Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors
June 04 2018 - 09:00AM
Business Wire
– 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 –
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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