Kite Announces Initiation of Axicabtagene Ciloleucel CAR-T Clinical Program in the European Union
August 07 2017 - 7:30AM
Business Wire
- First Patient Dosed in Safety Expansion
Cohort of ZUMA-1 in the European Union (EU)
- Axicabtagene Ciloleucel Being Developed
Under Priority Medicines (PRIME) Designation in the EU
- Marketing Authorization Application to
the European Medicines Agency for Axicabtagene Ciloleucel Submitted
in July 2017
Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy
company, today announced that patients in the European Union (EU)
are now being treated with its lead investigational candidate,
axicabtagene ciloleucel, in the safety expansion cohort of ZUMA-1
(ClinicalTrials.gov, NCT: 02348216). Kite is currently enrolling
adult patients with relapsed/refractory diffuse large B-cell
lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and
transformed follicular lymphoma (TFL) at multiple EU medical
centers. Kite filed a Marketing Authorization Application (MAA) to
the European Medicines Agency (EMA) for axicabtagene ciloleucel in
July 2017, the first CAR-T application in Europe.
“This important milestone underscores our commitment to
providing a potentially curative therapy to patients with serious
blood cancers worldwide,” said David Chang, M.D., Ph.D., Executive
Vice President of Research and Development and Chief Medical
Officer of Kite. “Our CAR-T expertise established in the United
States will be key as we expand our global footprint this
year.”
The first patient treated in the safety expansion cohort was at
the Academic Medical Center (AMC) in Amsterdam by Professor Dr.
Marie José Kersten. Additional patients are expected to be treated
in multiple clinical sites across Europe in 2017.
“We are encouraged by the promising results observed in ZUMA-1
in the United States and are excited to be one of the first medical
centers to bring this novel treatment modality to the EU,” said
Professor Dr. Marie José Kersten, Principal Investigator and Head
of the Department of Hematology of the AMC in Amsterdam. “As a
lymphoma specialist, I am gratified that we can now offer this
potentially transformative therapy to patients with refractory,
aggressive NHL who previously had no other therapeutic
options.”
Kite has been granted access to Priority Medicines (PRIME)
regulatory support in the EU for treatment of refractory DLBCL.
Access to the PRIME initiative is granted by the EMA to support the
development and accelerate the review of new therapies to treat
patients with a high unmet need.
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel, is an
investigational therapy in which a patient's T cells are engineered
to express a chimeric antigen receptor (CAR) to target the antigen
CD19, a protein expressed on the cell surface of B-cell lymphomas
and leukemias, and redirect the T cells to kill cancer cells.
Axicabtagene ciloleucel is currently under review by the U.S. Food
and Drug Administration (FDA) for aggressive non-Hodgkin lymphoma
and was granted Breakthrough Therapy Designation status for diffuse
large B-cell lymphoma (DLBCL), transformed follicular lymphoma
(TFL), and primary mediastinal B-cell lymphoma (PMBCL).
About Kite
Kite is a biopharmaceutical company engaged in the development
of innovative cancer immunotherapies with a goal of providing
rapid, long-term durable response and eliminating the burden of
chronic care. The company is focused on chimeric antigen receptor
(CAR) and T cell receptor (TCR) engineered cell therapies designed
to empower the immune system's ability to recognize and kill
tumors. Kite is based in Santa Monica, CA, with EU locations
in London and Amsterdam. For more information on Kite,
please visit www.kitepharma.com. Sign up to follow @KitePharma on
Twitter at www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. The press release may, in some
cases, use terms such as "predicts," "believes," "potential,"
"proposed," "continue," "estimates," "anticipates," "expects,"
"plans," "intends," "may," "could," "might," "will," "should" or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Forward-looking
statements include statements regarding intentions, beliefs,
projections, outlook, analyses or current expectations concerning,
among other things: the ability and timing of advancing
axicabtagene ciloleucel in the EU and additional countries. Various
factors may cause differences between Kite's expectations and
actual results as discussed in greater detail in Kite's filings
with the Securities and Exchange Commission, including without
limitation in its Form 10-Q for the quarter ended March 31, 2017.
Any forward-looking statements that are made in this press release
speak only as of the date of this press release. Kite assumes no
obligation to update the forward-looking statements whether as a
result of new information, future events or otherwise, after the
date of this press release.
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KITE CONTACTS:Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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