TBI 1301

Drug Profile

TBI 1301

Alternative Names: NY-ESO-1 antigen-specific RetroNectin® TCR gene therapy - Takara Bio; NY-ESO-1 antigen-specific TCR-gene-transduced autologous lymphocytes - Takara Bio; TBI-1301

Latest Information Update: 28 Sep 2016

Price : $50

At a glance

  • Originator Takara Bio
  • Developer Fred Hutchinson Cancer Research Center; Mie University; National Cancer Institute (USA); Takara Bio; University Health Network
  • Class Gene therapies; T lymphocyte cell therapies
  • Mechanism of Action Gene transference; Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Phase II Malignant melanoma
  • Phase I Sarcoma; Solid tumours

Most Recent Events

  • 01 Sep 2016 Phase-I clinical trials in Solid tumours (Metastatic disease, Inoperable/Unresectable, Recurrent) in Canada (IV) (NCT02869217)
  • 15 Aug 2016 University Health Network, Toronto and Takara Bio plan a phase Ib trial in Solid tumours (Metastatic disease, Recurrent, Inoperable/Unresectable) in Canada (NCT02869217)
  • 01 Mar 2015 Phase-I clinical trials in Solid tumours (Inoperable/unresectable, Refractory metastatic disease, Second-line therapy or greater) in Japan (IV) (NCT02366546)
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