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Cell and Gene Therapy Updates

March 3rd Week, 2025



Regulatory Events



🎯 The European commission granted approval to Bristol Myers Squibb’ Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) for the treatment of adult patients with ≥3L FL (Ref 1) 


❓ How many CAR-Ts are currently approved for FL, and what makes Breyanzi unique? 




🎯 The US FDA granted Fast Track Designation (FTD) to Imugene Limited’s azercabtagene zapreleucel (azer-cel; an allogeneic, anti-CD19 CAR-T) for the treatment of R/R DLBCL patients who progressed on prior therapies, including autologous CAR-T (Ref 2) 


❓ How many allogeneic CAR-Ts have been granted FTD and what are they? 



🎯 Anocca received Clinical Trial Application (CTA) authorization from the regulatory authorities in four European countries under the EU harmonized framework for Phase 1/2/VIDAR-1 clinical trial evaluating ANOC-001 (KRAS G12V targeting non-viral gene edited TCR-T) for the treatment of PDAC. (Ref 3) 


❓ How do non-viral gene-edited TCR-T therapies, such as ANOC-001, stand out from viral edited TCR-T therapies? 



Mergers and Acquisitions



🤝 AstraZeneca concluded a $1 billion agreement to acquire EsoBiotec, a company specializing in in vivo cell therapies. The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform employs highly targeted lentiviruses to deliver genetic instructions directly to specific immune cells—such as T cells—programming them to recognize and destroy tumor cells. (Ref 4) 


❓ Which other companies are developing In Vivo cell therapies? 



Setbacks



🛑 CARGO Therapeutics discontinued its remaining assets, including CRG-023 (an autologous, anti-CD19/CD20/CD22 tri-specific CAR-T) that was in preclinical development for the treatment of B-cell malignancies and its allogeneic platform (Ref 5) 


❓ What led Cargo Therapeutics to discontinue its remaining assets?



🛑 Adaptimmune has raised concerns about its sustainability, leading to the discontinuation of two preclinical programs—ADP-600 (an autologous, PRAME targeting TCR-T) for solid tumors, and ADP-520 (an autologous, CD70 targeting TCR-T). The company is also actively evaluating strategic options for its future. (Ref 6) 


❓ Why is Adaptimmune exploring strategic options despite having an approved product?



🛑 BioNTech SE has chosen to let its collaboration option expire for Autolus Therapeutics’ AUTO1/22 (an autologous, anti-CD19/CD22 dual CAR-T) as part of its portfolio prioritization (Ref 7) 


❓ What other collaboration opportunities remain for BioNTech with Autolus? 



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



🌐 References: 



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