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LOS ANGELES, CA--(Marketwired - February 21, 2017) - ITUS Corporation ("ITUS") ( : ITUS), a company using the power of the immune system to diagnose cancer, today announced that its abstract titled "Immuno-Profiling Circulating Blood as a Means of Early Detection of Solid Tumors," has been accepted for a presentation at the national conference of the American Association of Cancer Research ("AACR"), which will be held from April 1 to April 5 in Washington, D.C. Data from ITUS's ongoing cancer patient study will be presented during a poster discussion session. The discussion will be led by Dr. Amit Kumar, inventor of ITUS's early cancer detection technology. The presentation will be part of a session entitled "Checkpoint Inhibitor and Prognostic Biomarkers," which will take place on April 2, 2017 from 1:00 P.M. to 5:00 P.M, Eastern Time. The abstract will also be published in the Proceedings of the AACR. Dr. Kumar, Executive Chairman of ITUS Corporation, stated, "We are pleased to have the opportunity to present the latest data from our patient study to a distinguished scientific audience, as AACR attracts leading scientists and physicians at the forefront of cancer research. AACR will mark the first scientific presentation of our data, and as our research and development progresses, we will seek additional opportunities to present our data and publish our results in leading scientific journals." The AACR (www.aacr.org) is the oldest and largest scientific organization in the world focused on every aspect of high-quality, innovative cancer research. Its reputation for scientific breadth and excellence attract the premier researchers in the cancer field. The programs and services of the AACR foster the exchange of knowledge and new ideas among scientists dedicated to cancer research, provide training opportunities for the next generation of cancer researchers, and increase public understanding of cancer. The mission of the American Association for Cancer Research is to prevent and cure cancer through research, education, communication, and collaboration. ITUS funds, develops, acquires, and licenses emerging technologies in areas such as biotechnology. The Company is developing a platform called Cchek™, a series of non-invasive, blood tests for the early detection of solid tumor based cancers, which is based on the body's immunological response to the presence of a malignancy. Additional information is available at www.ITUScorp.com. Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2016 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.


Bottom Line: Women who consumed a diet as adolescents or young adults associated with chronic inflammation had a higher risk for premenopausal breast cancer compared with those whose adolescent and early adulthood diet was not associated with chronic inflammation Journal in Which the Study was Published: Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. Author: Karin B. Michels, ScD, PhD, professor and chair of the Department of Epidemiology at the UCLA Fielding School of Public Health, Los Angeles. Background: A diet low in vegetables and high in sugar-sweetened and diet soft drinks, refined sugars and carbohydrates, red and processed meats, and margarine has been linked to high levels of inflammatory markers in the blood, according to Michels. "Because breast cancer takes many years to arise, we were curious whether such a diet during the early phases of a woman's life is a risk factor for breast cancer," she said. How the Study Was Conducted and Results: For this study, Michels and colleagues used data from 45,204 women enrolled in the Nurses' Health Study II who had completed a food frequency questionnaire in 1998, when they were ages 33-52, about their diet during high school. Adult diet was assessed first using a food frequency questionnaire in 1991, when participants were ages 27-44, and then every four years after that. Each woman's diet was given an inflammatory score using a method previously developed that links diet with inflammatory markers in the blood. During 22 years of follow-up, 870 of the women who completed the high school food frequency questionnaire were diagnosed with premenopausal breast cancer and 490 were diagnosed with postmenopausal breast cancer. When women were divided into five groups based on the inflammatory score of their adolescent diet, those in the highest score group had a 35 percent higher risk for premenopausal breast cancer relative to those in the lowest score group. When the same analysis was done based on early adulthood diet, those in the highest inflammatory score group had a 41 percent higher risk for premenopausal breast cancer relative to those in the lowest score group. Diet inflammatory score was not associated with overall breast cancer incidence or postmenopausal breast cancer. Author Comment: "Our results suggest that a habitual diet that promotes chronic inflammation when consumed during adolescence or early adulthood may indeed increase the risk of breast cancer in younger women before menopause," said Michels. "About 12 percent of women in the United States develop breast cancer in their lifetimes," she added. "However, each woman's breast cancer risk is different based on numerous factors, including genetic predisposition, demographics, and lifestyle. Our study suggests that a habitual adolescent/early adulthood diet that promotes chronic inflammation may be another factor that impacts an individual woman's risk. "During adolescence and early adulthood, when the mammary gland is rapidly developing and is therefore particularly susceptible to lifestyle factors, it is important to consume a diet rich in vegetables, fruit, whole grains, nuts, seeds, and legumes and to avoid soda consumption and a high intake of sugar, refined carbohydrates, and red and processed meats," Michels noted. Limitations: According to Michels, it is important to note that although this is an association study, it is not feasible to perform a causal study because that would require randomizing individuals to a particular diet for a long period of time and following them for decades. She also explained that the main limitations of the current study are that diet during adolescence was recalled by the participants at a later date and that the researchers did not have adolescent or early adulthood measurements of blood markers of inflammation in this study. Funding & Disclosures: Grants from the National Cancer Institute supported this study and continue to support the Nurses' Health Study II. Michels declares no conflicts of interest. About the American Association for Cancer Research Founded in 1907, the American Association for Cancer Research (AACR) is the world's first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 37,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 108 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops, the largest of which is the AACR Annual Meeting with nearly 19,500 attendees. In addition, the AACR publishes eight prestigious, peer-reviewed scientific journals and a magazine for cancer survivors, patients, and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration, and scientific oversight of team science and individual investigator grants in cancer research that have the potential for near-term patient benefit. The AACR actively communicates with legislators and other policymakers about the value of cancer research and related biomedical science in saving lives from cancer. For more information about the AACR, visit http://www. . To interview Karin B. Michels, contact Julia Gunther at julia.gunther@aacr.org or 215-446-6896.


