Welcome to the January edition of our CGT Watch newsletter! Stay informed on the latest advancements in the CGT space—subscribe now to receive insightful updates straight to your inbox. Dear Readers, We’re excited to bring you Jan edition of CGT watch highlighting updates on novel targets, innovative approaches, first-of-its-kind combinations, and key developments. Since we’re keen to keep things concise and focused, this issue will exclusively cover cell therapies. 🎯 Regula

06/02/2026 The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma (Ref) The US FDA approved an update to Gilead's Yescarta® (axicabtagene ciloleucel; anti-CD19 CAR T-cell therapy) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous sy

21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 (Ref) The US FDA granted the fast track designation to BioNTech's BNT11

December 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? Clinical Events 🔬 The Phase 3 STAR-221 trial of A

December 1st Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Eli Lilly and Company's pirtobrutinib (BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to Bristol Myers Squibb's lisocabtage

November 4th Week, 2025 Regulatory Events 🎯 The EC granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (anti-CD19 CAR-T) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy including a BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to AstraZeneca’s neoadjuvant durvalumab (anti-PD-L1) + chemot

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL (Ref) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmacok

November 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted full approval to Kura Oncology, Inc. and Kyowa Kirin Co., Ltd.'s ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1) ❓ How is this approval expected to impact the Tx algorithm of AML? Clinical Events 🔬 In the Phase 3 PEAK trial, Cogent Biosciences' bezuclastinib (KIT inhibitor) + sunitinib met the primary en

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

August 2nd Week, 2025 Regulatory Events 🎯 The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for previously treated, unresectable/metastatic non-sqNSCLC with HER2 TKD activating mutations. (Ref 1) ❓ What proportion of NSCLC patients have HER2 TKD activating mutations? 🎯 The US FDA granted accelerated approval to Jazz Pharmaceuticals' dordaviprone (DRD2 antagonist and ClpP agonist) for previously treated, H3 K27M-mutant, diff

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE (Ref) Alphamab Oncology's IND application for JSKN022 (PD-L1 x integrin αvβ6 bispecific antibody-drug conjugate) has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company plans to initiate a first-in-human trial of JSKN022 for the treatment of advanced malignant solid tumors The Ph1 trial will evaluate the safety, tolerability, PK/P

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia (Ref) The US FDA granted the Orphan Drug Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory m

June 3rd week, 2025 Regulatory Updates 🎯 Senti Biosciences received an ODD from the US FDA for SENTI-202 (off-the-shelf CD33 and/or FLT3 targeting CAR-NK) for R/R AML (Ref 1) 👉 Why it matters: This is the first logic-gated CAR-NK with clinical data, demonstrating encouraging early results (ORR of 71.4% (n=7) with responses sustained beyond 8 months) 🎯 The US FDA granted ODD for CERo Therapeutics, Inc.’ CER-1236 (anti-TIM-4L CER-T), which is being evaluated in Ph1...

June 1st Week, 2025 Regulatory Events 🎯 Takeda and Pfizer’s brentuximab vedotin (Adcetris; CD30 ADC) + ECADD chemo regimen has been approved by the European commission for the Tx of adult patients with newly diagnosed stage IIb with risk factors/III/IV Hodgkin lymphoma. (Ref 1) ❓ Can brentuximab-based regimen be the standard of care? What are its strengths and limitations? 🎯 Tempest Therapeutics’ amezalpat (selective PPAR⍺ antagonist) has been granted an Orphan Drug Desi

June 2nd week, 2025 ⭐ Deals & Collaborations 🤝Neowise Biotechnology granted BeOne Medicines rights to one of its proprietary antigen-specific TCR molecule under a non-exclusive licensing deal for the development of next-generation, iPSC-based off-the-shelf cell therapies for the Tx of Solid Tumors (Ref 1) ❓ What are the advantages of the off-the-shelf cell therapies? ⭐ Regulatory Updates 🎯 Myrio Tx received the US FDA approval for an IND application to initiate Ph1, N

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 f

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

February 3rd Week, 2025 📝 BMS’ Breyanzi (liso-cel; an autologous, anti-CD19 CAR-T) received NICE recommendation as an option for treating Relapsed or Refractory Large B-cell Lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable (Ref 1) ❓ What new evidence led NICE to overturn its initial rejection of Breyanzi in Oct 2024? 📝 Anixa Biosciences received the approval to amend Ovarian Cancer Phase 1/NCT05316129 trial, allowing a second dose of FS

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