AMSTERDAM—Clinical-stage biopharmaceutical company Kiadis Pharma N.V. and Sanofi have teamed up in a license agreement centered on Kiadis' K-NK platform, specifically its proprietary CD38 knockout (CD38KO) K-NK therapeutic for combination with anti-CD38 monoclonal antibodies. The companies will explore the combination of CD38KO with Sarclisa, Sanofi's recently approved anti-CD38 antibody, for the diagnosis, prevention and treatment of multiple myeloma and CD38-positive blood cancers.
Per the terms of the agreement, Sanofi will pay Kiadis €17.5 million up front, with the potential for up to an additional €857.5 million should Sanofi reach predetermined preclinical, clinical, regulatory and commercial milestones. Kiadis also stands to receive up to low double-digit royalties on commercial sales of any products developed under this deal.
The agreement grants Sanofi exclusive worldwide rights to research, develop and commercialize K-NK004 based on Kiadis’ CD38KO K-NK cells in combination with CD38-targeting molecules for the treatment of multiple myeloma and other CD38 positive blood cancers. Sanofi also has exclusive rights to leverage Kiadis' platform for two other previously undisclosed preclinical platforms. Sanofi will lead—and assume responsibility for all costs related to—research and development, manufacturing, regulatory and commercial activities related to the licensed programs. For its part, Kiadis retains exclusive rights to PM21 particles and will supply those particles and select universal donors to Sanofi, which Sanofi will pay for.
“We are proud to announce this collaboration with Sanofi, which marks the start of the previously undisclosed K-NK004 program and expands the application of our K-NK platform into multiple myeloma. The agreement with Sanofi—with their world-class expertise and approved anti-CD38 monoclonal antibody, Sarclisa, in multiple myeloma and deep understanding of NK-cell biology—is a testament to the groundbreaking potential of our K-NK natural killer cell platform to treat life-threatening diseases,” Arthur Lahr, CEO of Kiadis, commented in a press release.
Natural killer (NK) cells are a key part of the body's immune response, and Kiadis' CD38KO K-NK cells are NK cells that are genetically engineered to reduce CD38 expression.
“Kiadis’ CD38KO K-NK cell therapy is highly complementary to Sanofi’s CD38 products and pipeline because it provides a way to deliver cancer-attacking natural killer cells to patients. NK cells express CD38, and thus therapeutic use of anti-CD38 antibodies can lead to depletion of the patient’s own NK cells, a process called fratricide,” Lahr explains. “Kiadis’ CD38KO K-NK cells have been modified to reduce expression of CD38 and are resistant to this fratricide effect. Adjunctive infusion of CD38KO K-NK cells can restore the natural synergism between NK cells and antibodies to kill tumor cells through CD38-targeting molecules like Sarclisa, thereby optimizing efficacy.”
Lahr tells DDN that this is the first time the two companies have worked together.
“The licensing of Kiadis’ CD38KO K-NK cells is particularly exciting for Sanofi since we will be studying this cell-based therapeutic with our recently FDA approved treatment for patients with difficult-to-treat multiple myeloma, in hopes of bringing even more options to these patients with this hematologic cancer,” said John Reed, Global Head of Research and Development at Sanofi. “At Sanofi, we are committed to pioneering treatments that address unmet healthcare challenges. Innovative collaborations, such as this partnership with Kiadis, have the potential to expand the clinical benefits of our medicines by combining them with synergistic partnered therapeutics to deliver improved outcomes for patients.”
According to Lahr, Kiadis is also looking to explore additional cancer indications, including additional blood cancers and some solid tumors.
“Kiadis’ proprietary approach to universal donor selection and robust ex-vivo expansion protocols result in hyperfunctional “off-the-shelf” NK cells suitable for therapeutic applications,” he remarks. “Such NK cells represent an attractive combination partner for other cancer therapies, such as monoclonal antibodies, that work in concert with NK cells to kill tumor cells through a process called antibody-dependent cell-mediated cytotoxicity.”