CAMBRIDGE, Mass., March 02, 2017 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that it will present data from the Phase IB dose expansion study of RAF dimer inhibitor BGB-283 in patients with B-RAF or K-RAS/N-RAS mutated solid tumors in an oral presentation during a Clinical Trials Plenary Session at the 2017 American Association for Cancer Research (AACR) Annual Meeting. In addition, the company expects a decision in the first quarter of 2017 from its partner Merck KGaA on its continuation option to develop and commercialize BGB-283 outside China after Merck’s review of Phase I data. At AACR, BeiGene will also present three posters related to its pipeline agents, BGB-A317 (PD-1 antibody), BGB-3111 (BTK inhibitor), and BGB-A425 (Tim-3 antibody). The AACR Annual Meeting will take place April 1-5 in Washington, DC. Details for the oral presentation and posters are provided below. Further details can be found on the AACR website. Title: A Phase IB study of RAF dimer inhibitor BGB-283 in patients with B-RAF or K-RAS/N-RAS mutated solid tumors Abstract #2010: Hu N. et al., BTK inhibitor BGB-3111 demonstrates anti-tumor activity in solid tumor models. Mon., Apr. 3, 8:00 AM -12:00 PM Abstract #5626: Luo L. et al., Investigation of T cell activation by anti-human PD-1 antibodies Nivolumab, Pembrolizumab and BGB-A317 using tumor-infiltrating lymphocytes (TILs) from colorectal cancer and colorectal liver metastasis patients. Wed., Apr. 5, 8:00 AM – 12:00 PM Discovered by BeiGene scientists, BGB-283 is a novel RAF inhibitor with unique RAF dimer and EGFR inhibition activities. BGB-283 has shown antitumor activities in preclinical models and in cancer patients not only in tumors with BRAF V600E mutation but also those with non-V600E BRAF mutations and KRAS/NRAS mutations. BGB-283 was partnered with Merck KGaA in 2013 prior to the initiation of its clinical development. Pursuant to the license agreements for territories in and outside China respectively, BeiGene has exclusive development and commercial rights to BGB-283 in China, and Merck KGaA has an exclusive license to develop and manufacture BGB-283, and, subject to the exercise of a continuation option based on review of Phase I data, to commercialize and manufacture BGB-283 in markets outside of China. BeiGene retained the responsibility to perform pre-specified Phase 1 clinical trials and if Merck KGaA exercises its continuation option, it will pay BeiGene a continuation fee based on the costs of conducting the relevant trials, subject to a certain cap. If Merck KGaA does not exercise its continuation option, the ex-China agreement will terminate in its entirety except for certain provisions that will survive the termination. BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 300 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the timing of Merck KGaA’s decision to exercise its continuation option to develop and commercialize BGB-283 outside China after Merck’s review of Phase I data. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.


News Article | March 1, 2017
Site: globenewswire.com

AMES, Iowa, March 01, 2017 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, today reported that two abstracts on the company’s indoximod program will be presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting in Washington, D.C. The complete text of Clinical Plenary Session abstracts that have not been selected for the press program will be posted online at 4:30 p.m. ET on Friday, March 31. The text of clinical trials abstracts that have been selected for inclusion in the press program will not be posted online until the date and time of presentation. "We are honored to have been selected by the AACR review committee for the Clinical Trials Plenary Session at the upcoming AACR meeting,” said Nicholas Vahanian, M.D., President and Chief Medical Officer.  “We look forward to sharing the data from both of these abstracts.” NewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer.  For more information, please visit http://www.newlinkgenetics.com This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties.  All statements, other than statements of historical fact, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.  These forward-looking statements include, among others, statements about  results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional indications into clinical development; and any other statements other than statements of historical fact.  Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink Genetics' Annual Report on Form 10-K for the year ended December 31, 2015 and other reports filed with the U.S. Securities and Exchange Commission (SEC).  The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change.  However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.  You should, therefore, not rely on these forward-looking statements as representing NewLink Genetics' views as of any date subsequent to the date of this press release.


