Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer

This is a multicenter double-blind controlled randomized Phase II study to evaluate the
activity of folate receptor alpha (FRα) peptide vaccine as a consolidation treatment
following completion of no less than 4 cycles of a platinum containing regimen in patients
with platinum-sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.

The patients will have demonstrated a tumor response or stable disease upon their last
regimen (per RECIST v1.1 and/or CA125 GCIG criteria) prior to enrolment in this study.

Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF
control alone. Patients will have booster doses and tumor assessments done every 12 weeks ± 1
week for up to 1.5 years, until objective disease progression or the patient withdraws
consent. Tumor responses will be assessed at the study sites by evaluating tumor images/scans
according to RECIST v1.1.

Criteria for Inclusion:

1. Female patient ≥ 18 years

2. Willing and able to give informed consent

3. Stage III-IV platinum-sensitive (defined as a lack of progression by RECIST v1.1
criteria following completion of standard-of-care chemotherapy, including a minimum of
4 cycles of a platinum-containing regimen) epithelial ovarian, fallopian tube or
primary peritoneal carcinoma in first remission.

4. Histologic documentation of diagnosis of carcinoma is required and the following
histologic subtypes are eligible: high grade (grade ≥3+) serous or endometrioid
carcinoma, carcinosarcoma, or poorly-differentiated adenocarcinoma, or mixed
(including above subtypes only). Note that synchronous serous or endometrioid uterine
or fallopian cancers are allowed.

5. The patient must have demonstrated an objective response (PR or CR) or stable disease
(SD) with the last chemotherapy prior to enrollment and this response must be stable
(without progressive disease) before randomization.

6. Patients must receive their first dose of vaccine within 1 year of completion of their
final dose of a chemotherapeutic agent of the platinum-containing regimen

7. Adequate normal organ and marrow function within 14 days prior to first vaccine
administration:

- Absolute neutrophil count > 1.5 x 109/L

- Platelet > 100 x 109/L

- Hemoglobin > 9.0 g/dL

- Serum bilirubin < 1.5 times ULN (unless Gilbert's syndrome without concurrent
clinically significant liver disease

- AST/ALT < 2.5 ULN unless liver metastasis in which case it must be < 5 x ULN

- Serum creatinine CL > 40 mL/min by Cockcroft-Gault formula.

8. Anti-nuclear antibody (ANA) negative or low-positive institutional range, as
determined within 28 days from registration. Intermediate values (usually defined by a
titer of ≤1:80, or as indicated by institutional range) are acceptable if there are,
in the opinion of the Investigator, no early signs of an autoimmune disease.

9. Female subjects must either be of non-reproductive potential (i.e. post-menopause by
history: > 60 years old and no menses for > 12 months naturally or secondary to
radiation/chemotherapy; OR serum FSH, LH and estradiol levels in the post-menopausal
range; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history
of bilateral oophorectomy), or must have a negative serum pregnancy test upon study
entry

10. Life expectancy > 24 weeks

11. ECOG performance status of 0 or 1

12. Formalin fixed, paraffin embedded tumor sample from the primary cancer must be sent
for central testing.

Criteria for Exclusion

1. Histology consistent with non-serous, non-endometrioid (i.e. mucinous or clear cell),
or low-grade or borderline serous ovarian carcinoma

2. Patients with a history of other cancers (other than non-melanoma skin cancers [i.e.
basal or squamous cell]) within the past 3 years.

3. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted
therapy, biological/cell therapy, tumor embolization, monoclonal antibodies, other
investigational agent) < 28 days prior to the first dose of study drug.

4. Current or prior use of immunosuppressive medication within 28 days prior to the fist
dose of study drug with the exception of topical, intranasal or inhaled
corticosteroids or systemic corticosteroids at physiological doses, which are not to
exceed 10 mg/day of prednisone, or an equivalent corticosteroid.

5. Active autoimmune disease requiring therapy within the past 2 years. Note: patients
with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within
the past 2 years are not excluded.

6. History of hypersensitivity to GM-CSF

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active
bleeding diatheses including any subject known to have evidence of acute or chronic
hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric
illness/social situations that would limit compliance with study requirements or
compromise the ability of the subject to give written informed consent

8. Symptomatic thyroid disease, unless negative for thyroid antibodies (TSH receptor,
TPO, thyroglobulin).

9. Subjects who are pregnant or are breast feeding.

10. Subjects who or of reproductive potential, and are either:

- Not abstinent;

- Not in an exclusive relationship with a partner who is surgically sterile;

- Not employing an effective method of birth control.

11. Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results

12. Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive
of but not limited to surgery, radiation and/or corticosteroids

13. Subject with uncontrolled seizures