— Novel Engineered Fusion Protein Designed for Selective IL-2 Receptor Activation to Enhance Tumor-Killing Immune Cells —
Details of the preclinical data poster presentations are as follows:
- 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.
- 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:
- 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
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
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Source:
Alkermes plc
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