T cell targeting therapies - January 2021

T cell targeting therapies - January 2021

Harpoon Therapeutics received Orphan Drug Designation from FDA for HPN217 for treatment of multiple myeloma

13 Jan 2021

Harpoon Therapeutics – HPN217 (Anti-BCMA Tri specific T-cell activating recombinant protein construct)

  • FDA granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma
  • HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells
  • HPN217 is being evaluated in a Phase 1/2 open-label, multicenter, dose-escalation, and dose-expansion study in patients with relapsed/refractory multiple myeloma
  • Trial details: NCT04184050; Phase 1/2 in R/R MM; N=70; HPN217 IV administered 1x weekly for about 1 hour; Primary outcomes: AEs, MTD/ RP2D, PK; PCD: Jan 2024; Recruiting; Locations: US, Spain
  • President and CEO of Harpoon Therapeutics stated that the designation is a significant milestone represented in the development of HPN217 and is considered as a potential therapy to address unmet needs for patients suffering from multiple myeloma

FDA’s Orphan drug designation for HPN217 in multiple myeloma will expedite the development

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CI Scientists Remarks: 

  • HPN217, based on Harpoon’s TriTAC platform is a single polypeptide consisting of three domains that recognize human BCMA for myeloma cell targeting, serum albumin for half-life extension, and CD3ε for T cell engagement
  • In preclinical studies, HPN217 demonstrated BCMA- and T cell-dependent antitumor activity in tissue culture and in xenografts modeling multiple myeloma and lymphoma
  • In Nov’19, Harpoon entered into a development and option agreement with AbbVie pursuant to which Harpoon granted AbbVie an option to license worldwide exclusive rights to HPN217
    • Harpoon will be responsible for developing HPN217 through a Phase 1/2 clinical trial and AbbVie will be responsible for further clinical development, manufacturing, and commercialization activities
    • The agreement represents a transaction value of up to $510 million in upfront, option, and milestone payments, plus royalties on global commercial sales
  • In Apr’20, Harpoon dosed the first patient with HPN217 in a Phase 1/2 trial for relapsed/refractory multiple myeloma
    • The dose-escalation part of the study is progressing rapidly
    • As of Dec’20 (data cut-off), HPN217 has shown good tolerability and no DLTs were observed
  • Presentation of interim data is anticipated in late-2021 and initiation of dose-expansion is expected in the H2’21
  • Harpoon has four drug product candidates in development based on its proprietary TriTAC (tri-specific T cell activating construct) platform and one product candidate based on the ProTriTAC platform

    Product candidate

    Indication

    Phase

    TriTAC platform

    HPN424

    Prostate Cancer

    Phase 1

    HPN536

    Ovarian Cancer & Other Solid Tumors

    Phase 1

    HPN217

    Multiple Myeloma

    Phase 1

    HPN328

    Small Cell Lung Cancer

    Phase 1

    ProTriTAC platform

    HPN601

    GI Cancers

    Preclinical

– Dr. Kowndinya, CI Scientists

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