Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDS

Inclusion Criteria: * Diagnosed with AML or MDS, as assessed by their Treating Physician; * Have no appropriate, comparable, or satisfactory alternative treatment available, or such alternatives have been tried without clinical success, including clinical studies; * Inability to participate in a GPS clinical study for the disease or conditions; and * Have a treating physician who has appropriately evaluated the benefit/risk profile for potential GPS treatment. * Patients must have a diagnosis of either AML or MDS. * Male or female patients \> 18 years of age on the day of signing informed consent. * Patients, or their legal representatives, must be able to communicate well with the Treating Physician, to understand and comply with the requirements for the provision of Expanded Access to GPS. * Patients, or their legally acceptable representatives, must be willing and able to understand and provide signed informed consent for the EAP prior to the start of treatment that fulfills Institution Review Board (IRB) guidelines. * Patients with AML must have had undergone SCT following morphological complete remission with or without peripheral blood (PB) counts recovery (CR/CRi). Patients with MDS are not required to have had CR prior to transplant. * Patients with AML must have had Minimal Residual Disease (MRD) positivity per flow cytometry, RT PCR or NGS prior to SCT conditioning. Patients with MDS may have had less than CR prior to SCT. There is no requirement for specific SCT c…