Ambit Biosciences Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of drugs for the treatment of oncology, autoimmune, and inflammatory diseases in the United States. The company’s products include quizartinib, an orally administered FMS-like tyrosine kinase 3 inhibitor that has completed Phase II clinical trials for the treatment of patients with relapsed/refractory acute myeloid leukemia. Its drug candidates also comprise AC410, a small molecule inhibitor of Janus kinase 2, which is in Phase 1 clinical trials; and AC708, a receptor tyrosine kinase inhibitor that is in pre-clinical studies for the treatment of oncology, autoimmune, and i...
11080 Roselle Street
San Diego, CA 92121
Founded in 2000
Ambit Announces Initiation of Phase 2 Cohort in MD Anderson Sponsored Study of Quizartinib in AML and High Risk MDS
Apr 7 14
Ambit Biosciences announced the initiation of the Phase 2 cohort of the MD Anderson Cancer Center-sponsored Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse. The trial is being conducted under the principal direction of Jorge Cortes, M.D., of The University of Texas MD Anderson Cancer Center. Dr. Cortes is also the principal investigator of the upcoming Phase 3 QUANTUM-R trial, the Company's randomized trial comparing quizartinib to standard chemotherapy in FLT3-ITD positive AML patients over the age of 18 who have relapsed from, or are refractory to, frontline chemotherapy, including those patients relapsing following a hematopoietic stem cell transplant (HSCT). The Phase 2 cohort follows completion of the Phase 1 open-label, two-arm portion which included twelve total patients, six in each arm. Phase 1 included patients who were 18 years of age or older and who had relapsed AML or myelodysplastic syndrome (MDS) and were treated with quizartinib in combination with either 5-azacitidine or cytarabine. Up to a total of 64 patients are planned to be treated in this clinical trial. The regimen was found to be generally well tolerated, and there were no early mortalities. Despite limited follow up, evidence of anti-leukemia activity has been observed in a number of patients. Full results, including data from the Phase 2 cohort, are expected to be submitted to a medical conference in 2014.
Ambit Biosciences Corporation Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2013; Provides Operational Update on Phase 3 Trial in Relapsed/Refractory FLT3-ITD+ AML
Mar 20 14
Ambit Biosciences Corporation reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2013. For the quarter, the company reported that revenues were $1,276,000 compared to $2,944,000 a year ago. Loss from operations was $8,148,000 compared to $4,787,000 a year ago. Net loss was $2,045,000 compared to $5,061,000 a year ago. The decrease in revenue of $1.7 million was primarily due to the termination of the company's collaboration with Astellas Pharma, which occurred in September 2013. The decrease was partially offset by a $1.0 million clinical milestone from Teva Pharmaceuticals.
For the year, the company reported that revenues were $27,093,000 compared to $17,633,000 a year ago. Loss from operations was $7,033,000 compared to $23,151,000 a year ago. Net loss was $11,256,000 compared to $27,029,000 a year ago. The increase in revenue of $9.5 million was primarily due to acceleration in the recognition of license fee revenue related to the company's collaboration with Astellas Pharma, which terminated effective September 2013.
The company also provided update on Phase 3 trial in relapsed/refractory FLT3-ITD+ AML. The company reported that it plans to initiate a registrational Phase 3 clinical trial in relapsed/refractory acute myeloid leukemia (AML) patients with the FLT3-ITD mutation in the second quarter of 2014. The interim analysis is anticipated in the second half of 2015 and top line data in the first quarter of 2016, both of which are event driven outcomes. This Phase 3 clinical trial will compare quizartinib as monotherapy to one of three chemotherapy regimens with a 2:1 randomization of quizartinib to chemotherapy. The trial will be conducted in FLT3-ITD positive patients over the age of 18 who have relapsed from, or are refractory to, frontline chemotherapy, including those patients relapsing following a hematopoietic stem cell transplant (HSCT). Those patients who proceed to HSCT after quizartinib treatment will have the option to reinitiate treatment with quizartinib following the transplant. Quizartinib dosed as a continuous maintenance therapy following a HSCT has the potential to increase duration of remission and overall survival. The trial is expected to enroll approximately 326 patients in the United States, Western Europe, Canada and Australia. The primary endpoint for the Phase 3 clinical trial will be overall survival. An investigator-sponsored Phase 1/2 dose escalation clinical trial is currently underway to evaluate quizartinib in combination with either 5-azacitidine or low dose cytarabine for patients 18 years or older who had relapsed AML or MDS. Pending completion of Part 1 (dose escalation phase), the clinical trial is expected to proceed to Part 2, where previously-untreated FLT3-ITD positive AML patients 60 years or older or FLT3-ITD positive AML patients 18 years or older in first relapse will be enrolled. Approximately 50 patients are planned to be treated in this clinical trial. In addition to the clinical development program for the treatment of adult patients, an investigator-sponsored Phase 1 clinical trial has been completed which evaluated quizartinib in 22 pediatric patients with either relapsed acute lymphoblastic leukemia (ALL) or relapsed AML. This clinical trial was sponsored by the Therapeutic Advances in Childhood Leukemia & Lymphoma Cooperative Group and data was presented at the 2013 Annual Meeting of ASH. A follow-on Phase 2 clinical trial in pediatric patients is planned. The company also reported that it plans to move forward in the development of its pipeline of proprietary kinase inhibitors in 2014, including AC410 and AC708. AC410 is a potent, selective, orally-administered, small molecule inhibitor of JAK2, which has potential utility for the treatment of autoimmune and inflammatory diseases or as immunotherapy in oncology. AC708 is a potent and selective small molecule inhibitor of colony stimulating factor 1 receptor (CSF1R). CSF1R is thought to play a key role in the proliferation of macrophages, which are involved in oncology, autoimmune and inflammatory diseases.
Ambit Biosciences Corporation, Q4 2013 Earnings Call, Mar 20, 2014
Mar 6 14
Ambit Biosciences Corporation, Q4 2013 Earnings Call, Mar 20, 2014