Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

key Inclusion Criteria:

   - Morphologically confirmed diagnosis of MDS/CMMoL according to FAB or WHO
   classification, including RAEB-t and MDS/MPN

   - International prognostic score-revised (IPSS-R) of >3.5 (Intermediate, High or Very
   High)

   - Previously untreated with hypomethylating agents for MDS/CMMoL

   - Performance status of 0, 1 or 2 by the ECOG scale

   - Adequate renal and liver function

   - Female subjects of childbearing potential must have a negative serum pregnancy test at
   screening within 96 hours prior to the first study dose.

   - Female subjects of childbearing potential and male subjects with partners of
   childbearing potential should ensure use of a highly effective method of birth control
   as defined by the investigator, for example, those which result in a low failure rate
   (i.e., less than 1% per year) when used consistently and correctly during the study
   and for a period of 3 months following the last dose of any drug administered during
   the study.

Key Exclusion Criteria:

   - Relapsed or refractory to hypomethylating agents

   - Acute myeloid leukemia (AML), except those patients with RAEB-t who are not candidates
   for intensive AML therapy.

   - Participated in any interventional study within 4 weeks of randomization or 5 half
   lives (whichever is longer).

   - Received any hematopoietic growth factors within 14 days prior to screening.

   - Prior malignancy or secondary malignancy within the prior 2 years (except in situ
   cervical cancer, squamous cell carcinoma or basal cell carcinoma of the skin).

   - known diagnosis of human immunodeficiency virus or chronic active Hep B or C.

   - Uncontrolled hypertension

   - Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or
   clinically significant cardiac disease

   - Lack of recovery of prior adverse events to Grade ≤1 severity (National Cancer
   Institute Common Terminology Criteria for Adverse Events version 4) (except alopecia)
   due to therapy administered prior to the initiation of study drug dosing.

   - Nursing or pregnant.

   - Known allergy or hypersensitivity to any of the formulation components

   - Any concurrent disease and/or medical condition that, in the opinion of the
   Investigator, would prevent the subject's participation.

   - History of cranial nerve palsy.

   - Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy
   within 5 half-lives of randomization.