Overview

Our pipeline includes clinical-stage drug candidates each with its own unique mechanism of action that can target pathways involved in driving various hematological malignancies and/or solid tumors.

Voruciclib
Oral CDK9 Inhibitor

Voruciclib, a selective, orally administered, inhibitor of cyclin-dependent kinase 9 (CDK9) with potential to treat both hematological malignancies and solid tumors. It is in clinical development for patients with relapsed or refractory acute myeloid leukemia. Studies in solid tumors are also being considered.

ME-344
Mitochondrial Inhibitor of OXPHOS

ME-344 is a novel inhibitor of mitochondrial oxidative phosphorylation (OXPHOS), a fundamental metabolic pathway involved in the production of adenosine triphosphate (ATP) in the mitochondria. ME-344 has demonstrated clinically activity in multiple clinical studies in combinations, including with bevacizumab (Avastin®). ME-344 is continuing to advance via the ongoing development of a new formulation intended to improve biologic activity and patient convenience.

INVESTIGATIONAL AGENTS THERAPEUTIC AREA COMBINATION PRE-IND PHASE 1/1B PHASE 1/2 Info
Commercial Rights:

Acute Myeloid Leukemia

 Relapsed/refractory (2L+)
Single-agent VENCLEXTA®
(venetoclax) 		Completed Ongoing Info

Solid Tumors*
Single-agent & Vemurafenib Completed Info

Voruciclib is an orally administered CDK9 inhibitor. Inhibition of CDK9 blocks the production of MCL1, an established resistance mechanism to the BCL2 inhibitor venetoclax. CDK9 also inhibits MYC, a transcription factor regulating cell proliferation and growth that has also been implicated in KRAS mutant tumors. This Phase 1b trial is evaluating voruciclib dose and schedule in patients with acute myeloid leukemia and B-cell malignancies.

We are evaluating the dose and schedule of voruciclib as a single-agent and in combination venetoclax, initially in patients with AML and subsequently across multiple indications.

Enrollment Status
AML: Ongoing
B-Cell Malignancies: Ongoing

 Publications Clinical Trials
Commercial Rights:

HER2-Negative Breast Cancer**
AVASTIN®
(Bevacizumab) 		Completed Info

ME-344 is a novel tumor selective mitochondrial inhibitor drug candidate that has been investigated clinically in patients with solid tumors. Data was reported at ASCO 2019 from an investigator-initiated, multi-center, randomized study of ME-344 in combination with placebo or the VEGF inhibitor bevacizumab (marketed as Avastin®). The data demonstrated that ME-344 in combination with bevacizumab was biologically active in HER2 negative breast cancer patients consistent with decreased cancer proliferation. MEI is planning to initiate a Phase 1b clinical study evaluating ME-344 with bevacizumab or other anti-angiogenic agent in patients with select solid tumors.

Enrollment Status
Study Complete

 Publications Clinical Trials

Colorectal Cancer

 Relapsed
AVASTIN®
(Bevacizumab) 		Completed Info

Solid Tumors
VEGF Inhibitors
(Bevacizumab & tyrosine kinase inhibitors) 		New Formulation New
Formulation 		Info

*Three Phase 1 Studies in a total of 77 patients.  **Phase 0 window of opportunity study: investigator initiated; placebo controlled.

Patients & Caregivers
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Patients & Caregivers

Our driving purpose and principle is simple: deliver novel and differentiated cancer therapies that provide improved outcomes for patients.
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