Naval Daver

As a clinical investigator who is PI, Co-PI, or co-investigator on numerous industry and academic co-development phase I/II/III clinical trials (including strategic alliance studies between MDACC and industry) I believe I have the requisite knowledge, experience, collaborations, funding support, and optimal environment to support the proposed research. My primary areas of interest are AML/MDS. I am currently PI on multiple ongoing clinical trials (majority of these are investigator-initiated studies) including three registrational multinational phase III studies in the Department of Leukemia, MDACC. The majority of these trials are early phase trials in AML focused on developing a personalized therapy approach by targeting specific mutations or immune antigens expressed by patients with AML and MDS and overcoming resistance by applying novel combinations. I have been able to publish >300 peer-reviewed manuscripts, the majority being in the field of novel therapies and combinations in AML. My current clinical research focuses on developing immunotherapeutic approaches for AML/MDS, as well as novel venetoclax combinations in AML by identifying biomarkers of sensitivity/resistance and mechanisms of resistance to venetoclax in combination with hypomethylating agent or with LDAC. These efforts have led to rationally designed phase I/II clinical trials of venetoclax or HMA-venetoclax in combination with second generation FLT3-inhibitors (doublets and triplets with gilteritinib and quizartinib), with MCL-1 inhibitors (S64315), with CD47 antibody magrolimab, with CD123 antibody IMGN632, PD1 inhibitor nivolumab and with idasanutlin (MDM2 inhibitor). I am leading or co-leading these clinical trials at the national/international level including the FLT3-VEN combinations and registrational trials with CD47 antibody magrolimab that have shown great promise. I have a long-standing collaboration with Drs DiNardo, Patel, and Konopleva, and we have co-authored multiple papers and conducted numerous trials together. The proposal to test novel MRD directed combinations in AML is the first of its kind platform and will be a high priority trial for accrual at MDACC and in our AML/MDS clinical trial research group.