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News Article | May 16, 2017
Site: globenewswire.com

GAITHERSBURG, Md., May 16, 2017 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced the promotion of Sybil Tasker, M.D., FACP, FIDSA, to the position of Chief Medical Officer.  Dr. Tasker joined the company in April 2016 as Senior Vice President, Clinical Research and Development, with responsibility for overseeing Altimmune’s clinical research and development programs. Bill Enright, President and Chief Executive Officer of Altimmune, stated, “Dr. Tasker has played a critical role in the advancement of our immunotherapeutic and vaccine product candidates, and we are delighted to recognize her contributions to our success during the past year.  Her expertise in the treatment of infectious diseases and the clinical evaluation of novel vaccine candidates will be invaluable as we continue our NasoVAX™ influenza vaccine, NasoShield™ and Sparvax-L™ anthrax vaccines and HepTcell™ chronic hepatitis B immunotherapeutic development programs and advance our Oncosyn™ cancer immunotherapeutics into human clinical studies.” Before joining Altimmune, Dr. Tasker was Senior Director of Clinical Development at Genocea Biosciences where she led the GEN-003 therapeutic vaccine program.  Previously, Dr. Tasker had positions of increasing responsibility in infectious-disease product development strategy at two global CROs and was the senior U.S. Navy physician and technical advisor to the Department of Defense on a wide variety of infectious-disease policy issues, including HIV, tropical disease, vaccination, infection control, bioterrorism and pandemic preparedness.  Dr. Tasker is board-certified in internal medicine and infectious diseases and received an A.B. in biochemistry from Princeton University, a Master of Public Health degree from Johns Hopkins University and an M.D. from Columbia University. About Altimmune Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines. Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.


News Article | May 16, 2017
Site: globenewswire.com

GAITHERSBURG, Md., May 16, 2017 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced the promotion of Sybil Tasker, M.D., FACP, FIDSA, to the position of Chief Medical Officer.  Dr. Tasker joined the company in April 2016 as Senior Vice President, Clinical Research and Development, with responsibility for overseeing Altimmune’s clinical research and development programs. Bill Enright, President and Chief Executive Officer of Altimmune, stated, “Dr. Tasker has played a critical role in the advancement of our immunotherapeutic and vaccine product candidates, and we are delighted to recognize her contributions to our success during the past year.  Her expertise in the treatment of infectious diseases and the clinical evaluation of novel vaccine candidates will be invaluable as we continue our NasoVAX™ influenza vaccine, NasoShield™ and Sparvax-L™ anthrax vaccines and HepTcell™ chronic hepatitis B immunotherapeutic development programs and advance our Oncosyn™ cancer immunotherapeutics into human clinical studies.” Before joining Altimmune, Dr. Tasker was Senior Director of Clinical Development at Genocea Biosciences where she led the GEN-003 therapeutic vaccine program.  Previously, Dr. Tasker had positions of increasing responsibility in infectious-disease product development strategy at two global CROs and was the senior U.S. Navy physician and technical advisor to the Department of Defense on a wide variety of infectious-disease policy issues, including HIV, tropical disease, vaccination, infection control, bioterrorism and pandemic preparedness.  Dr. Tasker is board-certified in internal medicine and infectious diseases and received an A.B. in biochemistry from Princeton University, a Master of Public Health degree from Johns Hopkins University and an M.D. from Columbia University. About Altimmune Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines. Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.


News Article | May 16, 2017
Site: globenewswire.com

GAITHERSBURG, Md., May 16, 2017 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced the promotion of Sybil Tasker, M.D., FACP, FIDSA, to the position of Chief Medical Officer.  Dr. Tasker joined the company in April 2016 as Senior Vice President, Clinical Research and Development, with responsibility for overseeing Altimmune’s clinical research and development programs. Bill Enright, President and Chief Executive Officer of Altimmune, stated, “Dr. Tasker has played a critical role in the advancement of our immunotherapeutic and vaccine product candidates, and we are delighted to recognize her contributions to our success during the past year.  Her expertise in the treatment of infectious diseases and the clinical evaluation of novel vaccine candidates will be invaluable as we continue our NasoVAX™ influenza vaccine, NasoShield™ and Sparvax-L™ anthrax vaccines and HepTcell™ chronic hepatitis B immunotherapeutic development programs and advance our Oncosyn™ cancer immunotherapeutics into human clinical studies.” Before joining Altimmune, Dr. Tasker was Senior Director of Clinical Development at Genocea Biosciences where she led the GEN-003 therapeutic vaccine program.  Previously, Dr. Tasker had positions of increasing responsibility in infectious-disease product development strategy at two global CROs and was the senior U.S. Navy physician and technical advisor to the Department of Defense on a wide variety of infectious-disease policy issues, including HIV, tropical disease, vaccination, infection control, bioterrorism and pandemic preparedness.  Dr. Tasker is board-certified in internal medicine and infectious diseases and received an A.B. in biochemistry from Princeton University, a Master of Public Health degree from Johns Hopkins University and an M.D. from Columbia University. About Altimmune Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines. Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.


News Article | May 16, 2017
Site: globenewswire.com

GAITHERSBURG, Md., May 16, 2017 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced the promotion of Sybil Tasker, M.D., FACP, FIDSA, to the position of Chief Medical Officer.  Dr. Tasker joined the company in April 2016 as Senior Vice President, Clinical Research and Development, with responsibility for overseeing Altimmune’s clinical research and development programs. Bill Enright, President and Chief Executive Officer of Altimmune, stated, “Dr. Tasker has played a critical role in the advancement of our immunotherapeutic and vaccine product candidates, and we are delighted to recognize her contributions to our success during the past year.  Her expertise in the treatment of infectious diseases and the clinical evaluation of novel vaccine candidates will be invaluable as we continue our NasoVAX™ influenza vaccine, NasoShield™ and Sparvax-L™ anthrax vaccines and HepTcell™ chronic hepatitis B immunotherapeutic development programs and advance our Oncosyn™ cancer immunotherapeutics into human clinical studies.” Before joining Altimmune, Dr. Tasker was Senior Director of Clinical Development at Genocea Biosciences where she led the GEN-003 therapeutic vaccine program.  Previously, Dr. Tasker had positions of increasing responsibility in infectious-disease product development strategy at two global CROs and was the senior U.S. Navy physician and technical advisor to the Department of Defense on a wide variety of infectious-disease policy issues, including HIV, tropical disease, vaccination, infection control, bioterrorism and pandemic preparedness.  Dr. Tasker is board-certified in internal medicine and infectious diseases and received an A.B. in biochemistry from Princeton University, a Master of Public Health degree from Johns Hopkins University and an M.D. from Columbia University. About Altimmune Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines. The company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines. Forward-Looking Statement Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.

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