Cell and Gene Therapy Updates

February 4th Week, 2025

📝 The US FDA granted RMAT designation for ImmunityBio’s Anktiva (n ogapendekin alfa inbakicept; IL-15 superagonist) and its PD-L1 t-haNK (an allogeneic, a-PD-L1 CAR-NK) for the reversal of lymphopenia in patients receiving SOC chemo/radiotherapy and in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer (Ref 1) 

❓ What are the next steps in the development process for Anktiva and PD-L1 t-haNK following the RMAT designation? 

📝 UCARsgen secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the allogeneic CAR-T products from CARsgen Therapeutics (Ref 2) 

❓ Which allogeneic CAR-T products are covered under this agreement, and what are the financial details associated with it? 

📝 Cellectis unveiled its 'Smart CAR-T' strategy at AACR IO 2025, showcasing a design that enables CAR-inducible expression of the synthetically engineered FAP-IL-2 variant (IL-2v) immunocytokine to boost persistent anti-tumor activity of allogeneic CAR-Ts without associated IL-2 toxicity (Ref 3)

❓ How does the 'Smart CAR-T' strategy overcome the obstacles of targeting the solid tumor microenvironment (TME) while mitigating IL-2 toxicity, and what preclinical data supports this approach? 

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

🌐 References:

1) https://immunitybio.com/immunitybio-receives-fda-rmat-designation-for-anktiva-and-car-nk-for-the-reversal-of-lymphopenia-in-patients-receiving-standard-of-care-chemotherapy-radiotherapy-and-in-treatment-of-multiply-rel/

2) https://www.carsgen.com/en/news/20250225/

3) https://www.cellectis.com/en/press/cellectis-presents-smart-car-t-strategy-to-enhance-efficacy-against-solid-tumors-at-aacr-io-2025/