Nemvaleukin alfa (Nemvaleukin) – Novel engineered IL-2
Understanding Our Treatment Candidates
Nemvaleukin is an innovative engineered interleukin-2 (IL-2) variant designed to harness the potent anti-cancer capabilities of high-dose rhIL-2 while minimizing toxicity by selectively activating cancer-fighting CD8 T cells and NK cells, making it a promising candidate in cancer immunotherapy.
As the first immunotherapy ever approved, recombinant human interleukin-2 (IL-2) (rhIL-2) or high-dose IL-2, has demonstrated complete and durable responses in certain tumor types. Unfortunately, its toxicity profile significantly limits its use. As a natural regulator of the immune system, it achieves high efficacy by activating different cancer-fighting immune cells such as NK cells and CD8 T cells. The problem is IL-2 can also bind with and activate T regulatory cells (Tregs) and vascular endothelial cells (VECs), which are known to dampen anti-tumor immune responses and cause severe toxicity.
We engineered nemvaleukin, a novel, investigational IL-2 variant, to expand the therapeutic benefits of high-dose rhIL-2, while mitigating the toxicities. Nemvaleukin is designed to avoid Tregs and VECs, while activating the cells of interest – CD8 T cells and NK cells. Using our proprietary PICASSO® platform, we engineered a modified version of IL-2 that includes the high affinity IL-2 alpha receptor chain, which prevents nemvaleukin from binding to the Tregs and VECs. The result is that it binds preferentially to and activates cancer fighting CD8 T and NK Cells. Because nemavaleukin is a stable fusion protein, it does not degrade and has a longer half-life than other IL-2 based drugs.
Nemvaleukin is currently being evaluated in registrational studies, ARTISTRY-7 in platinum-resistant ovarian cancer (PROC) and ARTISTRY-6 in advanced melanoma. Nemvaleukin has received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of mucosal melanoma. It has also received Fast Track designation for the treatment of platinum-resistant ovarian cancer (PROC) in combination with pembrolizumab.