornell Medicine’s Department of Genetic Medicine’s unique understanding of chronic airway diseases and experience in the investigation of novel therapeutic concepts for airway repair with Boehringer Ingelheim’s expertise in the discovery and development of new therapies for respiratory diseases. This collaboration is the second collaboration between Boehringer Ingelheim and Weill Cornell Medicine, following prior work in inflammatory bowel disease (IBD). Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD. It cannot be cured and current treatment approaches focus on bronchodilation, reducing symptoms and preventing exacerbations to decelerate the downward spiral of the disease. The goal is to help patients keep as active as possible and overall, improve their quality of life. “Our continuous search for molecular drivers of chronic obstructive airway diseases has revealed novel repair mechanisms that warrant further investigation of their potential as therapeutic approaches,” said Dr. Ronald G. Crystal, Chairman of Genetic Medicine at Weill Cornell Medicine and lead investigator in the new collaboration. “We will look to further expand our knowledge about progressive airway destruction in close collaboration with Boehringer Ingelheim and focus on promising therapeutic concepts with the potential to slow down or halt progressive airway damage in patients with COPD.” “We are delighted to work with Dr. Crystal at Weill Cornell Medicine, who is one of the leading scientists in severe progressive airway diseases worldwide,” said Dr. Clive R. Wood, Senior Corporate Vice President, Discovery Research at Boehringer Ingelheim. “The scientists at Weill Cornell Medicine and Boehringer Ingelheim will work hand in hand to translate new discoveries into drug discovery and development programs at Boehringer Ingelheim. The new collaboration is an excellent example of our unique partnering approach and our focus on early innovation, underscoring our ambition to develop the next generation of medical treatments for patients with COPD.” Boehringer Ingelheim is combining a focus on cutting-edge science with a long-term view enabling the company to create a stable environment for the development of the next generation of medical breakthroughs. This new project adds another building block in this long-term strategy to improve the lives of patients with high unmet medical needs. Weill Cornell's Office of BioPharma Alliances and Research Collaborations negotiated the three-year collaboration. The office’s mission is to proactively generate, structure and market translational research alliances with industry in order to advance promising research projects that have commercial potential. For more information, contact Larry Schlossman at email@example.com or at 212-746-6909. For references and notes to editors, please visit:
Lieberman L.A.,Discovery Research |
Zeng W.,Discovery Research |
Singh C.,Discovery Research |
Wang W.,Discovery Research |
And 6 more authors.
Neurology | Year: 2016
Objective: To assess if the percentage of CD3 + CD4 + CD62L + cells in cryopreserved peripheral blood mononuclear cells (PBMCs) (here termed %CD62L) can predict risk of developing progressive multifocal leukoencephalopathy (PML) and better inform the physician for benefit-risk assessment of natalizumab treatment decisions in a global setting. Methods: Cryopreserved PBMCs from 21 natalizumab-treated patients who developed PML and 104 matched natalizumab-treated patients with multiple sclerosis (MS) without PML collected as a part of Biogen clinical trials were retrospectively examined for CD3, CD4, CCR7, CD45RA, and CD62L by flow cytometry. Results: In this cohort, %CD62L in natalizumab-treated patients did not predict PML risk. Natalizumab-treated patients with MS without PML showed highly variable %CD62L upon serial sampling. In the STRATA study, the distribution of %CD62L in samples collected more than 6 months before a PML diagnosis, at diagnosis, and in natalizumab-treated patients without PML overlapped. No statistical threshold for risk could be determined. In addition, we demonstrated that lymphocyte viability strongly affects %CD62L, supporting previous reports that %CD62L is inherently unstable following cryopreservation and is sensitive to sample collection. Conclusion: Data from this well-controlled cohort of natalizumab-treated patients indicate that %CD62L is not a biomarker of PML risk. © 2015 American Academy of Neurology.