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Germany - Berlin/Buch
http://www.pgdiakonie.de/evangelische-lungenklinik-berlin/patientenstudien/
The 2nd one in Berlin is Charite.
Bayer supports cancer biomarker research in Europe
Bayer HealthCare and University Medical Center Hamburg-Eppendorf are the main coordinators of the international consortium to validate blood-based biomarker technologies
Leverkusen, April 23, 2015 – Bayer HealthCare and University Medical Center Hamburg-Eppendorf (UKE) are the main coordinators of the newly founded international consortium CANCER-ID to develop and validate novel blood-based biomarker technologies in cancer. The five-year project will focus on establishing commonly agreed standards for the isolation, identification and analysis of novel circulating biomarkers with the aim to improve the development of personalized medicines for cancer patients. CANCER-ID is a public-private partnership supported by Europe’s Innovative Medicines Initiative (IMI).
Blood-based biomarkers such as circulating tumor cells (CTCs), circulating free tumor DNA (cfDNA) and microRNAs (miRNAs) are potential indicators for the tumor burden of patients living with cancer. Derivation of these markers from blood may offer an additional invaluable tool for modern cancer therapy: apart from being of high importance when tumor biopsies are not accessible, blood-based tests may allow a continuous follow-up of disease markers offering a means to closely monitor the efficacy of treatment and potentially guide the selection of therapy.
“CANCER-ID is an excellent example of a project in which a public-private partnership enables a collaborative research approach to come up with novel concepts in modern cancer therapy”, said Dr. Thomas Schlange, Senior Scientist of Global Biomarker Research at Bayer HealthCare Global Drug Discovery and Coordinator of CANCER-ID. “The consortium brings together a large experienced team of biomarker experts from academia and industry as well as smaller companies creating a Europe-wide network of complementary capabilities that extends far beyond the scope of traditional ‘one-on-one’ industry-academia collaborations.”
Important challenges for the development of all circulating biomarkers are assay sensitivity, specificity and standardization as well as validation. In the last phase of the project, the validated assays will be deployed in controlled clinical studies to prove their broad applicability and clinical utility in the treatment of patients living with cancer.
“Blood-based analysis of tumor derived cells and nucleic acids offer a novel concept of “liquid biopsies” which allows to receive real-time information relevant to cancer diagnosis and therapy”, said Prof. Klaus Pantel, Head of the Department of Tumor Biology at the University Medical Center Hamburg-Eppendorf, Germany, and the academic lead of the CANCER-ID consortium. “The CANCER-ID project fills the substantial gap between basic research focused on novel methods for the detection and characterization of circulating tumor cells and nucleic acids and the development of robust validated assays required to bring the liquid biopsy concept into the clinic.”
The CANCER-ID consortium consists of pharma and non-pharma industrial companies, universities and clinical trial institutes, as well as small and medium enterprises (SMEs) from all over Europe. The 33 consortium partners are all key players in their fields constituting a unique network of experts in the areas of tumor biology, biomarker development, clinical sciences and bioinformatics. The in-kind contributions to the project of around 8.2 million EUR by the industrial partners are complemented by IMI-funding from the European Union's Seventh Framework Programme resulting in a total budget of EUR 14.5 million.
About the Innovative Medicines Initiative (IMI)
The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators.
IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Through the IMI 2 programme, IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU’s research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources.
The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° [115749], resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.
More info: www.imi.europa.eu
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
Follow us on facebook: www.facebook.com/healthcare.bayer
Follow us on Twitter: https://twitter.com/BayerHealthCare
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
That makes me a little bit nervous:
COMBO DRUG - it's on the tablet at 45:30 min. with MDSC
I think I've heard that some were......
