On March 27, 2017 Alkermes plc (NASDAQ: ALKS) reported 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) (Free AACR Whitepaper) Annual Meeting to be held from April 1-5, 2017 in Washington D.C (Press release, Alkermes, MAR 27, 2017, View Source [SID1234518272]). 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. Schedule your 30 min Free 1stOncology Demo! Details of the preclinical data poster presentations are as follows:
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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 (Free AACR Whitepaper) website at View Source
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.