Cell and Gene Therapy Updates

March 1st Week, 2025

⭐ Regulatory Events

🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel; CT041; an autologous, anti-CLDN18.2 CAR-T) for the treatment of Claudin18.2-positive ≥third-line G/GEJ cancer (Ref 1) 

❓ What are CARsgen’s next steps in advancing satri-cel? Has CARsgen obtained similar designations in other markets?

🎯 The US FDA accepted Bioheng Therapeutics’ IND application for CTD402 (anti-CD7 UCAR-T) for the treatment of pediatric and adult patients with R/R T-ALL/LBL (Ref 2) 

❓ How many CD7 targeting UCAR-Ts are in development? How UCAR-Ts are different from conventional CAR-Ts? 

⭐ Setbacks

🛑 Atara Biotherapeutics discontinued all development activities for ATA3219 (an allogeneic, anti-CD19 EBV CAR-T) currently in Phase 1 for the treatment of B-NHL, and ATA3431 (an allogeneic, anti-CD19/CD20 bispecific EBV CAR-T), which is in preclinical development for the treatment of B-cell malignancies (Ref 3) 

❓ Did the previous clinical hold on ATA3219 play a role in Atara's decision to discontinue its allogeneic CAR-T programs?

🌐 References: 

1) https://www.carsgen.com/en/news/20250303/

2) https://www.bioheng.com/News_Details/27.html

3) https://investors.atarabio.com/sec-filings/all-sec-filings/content/0000950170-25-030832/0000950170-25-030832.pdf