Could be..... I hope so....but: volume still to low, but that could change soon
we have 55k bid at 1,46
Peregrine Pharmaceuticals Inc data presented at AACR demonstrate synergistic anti-tumor effects of peregrine pharmaceuticals' phosphatidylserine (PS) PPHM.OQ - RINB
21-Apr-2015 14:11
Peregrine Pharmaceuticals Inc:
• Says presentation of data from preclinical studies demonstrating combination of phosphatidylserine (PS) blockade with anti-PD-1 or anti-CTLA-4 immune checkpoint inhibitors promoted strong, localized and enhanced efficacy in models of melanoma and breast cancer
• Says these data were presented at 106th Annual Meeting of the American Association for Cancer Research (AACR) being held in Philadelphia, Pennsylvania from April 18-22, 2015
• Says Peregrine's lead PS-blocking antibody, bavituximab, is currently being evaluated in second-line non-small cell lung cancer (NSCLC) in Phase III clinical trial named Sunrise
• 21-Apr-2015 14:11 - PEREGRINE PHARMACEUTICALS - SHARES UP 4.96 PCT AT $1.48 PREMARKET AFTER CO'S PHOSPHATIDYLSERINE SHOWS ANTI-TUMOR EFFECTS IN PRECLINICAL DATA
PEREGRINE PHARMACEUTICALS - SHARES UP 4.96 PCT AT $1.48 PREMARKET AFTER CO'S PHOSPHATIDYLSERINE SHOWS ANTI-TUMOR EFFECTS IN PRECLINICAL DATA PPHM.O - RTRS
Preclinical Data Presented at AACR Demonstrate Synergistic Anti-Tumor Effects of Peregrine Pharmaceuticals' Phosphatidylserine (PS)-Targeting Antibodies With Immune Checkpoint Inhibitors in Models of Melanoma and Breast Canc PPHM.O - GNW
21-Apr-2015 14:00
• Combination Treatment Reduces Tumor Immune System Blockade and Enhances Tumor Specific Immune Responses -
• Studies Reveal Significant Increases in Tumor-Infiltrating CD8+ T Cells and Immune-Activating Cytokines while Decreasing Tumor-Promoting Macrophages and Myeloid Cells -
TUSTIN, Calif., April 21, 2015 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP) today announced the presentation of data from preclinical studies demonstrating the combination of phosphatidylserine (PS) blockade with anti-PD-1 or anti-CTLA-4 immune checkpoint inhibitors promoted strong, localized and enhanced efficacy in models of melanoma and breast cancer. These data were presented at the 106th Annual Meeting of the American Association for Cancer Research (AACR) being held in Philadelphia, Pennsylvania from April 18-22, 2015. Peregrine's lead PS-blocking antibody, bavituximab, is currently being evaluated in second-line non-small cell lung cancer (NSCLC) in a Phase III clinical trial named Sunrise.
"The data presented this week at AACR showed in much greater detail the collective ability of PS and PD-1 blockade to change the immune response in melanoma and breast cancer models," said Jeff T. Hutchins, Ph.D., vice president of preclinical research at Peregrine. "These data showed that blocking PS resulted in a decrease in immune-blocking cell types such as myeloid-derived suppressor cells and M2 macrophages while increasing the number of activated T-cells that are able to specifically recognize and kill tumor cells which set the stage for anti-PD-1 therapy that keeps the immune response going. The result were synergistic anti-tumor effects in established melanoma and breast cancers. The consistency of the data generated from pre-clinical experiments, and, more recently, in clinical translational studies is impressive. When taken together with the additional lung cancer translational data presented Sunday, we are obtaining a clearer picture as to the potential of bavituximab in different immuno-oncology combinations. We look forward to presenting additional supporting data over the coming months."
In a poster titled: "Antibody-mediated phosphatidylserine blockade significantly enhances the efficacy of immune checkpoint blockades in K1735 and B16 mouse melanoma models," researchers from Peregrine, UT Southwestern Medical Center and the University of California at Irvine presented data assessing the antitumor effect of the combination of PS blockade and anti-CTLA-4 or anti-PD-1 antibodies in preclinical models of melanoma. Both combinations showed significantly superior tumor growth inhibition over single treatment, with many subjects achieving complete tumor regressions. The combination treatment showed significantly greater total and functional tumor-infiltrating CD8+ T, more IL-2- and interferon gamma (IFN?)-producing splenic T cells, and lower number of splenic myeloid derived suppressor cells myeloid-derived suppressor cells (MDSCs) than did single treatment. In addition, the ratio of M2 to M1 macrophages in the tumor was significantly lower in the combination treatment than that in single treatment. Finally, no toxicity was observed in any of the treatment groups following multiple treatment doses.
