China Rewards Breakthrough Therapy Designation to Innovent & IASO’s CAR-T Cell Therapy

Date: February 24, 2021 | Country: CHINA | Region: ASIA & SOUTH PACIFIC | Type: Regulation | Keywords: #breakthroughtherapydesignation #cartherapy #cde #cellandgenetherapy 
#ct103a #drugapproval #iasobiotherapeutics #ibi326 #innovent #multiplemyeloma #nmpa #oncology

PRICENTRIC BRIEF:

  • The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation (BTD) to Innovent and IASO Biotherapeutics’ investigational CAR-T cell therapy IBI326/CT103A for the treatment of relapsed/refractory (R/R) multiple myeloma (MM)
  • The CDE elected BTD for IBI326/CT103A based on results from an ongoing Phase 1/2 study of the CAR-T therapy being conducted in R/R MM patients in China—IBI326/CT103A is currently amid a Phase 2 pivotal trial
  • Jinhua Zhang, IASO BIO Founder and CEO, said, “We anticipate expedited development and review in China, allowing more patients with relapsed or refractory multiple myeloma to benefit from this therapy at the earliest possible time”

 

THE DETAILS

BEIJING, China – The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation (BTD) to Innovent and IASO Biotherapeutics’ investigational CAR-T cell therapy IBI326/CT103A for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).

IBI326/CT103A is a fully-human anti-B cell maturation antigen (BCMA) targeted CAR-T cell therapy that utilizes lentivirus as a gene vector to transfect autologous T cells, explained Innovent.

In China, BTD is reserved for new medicines that target serious conditions for which clinical evidence suggests the drug in question may demonstrate significant improvement over available therapies.

The CDE elected BTD for IBI326/CT103A based on results from an ongoing Phase 1/2 study of the CAR-T therapy being conducted in R/R MM patients in China—IBI326/CT103A is currently amid a Phase 2 pivotal trial.

Previously, clinical results demonstrating the “impressive” safety, efficacy, and durability of response of IBI326/CT103A as observed in RRMM trials were presented at the 61st Annual Meeting of the American Society for Hematology (ASH) in 2019.

Dr. Hui Zhou, Vice President of Medical Science and Strategy Oncology at Innovent, commented, “The breakthrough therapy designation from NMPA indicated that IBI326[/CT103A] possesses great potential in treating relapsed or refractory multiple myeloma.”

Jinhua Zhang, IASO BIO Founder and CEO, added, “We anticipate expedited development and review in China, allowing more patients with relapsed or refractory multiple myeloma to benefit from this therapy at the earliest possible time.”

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