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Alkermes to Present Preclinical Data on ALKS 4230 at the American Association for Cancer Research Annual Meeting

Novel Engineered Fusion Protein Designed for Selective IL-2 Receptor Activation to Enhance Tumor-Killing Immune Cells

DUBLIN--(BUSINESS WIRE)--Mar. 27, 2017-- Alkermes plc (NASDAQ: ALKS) today announced that preclinical data on the company’s immuno-oncology drug candidate, ALKS 4230, an engineered fusion protein designed for selective activation of the interleukin-2 (IL-2) receptor, will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting to be held from April 1-5, 2017 in Washington D.C. ALKS 4230 is designed to preferentially bind and signal through the intermediate affinity IL-2 receptor complex, thereby selectively activating and increasing the number of tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response.

Details of the preclinical data poster presentations are as follows:

April 2, 2017, 1:00 - 5:00 p.m. ET – Abstract 591 (Poster): Efficacy of ALKS 4230, a novel immunotherapeutic agent, in murine syngeneic tumor models alone and in combination with immune checkpoint inhibitors.

  • In a murine lung tumor metastasis model, treatment with ALKS 4230 as a single agent resulted in greater anti-tumor efficacy relative to recombinant human IL-2 (rhIL-2) and was associated with selective expansion of memory CD8+ T cells and NK cells (tumor-killing cells), without expansion of regulatory T (Treg) cells. Specifically, ALKS 4230 treatment resulted in dose-dependent reduction of lung tumor colonization, with 100% inhibition at the highest dose tested. In contrast, the maximal level of inhibition achieved by rhIL-2 was 60-70% at multiple dose levels, demonstrating that increasing doses of rhIL-2 did not result in greater inhibition.
  • Combination regimens with ALKS 4230 and either anti-CTLA4 or anti-PD-1 checkpoint inhibitor therapies in murine tumor models resulted in durable anti-tumor immunotherapeutic effects and increased survival rates.

April 3, 2017, 1:00 - 5:00 p.m. ET – Abstract 2663 (Poster): Characterization of the pharmacodynamic immune response to a novel immunotherapeutic agent, ALKS 4230, in mice and non-human primates.

  • Data demonstrated that ALKS 4230 drove dose-dependent expansion of memory CD8+ T cells and NK cells in mice, and total CD8+ T cells and NK cells in non-human primates, without activation and minimal expansion of CD4+ Tregs in mice and non-human primates. These pharmacodynamics effects persisted for several days after ALKS 4230 was cleared from circulation.

In addition to these preclinical data presentations, a poster outlining the dose selection rationale for the ongoing phase 1 study of ALKS 4230 will be presented. The poster presentation details are as follows:

April 4, 2017, 1:00 - 5:00 p.m. ET – Abstract 4088 (Poster): First-in-human dose selection for ALKS 4230, an investigational immunotherapeutic agent.

  • The selection of the 0.1 µg/kg starting dose for the first-in-human study of ALKS 4230 was determined, based on the Minimal Anticipated Biological Effect Level (MABEL) approach.

For more information, including a complete list of abstracts, please visit the AACR website at http://www.aacr.org.

About ALKS 4230
ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects while overcoming limitations of existing IL-2 therapy, which activates both immunosuppressive and tumor-killing immune cells.

About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the therapeutic value of, and clinical development plans for, ALKS 4230. The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether preclinical results for ALKS 4230 will be predictive of future clinical study results; whether ALKS 4230 could be shown to be unsafe or ineffective; whether future clinical trials for ALKS 4230 will be initiated or completed on time or at all; changes in the cost, scope and duration of ALKS 4230 clinical trials; and those risks described in the Alkermes plc Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2016, and in other subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. The information contained in this press release is provided by the company as of the date hereof, and, except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking information contained in this press release.

Source: Alkermes plc

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