In a poster titled: "Targeting of phosphatidylserine by monoclonal antibodies enhances the activity of immune checkpoint inhibitors in breast tumors," Peregrine researchers presented data demonstrating that PS blockade enhances the anti-tumor activity of combination therapies including anti-PD-1 antibodies in an immune competent model of breast cancer. Tumor growth inhibition correlates with statistically significant increases in the infiltration of CD8+ T cells and a reduction of myeloid-derived suppressor cells (MDSCs). The combination of these mechanisms promotes strong and localized anti-tumor responses without the side-effects of systemic immune activation.
Copies of these presentations can be found on the front page of Peregrine's website at www.peregrineinc.com
http://www.globenewswire.com/newsroom/ctr...
.
About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection due partly to the expression of phosphatidylserine, or PS, a highly immunosuppressive molecule. Peregrine's immuno-oncology development program has developed bavituximab, an investigational monoclonal antibody that targets and binds to PS, blocking its immunosuppressive effects while activating tumor fighting immune cells, thus enabling the immune system with the ability to better recognize and fight cancer. Bavituximab's immune-stimulatory mechanism-of-action data is the subject of a manuscript published in the October 2013 issue of the American Association for Cancer Research (AACR) peer-reviewed journal, Cancer Immunology Research. Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer (the SUNRISE Phase III trial), breast cancer, liver cancer, rectal cancer and advanced melanoma. In January 2014, bavituximab received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential second-line treatment of patients with non-small cell lung cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com http://www.globenewswire.com/newsroom/ctr... ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit www.peregrineinc.com http://www.globenewswire.com/newsroom/ctr...
.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that data from pre-clinical studies may not correlate with the results from human clinical studies. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2014 as well as any updates to these risk factors filed from time to time in the company's other filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
Breast cancer news TOMORROW
Data Presented at AACR Demonstrate Peregrine Pharmaceuticals' Bavituximab Induces Immune Activation in PD-L1 Negative NSCLC Tumors PPHM.O - GNW
20-Apr-2015 14:00
Bavituximab Alone and in Combination with Docetaxel Elicit a Tumor-Specific Immune Response in PD-L1 Negative Tumors Extracted from NSCLC Patients -
Immune Modulating Results Consistent with Previously Conducted Translational Studies in Liver Cancer -
Presented Data Further Support Clinical Studies Evaluating the Effectiveness of Bavituximab Immunotherapy Combinations in Patients with PD-L1 Negative Tumors -
TUSTIN, Calif., April 20, 2015 (GLOBE NEWSWIRE) -- Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP) today announced the presentation of data from clinical translational studies of the company's phosphatidylserine (PS)-targeting immunotherapy bavituximab. Initial data from a pilot study of clinical translational ex vivo cultures show that bavituximab, both alone and with docetaxel, elicits evidence of a tumor-specific immune response in patients with human adenocarcinoma of the lung and that bavituximab exhibits an impact on tumors with negative PD-L1 expression. These data were presented yesterday, Sunday, April 19th, in a poster presentation at the 106th Annual Meeting of the American Association for Cancer Research (AACR) being held in Philadelphia, Pennsylvania from April 18-22, 2015. Bavituximab is currently being evaluated in second-line non-small cell lung cancer (NSCLC) as part of the SUNRISE pivotal Phase III clinical trial.
"Our translational findings of a cytokine profile that reflects an immune response following either bavituximab single-agent or combination treatment are encouraging. Furthermore, these preliminary translational data show that tumors with negative PD-L1 expression and low levels of PD-1 expression on CD8+ tumor infiltrating T cells showed immune response to bavituximab treatment ex vivo," said Sigrid M. Volko, Ph.D., CLP the lead investigator on the study and President and Chief Executive Officer of Nilogen Oncosystems. "It is an exciting time for the field of immunotherapy and the data we have been generating support that bavituximab has the potential to activate a tumor specific immune response in patients with PD-L1 negative tumors that generally do not respond as well to PD-1 or PD-L1 inhibitors."