CLINICAL AND PRECLINICAL DATA ON MONALIZUMAB TO BE PRESENTED AT AACR ANNUAL MEETING 2017 Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH) today announces that data on monalizumab will be presented at the American Association for Cancer Research (AACR) Annual Meeting, April 1 - 5, 2017, in Washington, D.C. Abstracts are available on the AACR website. Monalizumab is Innate Pharma's investigational first-in-class anti-NKG2A antibody partnered with AstraZeneca. These data support the rationale for the development of monalizumab: -      Preclinical data will be presented in a mini-symposium and show NKG2A expression on tumor-infiltrating CD8+ T cells in patients with head and neck cancer as well as synergy between treatment with a HPV vaccine and NKG2A blockade in a mouse tumor model; -      During a poster session, safety data from the dose-escalation part of a Phase Ib/II study evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck will be presented. In this study, monalizumab plus cetuximab were well tolerated with no additional safety concerns compared to monalizumab or cetuximab alone. Monalizumab is currently being tested in five Phase I and I/II clinical trials in various cancer as a single agent and in combination with other therapies. Monalizumab is a first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8 T lymphocytes and NK cells. NKG2A is an inhibitory receptor binding HLA-E. Expression of HLA-E can protect cancer cells from killing by NKG2A+ immune cells. HLA-E is frequently up-regulated and widely expressed on cancer cells of many solid tumors or hematological malignancies. In some cancers, HLA-E expression is associated with poor prognosis. Monalizumab, a humanized IgG4, blocks the binding of NKG2A to HLA-E allowing activation of NK and cytotoxic T cell responses. By blocking inhibitory NKG2A receptors, monalizumab may re-establish a broad anti-tumor response mediated by NK and T cells. Monalizumab may also enhance the cytotoxic potential of other therapeutic antibodies. Monalizumab is partnered with AstraZeneca and MedImmune, AstraZeneca's global biologics research and development arm, through a co-development and commercialization agreement. The initial development plan includes a combination trial with durvalumab (MEDI4736) in solid tumors conducted by AstraZeneca as well as multiple Phase II trials conducted by Innate Pharma, to study monalizumab efficacy as a monotherapy and in combinations with currently approved treatments in several cancer indications. As previously announced, under the terms of this agreement, Innate Pharma is eligible to cash payments of up to $1.275 billion as well as double digit royalties on sales. In addition to the initial payment of $250 million, AstraZeneca will pay Innate Pharma a further $100 million at the decision to go into Phase III development, as well as additional regulatory and sales-related milestones of up to $925 million. AstraZeneca will book all sales and will pay Innate Pharma double-digit royalties on net sales. The arrangement includes the right for Innate Pharma to co-promote in Europe for a 50% profit share in the territory. Innate Pharma S.A. is a clinical-stage biotechnology company with a focus on discovering and developing first-in-class therapeutic antibodies that harness the innate immune system to improve cancer treatment and clinical outcomes for patients. Innate Pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body's immune system to recognize and kill cancer cells. The Company's aim is to become a fully-integrated biopharmaceutical company in the area of immunotherapy and focused on serious unmet medical needs in cancer. Innate Pharma has pioneered the discovery and development of checkpoint inhibitors to activate the innate immune system. Innate Pharma's innovative approach has resulted in three first-in-class, clinical-stage antibodies targeting natural killer cell receptors that may address a broad range of solid and hematological cancer indications as well as additional preclinical product candidates and technologies. Targeting receptors involved in innate immunity also creates opportunities for the Company to develop therapies for inflammatory diseases. The Company's expertise and understanding of natural killer cell biology have enabled it to enter into major alliances with leaders in the biopharmaceutical industry including AstraZeneca, Bristol-Myers Squibb and Sanofi. Based in Marseille, France, Innate Pharma has more than 150 employees and is listed on Euronext Paris. Learn more about Innate Pharma at www.innate-pharma.com. This press release contains certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference prospectus filed with the AMF, which is available on the AMF website (http://www.amf-france.org) or on Innate Pharma's website. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.


MENLO PARK, Calif., March 02, 2017 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced an abstract submitted by Janssen Research & Development, LLC describing non-clinical data on imetelstat has been accepted for presentation as a poster at the 2017 American Association for Cancer Research (AACR) Annual Meeting to be held in Washington, D.C. from April 1-5, 2017. The abstract is available on the AACR website at www.aacr.org. Abstract Title: Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia (Abstract #1101) In accordance with AACR policies, abstracts submitted to the AACR Annual Meeting are embargoed from the time of submission. To be eligible for presentation at the AACR Annual Meeting, information contained in the abstract, as well as additional data and information to be presented at the Annual Meeting, may not be made public before the abstract has been presented in connection with the AACR Annual Meeting. Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.


