Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma

The study will be conducted under an IRB approval, in accordance with FDA regulations and
Human Subject Protection regulations. Female patients will undergo standard of care therapy
to include exploratory laparotomy and cytoreduction (debulking) surgery followed by
chemotherapy. Only patients with histological confirmation of FIGO Stage III/IV epithelial
adenocarcinoma of ovarian, tubal or peritoneal origin will be screened and enrolled into the
study. At cytoreduction surgery a portion of the surgically resected tumor is preserved for
vaccine production. The surgically resected tumor as well as normal cells obtained from
peripheral blood shall be used for extraction of RNA and DNA sequencing of the tumor and
normal transcriptomes, as well as normal exome sequencing, in the Genomic Core Facility at
UConn Health. Patient's blood cells shall also be HLA typed.

When the patient has recovered from surgery, standard of care chemotherapy is given.
Following completion of standard chemotherapy (6-8 cycles) and Investigator's confirmation of
clinical remission, patients will be consented as subjects for the experimental investigative
portion of the study.

The overall purpose of this research study is to produce and test the safety of a new
experimental vaccine called OncoImmunome in people with Stage III/IV Ovarian Cancer. An
"experimental vaccine" is a vaccine that is being tested and is not approved for sale in the
United States by the U.S. Food and Drug Administration (FDA). The study has been divided into
two parts: 1)Tumor Tissue and Blood Sample Collection and 2) Vaccine and Follow-up.

Study participants will consent to the following:

1. Tumor Tissue and Blood Sample Collection: The purpose of this part of the study is to
collect participants' blood and tumor tissue and test it for genetic mutations. These
test results will be used to manufacture a study vaccine that is unique to the
participant and to their ovarian cancer.

2. Vaccine and Follow-up: The purpose of this part of the study is to test the safety of
the experimental drug (vaccine) called OncoImmunome, which has been produced
specifically for each participant.

Subject participation in this research study will last up to 5 years. The vaccine will be
produced over a 6 month period, and for six months subjects will receive the study vaccine (1
study vaccine dose per month or 6 study vaccine doses total). However, the researchers will
continue to collect all subjects information for up 5 years from the time they provided their
tumor sample and blood for the research.

Inclusion Criteria:

1. Female patients >18 years of age must have a diagnosis of histologically confirmed
Stage III/IV epithelial ovarian/fallopian tube/primary peritoneal adenocarcinoma who
have not received any treatment or patients with recurrent Stage III/IV epithelial
ovarian/tubal/peritoneal carcinoma with first recurrence ≥12 months after initial
therapy and with resectable disease.

2. All patients must have cytoreduction/laparoscopic surgery at UConn Health and their
tissue must be stored in the UConn Health Center Research Tissue Registry/Repository
(Biorepository) using cryopreservation methods.

3. Patient must have completed standard platinum based adjuvant chemotherapy as per
standard-of-care (only applicable for Vaccine Phase).

4. Patients must have a life expectancy of at least 6 months.

5. In the clinical judgment of the investigator, patients must have adequate renal,
hepatic, and bone marrow function to complete the study:

- Hematologic function: Absolute neutrophil count (ANC) must be greater than 1000
per mcl. White blood count equal to or greater than 3000 per mcl, platelet count
greater than or equal to 100,000 per mcl.

- Renal function: Serum creatinine equal to or less than 2.0 mg/dl.

- Hepatic function: Bilirubin <1.5 x institutional normal.

6. Patients with Patients with ECOG/WHO/Zubrod scale performance status < or = 2.

7. No evidence of active infection.

8. No evidence of active infection requiring systemic therapy. Patients enrolled in the
Tissue and Blood Phase may receive IV antibiotics preoperatively, IV in surgery when
they have a Hysterectomy and also postoperatively.

9. Patients not participating in another experimental program/therapy at least 4 weeks
prior to enrollment.

10. Patients have enrolled and have adequate cancer tissue sample available from this
cytoreduction/laparoscopic surgery deposited in the UConn Health Center Research
Tissue Registry/Repository (Biorepository) study (Principal Investigator: Mary Melinda
Sanders, MD; UConn Health IRB# 08-310-1) for this study.

11. Patients must be English speaking and sign an approved informed consent form (ICF) and
HIPAA.

Exclusion Criteria:

1. Patient not enrolled in the UConn Health Center Research Tissue Registry/Repository
(Biorepository) study or there is inadequate tissue available for this study.

2. Patients not in clinical remission after standard chemotherapy.

3. Patients with recurrent Stage III/IV epithelial ovarian/tubal/peritoneal carcinoma
with first recurrence < 12 months after initial therapy.

4. Patients who have active autoimmune disease.

5. Patients with any medical condition that would interfere with their ability to
complete the study.

6. Patients who are receiving any experimental drug therapy within 4 weeks of enrollment.

7. Patients who are taking steroids (excludes topical steroids) within 4 weeks of
enrollment.

8. Patients with a prior malignancy within the previous 5 years or a synchronous primary
cancer (non-melanoma skin cancer or other In Situ cancers are excluded).

9. Patients unable or unwilling to provide informed consent.

10. Patients whose tumors are not able to be sequenced or from which sufficient suitable
neo- epitopes are not able to be identified.