top of page
Search

Cell and Gene Therapy Updates

June 3rd week, 2025



Regulatory Updates


 

 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1)


 👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months) 


 

🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1 CertainT-1/NCT06834282 trial for AML (Ref 2)


👉 Why it matters: CER-1236 is the first T cell therapeutic targeting TIM4L with built-in phagocytic activity, offering a precise way to treat AML while sparing healthy cells.



Clinical Data Readouts 



🔬 Bristol Myers Squibb presented first-time detailed results from the MZL cohort of the Ph2 TRANSCEND FL/NCT04245839 trial evaluating Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) in 3L+ setting. In 66 evaluable pts, ORR was 95.5% (CR: 62.1%) (Ref 3) 


👉 Why it matters: This data could pave the way for extending Breyanzi’s label to a fifth B-cell malignancy


 

🔬 Lyell Immunopharma presented updated Ph1/2, NCT05826535 results evaluating LYL314 (anti-CD19/CD20 dual-targeting CAR-T) in 3L+ LBCL pts. In 25 evaluable pts, ORR was 88.0% (Ref 4)


👉 Why it matters: Recent CD19/CD20 dual CAR-T updates reveal a growing competitive space, with early data suggesting superior efficacy over currently approved therapies


 

🔬 At ICML’25, Galapagos presented data from the Ph1/2 ATALANTA-1/NCT06561425 trial evaluating GLPG5101 (an autologous, freshly prepared anti-CD19 CAR-T) in 34 pts with R/R indolent NHL (FL, n=29; MZL, n=5) (Ref 5)


👉 Why it matters: Preliminary clinical data demonstrated the feasibility of Galapagos’ decentralized manufacturing platform. Long-term results are needed for further validation


 

🔬 First time results from the Ph1, NCT05838131 trial evaluating CARsgen Therapeutics’s CT071 (an autologous, anti-GPRC5D CAR-T) for high-risk newly diagnosed MM, showed 100% ORR in 10 pts (Ref 6)


👉 Why it matters: Early-line studies mark a new chapter for CAR-Ts in MM, building on later-line success 


 

Setback



🛑 BioNTech SE discontinued the development of BNT211 (an autologous, anti-CLDN6 CAR-T) for Testicular Cancer based on the Ph1/NCT04503278 readout (Ref 7)


👉 Why it matters: BioNTech is shifting away from cell therapies by dropping the Autolus AUTO1/22 co-development option & winding down the cell therapy manufacturing facility 



To know answers to these questions and for additional insights, write to us at support@oncofocus.com.



🌐 References: 



Comments

Commenting on this post isn't available anymore. Contact the site owner for more info.
bottom of page