BAYER AG 
By
Wednesday - March 28, 2012
Not intended for U.S. and UK Media - 103rd Annual Meeting American Association for Cancer Research:
Bayer to Present New Data on Oncology Pipeline
New Preclinical Data Evaluating Innovative Compounds will be presented / Growing Research and Development Portfolio
Berlin, March 28, 2012 - Bayer HealthCare today announced
that the company will present latest preclinical data that
introduce investigational compounds for both therapy and
imaging in its oncology pipeline at the American
Association for Cancer Research (AACR) 103rd Annual
Meeting, March 31 - April 4, 2012, in Chicago, IL. The
annual AACR meeting highlights the latest findings in all
major areas of cancer research.
This includes currently at Bayer developed investigational agents such as an antibody-drug conjugate (ADC, BAY 94-9343) and a phosphatidylinositol 3-kinase (PI3K) inhibitor (BAY 80-6946). The antibody-drug conjugate Mesothelin-ADC is being developed to target the antigen mesothelin which is selectively expressed on certain tumors. Mesothelin-ADC is developed in collaboration with ImmunoGen Inc. The PI3K inhibitor targets a lipid kinase involved in crucial cellular functions such as tumor cell proliferation and survival signaling. Both investigational agents are now in early clinical development (Phase I) at Bayer.
"Cancer is a complex disease process and as our understanding of these signaling mechanisms deepens, so does our ability to develop innovative, targeted approaches to combat this disease," said Dr. Karl Ziegelbauer, Head of Therapeutic Research Group Oncology/Gynecological Therapy at Bayer HealthCare. "The research data presented at this oncology research conference shows our commitment toward developing a wide variety of investigational agents against signaling pathways with the goal to treat cancer more effectively so patients can live longer."
Bayer has established a broad network with external partners in the area of oncology. Preclinical data from joint projects will be presented at the upcoming AACR meeting in Chicago, such as the bispecific BiTE® antibody (MT112/ BAY 2010112) targeting a prostate specific antigen which is currently being developed in collaboration with Amgen. A strategic partnership with the German Cancer Research Center (DKFZ) focuses on the translation of findings from research into innovative drugs and highlights of preclinical data from this partnership, like the characterization of DNA methyltransferase 3B, will also be presented at the AACR meeting. Another of Bayer's partners, OncoMed Pharmaceuticals Inc., will present new preclinical data on a Frizzled/Wnt pathway antagonist antibody OMP-18R5.
Additionally, preclinical data will also be presented on regorafenib (BAY 73-4506) and Alpharadin (radium-223 chloride), two investigational agents in late stage clinical development at Bayer.
Alpharadin (radium-223 chloride) is an investigational alpha-pharmaceutical in clinical development for cancer patients with bone or skeletal metastases. This investigational agent mimics calcium and targets radium-223 to areas of high bone deposition in and around bone metastases and is developed together with Algeta ASA. It has shown an increase in overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastasis in a pivotal Phase III trial. Alpharadin has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).
Regorafenib, a novel oral multi-kinase inhibitor of tumor neoangiogenesis is currently being investigated in clinical trials for its potential to treat patients with various tumor types. Regorafenib has shown an increase in overall survival in a Phase III trial in patients with metastatic colorectal cancer who have progressed after approved therapies, including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy if KRAS WT. The study was stopped early after an interim analysis which resulted in a statistically significant improvement of overall survival. Another ongoing Phase III trial in patients with tyrosine kinase inhibitor refractory gastrointestinal stromal tumors (GIST) is ongoing. The FDA has granted regorafenib Fast Track status for both indications. For GIST, regorafenib has also been granted "Orphan Drug Status". In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc. under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.
Data on two PET tracers L-5-F-18-ethoxy-Tryptophan for tumor specific imaging and FSPG (BAY 94-9392), a derivative of L-glutamate for improved diagnosis and staging of certain tumor types will also be shown at the conference.
A total of 15 abstracts evaluating investigational agents in Bayer's pipeline will be presented at AACR.
Poster Presentations
• Tumor specific imaging by L-5-F-18-ethoxy-Tryptophan mediated by LAT1 and IDO1
o Presentation #360, Session: Imaging of Molecular and Cellular Events in Tumors and Tumor Cells
• Comparison of commercially available phosphorylated ERK antibodies for immunohistochemical biomarker analysis
o Presentation #742, Session: Clinical Trials in Radiation Oncology / Regulatory Science
• Potent in vitro and in vivo anti-tumor activity of PI3K inhibitor BAY 80-6946 and MEK inhibitor BAY 86-9766 in preclinical biliary tract cancer models.
o Presentation #869, Session: Kinase and Phosphatase Inhibitors 1
• Antiproliferative effects of DNA methyltransferase 3B depletion are not associated with DNA demethylation.
o Presentation #1036, Session: Chromatin Regulators
• Regorafenib (BAY 73-4506): Anti-metastatic activity in a mouse model of colorectal cancer.
