On October 19, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported 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 (Press release, Kite Pharma, OCT 19, 2016, View Source [SID1234515917]).

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"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.