Development of CM-HZ01 as a non-alpha-IL2 therapeutic for the treatment of metastatic melanoma

Summary Melanoma incidence is increasing at an alarming rate; as the deadliest of all skin cancers, it is estimated that one person, every hour of every day, dies of melanoma. Interleukin-2 (IL-2) was the first effective cancer immunotherapy, approved for metastatic renal cancer in 1992 and metastatic melanoma in 1998. IL-2 plays a central role in suppressing or activating lymphocyte responses through differential binding to IL-2 receptors expressed on regulatory T-cells or CD8 cytotoxic T-cells, and NK cells, respectively. Engineering selective IL-2 activity, however, has posed a significant challenge for generating effective immunotherapies lacking substantial toxicity. We are developing CM-HZ01 as a high avidity IL-2 super-agonist that preferentially promotes CD8 effector T-cell expansion and improves anti-tumor activity. In this Direct to Phase II application, we seek to advance CM-HZ01 to IND for metastatic melanoma, providing a best-in-class therapeutic for patients with limited effective treatment options.