o Presentation #2337, Session: Angiogenesis Inhibitors
• Efficacy and Candidate Biomarker Evaluation for the anti-Mesothelin antibody drug conjugate BAY 94-9343, Mesothelin-ADC in Mesothelin positive preclinical xenograft models.
o Presentation #2726, Session: Biological Therapy Based on Viruses, Antibodies, or Metformin
• BAY 1082439, a highly selective and balanced PI3K
This includes currently at Bayer developed investigational agents such as an antibody-drug conjugate (ADC, BAY 94-9343) and a phosphatidylinositol 3-kinase (PI3K) inhibitor (BAY 80-6946). The antibody-drug conjugate Mesothelin-ADC is being developed to target the antigen mesothelin which is selectively expressed on certain tumors. Mesothelin-ADC is developed in collaboration with ImmunoGen Inc. The PI3K inhibitor targets a lipid kinase involved in crucial cellular functions such as tumor cell proliferation and survival signaling. Both investigational agents are now in early clinical development (Phase I) at Bayer.
"Cancer is a complex disease process and as our understanding of these signaling mechanisms deepens, so does our ability to develop innovative, targeted approaches to combat this disease," said Dr. Karl Ziegelbauer, Head of Therapeutic Research Group Oncology/Gynecological Therapy at Bayer HealthCare. "The research data presented at this oncology research conference shows our commitment toward developing a wide variety of investigational agents against signaling pathways with the goal to treat cancer more effectively so patients can live longer."
Bayer has established a broad network with external partners in the area of oncology. Preclinical data from joint projects will be presented at the upcoming AACR meeting in Chicago, such as the bispecific BiTE® antibody (MT112/ BAY 2010112) targeting a prostate specific antigen which is currently being developed in collaboration with Amgen. A strategic partnership with the German Cancer Research Center (DKFZ) focuses on the translation of findings from research into innovative drugs and highlights of preclinical data from this partnership, like the characterization of DNA methyltransferase 3B, will also be presented at the AACR meeting. Another of Bayer's partners, OncoMed Pharmaceuticals Inc., will present new preclinical data on a Frizzled/Wnt pathway antagonist antibody OMP-18R5.
Additionally, preclinical data will also be presented on regorafenib (BAY 73-4506) and Alpharadin (radium-223 chloride), two investigational agents in late stage clinical development at Bayer.
Alpharadin (radium-223 chloride) is an investigational alpha-pharmaceutical in clinical development for cancer patients with bone or skeletal metastases. This investigational agent mimics calcium and targets radium-223 to areas of high bone deposition in and around bone metastases and is developed together with Algeta ASA. It has shown an increase in overall survival in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastasis in a pivotal Phase III trial. Alpharadin has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).
Regorafenib, a novel oral multi-kinase inhibitor of tumor neoangiogenesis is currently being investigated in clinical trials for its potential to treat patients with various tumor types. Regorafenib has shown an increase in overall survival in a Phase III trial in patients with metastatic colorectal cancer who have progressed after approved therapies, including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy if KRAS WT. The study was stopped early after an interim analysis which resulted in a statistically significant improvement of overall survival. Another ongoing Phase III trial in patients with tyrosine kinase inhibitor refractory gastrointestinal stromal tumors (GIST) is ongoing. The FDA has granted regorafenib Fast Track status for both indications. For GIST, regorafenib has also been granted "Orphan Drug Status". In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc. under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology.
Data on two PET tracers L-5-F-18-ethoxy-Tryptophan for tumor specific imaging and FSPG (BAY 94-9392), a derivative of L-glutamate for improved diagnosis and staging of certain tumor types will also be shown at the conference.
A total of 15 abstracts evaluating investigational agents in Bayer's pipeline will be presented at AACR.
Poster Presentations
• Tumor specific imaging by L-5-F-18-ethoxy-Tryptophan mediated by LAT1 and IDO1
o Presentation #360, Session: Imaging of Molecular and Cellular Events in Tumors and Tumor Cells
• Comparison of commercially available phosphorylated ERK antibodies for immunohistochemical biomarker analysis
o Presentation #742, Session: Clinical Trials in Radiation Oncology / Regulatory Science
• Potent in vitro and in vivo anti-tumor activity of PI3K inhibitor BAY 80-6946 and MEK inhibitor BAY 86-9766 in preclinical biliary tract cancer models.
o Presentation #869, Session: Kinase and Phosphatase Inhibitors 1
• Antiproliferative effects of DNA methyltransferase 3B depletion are not associated with DNA demethylation.
o Presentation #1036, Session: Chromatin Regulators
• Regorafenib (BAY 73-4506): Anti-metastatic activity in a mouse model of colorectal cancer.
o Presentation #2337, Session: Angiogenesis Inhibitors
• Efficacy and Candidate Biomarker Evaluation for the anti-Mesothelin antibody drug conjugate BAY 94-9343, Mesothelin-ADC in Mesothelin positive preclinical xenograft models.
o Presentation #2726, Session: Biological Therapy Based on Viruses, Antibodies, or Metformin
• BAY 1082439, a highly selective and balanced PI3K
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