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, orsuch alternatives have been tried without clinical success, including clinicalstudies;

• 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 profilefor 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 theTreating Physician, to understand and comply with the requirements for the provisionof Expanded Access to GPS.

• Patients, or their legally acceptable representatives, must be willing and able tounderstand and provide signed informed consent for the EAP prior to the start oftreatment that fulfills Institution Review Board (IRB) guidelines.

• Patients with AML must have had undergone SCT following morphological completeremission with or without peripheral blood (PB) counts recovery (CR/CRi). Patientswith MDS are not required to have had CR prior to transplant.

• Patients with AML must have had Minimal Residual Disease (MRD) positivity per flowcytometry, RT PCR or NGS prior to SCT conditioning. Patients with MDS may have hadless than CR prior to SCT. There is no requirement for specific SCT conditioning andconditioning intensity could have been myeloablative or nonmyeloablative (reducedintensity) conditioning.

• Patients must be consented within 30 -120 days after the date of SCT.

• Patients may concurrently be administered HMA +/- venetoclax and/or FLT3 ITDtargeted agents at the discretion of the Treating Physician, in which case theirregimen of GPS administrations will continue in parallel with the prescribed HMA +/-venetoclax and/or FLT3 ITD targeted agents regimen.

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance statusof 0, 1, 2 or 3.

• Patients must have an estimated life expectancy >6 months.

• If female, patients must be postmenopausal (at least 12 sequential months ofamenorrhea) or surgically sterile. Females of childbearing potential must have anegative pregnancy test.

• Female patients of childbearing potential who are heterosexually active and malepatients with female sexual partners of childbearing potential must agree to use aneffective method of contraception (e.g., oral contraceptives, double-barrier methodssuch as a condom and a diaphragm, intrauterine device) during the GPS treatment andfor 4 months following the last dose of GPS, or to abstain from sexual intercoursefor this time; a woman not of childbearing potential is one who has undergonebilateral oophorectomies or who is post-menopausal, defined as the absence ofmenstrual periods for 12 consecutive months.

• Patients must not have end stage renal disease.

• Patients must have adequate hepatic function defined as a serum total bilirubin <2 ×ULN (except for Gilbert'ssyndrome, which will allow bilirubin ≤3.0 mg/dL), andalanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN.

• Patients must be willing and able to return to the clinical site for adequatefollow-up and to comply with the EAP treatment schedule, as required.

Exclusion Criteria:

• Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF)or filgrastim (granulocyte colony stimulating factor [G-CSF]).

• Patients with acute promyelocytic leukemia (APL) or any morphologic and molecularvariants, inclusive.

• Patients with a serious concurrent illness that in the opinion of the TreatingPhysician would pose an undue risk to the patient.

• Patients who currently have central nervous system leukemia.

• Patients who have received a live vaccine within 30 days prior to the first dose ofEAP drug. Examples of live vaccines include, but are not limited to, the following:measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies,Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines forinjection are generally killed virus vaccines and are allowed; however, intranasalinfluenza vaccines (e.g., FluMist®) are live attenuated vaccines and are notallowed. Vaccines used for the prevention of COVID-19 are allowed to be used as theyare not live vaccines.

• Patients currently receiving systemic immunosuppressive therapy in dosing exceeding 10 mg daily of prednisone equivalent. The use of physiologic doses ofcorticosteroids or other immunosuppressive agents may be approved after consultationwith the Sponsor. Steroids taken as short-term therapy (≤ 7 days) for antiemesis arepermissible as are steroids with low systemic bioavailability (e.g., budesonide).

• Patients who have a known additional malignancy that is progressing or has requiredactive treatment within the past 5 years, even if currently inactive or unapparent.

• Patients who have a known active CNS metastases and/or carcinomatous meningitis.Patients with previously treated brain metastases may participate provided they areradiologically stable, i.e., without evidence of progression for at least 4 weeks byrepeat imaging (note that the repeat imaging should be performed during EAPscreening), clinically stable and without requirement of steroid treatment for atleast 14 days prior to first dose of treatment.

• Patients who had a previous clinically significant systemic allergic reaction toMontanide, sargramostim (GMCSF), or filgrastim (G-CSF).

• Patients who have an active life-threatening infection requiring systemic therapy.

• Patients who have a history or current evidence of any condition, therapy, orlaboratory abnormality that is not in the best interest of the patient toparticipate, in the opinion of the Treating Physician. This includes any serious,intercurrent, chronic, or acute illness, such as cardiac disease (New York HeartAssociation [NYHA] class III or IV), hepatic disease, or other illness considered bythe Treating Physician as an unwarranted high risk for investigational drugtreatment.

• Patients who have a known psychiatric or substance abuse disorder that wouldinterfere with the patient's ability to cooperate with the requirements of the EAP.

• Patients who are pregnant or breastfeeding or expecting to conceive or fatherchildren within the projected duration of the EAP, starting with the screening visitthrough 30 days after the last dose of EAP treatment.

• Patients who have had an allogeneic solid organ transplant.