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 Sci

May 1st & 2nd Week, 2025 ⭐ Deals & Collaborations 🤝 NKure Therapeutics and CRISPR Therapeutics partnered to co-develop CRISPR’s CTX112 (an allogeneic, anti-CD19 CAR-T) for the treatment of R/R B-cell malignancies in India. NKure plans to seek the CDSCO approval by Jun’25 to begin Ph2 trials in India (Ref 1) ❓ What is the competitive landscape of CAR-Ts in India? 🤝 Chong Kun Dang Pharm. acquired a 7.3% stake in AbClon, and received priority rights to commercialize nespecab

April 2nd April, 2025 ⭐ Regulatory Events 🎯 The US FDA cleared an IND application of CERo Therapeutics, Inc.’s CER-1236 (anti-Tim-4L chimeric engulfment receptor T-cell (CER-T)) for a Phase 1 trial in advanced solid tumors specifically NSCLC and ovarian cancer (Ref 1) ❓ What is the difference between CER-T and CAR-Ts and what benefits do CER-Ts offer? ⭐ Setbacks 🛑 Carisma Therapeutics paused R&D activities and is exploring strategic alternatives to maximize value, incl

March 1st Week, 2025 ⭐ Regulatory Events 🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel; CT041; an autologous, anti-CLDN18.2 CAR-T) for the treatment of Claudin18.2-positive ≥third-line G/GEJ cancer (Ref 1) ❓ What are CARsgen’s next steps in advancing satri-cel? Has CARsgen obtained similar designations in other markets? 🎯 The US FDA accepted Bioheng Therapeutics’ IND application for CTD402 (anti-

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

February 2nd Week, 2025 📝 BMS’ Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel; an autologous, anti-CD19 CAR-T) met primary endpoint of ORR and key secondary endpoint of CRR in marginal zone lymphoma (MZL) cohort. Detailed results will be presented at an upcoming conference (Ref 1, 2) ❓ What are the current benchmarks in MZL? 📝 Imugene’s Azer-cel (an allogeneic, anti-CD19 CAR-T) + low dose IL-2 elicited two additional complete responses resulting in a CRR o

Welcome to the April edition of our CGT Watch newsletter! Autolus’ Aucatzyl’s UK approval; BrainChild Bio’s BCB-276 BTD; Lyell’s LYL314 RMAT designation; TScan’s Ph1 trial update; CERo’s IND approval; CARGO's assets discontinuation; Carisma assessing strategic alternatives; BioNtech co-development option expiration; Caribou Bio restructuring. Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear R

Dear Readers, Welcome to our inaugural CGT Watch newsletter! We’re excited to bring you monthly highlights on novel targets, innovative therapeutic approaches, and emerging companies in the cell and gene therapy space. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. We’re using a 45-day window for these highlights; from our next issue onward, we’ll transition to a monthly update schedule. Section 1: Key Monthly Updates 🎯