Kite Pharma Details KTE-C19 Launch Preparedness and Near-Term, Next Generation CAR/TCR Product Candidates at Investor Day
October 19 2016 - 8:41AM
Business Wire
- Four New Clinical Programs Unveiled to
Drive Long-Term Growth
- T cells 2.0 Next Generation Programming
to Realize Full Potential of Cell Therapy
- KTE-C19 Expansion Studies with the
Potential to Deliver Six Additional Indications in B-cell
Malignancies
- Manufacturing and Commercial
Preparations to Successfully Launch KTE-C19 following U.S.
Approval
Kite Pharma, Inc. (Nasdaq:KITE) presented updates on its
advancing pipeline of chimeric antigen receptor (CAR) and T cell
receptor (TCR) product candidates and KTE-C19 launch readiness at
its Investor Day in New York on October 18, 2016.
“At Kite, our goal is to cure cancer. With KTE-C19, we may have
the opportunity to transform the treatment of aggressive
non-Hodgkin lymphoma (NHL),” said Arie Belldegrun, M.D., FACS,
Chairman, President and Chief Executive Officer of Kite. “While we
prepare to manufacture and commercialize KTE-C19 upon approval, we
believe this is just the beginning. The breadth of the pipeline we
unveiled today, combined with our innovative T cells 2.0
programming, has the potential to deliver hope for a cure to
thousands of people across 15 hematological and solid cancer
indications.”
Kite detailed four new near-term clinical development programs,
including timelines for planned Investigational New Drug (IND)
applications:
- KITE-796: IND in 2018
- Directed against the most promising
target for acute myeloid leukemia (AML)
- single-chain variable fragment (scFv)
from human anti-CLL-1 monoclonal antibody (mAb) to minimize
immunogenicity
- “Control CAR” to incorporate dynamic
switch technology
- First Kite product candidate from Amgen
collaboration
- KITE-585: IND in 2017
- Directed against the best and a
validated target for multiple myeloma (MM)
- scFv from human anti-BCMA mAb to
minimize immunogenicity
- Will leverage Kite’s clinical
development and manufacturing expertise for program
acceleration
- KITE-718: IND in 2016
- Directed against next generation MAGE
A3/A6, a cancer testis antigen and validated target for TCR therapy
for non-small cell lung cancer and bladder cancer
- Built on National Cancer Institute
(NCI) proof of concept with improved T cell manufacturing
technologies
- KITE-439: IND in 2018
- Directed against HPV-16 E7, a viral
oncoprotein target for TCR therapy for cervical cancer and head and
neck cancer
- Internal expertise to select
best-in-class TCR candidates without affinity enhancement
T cells 2.0 next generation cell programming is in development
to design engineered T cells that increase safety, potency and
effectiveness:
- Safety: Dynamic control switch
technology (“Control CAR”) that may regulate and allow the ability
to dial up and dial down engineered T-cell expansion
- Potency: Transmembrane Immunomodulatory
Proteins (TIPs) for solid tumors that may function at the immune
synapse thereby limiting immune-activation to engineered T
cells
- Effectiveness: T-cell differentiation
technology that may enable a reliable and renewable cell source to
advance the clinical application of universal allogeneic T-cell
therapy
Kite is advancing its KTE-C19 pipeline with ongoing and expanded
ZUMA studies to evaluate six additional indications:
- ZUMA-2: Mantle cell lymphoma (MCL),
with initial Phase 2 data expected in 2017
- ZUMA-3: Adult acute lymphoblastic
leukemia (Adult ALL), with initial Phase 1 data expected in
2016
- ZUMA-4: Pediatric acute lymphoblastic
leukemia (Pediatric ALL), with initial Phase 1 data expected in
2016
- ZUMA-5: Indolent NHL, with first
patient enrolled expected in the first quarter of 2017
- ZUMA-7: 2nd line DLBCL, with first
patient enrolled expected in 2017
- ZUMA-8: Chronic lymphocytic leukemia
(CLL), with first patient enrolled expected in 2017
Kite reviewed its proven clinical cell manufacturing capability,
preparations to produce and deliver KTE-C19 at commercial scale
following U.S. regulatory approval, and ongoing activities to
automate next generation manufacturing:
- Efficient and consistent manufacturing
process
- High clinical manufacturing success
rate – 99 percent manufacturing of KTE-C19 for patients enrolled in
ZUMA-1
- Estimated capacity for 4,000+ patient
treatments per year and ability to expand quickly
- Next generation automation planned to
enter feasibility testing in 2017 through collaboration with GE
Research
Kite discussed its ongoing activities to build scientific
awareness and to commercialize KTE-C19 following U.S. regulatory
approval:
- Early market research substantiates
awareness of CAR-T therapy and potential for adoption
- Medical Science Liaison team ready for
deployment in the fourth quarter of 2016
- Proactive Market Access strategy and
engagement with payers
- Controlled launch approach lays
groundwork for expansion, understanding of therapy, patient
management, and reimbursement
A replay of the audio webcast will be available for
approximately 30 days and can be accessed through the Events and
Presentations section under the Investors tab of Kite’s website at
www.kitepharma.com.
About KTE-C19
Kite Pharma’s lead product candidate, KTE-C19, is an
investigational therapy in which a patient's T cells are engineered
to express a 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. KTE-C19 has been granted
Breakthrough Therapy Designation status for diffuse large B-cell
lymphoma (DLBCL), transformed follicular lymphoma (TFL), and
primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food
and Drug Administration and Priority Medicines (PRIME) regulatory
support for DLBCL in the EU.
About Kite Pharma
Kite Pharma, Inc. is a clinical-stage biopharmaceutical company
engaged in the development of novel cancer immunotherapy products,
with a primary focus on engineered autologous cell therapy (eACT™)
designed to restore the immune system's ability to recognize and
eradicate tumors. Kite is based in Santa Monica, CA. For
more information on Kite Pharma, please
visit www.kitepharma.com. Sign up to follow @KitePharma on
Twitter at www.twitter.com/kitepharma.
Kite Pharma, Inc. 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 initiating new
clinical development programs, researching and developing T cells
2.0 next generation cell programming, advancing ongoing and
additional ZUMA studies, obtaining regulatory approval based on the
studies of KTE-C19, commercially launching KTE-C19, and
manufacturing KTE-C19 and additional product candidates and
automating manufacturing. 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 June 30, 2016. 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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version on businesswire.com: http://www.businesswire.com/news/home/20161019005742/en/
Kite Pharma, Inc.Christine CassianoSVP, Corporate
Communications & Investor
Relationsccassiano@kitepharma.comorGreg MannVP, Investor
Relationsgmann@kitepharma.com
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