Incyte and Cellenkos, Inc., a privately held, clinical-stage biotech company, announced a development collaboration to investigate the combination of Incyte’s blockbuster blood disorder drug ruxolitinib (Jakafi) and CK0804, Cellenkos’ CXCR4 umbilical cord blood-derived T-regulatory cells) in patients with myelofibrosis.
In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications. Hematology is the study of diseases of the blood.
“This collaboration supports our continued commitment to developing new therapeutic options that may improve and expand treatment options for patients with MF, part of a group of rare blood cancers known as myeloproliferative neoplasms (MPNs),” said Steven Stein, M.D., chief medical officer, Incyte. “We are excited to partner with Cellenkos to initiate this study as part of our LIMBER clinical development program, designed to evaluate new monotherapy and combination strategies for patients with MPNs.”
The companies plan to initiate a Phase 1b study evaluating Jakafi in combination with CK0804 in patients with MF. Incyte will fund the study.
Incyte will have an option to acquire an exclusive global license to develop and commercialize the program. 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.
MF is a rare, chronic blood cancer that is part of a group of diseases known as 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 the disorder.
The Leadership In MPNs BEyond Ruxolitinib (LIMBER) program is designed to evaluate multiple strategies to improve and expand treatments for patients with myeloproliferative neoplasms (MPNs).
Incyte is a global biopharmaceutical company based near Wilmington. For additional information on Incyte, please visit Incyte.com.
Incyte continues to seek additional therapies for Jakafi, which recorded annual sales of $1.7 billion.