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June 13, 2014
08:04 EDTAGIO, CELGAgios says Celgene exercised option to license AG-221
Agios Pharmaceuticals (AGIO) announced that its partner Celgene (CELG) has exercised its option to an exclusive worldwide license to AG-221, an oral, first-in-class, potent inhibitor of the mutant IDH2 protein. Under the terms of the agreement, the option to license extended to Celgene through the end of Phase 1, but AG-221 has been exercised early based on the Phase 1 data generated to date. AG-221 is currently in a Phase 1 dose escalation study in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia. Agios and Celgene entered into a global strategic collaboration in April 2010 to develop new therapeutics targeting cancer metabolism. By exercising its exclusive option under the terms of the agreement, Celgene gains worldwide development and commercialization rights for AG-221. Agios, in addition to contributing its scientific and translational expertise, will continue to conduct early clinical development and regulatory activities within the AG-221 development program in collaboration with Celgene. Celgene is responsible for all development costs for AG-221. Agios is eligible for up to $120 million in milestone payments and a tiered royalty on any net sales. Agios also has the right to conduct a portion of any commercialization activities for AG-221 in the United States. AG-221 is part of Agios’ IDH portfolio that also includes the IDH1 mutant inhibitor AG-120, which the company continues to develop and is in Phase 1 clinical trials in advanced solid tumors and hematologic malignancies. Agios retains U.S. rights to the IDH1 program, and Celgene has an exclusive option to ex-U.S. rights for the program. Agios continues to advance its discovery and research of cancer metabolism targets.
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August 19, 2014
09:38 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA CELG VLO VZ FB HD
07:33 EDTCELGCelgene announces publication of REVLIMID combination results
Celgene announced that results of a study evaluating the combination of REVLIMID with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in untreated diffuse large b-cell lymphoma were published online ahead of print in the Journal of Clinical Oncology. In a phase II, open label, single arm study, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP. Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response rate was 98% with 80% achieving a complete response. The 24-month EFS, which was identical to PFS, and OS rates were 59% and 78%, respectively. The company said, "This study demonstrated that the addition of lenalidomide to conventional R-CHOP resulted in similar PFS rates and OS rates between sub-types. This is intriguing as patients with the non-GCB phenotype have traditionally experienced poorer outcomes. The results of this study support further evaluation of this regimen in this sub-type of DLBCL.”
August 13, 2014
08:34 EDTAGIOAgios announces AG-221 fast track designation from FDA
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August 7, 2014
07:37 EDTAGIOAgios Pharmaceuticals reports Q2 EPS (54c), consensus (41c)
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August 6, 2014
08:33 EDTCELGCelgene shares poised to advance, says RBC Capital
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