ASH 2023 | Results of a Phase I trial investigating CYNK-001, a placental NK-cell product, in patients with AML

So COVALENT-103 is a Phase I study that is planned for patients with relapsed and refractory FLT3-mutant AML, examining the safety, tolerability and Phase II dose of a novel FLT3 inhibitor.

Now this FLT3 inhibitor, in contrast to our FDA inhibitors midostaurin, quizartinib, and gilteritinib, differs in that it’s what we would consider maybe a third-generation agent. It is a irreversibly, covalently binding inhibitor, BMF-500, which in the laboratory binds with high affinity and stays bound, thereby potentially conferring greater potency and durability of response.

In this Phase I trial, there’s going to be two cohorts. There is known interactions of the drug with CYP3A inhibitors, so of course there’s going to be an arm with and without commonly used azole medications. And really again looking at initial responses, efficacy. We’re hopeful that this could represent again the next generation and this particular pharmaceutical company has developed many covalent or irreversible inhibitors, targeting not only FLT3, but also menin inhibition, which is of great interest as we move forward with some of these newer agents in treatment of relapsed/refractory AML.