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Cellerant Therapeutics, Inc. Presents Phase 2 Results Showing CLT-008 Significantly Reduces Risk of Infections in AML Patients Undergoing Standard Induction Chemotherapy

Cellerant Therapeutics, Inc., a clinical-stage company developing
innovative immunotherapies for hematologic malignancies and other
blood-related disorders, presented results from its randomized
controlled Phase 2 clinical trial of CLT-008 (romyelocel-L, human
myeloid progenitor cells), an off-the-shelf cell therapy which does not
require HLA matching intended to prevent bacterial and fungal infections
during neutropenia. As part of the Phase 2 trial, CLT-008 was evaluated
in newly diagnosed acute myeloid leukemia (AML) patients who underwent
standard “7+3” (cytarabine and an anthracycline) induction chemotherapy.
One of the major side effects of 7+3 and other myelosuppressive
chemotherapies is neutropenia, which leaves patients at high risk of
serious infections. Results from the Phase 2 study showed that CLT-008
reduced the incidence of serious infections by 73% and reduced hospital
length of stay by three days in patients who received 7+3 chemotherapy.
The data were presented on Saturday, June 16, at the European Hematology
Association (EHA) 23rd Congress in Stockholm.

AML is an aggressive cancer of the blood and bone marrow that
disproportionately afflicts older patients (median age at diagnosis in
the United States is 68 years). Older patients, those 65 years and
older, have a significantly lower overall survival rate than younger
patients in large part because of the risk of infection and
infection-related morbidity and mortality which arise from neutropenia
induced by induction chemotherapy.

“Infection is one of the main reasons for morbidity and mortality in AML
patients receiving induction chemotherapy. The exciting results from
this study show that this innovative approach to treatment of infections
could allow more patients to safely survive optimal induction
chemotherapy treatment and survive longer, particularly many elderly
patients who are not offered induction chemotherapy due to the risk of
infection,” said Dr. Pinkal Desai, Assistant Professor of Medicine,
Weill Cornell Medicine and one of the Phase 2 study’s principal
investigators.

“CLT-008 is designed to provide innate immunity until the patient’s own
immune system recovers. Prolonged neutropenia commonly occurs with most
myelosuppressive treatments such as AML induction therapy, and these
results demonstrate the potential of CLT-008 to mitigate the effects of
neutropenia by bridging patients to neutrophil recovery, resulting in
improved outcomes,” added Ram Mandalam, President and CEO of Cellerant.

Presentation details:

EHA Abstract #1405: Desai, et al., Decreased incidence of
infection, use of antibacterials and days in hospital after
administration of CLT-008 myeloid progenitor cells to subjects receiving
AML induction therapy: Phase 2 Study Results. Oral presentation on June
16, 2018, 4:45-5:00pm CEST. Presenting author: Pinkal Desai, M.D.,
M.P.H., Assistant Professor of Medicine, Weill Cornell Medicine, New
York.

About Cellerant Therapeutics

Cellerant Therapeutics is a clinical-stage company developing innovative
cell- and antibody-based immunotherapies for hematologic malignancies
and other blood-related disorders. Cellerant’s CLT-008 (romyelocel-L) is
a universal cell therapy intended to prevent bacterial and fungal
infections during neutropenia. Neutropenia is a severe side effect of
many chemotherapy regimens, particularly for acute myeloid leukemia
(AML) and other hematologic malignancies, and is also a serious
condition in acute radiation syndrome. Cellerant has completed a
randomized, controlled Phase 2 clinical trial of CLT-008 in patients
with AML which showed that CLT-008 significantly reduces infections, use
of antimicrobials and days in hospital. Cellerant’s CLT-008 program has
been supported by federal funds from the Biomedical Advanced Research
and Development Authority (BARDA), Department of Health and Human
Services, under contract HHSO100201000051C. Cellerant is also developing
a novel antibody drug-conjugate (ADC) product, CLT030, to treat AML by
selectively targeting and killing leukemic stem and blast cells. For
more information, visit: www.cellerant.com

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