Kite Pharma (KITE) Announces Details on CAR/TCR Pipeline, KTE-C19 Launch Outlook

October 19, 2016 8:42 AM EDT
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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

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