News Article | March 1, 2017
Site: globenewswire.com

Heidelberg, Germany, March 1, 2017 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, announced today that preclinical data for Affimed's lead candidate AFM13, the Company's preclinical programs AFM24 and AFM26, as well as data on its MHC-peptide-targeting discovery program will be presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting being held April 1 - 5, 2017 in Washington, D.C. Abstract: The tetravalent bispecific antibody AFM13 engages and primes innate immune cells for anti-cancer immunity (#2997) Presentation (Minisymposium): Monday April 3, 2017, 4:05 - 4:20 PM; Room 152, Level 1 AFM13 is a high affinity tetravalent bispecific antibody with bivalent binding to both CD30 and CD16A, which is currently being tested as monotherapy in Phase 2 and in combination with Merck's Keytruda® in Phase 1b clinical trials. Affimed has previously shown that AFM13 enhances the sensitivity of NK-cells to low doses of IL-2 and IL-15, leading to an increased NK-cell proliferative potential. In the present study, the Company describes an expanded panel of phenotypic NK-cell markers modulated after exposure to CD30+ tumor cells in the presence of AFM13. In addition, Affimed presents data on the kinetics of NK-cell responses to AFM13 exposure, demonstrating in vitro that the transiently reduced potency induced by long-term AFM13 exposure can be rescued via cytokine stimulation. Taken together, AFM13 specifically enhances the cytotoxic, proliferative and cytokine-producing potential of NK-cells, which are parameters that can be utilized to monitor NK-cell responses during AFM13 therapy. Based on Affimed's data, recruiting of CD16A+ cells to the tumor site might enable several immune effector functions for synergistic anti-tumoral activity. Abstract: EGFR/CD16A TandAbs are efficacious NK-cell engagers with favorable biological properties which potently kill EGFR+ tumors with and without Ras mutation (#3641/14) Presentation (Poster): Tuesday April 4, 2017 8:00 AM - 12:00 PM; Poster Section 26 Constitutive EGFR activation plays an important role in the pathophysiology of various solid cancers. Although molecules modulating signal transduction and activation of EGFR, such as tyrosine kinase inhibitors and monoclonal antibodies (mAbs), are approved for treatment of EGFR+ cancers, intrinsic or acquired resistance to these agents has been described for a larger number of patients. Utilizing the cytotoxic potential of NK-cells to eliminate EGFR-expressing tumors, Affimed has developed AFM24, a tetravalent, bispecific EGFR/CD16A-targeting antibody. In the present study, AFM24's cytotoxic activity was tested against several EGFR+ tumor cell lines with and without Ras mutation, which is a negative prognostic biomarker for mAbs such as cetuximab or panitumumab. AFM24 induced efficient killing of cetuximab-resistant cells in vitro and in vivo. Importantly, AFM24 did not activate NK-cells without target cell-binding. A further differentiating feature of AFM24 is that its binding to CD16A and cytotoxic efficacy is virtually unaffected by serum IgG, resulting in higher efficacy compared to monoclonal antibodies. These data demonstrate that AFM24 has the potential to exhibit a favorable side effect profile, reduce toxicity and overcome resistance to other targeted anti-EGFR therapeutic agents. Abstract: AFM26 - A novel CD16A-directed bispecific TandAb targeting BCMA for multiple myeloma (#5671/25) Presentation (Poster): Wednesday April 5, 2017 8:00 AM - 12:00 PM; Poster Section 28 Multiple myeloma (MM) is the second most common hematological cancer and is characterized by the accumulation of neoplastic plasma cells in the bone marrow and production of high levels of monoclonal immunoglobulin (M-protein). While new treatments of MM have been developed recently, an unmet need remains as most patients eventually relapse and/or become refractory to currently available treatments. B-cell maturation antigen (BCMA, CD269) has emerged as a particularly attractive target due to its limited expression on healthy tissues and almost universal expression on myeloma cells in the majority of patients. In the present study, Affimed describes the characterization of AFM26, a novel tetravalent bispecific NK-cell engager targeting BCMA and CD16A. AFM26 interacts bivalently with NK-cells, resulting in high avidity, prolonged cell surface retention and potent induction of NK-cell-mediated in vitro lysis of target cells. Binding and cytotoxicity are not impaired at high levels of polyclonal IgG, suggesting that, AFM26, in contrast to classical mAbs, retains full ADCC activity at high serum IgG levels. This is particularly important as about half of MM patients present with high levels of IgG-type M-protein. These data support development of AFM26 as a promising and highly potent drug candidate for MM treatment. Abstract: Identification of antibodies against a novel tumor-associated MHC/peptide-target and generation of highly specific and potent HLA-A*02MMP1-003/CD3 TandAbs (#3753/9) Presentation (Poster): Tuesday April 4, 2017 8:00 AM - 12:00 PM; Poster Section 30 Tumor-specific antigens for effective and safe T-cell engagement are very limited, leaving a high need to widen the therapeutic target space. Targeting disease-specific MHC/peptide complexes with bispecific T-cell-recruiting antibodies is a highly attractive strategy to address this need. However, so far, generation of antibodies against these peptides has been reported to be challenging. Together with its collaboration partner Immatics, Affimed has identified a novel tumor-associated MHC/peptide complex, the HLA-A*02-binding peptide MMP1-003, originating from matrix metalloproteinase 1 (MMP1). Overcoming the barrier of developing antibodies targeting specific MHC/peptide complexes, Affimed has generated and characterized highly specific and potent T-cell-recruiting tetravalent bispecific antibodies directed towards MMP1-003. In a panel of endogenously target-expressing cancer cell lines, the lead molecule demonstrated excellent target specificity as well as potent cytotoxicity with EC50 values in the pM range. Thus, Affimed's antibody technology holds the potential for opening up the therapeutic