Kite Pharma Details KTE-C19 Launch Preparedness and Near-Term, Next Generation CAR/TCR Product Candidates at Investor Day

SANTA MONICA, Calif.–(BUSINESS WIRE)– 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: 2^nd 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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