Agios Pharmaceuticals, Inc. (AGIO) announced new data from the ongoing phase I dose escalation study on pipeline candidate AG-221.
The company is developing the candidate in partnership with Celgene Corp. (CELG).
The study on AG-221 had enrolled 73 patients with IDH2 mutation in a wide range of late-stage hematologic malignancies on Oct 1, 2014, the data cutoff date.
These patients were suffering from relapsed or refractory acute myeloid leukemia (AML), myelodysplastic syndrome, chronic myelomonocytic leukemia and untreated AML who refused intensive chemotherapy.
The primary endpoints of the trial are to establish the safety profile, determine the maximum tolerated dose and assess the preliminary clinical activity of AG-221 as a single agent administered orally in 28-day cycles.
Out of 45 patients available for evaluation, 25 achieved investigator-assessed objective responses, which included six complete remissions, nine complete remissions with various degrees of hematologic recovery and ten partial remissions. Patients who achieved a complete remission did not show any progress with their cancer on therapy.
The data showed that AG-221 was well tolerated and the overall safety profile observed was consistent with the previously reported data. However, a maximum tolerated dose had not been reached yet. Agios stated that these data form the basis for the planned initiation of a global registration program in 2015.
The positive initial data on AG-221 will greatly boost the development plan of the candidate. We expect investor focus to remain on further data from AG-221.
Agios is also developing AG-120 under an agreement with Celgene. We are positive about the company’s partnership with Celgene, since the latter is a key player in the cancer market. Celgene’s experience is also expected to help Agios drive its pipeline.
Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broad health care sector include Biogen Idec (BIIB) and Allergan Inc. (AGN). Both carry a Zacks Rank #1 (Strong Buy).
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