SAN DIEGO, CA, USA I December 6, 2019 I Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has licensed its fifth late-stage drug asset: Vosaroxin from Sunesis Pharmaceuticals. Denovo gains global rights to develop, manufacture and commercialize Vosaroxin.
Vosaroxin is a potent, first-in-class quinolone derivative, nonanthracycline topoisomerase II inhibitor that may be useful for oncology indications such as acute myeloid leukemia (AML) and solid tumors. More than 1,200 patients across 16 clinical studies have been dosed with vosaroxin, which has shown a manageable safety profile and variable efficacy. In the 711-patient Phase 3 VALOR clinical study there were significant improvements in OS and CR rates in certain sub-populations, specifically in patients with the poorest prognosis such as patients over the age of 60 with relapsed and refractory AML.
“Vosaroxin (now also known as DB106) is Denovo’s second oncology asset and its safety profile and potential efficacy in subsets of patients fit perfectly in to Denovo’s precision medicine-based drug development platform,” said Michael F. Haller, Denovo’s Chief Business Officer. “With our unique biomarker approach, we have potentially given new life to enzastaurin (DB102), our first oncology asset, acquired from Eli Lilly and Company, in a biomarker-guided population in an ongoing DLBCL Phase 3 trial and a planned GBM Phase 2b study. We believe our deep expertise in precision medicine could lead to the successful development of vosaroxin in treating AML and potentially other cancers. We are excited to build upon the data and insights gained from Sunesis’ development of vosaroxin.”
“We are excited about partnering with Denovo and advancing the development of Vosaroxin. Denovo’s capabilities and expertise will be an excellent fit for Vosaroxin. Vosaroxin has the opportunity to meet the needs of many patients with relapsed and refractory AML,” said Dayton Misfeldt, interim CEO Sunesis.
About AML
AML is a rapidly progressing cancer of the blood characterised by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 21,450 new cases of AML and approximately 10,920 deaths from AML in the US in 2019. Additionally, it is estimated that the prevalence of AML across major global markets (US, France, Germany, Italy, Spain, United Kingdom and Japan) is over 50,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Denovo Biopharma
Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients’ responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo is enrolling patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and will start a phase 2B study in Glioblastoma (GBM) for its lead product candidate, DB102, which was in-licensed from Eli Lilly. The company has four additional late stage programs targeting major unmet needs: DB103 for schizophrenia, DB104 for depression, DB105 for Alzheimer’s Disease, and DB106 for acute myeloid leukemia (AML). For additional information please visit www.denovobiopharma.com.
SOURCE: Denovo Biopharma
Post Views: 16
SAN DIEGO, CA, USA I December 6, 2019 I Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has licensed its fifth late-stage drug asset: Vosaroxin from Sunesis Pharmaceuticals. Denovo gains global rights to develop, manufacture and commercialize Vosaroxin.
Vosaroxin is a potent, first-in-class quinolone derivative, nonanthracycline topoisomerase II inhibitor that may be useful for oncology indications such as acute myeloid leukemia (AML) and solid tumors. More than 1,200 patients across 16 clinical studies have been dosed with vosaroxin, which has shown a manageable safety profile and variable efficacy. In the 711-patient Phase 3 VALOR clinical study there were significant improvements in OS and CR rates in certain sub-populations, specifically in patients with the poorest prognosis such as patients over the age of 60 with relapsed and refractory AML.
“Vosaroxin (now also known as DB106) is Denovo’s second oncology asset and its safety profile and potential efficacy in subsets of patients fit perfectly in to Denovo’s precision medicine-based drug development platform,” said Michael F. Haller, Denovo’s Chief Business Officer. “With our unique biomarker approach, we have potentially given new life to enzastaurin (DB102), our first oncology asset, acquired from Eli Lilly and Company, in a biomarker-guided population in an ongoing DLBCL Phase 3 trial and a planned GBM Phase 2b study. We believe our deep expertise in precision medicine could lead to the successful development of vosaroxin in treating AML and potentially other cancers. We are excited to build upon the data and insights gained from Sunesis’ development of vosaroxin.”
“We are excited about partnering with Denovo and advancing the development of Vosaroxin. Denovo’s capabilities and expertise will be an excellent fit for Vosaroxin. Vosaroxin has the opportunity to meet the needs of many patients with relapsed and refractory AML,” said Dayton Misfeldt, interim CEO Sunesis.
About AML
AML is a rapidly progressing cancer of the blood characterised by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 21,450 new cases of AML and approximately 10,920 deaths from AML in the US in 2019. Additionally, it is estimated that the prevalence of AML across major global markets (US, France, Germany, Italy, Spain, United Kingdom and Japan) is over 50,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Denovo Biopharma
Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. The company seeks to discover genomic biomarkers correlated with patients’ responses to drug candidates retrospectively. Denovo then designs and executes efficient clinical trials in targeted patient populations to optimize the probability of a successful trial. Denovo is enrolling patients in the U.S. and China with diffuse large B-cell lymphoma (DLBCL) in a Phase 3 clinical trial and will start a phase 2B study in Glioblastoma (GBM) for its lead product candidate, DB102, which was in-licensed from Eli Lilly. The company has four additional late stage programs targeting major unmet needs: DB103 for schizophrenia, DB104 for depression, DB105 for Alzheimer’s Disease, and DB106 for acute myeloid leukemia (AML). For additional information please visit www.denovobiopharma.com.
SOURCE: Denovo Biopharma
Post Views: 16
