Single Patient Safety Concern Hits Allogene’s Off-The-Shelf CAR-T

All Of Company’s Trials Halted

Allogene is the frontrunner in the allogeneic CAR-T field but must assess whether or not its therapy could have caused a patient’s unexpected chromosomal abnormality.

Allogene building
The first autologous CAR-Ts gained approval in 2017, but the wait for the first allogeneic version goes on.

All of Allogene Therapeutics’ off-the-shelf CAR T therapy trials have been placed on hold by the US Food and Drug Administration after a single patient experienced a chromosomal abnormality following treatment, sending the company’s share price plunging by 42%.

The decision is another sign of the US regulator’s caution in cell and gene therapy studies and follows a string...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Business

GSK Gains Hengrui’s PDE3/4 inhibitor, Options For 11 Early Assets In Potential $12bn Deal

 

Deal Snapshot: The addition of Hengrui's HRS-9821, a China-originated fast-follower of Verona’s Ohtuvayre in chronic obstructive pulmonary disease, should enable GSK’s COPD therapy portfolio to stack up well against increasing competitors in the indication, including biologics and small molecules.

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: Sanofi’s Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech’s Columvi; and an interview with Novavax.

Bristol Appoints AstraZeneca’s Massacesi As Next CMO

 

Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

More from Scrip

Bristol Appoints AstraZeneca’s Massacesi As Next CMO

 

Chief Medical Officer Samit Hirawat will step down to pursue new career opportunities, the company said.

GSK’s Blenrep US Setback Could Go From Bad To Worse

 

With a US approval any time soon now looking unlikely, analysts are revising Blenrep’s peak sales guidance downwards.

Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.