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Cell and Gene Therapy Updates
- Oncofocus Team
- 5 days ago
- 2 min read
May 3rd Week, 2025
⭐ Regulatory Update
🎯 The US FDA granted the RMAT designation to BrainChild Bio’s BCB-276 (an autologous, B7-H3 CAR-T) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG) based on the positive survival data from the Ph1 BrainChild-03/NCT04185038 trial (Ref 1)
❓ Which other CAR-Ts are currently being investigated in clinical trials for DIPG?
⭐ Clinical DataReadouts
🔬 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 Mutliple Myeloma (MM) demonstrated an ORR of 97.4% (67.5% CR/sCR) with a median follow-up of 12.6 mos in 117 pts (Ref 2)
❓ Which other BCMA CAR-Ts are currently in registrational trials for the treatment of R/R MM?
🔬 Artiva Biotherapeutics presented long-term Ph1/2, NCT04673617 data at ASGCT for AlloNK (AB-101; an allogenic, non-genetically modified NK cell therapy) + rituximab in patients with R/R B-NHL that were CAR-T naive (CRR: 64.3%; mDOR: not reached in 14 patients) (Ref 3)
❓ How does the efficacy of AlloNK compare with the approved CD19 CAR-Ts for R/R B-NHL?
🔬 NeoImmuneTech reported final topline Ph1b, NCT05075603 results for efineptakin alfa (NT-I7; IL-7Rα agonist) + CD19 CAR-T (Novartis’ Kymriah/Gilead Sciences’s Yescarta/Bristol Myers Squibb’s Breyanzi) for R/R LBCL with 100.0% ORR in high-dose cohort (n=8) (Ref 4)
❓ What are the other key combination strategies being explored alongside CAR-T therapies in R/R LBCL?
⭐ Business Update
💼 Galapagos decided to re-evaluate the previously proposed separation into two entities (Galapagos, on cell therapy, and SpinCo, on building a pipeline of innovative medicines) and will explore all strategic alternatives for its existing businesses (Ref 5)
❓ Which CGT assets will be impacted by this strategic assessment?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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