Recently, Salubris announced that phase 1 trial of JK08 has been initiated after the submission of CTA (European Clinical Trial Application), and recruiting is now ongoing. JK08 is independently developed by its subsidiary Salubris Biotherapeutics, Inc. (SalubrisBio).

JK08 is a fusion protein of IL-15/IL-15Rα complex and anti-CTLA-4 antibody. It is an innovative first-in-class anti-tumor biologics developed by SalubrisBio with intellectual property rights, which is intended for the treatment of advanced solid tumors.

As a monotherapy, JK08 showed a longer serum half-life and response duration. If JK08 can be successfully developed and approved for marketing, it is expected to reduce the frequency of drug administration, make drug administration more convenient, improve patients' compliance, and have great development potential.

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IL-15 /IL-15Rα complex can effectively promote the proliferation and activation of CD8+T cells and NK cells. Anti-CTLA-4 antibody can target the tumor microenvironment, exhaust the tumor regulatory T cells (Treg), and specifically induce the activation and degranulation of NK cells in the tumor microenvironment to achieve anti-tumor immune effect. The CTLA-4 antibody validated CTLA-4 as a target for cancer therapy, but its response rates are limited, and immunotherapy-related adverse effects (irAE) are relatively high.

In terms of mechanism, JK08 can not only relieve immune suppression by using targeted antibodies, but also promote the proliferation of immune cells in tumor microenvironment, which can not only reduce the number of immunosuppressive cells, but also enhance immunoreactive cells. Moreover, it will not significantly increase irAE while enhancing the immunotherapy effect.