Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and
effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in
combination with DPX-Survivac and cyclophosphamide.

The Phase 2 component was initially a multicenter, randomized, open-label study to evaluate
the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of
epacadostat. The design of the study has been amended to a single arm study in which up to 16
evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose
cyclophosphamide (i.e. treatment arm 2).

Key Inclusion Criteria:

- Histologically confirmed, stage IIc-IV epithelial ovarian, fallopian tube or
peritoneal cancer

- Platinum-resistant or -sensitive subjects after completing first-line treatment
(debulking surgery and adjuvant or neoadjuvant treatment with standard of care
treatment such as carboplatin and paclitaxel). Subjects may have had any number of
subsequent lines of chemotherapy.

- Must have evidence of progressive disease with either biochemical (i.e. rising CA-125)
and/or radiologic progression

- Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy,
and be willing to undergo tumor biopsy during treatment

- The sum of baseline target lesions, measured by RECIST v1.1, must be less than 5 cm.

- Ambulatory with an ECOG 0-1

- Life expectancy ≥ 6 months

- Meet protocol-specified laboratory requirements

Key Exclusion Criteria:

- Eligible for otherwise curative treatment or undergoing concurrent therapy

- Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g.
anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically
targeting T cell co-stimulation) or an IDO inhibitor

- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma
in situ, or controlled bladder cancer

- Clinical ascites or metastatic pleural fluid

- Malignant bowel obstruction

- History of autoimmune disease requiring treatment within the last two years (except
vitiligo or diabetes)

- Recent history of thyroiditis

- Presence of a serious acute infection or chronic infection

- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)

- GI condition that might limit absorption of oral agents

- Other serious intercurrent chronic or acute illness, including myocardial infarction
or cerebrovascular event within 6 months

- Ongoing treatment with steroid therapy or other immunosuppressive

- Receipt of monoamine oxidase inhibitors (MAOIs) or UGT1A9 inhibitors

- Receipt of live attenuated vaccines

- Acute or chronic skin and/or microvascular disorders

- Edema or lymphedema in the lower limbs > grade 2