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Cell and Gene Therapy Updates
- Oncofocus Team
- Jun 20
- 2 min read
April 3rd & 4th, 2025
Regulatory Updates
🎯 The UK MHRA granted conditional marketing authorization for Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel; an autologous, anti-CD19 CAR-T) for the treatment of adult R/R B-ALL patients based on the results from the Ph1/2 FELIX/NCT04404660 study (Ref 1)
❓ In what ways does Aucatzyl’s fast off-rate CD19 binding domain differentiate it from existing CD19 CAR-Ts for B-ALL?
🎯 Lyell Immunopharma received RMAT designation for LYL314 (formerly IMPT-314; an autologous, dual-targeting CD19/CD20 CAR-T) for the treatment of ≥3L LBCL based on promising clinical data from the ongoing Ph1/2 Duali-T-1/NCT05826535 trial in CAR-T naïve LBCL pts (Ref 2)
❓ What are the next steps planned for this ongoing Ph1/2 trial of LYL314?
🎯 The US FDA granted Breakthrough Therapy Designation for BrainChild Bio’s BCB-276 (an autologous, anti-B7-H3 CAR-T) for the treatment of diffuse intrinsic pontine glioma (DIPG) based on the encouraging survival data from the Ph1 BrainChild-03/NCT04185038 trial (Ref 3)
❓ What are the other CAR-Ts that are being studied in clinical trials for DIPG?
Clinical Data Readouts
🔬 Updated results from the Ph1 SENTI-202-101/NCT06325748 clinical trial evaluating SENTI-202 (an off-the-shelf, logic gated, selective CD33/FLT3-targeting CAR-NK) for R/R AML were presented at AACR 2025 (ORR was 71.4% in 7 evaluable pts) (Ref 4)
❓ What advantages do logic-gated designs offer in minimizing off-target effects?
Deals and Collaborations:
🤝 DAAN Biotherapeutics signed an exclusive licensing agreement with GC Cell, granting GC Cell sole rights to leverage DAAN's antibody sequence for R&D of CAR-T and CAR-NK therapies (Ref 5)
❓ What key advantages does GC Cell gain by utilizing the antibody sequence?
Setbacks:
🛑 Caribou Biosciences announced strategic pipeline prioritization to focus on clinical assets CB-010 (an allogeneic, anti-CD19 CAR-T) and CB-011(an allogeneic, anti-BCMA CAR-T); discontinued CB-012 (an allogenic, anti-CLL-1 CAR-T) which was in Ph1 AMpLify/NCT06128044 trial for the treatment of R/R AML (Ref 6)
❓ What early findings provide the rationale for prioritizing CB-010 and CB-011?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References
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