A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease

The objective of this Phase 1 safety study is to provide access to the potential therapeutic
benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to
plasma from donors who may be infected with other transfusion-transmitted pathogens, not
detectable by current licensed donor testing procedures, will be mitigated by using pathogen
inactivation to minimize the risk of the TTI from these donors, who would otherwise be
deferred and ineligible for blood donation.

The study is designed as a prospective, open label, multi-center, single arm study to
evaluate the safety and efficacy of INTERCEPT plasma prepared from EBOV convalescent donors
for passive immune therapy in subjects with acute EVD.

Data will be collected to assess the safety of this intervention by monitoring adverse events
in the immediate 24-hour post transfusion period. Efficacy will be assessed by monitoring the
clinical status of treated subjects with respect to clearance of EBOV by using nucleic acid
assays to measure pre and post treatment viral titers. A number of clinical parameters
indicative of end-organ damage during acute EVD will be monitored to determine if passive
immune therapy affects the onset and duration of renal failure and acute lung injury. In
addition, blood samples will be collected pre and post transfusion of convalescent EBOV
INTERCEPT plasma to determine if biomarkers of endothelial injury are impacted, and if they
can be used to guide plasma transfusion therapy to establish a dosing regimen and duration of
treatment.

Inclusion Criteria:

EBOV Convalescent Donor Inclusion Criteria:

- Recovered from Ebola Virus Disease (EVD) by clinical criteria and declared clinically
asymptomatic of active EVD.

- Twenty-eight (28) days from hospital discharge.

- Two negative test results for EBOV nucleic acid by a sensitive nucleic acid test
method with blood samples drawn at least 48 hours apart.

- Plasma/serum tested for HIV, HTLV, HCV, HBV, syphilis, and other pathogens (per
institutional practice) using licensed test methods. Inclusion of donors with positive
test results for these pathogens will be at the discretion of treating physicians,
with respect to the relative benefit of donor subject convalescent plasma treated with
INTERCEPT pathogen inactivation, compared to the risk to recipients of not receiving
EBOV convalescent plasma transfusion therapy.

- ABO blood group and RhD typing performed and donor anti-A and anti-B titers performed.

- Plasma/serum tested for human leukocyte antigen (HLA) antibodies for female donors
with history of pregnancy and for donors with a history of transfusions (per
institutional practice) using licensed test methods for transfusion-related acute lung
injury (TRALI) risk mitigation. Inclusion of donors with positive test results will be
at the discretion of treating physicians, with respect to the relative benefit of
donor subject convalescent plasma compared to the risk to recipients of not receiving
EBOV convalescent plasma transfusion therapy.

- Measurement of antibodies to EBOV, when feasible and ultimately measurement of
neutralizing antibodies to EBOV, when available.

- Conformity to age and weight standards for blood donors for plasma donation. Variance
from standards may be acceptable with evaluation by treating physician(s) and with
donor or legal guardian consent for non-conforming donors when collection of reduced
volumes of plasma may be of therapeutic value.

- Cleared by treating physician for apheresis plasma donation.

- Written signed informed consent to donate 650-1300 mL plasma by apheresis at
frequencies of twice per week, at the discretion of the treating physician.

Recipient Subject Inclusion Criteria:

- Acute EVD diagnosed by nucleic acid testing and meeting established case definitions
(World Health Organization 2014).

- Subject or legal guardian provides written informed consent to receive INTERCEPT
plasma.

Exclusion Criteria:

EBOV Convalescent Donor Exclusion Criteria:

• Active EVD

Recipient Subject Exclusion Criteria:

• Documented food allergy to psoralens