target space for T-cell engagement by providing access to intracellular target antigens that are presented in a disease-specific manner as MHC/peptide complexes. Full abstracts of the presentations can be accessed on the AACR website at www.aacr.org Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK- and T-cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit www.affimed.com. This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates our intellectual property position, our collaboration activities, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading "Risk Factors" in Affimed's filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines to control the expression of disease-driving genes, today announced that the Company will present new data on three of its clinical and preclinical programs at the American Association for Cancer Research (AACR) Annual Meeting taking place April 1-5 in Washington, D.C. The new data will be highlighted in five presentations: “The presentations at AACR showcase both the productivity of Syros’ gene control platform and the potential of our first-in-class programs to provide a meaningful benefit for patients with a range of aggressive cancers both as single agents and in combination with other targeted therapies,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “Our platform is the first focused solely on the regulatory genome to systematically identify and target disease-causing alterations in gene expression with the aim of treating diseases that have eluded other genomic-based approaches. In just three years since our inception, this pioneering approach has led to a robust and growing pipeline, with our lead program in a Phase 2 clinical trial, our second program poised to start clinical development in the first half of this year and multiple other programs in preclinical development. We are excited to be presenting data from multiple programs across all stages of our pipeline.” Details on the presentations are as follow: Date & Time: Monday, April 3, from 8 a.m. - 12 p.m. ET Presentation Title: AML patient clustering by super-enhancers reveals an RARA associated transcription factor signaling partner Session Category: Molecular and Cellular Biology / Genetics Session Title: Targeting Aberrant Transcription in Cancer Presenter: Michael R. McKeown, Ph.D., Senior Scientist, Translational Biology, Syros Abstract Number: 1511 Location: Walter E. Washington Convention Center, Halls A-C, Poster Section 20 Date & Time: Monday, April 3, from 8 a.m. - 12 p.m. ET Presentation Title: SY-1365, a potent and selective CDK7 inhibitor, exhibits promising anti-tumor activity in multiple preclinical models of aggressive solid tumors Session Category: Experimental and Molecular Therapeutics Session Title: New Targets 1 Presenter: Christian Fritz, Ph.D., Vice President, Biology, Syros Abstract Number: 1151 Location: Walter E. Washington Convention Center, Halls A-C, Poster Section 4 Date & Time: Monday, April 3, from 8 a.m. - 12 p.m. ET Presentation Title: Targeting the transcriptional kinases CDK12 and CDK13 in breast and ovarian cancer Session Category: Experimental and Molecular Therapeutics Session Title: New Targets 1 Presenter: Michael Bradley, Ph.D., Principal Scientist, Biochemistry & Biophysics, Syros Abstract Number: 1143 Location: Walter E. Washington Convention Center, Halls A-C, Poster Section 4 Date & Time: Monday, April 3, from 1 - 5 p.m. ET Presentation Title: SY-1425, a selective RARα agonist, induces high levels of CD38 expression in RARA-high AML tumors creating a susceptibility to anti-CD38 therapeutic antibody treatment Session Category: Immunology Session Title: Immune Response to Hematopoietic Tumors: New Development in Tumor Immunology Presenter: Kathryn Austgen, Ph.D., Senior Scientist, Immuno-Oncology, Syros Abstract Number: 2644 Location: Walter E. Washington Convention Center, Halls A-C, Poster Section 26 Date & Time: Tuesday, April 4, from 8 a.m. – 12 p.m. ET Presentation Title: SY-1425 (tamibarotene), a selective RARα agonist, shows synergistic anti-tumor activity with hypomethylating agents in a biomarker selected subset of AML Session Category: Experimental and Molecular Therapeutics Session Title: Differentiation Therapy Presenter: Michael R. McKeown, Ph.D., Senior Scientist, Translational Biology, Syros Abstract Number: 3085 Location: Walter E. Washington Convention Center, Halls A-C, Poster Section 3 About Syros Pharmaceuticals Syros Pharmaceuticals is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of disease-driving genes. Syros has built a proprietary platform that is designed to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, Syros’ gene control platform has broad potential to create medicines that achieve profound and durable benefit across a range of diseases. Syros is currently focused on cancer and immune-mediated diseases and is advancing a growing pipeline of gene control medicines. Syros’ lead drug candidates are SY-1425, a selective RARα agonist in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor with potential in a range of solid tumors and blood cancers. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Mass. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the clinical progress of and potential benefits from treatment with SY-1425, the initiation of clinical development of SY-1365, the ability to advance preclinical programs, and the benefits of Syros’ gene control platform. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: Syros’ ability to: advance the development of its programs, including SY-1425 and SY-1365, under the timelines it projects ; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; replicate scientific and non-clinical data in clinical trials; successfully develop a companion diagnostic test to identify patients with biomarkers associated with the RARA super-enhancer; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; risks described under the caption “Risk Factors” in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, which is on file with the Securities and Exchange Commission; and risks described in other filings that the company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Syros expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.


