Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies

The purpose of this study is to determine whether VRx-3996 in combination with valganciclovir
is safe, determine the side effect profile, and to determine whether this therapy may help
patients with EBV-related lymphomas. The study has two phases. Goals of the first phase
include determining a safe and tolerable dose that can be administered in phase 2. Goals of
the second phase include further evaluating the safety and tolerability of VRx-3996 in
combination with valganciclovir, evaluating how the drugs are metabolized in the body,
evaluating response rates and other exploratory objectives that will help the researchers
evaluate how these drugs work in the body. Participants will receive daily oral doses of the
two study drugs and will have multiple study visits where they will have blood collected,
physical examinations, and other medical monitoring.

Key Inclusion Criteria:

- Relapsed/refractory, pathologically confirmed EBV+ lymphoid malignancy or
lymphoproliferative disease

- Absence of available therapy with reasonable likelihood of cure or significant
clinical benefit

- Adequate hematologic, hepatic and renal function as defined by laboratory assessment

Key Exclusion Criteria:

- Known primary CNS lymphoma

- Known CNS metastases or leptomeningeal disease unless appropriately treated and
neurologically stable for at least 4 weeks

- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy

- Refractory graft versus host disease (GvHD) not responding to treatment

- Known active hepatitis B virus infection

- Circulating hepatitis C virus on qPCR