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Cell and Gene Therapy Updates
- Oncofocus Team
- 5 days ago
- 2 min read
May 5th & June 1st Week
⭐ Regulatory Updates
🎯 China’s NMPA granted Priority Review to CARsgen Therapeutics’ satri-cel (CT041; an autologous, anti-CLDN18.2 CAR-T) for ≥3L aGC/GEJA pts (Ref 1)
❓ What is the current landscape of cell therapies in GC?
🎯 Autolus Therapeutics’ obe-cel (an autologous, anti-CD-19 CAR-T) received a positive CHMP opinion in the EU for the treatment of R/R B-ALL in adults, based upon Ph1/2 FELIX/NCT04404660 study results (Ref 2)
❓ What are the approved CAR-Ts for the treatment of B-ALL in Europe?
🎯 The US FDA granted RMAT designation to BrainChild Bio’s BCB-276 (an autologous, B7-H3 CAR-T) for the treatment of DIPG based on the positive survival data from the Ph1 BrainChild-03/NCT04185038 trial. (Ref 3)
❓ How many CAR-Ts have received RMAT designation for the treatment of DIPG?
🎯 The US FDA granted FTD to Chimeric Therapeutics’ CHM-2101 (an autologous, third generation, anti-CDH17 CAR-T) for the treatment of Gastroenteropancreatic Neuroendocrine Tumors (Ref 4)
❓ Why is CDH17 significant, and at what stage is CHM-2101 in clinical development?
⭐ Clinical Data Readouts
🔬 Updated data from the pivotal Ph2, iMMagine-1/NCT05396885 trial of Gilead Sciences & Arcellx’s anitocabtagene autoleucel (an autologous, anti-BCMA CAR-T) in ≥ 4L MM demonstrated an ORR of 97.4% (67.5% CR/sCR) with a mFU of 12.6 mos in 117 pts (Ref 5)
❓ How are the efficacy outcomes of anito-cel comparable with other approved BCMA CAR-Ts?
🔬 Updated results from Ph1 TRAVERSE/NCT04696731 trial evaluating Allogene Therapeutics’ ALLO-316 (an-allogeneic, anti-CD70 CAR-T) for heavily pretreated aRCC demonstrated confirmed ORR of 20.0% (Ref 6)
❓ How many CAR-Ts are being developed for the treatment of RCC?
🔬 NeoImmuneTech reported final top-line Ph1b, NCT05075603 results for efineptakin alfa (NT-I7; IL-7Rα agonist) + CD19 CAR-T (Novartis’ Kymriah/ Gilead Sciences’ Yescarta/ Bristol Myers Squibb’ Breyanzi) for R/R LBCL with 100.0% ORR in high-dose cohort (n=8) (Ref 7)
❓ What are the other combinational strategies that are being used to increase the CAR-T efficacy?
🔬 Ph1, NCT05168423 results of intracerebroventricular delivery of Gilead Sciences and University of Pennsylvania’s bivalent CAR-Ts targeting EGFR and IL13Rα2 in patients with Recurrent Glioblastoma were presented at ASCO’25 (Ref 8)
❓ How are the clinical outcomes for this bivalent CAR-T?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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