Isis Pharmaceuticals, Inc. (ISIS) recently announced the presentation of encouraging phase I data on its oncology candidate, ISIS-STAT3Rx, at the American Society of Clinical Oncology.
ISIS-STAT3Rx is being developed in collaboration with AstraZeneca (AZN). Results from the open-label, dose-escalation study sahowed that treatment with ISIS-STAT3Rx helped achieve partial responses that were durable and prolonged in two out of three diffuse large B-cell lymphoma (:DLBCL) patients who were refractory to earlier chemotherapy treatments.
The study was conducted in 15 patients with advanced solid tumors and lymphoma who had relapsed or were not responding to several chemotherapy regimens. Isis Pharma reported that a patient who had previously failed ten different chemotherapy regimens experienced a 50% reduction in tumor burden - partial response was maintained for more than a year and the patient continues to be treated with ISIS-STAT3Rx. Another patient with DLBCL experienced a 65% reduction in tumor burden and was, therefore, able to receive an autologous stem cell transplant. The patient remained disease free following the bone marrow transplant.
ISIS-STAT3Rx is currently in two phase Ib/IIa studies from which results are expected next year – while one study is being conducted in patients with advanced lymphomas like DLBCL, the other study is being conducted in patients with metastatic liver cancer.
We note that ISIS-STAT3Rx is the first of Isis Pharma’s generation 2.5 chemistry candidates which are supposed to be significantly more potent than drugs currently in development and which could, therefore, be more effective in addressing difficult-to-treat cancers like DLBCL.
In addition to presenting the encouraging efficacy data on ISIS-STAT3Rx, Isis Pharma announced that it has achieved a milestone payment from AstraZeneca with the latter selecting a second development candidate under its collaboration agreement with Isis Pharma. The $10 million milestone payment was triggered with the selection of ISIS-ARRx, which will be evaluated as a monotherapy as well as in combination with other drugs for the treatment of prostate cancer.
Isis Pharma currently carries a Zacks Rank #2 (Buy). We are encouraged by the company’s progress with its pipeline - Isis Pharma has several candidates in phase II or phase III development. The next 12-18 months should be catalyst-filled with Isis Pharma expected to report results from several studies.
We view Kynamro’s Jan 2013 approval in the US as a major milestone for the company. Kynamro was launched in late Mar 2013 and we expect investor focus to remain on the product’s performance.