News Article | February 20, 2017
Site: globenewswire.com

Basel, Switzerland, February 20, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced its financial results for 2016 today with product sales from Cresemba® (isavuconazole) and Zevtera®/Mabelio® (ceftobiprole) of CHF 7.1 million in Europe, royalties on US Cresemba sales of CHF 7.3 million, total revenue of CHF 66.0 million, a year-end cash and financial investment position of CHF 289.0 million and a reduced operating loss of CHF 43.9 million. Basilea's CEO Ronald Scott said: "We've launched Cresemba addressing severe fungal infections in the first European markets and made substantial progress in the commercialization of both Cresemba and our antibiotic Zevtera/Mabelio. We are pleased to announce that we achieved sales for the full year of CHF 7.1 million in Europe. The Cresemba launch is also going well in the USA, where our license partner Astellas Pharma US reported 2016 sales of USD 46 million, on which we received CHF 7.3 million in royalties." He continued: "We plan to initiate a ceftobiprole clinical phase 3 development program under our agreement with BARDA in mid-2017 to support a potential future US regulatory filing and we continue to make good progress on our oncology development programs addressing tumor resistance. We were able to expand our BAL101553 oral phase 1/2a study to include brain cancer patients according to plan." Anti-infectives: Cresemba and Zevtera/Mabelio marketed by Basilea in first European countries with partnerships in place for important additional markets Basilea is marketing Cresemba and Zevtera/Mabelio in Germany, Italy, the UK, France and Austria; Zevtera is also marketed in Switzerland. Basilea's licensing partner Astellas Pharma US markets Cresemba in the United States. In 2016, Basilea entered into distribution agreements for isavuconazole and ceftobiprole with Grupo Biotoscana S.L. in nineteen Latin American countries and with Unimedic Pharma AB for the Nordics. The distribution agreement with Hikma Pharmaceuticals LLC for the Middle East and North Africa (MENA) region was extended to include isavuconazole in addition to ceftobiprole. In addition, Basilea concluded a license agreement with Asahi Kasei Pharma Corporation for the development and commercialization of isavuconazole in Japan. Basilea's existing partnerships cover more than forty countries around the world in addition to the countries that Basilea is directly serving. The latest guideline issued by the European Conference on Infections in Leukaemia (ECIL) recommends Cresemba for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients. The guideline states that isavuconazole is as effective as voriconazole with a better safety profile.1 This recommendation in one of the most relevant treatment guidelines in Europe underscores the potentially important clinical role of Cresemba in the treatment of patients with these life-threatening infections. Contract with BARDA to support ceftobiprole phase 3 development for US market Basilea entered into a contract in 2016 with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US, the largest market value-wise for branded hospital antibiotics. BARDA provides initial funding of approximately USD 20 million for the preparation of the phase 3 program. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Basilea submitted clinical study protocols to the US Food and Drug Administration (FDA) for two phase 3 studies, one in Staphylococcus aureus bacteremia (SAB) and one in acute bacterial skin and skin structure infections (ABSSSI). Basilea will initiate the phase 3 clinical development program once it completes the FDA Special Protocol Assessment (SPA) process. Two oncology drug candidates in clinical development: tumor checkpoint controller BAL101553 and panRAF/SRC kinase inhibitor BAL3833 In 2016 Basilea further strengthened its oncology pipeline, the second pillar of its hospital-focused strategy, by broadening BAL101553's clinical development program. A separate study arm for patients with glioblastoma was added to the ongoing phase 1/2a clinical study with oral BAL101553, based data in preclinical glioblastoma tumor models demonstrating activity of the drug candidate in this often lethal brain cancer. Potential patient-selection biomarkers have also been identified and will be assessed in BAL101553-treated glioblastoma patients. In addition, a further phase 1/2a clinical study was initiated to explore continuous intravenous infusion. Dose-escalation in the phase 1 study with orally administered BAL3833 in patients with solid tumor cancers, including metastatic melanoma, is continuing with the aim to determine the maximum tolerated dose. Preclinical data on BAL3833 presented at the American Association for Cancer Research (AACR) annual meeting showed that the drug candidate has anti-cancer activity in KRAS-driven in vitro and in vivo tumor models via inhibition of the RAF and SRC family kinases. This indicates that BAL3833 may also be effective in non-melanoma KRAS-mutant cancers such as pancreatic, colorectal and non-small-cell lung cancer, potentially providing a new therapeutic option in these indications. Focus 2017 on growing product sales and progress in pipeline Basilea's CEO Ronald Scott stated: "In 2017, we expect to further grow our product sales as we continue to execute on our commercialization and partnering strategy. We anticipate seeing initial contributions from our current distributors as their first marketing authorizations are granted. We are also working towards further agreements with potential partners to cover remaining commercially relevant markets including Asia Pacific, Russia/CIS, and certain European countries. In addition, we anticipate that Swissmedic will complete its review of our isavuconazole marketing authorization application in 2017." He added: "An important goal for us this year is to finalize the Special Protocol Assessment process with the US FDA in order to start the clinical phase 3 program for ceftobiprole under our BARDA contract. Our initial focus will be on skin and bloodstream infections, two areas of high medical need." Ceftobiprole will have a total of ten years of market exclusivity in the US from potential approval based on its Qualified Infectious Disease Product designation granted by the FDA. Upon successful