Receive our newsletter – data, insights and analysis delivered to you
  1. Comment
May 24, 2021

LoA Update: Shanghai Bioray Laboratory’s gene therapy BCMA-UCART for multiple myeloma plunges 12 points in FDA regulatory potential following updated Phase I completion date

As of 17 May, the Likelihood of Approval (LoA) for Shanghai Bioray Laboratory’s gene therapy BCMA-UCART for relapsed multiple myeloma (MM) dropped 12 points, according to GlobalData’s LoA data.

By William Newton

As of 17 May, the Likelihood of Approval (LoA) for Shanghai Bioray Laboratory’s gene therapy BCMA-UCART for relapsed multiple myeloma (MM) dropped 12 points, according to GlobalData’s LoA data. This is the result of a delay in the study’s estimated primary completion date from November 2020 to March 2022, according to a 7 March update to ClinicalTrials.gov.

The Shanghai, China-based Bioray Laboratory’s 20-patient Phase I is a dose escalation study of intravenously infused BCMA-UCART, measuring objective response rate for up to 90 days as its primary endpoint, according to ClinicalTrials.gov. Secondary endpoints include safety and persistence of BCMA-UCART, and the study is currently recruiting at Shanghai Tongji Hospital.

While the LoA prior to this news was 25%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has lowered the LoA to 13%. B-cell maturation antigen (BCMA) is a multiple myeloma tumour antigen, and BCMA-UCART is an allogenic chimeric antigen receptor in T cells (CART) with potential antitumor efficacy in multiple myeloma.

William Newton is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

Related Companies

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU