SOUTH SAN FRANCISCO, CA, USA I December 06, 2016 I Calithera Biosciences, Inc. (CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, announced that clinical data from its lead product candidate CB-839, a first-in-class glutaminase inhibitor, will be presented at the 2016 San Antonio Breast Cancer Symposium, December 6-10, 2016 in San Antonio, Texas. The data demonstrate the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with advanced/metastatic triple negative breast cancer (TNBC).
“Triple negative breast cancer in the advanced and metastatic population remains a significant unmet need. We are particularly pleased to observe responses with CB-839 plus paclitaxel in taxane-refractory patients,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.
Dr. Angela DeMichele from the University of Pennsylvania will present in a poster session, “Phase I study of CB-839, a small molecule inhibitor of glutaminase, in combination with paclitaxel in patients with triple negative breast cancer,” (Abstract P6-11-05). The abstract was selected for presentation on Saturday, December 10, 2016. Eligible patients must have locally advanced/metastatic TNBC, with prior paclitaxel treatment allowed. As of November 25, 2016, 28 triple negative breast cancer patients had been treated with doses of CB-839 of 400, 600 or 800 mg bid in combination with 80 mg/m2 IV paclitaxel, weekly, three weeks out of four; 23 were evaluable for response. The majority of patients had received at least three prior lines of therapy, with 43% of patients treated with five or more prior therapies in the advanced/metastatic setting. Most patients had received prior taxane therapy in either the neo-adjuvant or metastatic setting. Among evaluable patients treated with CB-839 doses of at least 600 mg bid (n=16), there are 5 partial responses (31%) and disease control (response or stable disease) in 11 patients (69%). In addition, the combination overcomes resistance to paclitaxel in heavily pretreated TNBC patients. There is a 38% response rate and 50% disease control rate in patients who received prior taxanes in the metastatic setting. There is a 50% response rate among taxane-refractory African American patients, consistent with higher glutamine utilization observed in tumors from this population.1
The combination of CB-839 and paclitaxel has been well tolerated to date, with adverse events that have been easily manageable and reversible, including several paclitaxel related toxicities. There was one case of dose-limiting, recurrent grade 3 neutropenia at the 400 mg dose level, which led to a reduction in the dose of paclitaxel for that patient. The most frequent adverse event ≥ Grade 3 is neutropenia (n=6).
1Terunuma et al., J Clin Invest 2014
About Calithera Biosciences
Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells. Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is currently in a Phase I clinical trial. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.
SOURCE: Calithera Biosciences
Post Views: 178
SOUTH SAN FRANCISCO, CA, USA I December 06, 2016 I Calithera Biosciences, Inc. (CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, announced that clinical data from its lead product candidate CB-839, a first-in-class glutaminase inhibitor, will be presented at the 2016 San Antonio Breast Cancer Symposium, December 6-10, 2016 in San Antonio, Texas. The data demonstrate the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with advanced/metastatic triple negative breast cancer (TNBC).
“Triple negative breast cancer in the advanced and metastatic population remains a significant unmet need. We are particularly pleased to observe responses with CB-839 plus paclitaxel in taxane-refractory patients,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera.
Dr. Angela DeMichele from the University of Pennsylvania will present in a poster session, “Phase I study of CB-839, a small molecule inhibitor of glutaminase, in combination with paclitaxel in patients with triple negative breast cancer,” (Abstract P6-11-05). The abstract was selected for presentation on Saturday, December 10, 2016. Eligible patients must have locally advanced/metastatic TNBC, with prior paclitaxel treatment allowed. As of November 25, 2016, 28 triple negative breast cancer patients had been treated with doses of CB-839 of 400, 600 or 800 mg bid in combination with 80 mg/m2 IV paclitaxel, weekly, three weeks out of four; 23 were evaluable for response. The majority of patients had received at least three prior lines of therapy, with 43% of patients treated with five or more prior therapies in the advanced/metastatic setting. Most patients had received prior taxane therapy in either the neo-adjuvant or metastatic setting. Among evaluable patients treated with CB-839 doses of at least 600 mg bid (n=16), there are 5 partial responses (31%) and disease control (response or stable disease) in 11 patients (69%). In addition, the combination overcomes resistance to paclitaxel in heavily pretreated TNBC patients. There is a 38% response rate and 50% disease control rate in patients who received prior taxanes in the metastatic setting. There is a 50% response rate among taxane-refractory African American patients, consistent with higher glutamine utilization observed in tumors from this population.1
The combination of CB-839 and paclitaxel has been well tolerated to date, with adverse events that have been easily manageable and reversible, including several paclitaxel related toxicities. There was one case of dose-limiting, recurrent grade 3 neutropenia at the 400 mg dose level, which led to a reduction in the dose of paclitaxel for that patient. The most frequent adverse event ≥ Grade 3 is neutropenia (n=6).
1Terunuma et al., J Clin Invest 2014
About Calithera Biosciences
Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells. Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is currently in a Phase I clinical trial. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.
SOURCE: Calithera Biosciences
Post Views: 178
