ALKS 4230 is an immunotherapy being developed by Alkermes as a potential treatment for different types of cancer. It selectively activates a patient’s immune system with the aim of fighting a tumor more effectively.

How ALKS 4230 works

ALKS 4230 is a type of treatment called a selective effector cell activator (SECA), a protein that was engineered in the laboratory to bind and activate another protein, known as interleukin-2 (IL-2). IL-2 is a cell signaling molecule or cytokine, which plays a key role in the immune response by controlling the life cycle of specialized immune cells called T-cells.

ALKS 4230 selectively binds to the “intermediate-affinity IL-2 receptor” — which works to both activate and increase in number immune cells that work to eliminate cancer cells (the so-called CD8+ T-cells and natural killer [NK] cells). Their selectivity, however, means they don’t bind to the “high-affinity IL-2 receptor,” so as not to  trigger greater activity or proliferation in  immune cells that could dampen an anti-tumor response (known as regulatory T-cells, or Tregs).

This means that when ALKS 4230 is administered, immune cells responsible for recognizing and killing cancer cells are more plentiful and active, while those that regulate the immune response (Tregs) are not. This has the possibility of being safer and more tolerable, as well as having strong anti-tumor effects.

ALKS 4230 in clinical trials

Preclinical data on ALKS 4230 were presented in April 2017 at the annual meeting of the American Association for Cancer Research (AACR). ALKS 4230 was used in a mouse model of lung cancer alone and in combination with cancer treatments called immune checkpoint inhibitors. Results were positive and showed the anti-tumor activity of ALKS 4230, both alone and with the checkpoint inhibitors. Animals treated with ALKS 4230 were seen to have lesser tumor growth and better survival. These results supported clinical evaluation of ALKS 4230 as a potential immunotherapy for cancer patients.

The treatment is now in a Phase 1 clinical trial (NCT02799095) evaluating its safety and tolerability in about 120 people with solid tumors that are resistant to conventional treatments. Patients are being given ALKS 4230 at a dose of 0.1 µg/kg, which was determined to be a safe starting dose in laboratory studies.

This trial is currently recruiting patients at six locations in the U.S.; more information is available by clicking on its identification number. It is due to conclude in June 2018.

New positive data involving preclinical work on ALKS 4230 was announced by Alkermes in November at an annual immunotherapy scientific conference. According to a company release, treatment with ALKS 4230 significantly delayed tumor growth and increased the number of tumor-killing T-cells in mice with tumors derived from cells of patients with metastatic melanoma.


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