Agios Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of therapeutics in the field of cancer metabolism and rare genetic disorders of metabolism in the United States. The company’s product candidates include AG-221, a potent inhibitor of the mutated isocitrate dehydrogenase (IDH) 2 protein for the treatment of patients with cancers that harbor IDH2 mutations; and AG-120, an oral inhibitor of the mutated IDH1 protein for the treatment of patients with cancers that harbor IDH1 mutations. Its product candidates also comprise AG-348, an oral small molecule and activator of the pyruvate kinase-R enzyme used for the treatment of patients with PK...
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Agios Pharmaceuticals, Inc. - Special Call
Nov 8 15
To review first data from the dose-escalation portion of the ongoing Phase 1 study evaluating single agent AG-120 presented at AACR-NCI-EORTC International Conference
Agios Pharmaceuticals, Inc. Announces Data from Dose-Escalation Phase 1 Study of AG-120 in Patients with IDHI Mutant Positive Advanced Solid Tumors
Nov 8 15
Agios Pharmaceuticals, Inc. announced the first data from the dose-escalation portion of the ongoing Phase 1 study evaluating single agent AG-120, a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-1 (IDH1), in advanced solid tumors. The data are being presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. AG-120 is being developed in collaboration with Celgene. This ongoing Phase 1 trial is assessing the safety and tolerability of AG-120 in advanced solid tumors, including glioma, intrahepatic cholangiocarcinoma (IHCC) and chondrosarcomas that harbor an IDH1 mutation in a dose-escalation phase followed by an expansion phase. As of September 3, 2015 (data cut-off), 62 patients have been treated with single agent AG-120, and 25 patients remain on treatment. Data reported at the meeting are from patients who received AG-120 administered from 200 mg to 1200 mg total daily doses in the dose-escalation arm. The median age of these patients is 56 (ranging from 23-88). Over half of the patients enrolled had high-grade tumors and received a median of three prior lines of therapy (ranging from one to six). Safety Data: The safety analysis conducted for all 62 treated patients as of September 3, 2015 demonstrated that AG-120 was well-tolerated with a favorable safety profile in advanced solid tumors including glioma, IHCC and chondrosarcoma. Specifically the analysis showed: No dose limiting toxicities have been observed; The majority of adverse events reported by investigators were mild to moderate, with the most common being nausea, diarrhea, vomiting, anemia and QT prolongation; The majority of serious adverse events (SAE) were disease-related; A maximum tolerated dose (MTD) has not been reached. Efficacy Data: Agios also analyzed efficacy data from 55 response-evaluable patients as of September 3, 2015, which showed: Treatment with AG-120 showed substantial reduction of the oncometabolite 2-hydroxglutarate (2HG) in plasma and tumor tissue; Imaging (magnetic resonance spectroscopy) results suggest that AG-120 can lower 2HG in the brain; Chondrosarcoma: Seven of the 11 patients with IDH1 mutant positive chondrosarcoma had stable disease. Five of these patients maintained stable disease for six months or more. The six-month clinical benefit response rate was 5/9 or 56%; IHCC: One out of 20 patients with IDH1 mutant positive IHCC had a partial response (PR) and 11 patients had stable disease. Six of these patients, including one with a PR and five with stable disease, maintained their response for six months or more. The six-month clinical benefit response rate was 6/14 or 43%; Glioma: Ten out of 20 patients with IDH1 mutant positive glioma had stable disease. Four of these patients maintained stable disease for six months or more. The six-month clinical benefit response rate was 4/16 or 25%; Other: One of the four patients with other IDH1 mutant positive solid tumors had stable disease.
Agios Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2015
Nov 5 15
Agios Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2015. For the quarter, the company reported gross collaboration revenue was $5.480 million compared to $33.9 million a year ago. Loss from operations was $40.475 million compared to income of $3.208 million a year ago. Loss before benefit for income taxes was $40.257 million compared to income of $3.256 million a year ago. Net loss was $40.257 million or $1.07 per diluted share compared to net income of $3.704 million or $0.10 per diluted share a year ago.
For nine months, the company reported gross collaboration revenue was $52.901 million compared to $50.722 million a year ago. Loss from operations was $77.802 million compared to $27.406 million a year ago. Loss before benefit for income taxes was $77.110 million compared to $27.288 million a year ago. Net loss was $77.110 million or $2.06 per diluted share compared to $26.840 million or $0.81 per diluted share a year ago.