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Press Release

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

Kite Pharma,Inc.
Posted on: 19 Oct 16

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161019005742/en/

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Last updated on: 19/10/2016

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