Chronic Lymphocytic Leukemia (CLL)

Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults, characterized by an accumulation of mature but defective B cells. Currently, there is no curative treatment for this disease. However, treatment has been revolutionized by targeted therapies such as BTK inhibitors and BCL2 inhibitors, which have led to excellent results and a significant prolongation of the period of stable disease. Over time, however, CLL cells often develop genetic alterations that lead to resistance to these drugs. This group of so-called “double-refractory” patients currently has few treatment options.

Since both BTK inhibitors and BCL2 inhibitors are now used as first-line therapy, virtually all CLL patients are exposed to both drug classes early on. Since CLL is a chronic disease in which patients live much longer thanks to these targeted therapies, an ever-growing pool of patients is developing resistance to both classes (up to half of all patients).

This specific “double-refractory” patient population is showing a significant annual increase. This trend is driven primarily by the United States (which accounts for nearly 40% of the global market) and Western Europe.

Recently approved drugs, such as the BTK inhibitor Jaypirca and CAR-T cell therapies, have improved the situation but only provide a prolonged period of stable disease lasting approximately two years, after which the disease continues to progress.

The very latest so-called protein-degrading BTK inhibitors are currently being evaluated in Phase 3 clinical trials in these vulnerable “double-refractory” patients. The interim results are very promising, and the prognosis indicates that these drugs are expected to be available before 2030 for the treatment of CLL patients.

Novakand intends to evaluate in preclinical studies whether Rugocrixan has properties that could complement these new drugs in the treatment of “double-refractory” CLL patients.