Our Programs

Our pipeline includes four clinical-stage drug candidates targeting different mechanisms critical to overcoming cancer progression and drug resistance:

  • ME-401, an oral PI3K delta inhibitor;
  • Voruciclib, an oral CDK inhibitor; and
  • ME-344, a mitochondrial inhibitor targeting the OXPHOS complex.
  • Pracinostat, an oral HDAC inhibitor;

Our portfolio is built around drug candidates with validated targets and is designed to develop medicines that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other medicines.

ME-401

Oral P13K Delta Inhibitor

INDICATION COMBINATION CLINICAL PROOF OF CONCEPT MARKETING APPROVAL STUDY COMMERCIAL RIGHTS

Follicular Lymphoma

Relapsed/refractory

Monotherapy

Phase 2 Accelerated Approval Trial 1

Excluding Japan

Japan

B-Cell Malignancies

Relapsed/refractory

Monotherapy

Rituxan® (rituximab)

Zanubrutinib2

60%
60%

clinical collaboration

Voruciclib

CDK Inhibitor

INDICATION COMBINATION CLINICAL PROOF OF CONCEPT MARKETING APPROVAL STUDY COMMERCIAL RIGHTS

B-Cell Malignancies & AML

Relapsed/refractory

Venclexta® (venetoclax)3
60%

ME-344

Mitochondrial Inhibitor

INDICATION COMBINATION CLINICAL PROOF OF CONCEPT MARKETING APPROVAL STUDY COMMERCIAL RIGHTS

HER2-Breast Cancer

Treatment-naive, early stage

Avastin® (bevacizumab)4
60%

Pracinostat

HDAC Inhibitor

INDICATION COMBINATION CLINICAL PROOF OF CONCEPT MARKETING APPROVAL STUDY COMMERCIAL RIGHTS

Acute Myeloid Leukemia

Treatment-naive

Vidaza®
(azacitidine)
Phase 3 Pivotal Trial

Myelodysplastic Syndrome

Treatment-naive

Vidaza®
(azacitidine)
60%

[title]

DRUG CANDIDATE

Pracinostat HDAC Inhibitor

INDICATION / COMBINATION

Acute Myeloid Leukemia

Unfit for intensive chemotherapy
Vidaza® (azacitidine)
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal
INDICATION / COMBINATION

Myelodysplastic Syndrome

High & very high risk
Vidaza® (azacitidine)
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal

[title]

DRUG CANDIDATE

ME-401 PI3K Delta Inhibitor

INDICATION / COMBINATION

Follicular Lymphoma

Relapsed/refractory
Single agent
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal
INDICATION / COMBINATION

B-Cell Malignancies

Relapsed/refractory
Single-agent
• Rituxan® (rituximab)
• Zanubrutinib
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal

[title]

DRUG CANDIDATE

Voruciclib CDK Inhibitor

INDICATION / COMBINATION

B-Cell Malignancies

Relapsed/refractory
Single agent
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal

[title]

DRUG CANDIDATE

ME-344 Mitochondrial Inhibitor

INDICATION / COMBINATION

HER2-Breast Cancer§

Treatment-naïve, early stage
Avastin® (bevacizumab)
Pre-Clinical
Clinical Proof-Of-Concept
Pivotal

 

1 Phase 2 study to support an accelerated approval marketing application with FDA
2 Study arm initiated under clinical collaboration with BeiGene, Ltd.
3 Evaluation in combination with venetoclax is subject to FDA approval
4 Investigator-initiated trial