Kadmon Holdings Inc. (NYSE:KDMN) announced the dosing of the first patient in its first phase clinical study evaluating KD033in metastatic or locally advanced solid tumors patients. As an anti-PD-L1/IL-15 fusion protein, KD033 is innovative immunotherapy designed to stimulate adaptive and innate immune responses targeting the tumor microenvironment.
KD033 demonstrated efficacy and durability in clinical models
Harlan Waksal, the CEO Kadmon, stated that they are delighted to commence KD033 clinical development, which has shown promising durability and efficacy in various types of tumors in preclinical models. He added that KD033 can stimulate immune responses in patients to fight cancer while preventing systemic toxicities. This is achieved through directing of IL-15 antitumor activity to the microenvironment of the tumor. The CEO added that the study’s commencement is a huge milestone for the company and its IL-15 fusion protein containing the platform.
Most importantly, the recombinant IL-15 has shown clinical activity in treating a variety of cancers. rIL-15, an immunostimulatory cytokine helps expand important tumor-fighting cells that include the natural killer T (NKT), Natural Killer (NK) cells, and Memory T Cells. This is done while maintaining immunosuppressive T cells and thus permitting durable and solid antitumor responses. Interestingly rIL-15’s clinical use is limited by its narrow therapeutic timeframe and short half-life.
KD033 to address rIL-15’s narrow therapeutic window limitation
Kadmon developed KD033 to address the limitations because it directs IL-15 activity to the microenvironment of PD-L1, showing tumors, and enhancing the therapeutic time frame. KD033 has been designed to stimulate long-lasting efficacy while minimizing the systemic contact of IL-15 to enhance tolerability and safety.
Previous preclinical studies have shown that KD033 can have significant in vivo pharmacological action and suppress tumor growth in several syngeneic mouse models. It has also shown to induce T cell memory, leading to mice that were tumor-free after numerous tumor re-challenges. The immunotherapy shows considerable tumor inhibition in various animal models resistant to PD-1, PD-L1, and CTLA-4 antibodies immunotherapies.