KDev Oncology AB

The Challenge

About 42.000 new cases of Acute Myeloid Leukemia (AML) are diagnosed in US/EU27/JP each year and deaths from AML total about 30.000¹.

The median AML patient age is 67 years. Current treatments are chemotherapy and bone marrow transplantation. No targeted treatments are approved. Due to the limited duration of complete remission, mainly due to chemotherapy resistance of the tumor cells, 5-year survival rates are 34% for adults aged below 65 and 4% for those aged 65 or older².

There is a very high unmet medical need for treatments with better anti-tumor effects as well as treatments with fewer side effects.

The Solution

Akinion's candidate drug AKN-028 is active against AML with FLT-3 mutations as well as AML without FLT-3 mutations, which potentially makes the compound usable for most AML patients. However, preclinical cell culture data show a superior safety profile compared with multitargeted kinase inhibitors, which have a broader inhibition spectrum and therefore more side effects. AKN-028, which is administered orally, clearly has first-in-class potential.

Competitive Advantages

Unlike other kinase inhibitors, Akinion AKN-028 is active in both FLT-3 mutated and FLT-3 wild type patient tumor cells. In preclinical studies and on chemotherapy resistant primary tumor cells the compound has a preferred antileukemic cytotoxic activity and high oral bioavailability, as well as a superior safety profile compared to multitargeted kinase inhibitors.

The Market

The number of patients with AML is four times higher than the number of patients with chronic myelogenous leukemia (CML). The market for Glivec, a kinase inhibitor and first line treatment for CML, was reported to be USD 4.3bn in 2010³. Even though AML is a heterogenous disease, the market for a successful oral AML treatment is expected to be at least as large as for Glivec.