In a poster titled: "Bavituximab modulates tumor microenvironment and activates CD8+ tumor infiltrating lymphocytes in a patient-derived 3D ex vivo system of lung cancer," researchers from Moffitt Cancer Center, Nilogen Oncosystems and Peregrine present initial data from a pilot translation study analyzing tumor tissue from six lung cancer patients to evaluate the immunomodulatory effects of bavituximab in a human ex vivo model of NSCLC. Researchers generated 3D tumor microspheres from tumor tissues produced at the time of surgical resection. These microspheres were treated ex vivo for 36 hours with bavituximab, bavituximab and docetaxel, or controls in the presence of Interleukin-2 (IL-2), a cytokine that regulates the activities of white blood cells that are responsible for immunity. Data show that bavituximab as a single agent or in combination with docetaxel induces lymphocyte activation in tumors as demonstrated by a significant increase in interferon-gamma (IFN?), TNF-alpha, and GM-CSF secretion when compared to tumors treated with IL-2 control. Researchers also concluded that the immune response to treatment with bavituximab correlates with negative PD-L1 expression in the resected tumor tissue and low PD-1 expression on CD8+ tumor infiltrates thus serving as a potential prognostic biomarker of positive response to bavituximab treatment.
"These data are exciting as the immune responses seen in this translational lung cancer study mirror what we saw in translational data from a liver cancer clinical trial and is perfectly aligned with what has been seen preclinically to date. It was also encouraging to see how well these data further support our ongoing Phase III SUNRISE trial in that the combination of bavituximab and docetaxel induces immune activity," said Joseph Shan, MPH, vice president of clinical and regulatory affairs at Peregrine. "These data are playing a key role in advancing the clinical portion of an Immuno-Oncology Development Program which has been built upon a growing body of favorable data supporting the potential combination of bavituximab and checkpoint inhibitors. Specifically, these data show that activating the immune system in this negative PD-L1 patient population provides a strong rational for combining bavituximab with inhibitors of the PD-1/PD-L1 pathway. We look forward to detailing our plans for additional immuno-oncology combination clinical trials in the near future."
Liver Cancer Translational Data
In November, clinical translational data from the company's Immuno-Oncology Development Program were presented assessing changes in immune response pre- and post-treatment in six patients participating in a Phase II IST evaluating bavituximab in combination with sorafenib in advanced hepatocellular carcinoma. Data from this translational sub-study of patients, show that half of the patients had an increase in tumor fighting immune cells following one cycle of treatment, similar to what has been shown for PS-targeting antibodies in multiple preclinical cancer models. In addition, the increase in immune response was associated with patients that remained on study treatment for longer time periods, consistent with an immunotherapeutic mechanism and suggest the possibility of a clinically meaningful anti-tumor immune response. Immune responding patients also had increased infiltration of CD8 T-cells in the tumor microenvironment which correlated with a prolonged time to disease progression. In addition, these immune responders expressed lower levels of PD-1, an established marker of T cell activation and disease outcome, prior to the initiation of therapy, followed by a measurable rise.
A link to this presentation is located on the front page of Peregrine's website at www.peregrineinc.com
http://www.globenewswire.com/newsroom/ctr...
.
About Bavituximab: A Targeted Investigational Immunotherapy
Scientific research has shown that tumors evade immune detection due partly to the expression of phosphatidylserine, or PS, a highly immunosuppressive molecule. Peregrine's immuno-oncology development program has developed bavituximab, an investigational monoclonal antibody that targets and binds to PS, blocking its immunosuppressive effects while activating tumor fighting immune cells, thus enabling the immune system with the ability to better recognize and fight cancer. Bavituximab's immune-stimulatory mechanism-of-action data is the subject of a manuscript published in the October 2013 issue of the American Association for Cancer Research's (AACR) peer-reviewed journal, Cancer Immunology Research. Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer (the SUNRISE Phase III trial), breast cancer, rectal cancer and advanced melanoma. In January 2014, bavituximab received Fast Track designation by the U.S. Food and Drug Administration (FDA) as a potential second-line treatment in patients with non-small cell lung cancer.
About Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com http://www.globenewswire.com/newsroom/ctr... ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit www.peregrineinc.com http://www.globenewswire.com/newsroom/ctr...
.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that data from human clinical studies may not correlate with data from translational and pre-clinical studies may not correlate with the results from human clinical studies. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2014 as well as any updates to these risk factors filed from time to time in the company's other filings with the Securities and Exchange Commission. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
CONTACT: Christopher Keenan
Peregrine Pharmaceuticals, Inc.
