– National Cancer Institute (NCI) Study Shows Investigational TCR
Therapy Induces Response in Patients with Epithelial Cancers –
– Data at the 2018 American Society of Clinical Oncology (ASCO)
Annual Meeting Support Development of KITE-439 for HPV-Associated Solid
Tumors –
CHICAGO -- (Business Wire)
Kite, a Gilead Company (Nasdaq: GILD), today announced results from an
ongoing Phase 1 study conducted by the National Cancer Institute (NCI)
showing that clinical responses were observed with investigational T
cell receptor (TCR) cell therapy targeting human papillomavirus type 16
(HPV-16) E7 in solid tumor cancers caused by HPV. These findings were
presented today in a poster session at the 2018 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #3043).
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TCR therapy is a type of personalized immunotherapy designed to activate
the immune system's ability to recognize and target specific tumors. TCR
therapy involves engineering an individual’s own T cells to express
naturally occurring receptors that can recognize specific tumor
antigens. Epithelial cancers caused by HPV, including cervical, head and
neck, anal and genital cancers, contain a protein called E7 inside tumor
cells. Patients with these tumors whose cancers have relapsed and/or are
refractory to standard therapy are currently incurable.
In this study, eight patients with metastatic HPV-16 cancers received a
single infusion of gene-engineered E7 T cells at one of three dose
levels. Patients had received between three and seven prior lines of
systemic cancer therapy. In the initial six patients, the E7 TCR was
expressed by 90-99 percent of the infused T cells, and E7 T cells were
detectable in the peripheral blood six weeks following treatment. The
study is ongoing.
Partial responses (Response Evaluation Criteria in Solid Tumors
(RECIST); RECIST 1.1) were observed in three out of the seven evaluable
patients and another two patients had stable disease. To date, the
responses have lasted as long as nine months and have occurred in
patients with vulvar, oropharyngeal and anal cancer. Two of these
patients had been previously treated with anti-PD1 checkpoint blockade.
“Metastatic HPV-cancers are incurable and poorly addressed by standard
therapies,” said Christian S. Hinrichs, MD, Lasker Clinical Research
Scholar at the Center for Cancer Research’s Experimental Transplantation
and Immunology Branch (ETIB) at the NCI and lead study investigator.
“The early results from this Phase 1 trial support the continued
evaluation of TCR therapy in HPV-associated cancers.”
No dose-limiting toxicity occurred. The most common grade 3 or higher
adverse events were anemia, lymphopenia, leukopenia and neutropenia,
each of which occurred in all seven evaluable patients.
The trial is part of a Cooperative Research and Development Agreement
(CRADA) between the ETIB of the NCI and Kite to further the research and
clinical development of TCR product candidates for the treatment of
HPV-associated cancers. Patients interested in enrolling in the
16-C-0154 clinical trial can call the National Cancer Institute’s
toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615)
or visit https://trials.cancer.gov.
HPV has a causal role in nearly all cervical cancers, and in many head
and neck and anogenital malignancies. HPV-16 is the most commonly found
strain in these cancers. More than 33,000 cases of HPV-associated
cancers are diagnosed each year in the U.S. and more than 10,000 deaths
are attributed to the disease, according to the Centers for Disease
Control and Prevention. Current therapies for HPV-associated tumors have
low response rates and poor response duration.
“Findings from this Phase 1 study validate the E7 protein as a viral
target for TCR therapy,” said Alessandro Riva, MD, Gilead’s Executive
Vice President, Oncology Therapeutics & Head, Cell Therapy. “We plan to
submit an IND for our TCR candidate, KITE-439, for HPV-16 E7 solid
tumors by the end of the year, and we continue to explore other
potential TCR therapy candidates for a variety of cancers in partnership
with the NCI.”
KITE-439 is investigational and has not been proven safe or efficacious.
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa
Monica, California. Kite is engaged in the development of innovative
cancer immunotherapies. The company is focused on chimeric antigen
receptor and T cell receptor engineered cell therapies. For more
information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com.
Forward-Looking Statement
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable results from additional clinical trials
involving KITE-439 for the treatment of HPV-16 E7 solid tumors or other
HPV-associated cancers. In addition, Kite may be unable to submit the
IND for KITE-439 in the currently anticipated timelines or at all. All
statements other than statements of historical fact are statements that
could be deemed forward-looking statements. These risks, uncertainties
and other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These and
other risks are described in detail in Gilead’s Quarterly Report on Form
10-Q for the quarter ended March 31, 2018, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements are
based on information currently available to Gilead and Kite, and Gilead
and Kite assume no obligation to update any such forward-looking
statements.
For more information on Kite, please visit the company’s website at www.kitepharma.com.Learn more about Gilead at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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Contacts:
Gilead Sciences, Inc.
Investors
Sung Lee, 650-524-7792
or
Media
Nathan
Kaiser, 650-522-1853
Source: Gilead Sciences, Inc.
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