completion of the studies, the phase 3 data could be used to support supplemental marketing authorization applications for ceftobiprole in Europe and other territories, potentially resulting in label extensions for ceftobiprole. In 2017, Basilea will further advance the clinical development of its oncology drug candidates and expects to complete dose-escalation in BAL101553's phase 1/2a studies and BAL 3833's phase 1 study. Notes: Consolidated figures in conformity with US GAAP; rounding was consistently applied. The consolidated financial statements of Basilea Pharmaceutica Ltd. for the financial year 2016 can be found on the company's website at http://annualreport.basilea.com. Full-year product revenue 2016 amounted to CHF 7.1 million (2015: none). Contract revenue 2016 amounted to CHF 57.7 million (2015: CHF 51.2 million), including CHF 37.7 million (2015: CHF 37.6 million) related to the global agreement for Toctino® and CHF 19.3 million (2015: CHF 13.6 million) related to the license agreement with Astellas for isavuconazole. Total operating income in 2016 including sales amounted to CHF 66.0 million (2015: CHF 52.8 million). Research and development net expenses in 2016 amounted to CHF 48.4 million (2015: CHF 60.1 million) and were mainly related to activities for the phase 1/2a development of oncology drug candidate BAL101533, phase 1 clinical development of oncology drug candidate BAL3833, costs for the pediatric program for ceftobiprole and activities related to isavuconazole. The decrease of CHF 11.7 million as compared to 2015 is mainly due to 2015 isavuconazole pre-launch activities. Selling, general and administration expenses in 2016 amounted to CHF 56.1 million (2015: CHF 54.2 million), and included costs related to the commercialization of Cresemba and Zevtera/Mabelio and stock-based compensation of CHF 4.2 million (2015: CHF 4.6 million). In 2016, the operating loss was reduced by 29% to CHF 43.9 million from CHF 61.5 million in 2015 and net loss 2016 was reduced to CHF 51.3 million (2015: CHF 61.6 million), resulting in a lower basic and diluted loss per share of CHF 5.07 (2015: CHF 6.09). The net cash used for operating activities in 2016 amounted to CHF 75.0 million as compared to CHF 67.8 million in 2015. The increase in comparison to 2015 is mainly due to the milestone payment from Astellas in 2015 upon approval of isavuconazole in the US, which reduced the net cash used in the previous period. Combined cash and financial investments amounted to CHF 289.0 million as of December 31, 2016, compared to CHF 364.7 million as of December 31, 2015. Basilea continues to focus on growing sales of its two marketed products while at the same time advancing its clinical development pipeline. Basilea anticipates total annual product sales of approximately CHF 15 million in 2017, a more than 100% increase over 2016, and a participation in US sales through royalties of approximately CHF 14 million. Total operating expenses after anticipated BARDA reimbursements for 2017 are estimated at approximately CHF 10 million on average per month with an operating loss of approximately CHF 3 million on average per month. Cresemba (isavuconazole) - an i.v. and oral azole antifungal for the treatment of invasive mold infections Isavuconazole is an i.v. and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.3 The European marketing authorization is valid in all 28 European Union (EU) member states, as well as in Iceland, Liechtenstein and Norway. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea is marketing isavuconazole as Cresemba in Germany, Italy, the UK, France and Austria. In the United States Cresemba is marketed by Basilea's licensee Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. The European Conference on Infections in Leukaemia (ECIL) recommends isavuconazole in its current guideline for the first-line treatment of invasive aspergillosis in leukemia and hematopoietic stem cell transplant patients.1 Zevtera/Mabelio (ceftobiprole) - a broad-spectrum antibiotic from the cephalosporin class for i.v. administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp. Ceftobiprole (European trade name Zevtera or Mabelio, depending on the country) is approved for sale in 13 European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).4 Basilea is currently marketing the drug in Germany, Italy, the UK, France, Austria and Switzerland. Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation from the US FDA for the potential treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The drug is not approved in the United States. In 2016, Basilea entered into a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the clinical phase 3 development of ceftobiprole to support a potential regulatory filing in the US. The total value of the BARDA contract could reach USD 100 million over a period of 4.5 years if pre-defined milestones are met. Initial studies are planned in acute bacterial skin structure infections (ABSSSI) and Staphylococcus aureus bacteremia (SAB). BAL101553 - a tumor checkpoint controller in phase 1/2a clinical testing in patients with advanced solid tumors including recurrent or progressive glioblastoma The small molecule oncology drug candidate BAL101553 (prodrug of BAL27862) is being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapeutics. The drug is currently undergoing clinical phase 1/2a evaluation (oral and continuous infusion) in patients with advanced solid tumors. In December 2016, the oral study was extended by adding a separate arm for patients with recurrent or progressive glioblastoma after prior radiotherapy. The drug candidate has shown evidence of clinical anti-tumor activity in a phase 1/2a study with weekly 2-hour i.v. infusion, during which the maximum tolerated dose and the recommended phase 2 dose for this administration regimen was established.5 BAL3833 (also known as CCT3833) is an orally administered small-molecule panRAF/SRC kinase inhibitor targeting cell proliferation signaling pathways that are associated with tumor growth and resistance development to current therapies. It is the lead compound of a series of kinase inhibitors in-licensed by Basilea in April 2015 under an agreement with The Institute of Cancer Research, Cancer Research Technology, the Wellcome Trust, and The University of Manchester. BAL3833 is currently being investigated in a phase 1 study in adult patients with advanced solid tumors including metastatic melanoma. The compound originates from the renowned UK cancer research institution, The Institute of Cancer Research, where it was developed by scientists funded by Cancer Research UK and the Wellcome Trust. Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Monday, February 20, 2017, 4 p.m. (CET), during which the company will discuss today's press release. A playback will be available 1 hour after the conference call until Wednesday, February 22, 2017, 6 p.m. (CET). Participants requesting a digital playback may dial: and will be asked to enter the ID 19991 followed by the # sign. The shareholders of Basilea Pharmaceutica Ltd. are informed that the Ordinary General Meeting of Shareholders of Basilea Pharmaceutica Ltd. for the business year 2016 will take place on Thursday, April 27, 2017 at 2 p.m. at the Radisson Blu Hotel in Basel, Switzerland. The invitation will be published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt, SHAB). Shareholders who are recorded in the share register with voting rights on April 13, 2017 will be entitled to participate and exercise their voting rights. Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address the medical problem of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com. This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: This press release can be downloaded from www.basilea.com. 1  F. Tissot et al. ECIL-6 guidelines for the treatment of invasive candidiasis, aspergillosis and mucormycosis in leukemia and hematopoietic stem cell transplant patients. Haematologica 2016 (101), published online ahead of print; www.haematologica.org/content/early/2016/12/20/haematol.2016.152900 [Accessed February 17, 2017] 2  Cresemba US prescribing information [Accessed: February 17, 2017] 3  European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: February 17, 2017] 4  UK Summary of Product Characteristics (SPC) Zevtera®: http://www.mhra.gov.uk/ [Accessed: February 17, 2017] 5  J. Lopez et al. Phase 1/2a trial of intravenous BAL101553, a novel tumor checkpoint controller (TCC), in advanced solid tumors. American Society of Clinical Oncology (ASCO) annual meeting 2016, abstract 2525, poster board #225


LONDON, UK / ACCESSWIRE / March 2, 2017 / Active Wall St. blog coverage looks at the headline from Kite Pharma Inc. (NASDAQ: KITE) as the Company announced on February 28th, 2017, announced that a preliminary analysis of ZUMA-1 for its lead CAR-T candidate axicabtagene ciloleucel, in patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL) revealed positive results. Register with us now for your free membership and blog access at: One of Kite Pharma's competitors within the Biotechnology space, Grifols, S.A. (NASDAQ: GRFS), is estimated to report earnings on March 06, 2017. AWS will be initiating a research report on Grifols following the release of its next earnings results. Today, AWS is promoting its blog coverage on KITE; touching on GRFS. Get all of our free blog coverage and more by clicking on the link below: Kite Pharma's lead product candidate, axicabtagene ciloleucel, formerly known as KTE-C19 is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the US Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU. Kite announced that the Zuma-1 study met the primary endpoint of achieving an objective response rate (ORR), or rates of tumor response recorded after a single infusion of axicabtagene ciloleucel, with 82%. The Company stated that these results demonstrated the treatment effect of axicabtagene ciloleucel in a patient population with multiple types of aggressive NHL, including diffuse large B-cell lymphoma (DLBCL) enrolled in Cohort 1, as well as primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) enrolled in Cohort 2. One hundred one patients were treated in ZUMA-1. Four of the 101 patients in ongoing CR did not have a month 6 tumor assessment prior to the data cut-off and are therefore categorized as non-responders for month 6. At month 6, 41% of treated patients achieved a response; including 36% in CR. Five of the 101 patients (5%) continue to experience highly significant and durable partial responses (PR) with minimal abnormalities in PET scans. One of these PRs converted to a CR at month 9. With a median follow-up of 8.7 months for this primary analysis, the median overall survival (OS) has not yet been reached. In a similar patient population, the median OS was estimated to be 6.6 months (SCHOLAR-1 study, ASCO 2016). "These results with axicabtagene ciloleucel are exceptional and suggest that more than a third of patients with refractory aggressive NHL could potentially be cured after a single infusion of axicabtagene ciloleucel," said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development, "The ZUMA-1 study was built on a foundation of support and commitment from Dr. Steven Rosenberg and the National Cancer Institute and our ZUMA-1 clinical trial investigators who believed in the potential for CAR-T therapy to change the paradigm of cancer treatment." Kite intends to seek regulatory approval of axicabtagene ciloleucel in aggressive NHL based upon the combined data from all 101 patients and plans to complete its rolling submission of the Biologics License Application (BLA) by the end of Q1 2017. In addition, Kite plans to submit a marketing authorization application (MAA) for axicabtagene ciloleucel for the treatment of relapsed or refractory DLBCL, PMBCL and TFL with the European Medicines Agency (EMA) in 2017. Kite announced that the full data from the primary analysis will be presented at the American Association for Cancer Research in April 2017 in Washington, D.C. On Wednesday, March 01, 2017, the stock closed the trading session at $79.62, surging 12.51% from its previous closing price of $70.77. A total volume of 6.98 million shares have exchanged hands, which was higher than the 3-month average volume of 1.04 million shares. Kite Pharma's stock price rallied 63.36% in the last month, 64.67% in the past three months, and 37.18% in the previous six months. The company's shares soared 77.56% since the beginning of the year. At Wednesday's closing price, the stock's net capitalization stands at $4.00 billion. 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