Bayer to Present New Data on Advancing Oncology Portfolio
New preclinical and clinical data evaluating innovative compounds in drug development
Berlin, April 15, 2015 – Bayer HealthCare (Bayer) will present latest preclinical and clinical data on oncolocgy compounds with new mechanism of action including several potent and selective small molecule inhibitors and an antibody-drug conjugate at the American Association for Cancer Research (AACR) 106th Annual Meeting, April 18-22, 2015, in Philadelphia, PA.
The oral presentations include preclinical anti-tumor activity data of BAY 1143572, an oral inhibitor of P-TEFb (positive transcription elongation factor b), which suppresses specific anti-apoptotic and proliferative signals. Bayer will also present new preclinical data on BAY 1238097, a novel bromodomain and extra-terminal (BET) inhibitor with strong anti-tumor activity in hematological tumor models (currently in Phase I), and two Mps1 kinase inhibitors (BAY 1161909 and BAY 1217389), which inactivate the mitotic checkpoint leading to severe chromosome missegregation and tumor cell death (currently in Phase I).
In addition, preclinical data for a selective small molecule pan FGFR1-3 kinase inhibitor (BAY 1163877) and an FGFR2 antibody-drug conjugate (ADC), BAY 1187982, both currently in Phase I clinical development, will be presented. Both investigational agents target fibroblast growth factor receptors (FGFRs), whose increased expression is linked with tumor progression, neoangiogenesis, and chemoresistance. The antibody-drug conjugate carries a microtubule-binding auristatin licensed from Seattle Genetics.
Bayer will also present clinical biomarker analyses of its Phase II development candidate refametinib (BAY 86-9766), an inhibitor of mitogen-activated ERK kinases (MEK), and of its multi-kinase inhibitor regorafenib (Stivarga® ), which is approved for the treatment of metastatic colorectal cancer and gastrointestinal stromal tumors (GIST).
Emerging data from joint projects with external academic and biotech partners will also be presented at AACR: these include new preclinical data presented by the National University of Singapore and/or the National Cancer Center of Singapore on Bayer’s pan CDK inhibitor roniciclib (BAY 1000394, currently in Phase II), the predominant alpha/delta PI3-kinase inhibitor copanlisib (BAY 80-6946, currently in Phase II) and the alpha/beta-balanced PI3-kinase inhibitor, BAY 1082439 (currently in Phase I). In addition, preclinical data from Bayer’s alliance with OncoMed Pharmaceuticals on the two Wnt pathway antagonists, ipafricept and vantictumab, currently in Phase I clinical testing, will be presented. Also, three collaborative Innovative Medicines Initiative (IMI) projects, funded by the unique public-private partnership of the pharmaceutical industry and the European Union, will be highlighted: OncoTrack (genomic cancer diagnostics); Cancer-ID (blood-based biomarker for cancer); and Cancer-PREDECT (in vitro platforms for target validation).
