Incyte and Cellenkos Enter into Global Development Collaboration of Combo Treatment for Myelofibrosis

Rare Daily Staff

Incyte and Cellenkos have entered into a development collaboration to investigate the combination of Incyte’s ruxolitinib with Cellenkos’ enriched cell therapy CK0804 in patients with myelofibrosis.

Myelofibrosis (MF) is a rare, chronic blood cancer that is part of a group of diseases known as myeloproliferative neoplasms (MPNs). In MF, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, and symptoms such as fatigue, itching, and night sweats, which can impact a patient’s quality of life. About 16,000 to 18,500 people in the United States are living with MF.

Cellenkos’ CK0804 is a novel allogeneic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units and manufactured using a proprietary process. The product is cryopreserved and readily available off-the-shelf, without any requirement for HLA matching, and is infused intravenously.

Under the terms of their agreement, the companies plan to initiate a phase 1b single arm, open-label study evaluating ruxolitinib in combination with CK0804 in patients with MF. Incyte will fund the study, which will be conducted by Cellenkos.

In addition, Incyte will have an option to acquire an exclusive global license to develop and commercialize the program, including genetically modified variants of CK0804, in benign and malignant hematology indications. Upon exercising the global licensing option, Incyte would be responsible for all activities and costs associated with research, development, and commercialization of the program. Cellenkos would be eligible to receive a $20 million licensing fee and, for each distinct product under the agreement, development, regulatory, and sales milestones totaling up to $294.5 million, as well as tiered royalties ranging from mid-single digit to low-double digits, if approved.

“This collaboration supports our continued commitment to developing new therapeutic options that may improve and expand treatment options for patients with MF,” said Steven Stein, chief medical officer of Incyte.

Ruxolitinib (Jakafi) is a first–in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for the treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk MF, including primary MF, post-poycythemia vera MF and post-essential thrombocythemia MF, and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. It is marketed by Incyte in the United States and by Novartis everywhere else.

“Our innovative strategy of exploiting the CXCR4/CXCL12 axis to redirect the immune modulatory T-regulatory cells specifically to the diseased bone marrow holds the promise of resolving inflammation to allow for normal hematopoiesis resulting in clinical improvement,” said Tara Sadeghi, vice president of clinical operations at Cellenkos. “This collaboration is in line with our corporate strategy to partner with world-leading major pharma companies in order to maximize access to our innovative cellular medicines.”

Photo: Steven Stein, chief medical officer of Incyte