ISIS-STAT3 Rx And ISIS-AR Rx Data Presented By AstraZeneca At European Cancer Symposium

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Isis Pharmaceuticals, Inc.
ISIS
announced today that data from two drugs in its anti-cancer franchise will be presented by researchers at AstraZeneca in three presentations at the 26th European Organization for Research and Treatment of Cancer (EORTC) – the National Cancer Institute (NCI) – and the American Association for Cancer Research (AACR) symposium. Results from a Phase 1/2 clinical study presented today provided preliminary evidence of antitumor activity for ISIS-STAT3Rx (AZD9150) in patients with cancer including advanced/metastatic hepatocellular carcinoma (HCC). This adds to previous data for ISIS-STAT3Rx showing evidence of antitumor activity in other cancer types, including diffuse large B cell lymphoma. Additional data to be presented at the conference demonstrate that ISIS-STAT3Rx reduced STAT3 levels in multiple cell types relevant to cancer growth and survival, clinically and pre-clinically. Based on these findings, as well as very encouraging preclinical data in animal models of cancer, AstraZeneca plans to evaluate ISIS-STAT3Rx as an immunomodulatory agent in combination with MEDI4736, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor. In addition, AstraZeneca will also present preclinical data on ISIS-ARRx (AZD5312) showing that the drug is active in several tumor models. Isis Pharmaceuticals, Inc. "Based on the data from the initial trials we are excited about the potential for STAT3 inhibition in the tumor microenvironment combined with immune checkpoint inhibition. Clinical studies are expected to initiate in the first half of 2015," said Susan Galbraith, Head of Oncology Innovative Medicines Unit, AstraZeneca. "AstraZeneca's expertise and development capabilities to develop anti-cancer drugs have significantly enhanced the development of ISIS-STAT3Rx and ISIS-ARRx. Both of these drugs have demonstrated substantial antitumor activity in preclinical studies. We are encouraged with the anti-cancer activity observed with ISIS-STAT3Rx treatment in clinical studies, in which we've observed durable responses in patients with advanced lymphoma and also in patients with metastatic liver cancer," said Brett Monia, Ph.D., senior vice president of Antisense Drug Discovery at Isis Pharmaceuticals. "In addition, we are encouraged with the progress of ISIS-ARRx and look forward to the results from the ongoing ISIS-ARRx clinical study in patients with cancer." Isis and AstraZeneca are collaborating on the development of ISIS-STAT3Rx and ISIS-ARRx for the treatment of patients with cancer. At EORTC-NCI-AACR researchers will present data on both ISIS-STAT3Rx and ISIS-ARRx, including: Clinical data from ISIS-STAT3Rx, which were presented in an oral presentation titled, 'Results of a Phase 1, open-label, muticentre study to assess the safety, tolerability, pharmacokinetics and preliminary antitumor activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma' on Thursday, Nov. 20. In this presentation, treatment with ISIS-STAT3Rx provided evidence of antitumor activity in patients with HCC. In this late-stage population, several patients experienced stable disease and one patient experienced a durable, partial response (78% tumor shrinkage) while on ISIS-STAT3Rx treatment. Preclinical data from ISIS-STAT3Rx, which will be presented in a poster titled, 'Immunological STAT3 knockdown associated with antitumor activity in preclinical models translates to clinical samples, suggesting immune modulation contributes to the clinical activity of AZD9150, a therapeutic STAT3 ASO' on Friday, Nov. 21. Preclinical and clinical data from this presentation show that ISIS-STAT3Rx is distributed to tumor, stromal and immune cells and are consistent with reduction of STAT3 in these cells contributing to antitumor activity. Preclinical data from ISIS-ARRx, which will be presented in a poster titled, 'Preclinical pharmacology of ISIS 560131, a generation 2.5 antisense oligonucleotide targeting the androgen receptor with differentiated activity from enzalutamide' on Friday, Nov. 21. Preclinical data from this presentation shows that ISIS-ARRx can substantially reduce levels of all forms of the androgen receptor, including splice variants that have been implicated in promoting androgen resistance in prostate cancer. Moreover, evidence was presented demonstrating that ISIS-ARRx is effective in prostate cancer models that display resistance to current standard of care prostate cancer treatments. Isis Pharmaceuticals and AstraZeneca entered into a collaboration, development and license agreement in 2012 in oncology, subsequently expanded in 2013 to include CVMD. Under the 2012 agreement, one of the molecules being developed is ISIS-STAT3Rx, a first-in-human, first-in-class, generation 2.5 antisense oligonucleotide inhibitor of STAT3, which is being developed as an immunomodulatory agent in combination with MEDI4736, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor. A second product of that collaboration, a generation 2.5 antisense drug targeting the androgen receptor, ISIS-ARRx, is in a Phase 1/2 study. This month, Isis and AstraZeneca expanded their relationship by entering into a collaboration to develop novel delivery methods for antisense oligonucleotides. This new collaboration builds on the existing relationship and could also bring benefits to these programs.
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