The following list comprises a selection of presentations on Bayer pipeline studies and projects presented at AACR 2015:
Selected Oral Presentations
- BAY 1143572: A first-in-class, highly selective, potent and orally available inhibitor of PTEFb/CDK9 currently in Phase I, inhibits MYC and shows convincing anti-tumor activity in multiple xenograft models by the induction of apoptosis
a) Drug Development Track: Special Session – New Drugs on the Horizon 2; Presentation# DDT02-02
b) Sunday, April 19, 3:45 p.m.-4:10 p.m., Room 204, Pennsylvania Convention Center
- Tumor genotyping in the Phase III GRID study of regorafenib vs placebo in tyrosine kinase inhibitor (TKI)-refractory GIST: Detection of KIT mutations in circulating tumor DNA comparing digital PCR and massive parallel sequencing
a) Minisymposium: Clinical Research: Liquid Biopsies; Presentation# 929
b) Sunday, April 19, 4:05 p.m.-4:20 p.m., Terrace Ballroom I (400 Level), Pennsylvania Convention Center
- Rapid identification of potent and highly selective, oral PTEFb Inhibitor BAY 1143572 with first in class potential
a) Minisymposium: Chemistry: Progress Toward New Drugs and New Drug Technologies; Presentation# 2828
b) Monday, April 20, 3:20 p.m.-3:35 p.m., Room 113, Pennsylvania Convention Center
Selected Poster Presentations
- Anti-tumor efficacy of the selective pan-FGFR Inhibitor BAY 1163877 in preclinical squamous cell carcinoma models of different origin
a) Poster Session: Experimental and Molecular Therapeutics: Tyrosine Kinase and Phosphatase Inhibitors; Abstract# 772
b) Sunday, April 19, 1:00 p.m.-5:00 p.m., Pennsylvania Convention Center, Poster Section 32, Poster# 4
- Pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic/toxicodynamic (TK/TD) modeling of preclinical data of FGFR2-ADC (BAY 1187982) to guide dosing in phase I
a) Poster Session: Experimental and Molecular Therapeutics: Growth Factor Receptors and Other Surface Antigens as Targets for Therapy; Abstract# 1683
b) Monday, April 20, 8:00 a.m.-12:00 p.m., Pennsylvania Convention Center, Poster Section 29, Poster# 16
- Preclinical anti-tumor efficacy of FGFR2-ADC BAY 1187982 in patient-derived gastric, breast and ovarian cancer models
a) Poster Session: Experimental and Molecular Therapeutics: Growth Factor Receptors and Other Surface Antigens as Targets for Therapy; Abstract# 1684
b) Monday, April 20, 8:00 a.m.-12:00 p.m., Pennsylvania Convention Center, Poster Section 29, Poster# 17
- Activity of BAY1082439, a balanced PI3K?/? inhibitor, in gastric cancer
a) Poster Session: Experimental and Molecular Therapeutics: PI3K Pathway and Metabolism Modulators; Abstract# 2674
b) Monday, April 20, 1:00 p.m.-5:00 p.m., Pennsylvania Convention Center, Poster Section 32, Poster# 26
- Novel Mps1 kinase inhibitors with potent anti-tumor activity
a) Poster Session: Molecular and Cellular Biology: Targeting Cyclin-Dependent Kinases and Checkpoint Kinases for Cancer Therapy; Abstract# 3090
b) Tuesday, April 21, 8:00 a.m.-12:00 p.m., Pennsylvania Convention Center, Poster Section 9, Poster# 3
- BAY 1238097, a novel BET inhibitor with strong efficacy in hematological tumor models
a) Poster Session: Experimental and Molecular Therapeutics: Epigenetic Targets and BET Inhibitors; Abstract# 3524
b) Tuesday, April 21, 8:00 a.m.-12:00 p.m., Pennsylvania Convention Center, Poster Section 28, Poster# 17
- KRAS wild-type status as detected by circulating tumor DNA analysis may be a prognostic or predictive factor for clinical benefit in patients with unresectable, locally advanced or metastatic pancreatic cancer (PC) treated with the MEK inhibitor refametinib (BAY 86-9766) and gemcitabine
a) Poster Session: Clinical Research: Circulating Free DNA 2; Abstract# 5239
b) Wednesday, April 22, 8:00 a.m.-12:00 p.m., Pennsylvania Convention Center, Poster Section 22, Poster# 10
- Liquid biopsies to prospectively select patients with KRAS or NRAS mutant hepatocellular carcinoma (HCC) in two phase II studies with refametinib
a) Poster Session: Clinical Research: Circulating Free DNA 2; Abstract# 5252
b) Wednesday, April 22, 8:00 a.m.-12:00 p.m., Pennsylvania Convention Center, Poster Section 22, Poster# 23
Further details on additional oral and poster presentations can be found at the AACR website (www.aacr.org).
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31, 2014) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
Follow us on Facebook: www.facebook.com/healthcare.bayer
Follow us on Twitter: https://twitter.com/BayerHealthCare
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Carbone has done his job at ELCC
AstraZeneca immune system drug wins orphan status in rare cancer
15-Apr-2015 08:00
LONDON, April 15 (Reuters) - An experimental medicine from AstraZeneca AZN.L that helps the immune system fight tumours has won "orphan" drug status in the United States for treating malignant mesothelioma, a rare type of cancer.
