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 www.kitepharma.com.



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