Calithera's (CALA) CB-839 Shows First Clear Evidence of Clinical Activity in AML; Leerink Affirms at 'Outperform'
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Leerink Partners affirms Calithera Biosciences, Inc. (Nasdaq: CALA) with an Outperform rating and $19 price target after the company announced that data from its lead, first-in-class program CB-839 will be presented at the 20th Congress of the European Hematology Association (EHA) June 11-15, 2015, in Vienna, Austria. CALA said, "These preliminary data demonstrate the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with acute leukemia."
Analyst Howard Liang, Ph.D., offered the following summary and observation: The finding of a complete response in the bone marrow of an AML patient with single-agent CB-839 provides for the first time clear evidence of clinical activity of CALA’s lead compound, after the firm had previously reported only stable disease as the best response in the Phase I solid tumor trial (data to be presented at ASCO). Although it is not clear at what dose each of the AML patients was treated (the press release and abstract state patients received between 100 and 1000 mg three times daily), we are also very encouraged that a therapeutic dose was reached without any significant safety signals, which is in line with the previously reported results from solid tumors. Although one would generally like to see more than a single response, we believe the first report of an objective response is highly encouraging as it provides support for the mechanism of action (MOA). The question for CB-839 in AML will become one of the frequency of the response, and there is a possibility that the response rate could be higher at the therapeutic dose (assuming the response was seen at one of the higher doses). Based on our understanding of the biology, we continue to believe the activity of glutaminase inhibitors could be context-dependent and there could be opportunities to enhance activity through patient selection or combination.
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