Tremelimumab is one of a number of immuno-oncology products that AstraZeneca is banking on as it focuses heavily on promising new treatments for cancer.
The British drugmaker said on Wednesday its antibody treatment had been awarded the orphan designation, which aims to encourage drug development for rare conditions, by the U.S. Food and Drug Administration.
Orphan drugs enjoy seven years of marketing exclusivity and are defined as those fighting rare diseases that affect fewer than 200,000 people in the United States.
AstraZeneca aims to submit tremelimumab for U.S. regulatory approval in the first half of 2016 as a treatment for mesothelioma, an aggressive disease that most often affects the lining of the lungs and abdomen.
The drug is also being tested in combination with AstraZeneca's so-called PD-L1 treatment MEDI4736 for lung cancer, which is a much bigger market opportunity.
volume still to low for "real" news coming soon
On April 13, 2015, Peregrine Pharmaceuticals, Inc. (the "Company") entered into an amendment (the "Amendment") to an existing At Market Issuance Sales Agreement (the "Sales Agreement") with MLV & Co. LLC ("MLV") dated June 13, 2014, to substitute registration statements from which shares of its common stock ("Common Stock") may be offered and sold under the Sales Agreement. The Amendment replaces the original registration statement specified in the Sales Agreement which expired on April 12, 2015, with the Company’s shelf registration statement on Form S-3 (File No. 333-201245), which became effective on January 15, 2015. As of the date of the Amendment, the Company may issue and sell through MLV, acting as its agent, shares of its Common Stock for aggregate gross proceeds of up to $12,328,645 under the Sales Agreement, as amended. MLV may sell the Common Stock by any method permitted by law, including sales deemed to be an "at-the-market" offering as defined in Rule 415 of the Securities Act, including without limitation, sales made directly on The NASDAQ Capital Market, on any other existing trading market for the Common Stock or to or through a market maker. MLV may also sell the Common Stock in privately negotiated transactions, subject to the Company’s prior approval. The Company will pay MLV a commission equal to 2.5% of the gross proceeds from the sale of shares of the Company’s Common Stock pursuant to the Sales Agreement.
This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state. The foregoing description of the Amendment and the transactions contemplated thereby do not purport to be complete and is qualified in its entirety by reference to such exhibit.
The legal opinion of K&L Gates LLP relating to the shares of Common Stock to be issued pursuant to the Sales Agreement, as amended is filed as Exhibit 5.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The following material is filed as an exhibit to this Current Report on Form 8-K:
Exhibit
Number
10.27 Amendment No. 1, dated April 13, 2015, to At Market Issuance Sales Agreement, dated June 13, 2014, between Peregrine Pharmaceuticals, Inc. and MLV & Co. LLC.
5.1 Opinion of K&L Gates LLP.
23.1 Consent of K&L Gates LLP (contained in Exhibit 5.1 hereto).
Tomorrow starts ELCC
http://www.esmo.org/content/download/39036/760655/file/ELCC-2015-Final-Programme.pdf
14:30 - 16:00 The evolving role of immunotherapy for lung cancer Room A
WITH: 15:30 - 15:50 Clinical trial design and perspectives
D. Carbone, OH/US
Another French-side:
http://www.oncologik.fr/index.php/Oncolor:Cancer_bronchique_non_%C3%A0_petites_cellules
search for "sunrise"
http://www.oncologie-gentilly.com/
But: my French is not so perfect
So they have 5 from 6 patients (17th March 2015)
Update from 17.3.2015
Rennes - CHU de Rennes - Site Hôpital Pontchaillou
Patients inclus/à inclure 5 / 6 17.3.2015
Quite a lot of good arguments here to invest another 150k $$$$
West Coast Avid for Asia/US
East Coast CSM for Europe/US
Nice weekend!
Hutschi
Important or not:
Why so negativ? Live is so wonderful.
I once had QCOR and ITMN - BUT: sold them because I thought I could do a little daytrading - my foult; the day when the real news came I had none of them.
I woun't make this mistake again with PPHM. That's just one episode of my life
Stay long
Hutschi
That's it and always good to hear from CP
+ 100
who is shorting? not so good idea!
I expect no news because to low volume
NO - Longs are buying more