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Cell and Gene Therapy Updates
- Oncofocus Team
- Jun 23
- 2 min read
June 2nd week, 2025
⭐ Deals & Collaborations
🤝Neowise Biotechnology granted BeOne Medicines rights to one of its proprietary antigen-specific TCR molecule under a non-exclusive licensing deal for the development of next-generation, iPSC-based off-the-shelf cell therapies for the Tx of Solid Tumors (Ref 1)
❓ What are the advantages of the off-the-shelf cell therapies?
⭐ Regulatory Updates
🎯 Myrio Tx received the US FDA approval for an IND application to initiate Ph1, NCT07007117 trial evaluating an HLA restricted, anti-PHOX2B Peptide-Centric CAR-T, for the Tx of Neuroblastoma co-developed with the Children's Hospital in Philadelphia (Ref 2)
❓ What is the significance of peptide centric CAR-Ts?
⭐ Clinical Data Readouts
🔬 First time results from the Ph1b, NCT05421663 trial of Johnson & Johnson Innovative Medicine JNJ-90014496 (formerly C-CAR039; an autologous, anti-CD19/CD20 bispecific CAR-T) in R/R LBCL demonstrated 100% ORR & 80% CRR as a 2L Tx (n=10), and 92% ORR & 75% CRR as ≥3L Tx (n=12) (Ref 3)
❓ Which company originally developed JNJ-90014496, and what licensing agreements have been involved in its transition?
🔬Updated data from Ph1/2, NCT05826535 trial of Beijing Gobroad Hospital’s anti-CD19/CD20 dual targeting CAR-T for the Tx of B-NHL were presented at EHA 2025. In 11 pts, ORR at 3 mos was 72.7% (63.6% CRR) and mOS and mPFS were NR at mFU of 20.4 mos. (Ref 4)
❓ How do the clinical outcomes of this therapy benchmark against other CD19/CD20 dual CAR-Ts?
🔬 Galapagos presented updated data from Ph1/2, ATALANTA-1/NCT06561425 trial evaluating GLPG5101 (an autologous, freshly prepared CD19 CAR-T) in 64 pts with R/R LBCL. 95.0% of pts were infused with fresh, stem-like early memory CD19 CAR-T cells avoiding the need for cryopreservation and cytotoxic bridging therapy (Ref 5)
❓ What is the advantage of decentralized manufacturing platform?
🔬 Autolus Therapeutics presented long term follow up from Ph1/2 FELIX/NCT04404660 trial, demonstrating obecabtagene autoleucel (Aucatzyl; an autologous, anti-CD-19 CAR-T) potential to deliver durable remissions in adult R/R B-ALL (At mFU of 32.8, mDOR was 42.6 mos) (Ref 6)
❓ How many CAR-Ts are approved for the Tx of R/R B-ALL and what is the clinical landscape?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 Reference:
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