CGT Watch Newsletter: Jan'26 Edition

Welcome to the January edition of our CGT Watch newsletter!

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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.

🎯 Regulatory Updates

⭐ The FDA cleared IND for Kelonia’s KLN-1010, advancing in vivo BCMA CAR-T therapy in R/R MM. (Ref)

Kelonia Therapeutics secured FDA IND clearance for KLN-1010 (in-vivo; anti-BCMA CAR-T) enabling US expansion of their Ph1 trial. To note, early MRD-negative responses have been observed in R/R Multiple Myeloma pts treated at sites in Australia.

👉 Why It Matters: KLN-1010 could reshape CAR-T therapy by generating anti-BCMA CAR-T cells in-vivo with a single infusion removing complex manufacturing and preconditioning chemotherapy.

⭐ FDA greenlights A2B543, expanding A2 Bio’s Tmod™ platform into advanced solid tumors (Ref)

A2 Biotherapeutics, Inc. secured FDA IND clearance for A2B543, (a logic-gated, anti-MSLN CAR-T) for the treatment of solid tumours and expanding the EVEREST-2 precision medicine trial.

👉 Why It Matters: A2B543 brings a novel IL-12 boosted Tmod™ cell therapy into clinical trials for solid tumors, marking a major step in expanding precision, logic-gated immunotherapies to patients with few treatment options.

⭐ FDA cleared Arovella’s game-changing off-the-shelf iNKT CAR Therapy for clinical studies (Ref)

FDA accepted IND application for Arovella Therapeutics ASX: ALA's ALA-101, (an allogeneic, anti-CD19 CAR-iNKT), enabling Ph1 trials in Australia and US for R/R NHL and leukemia.

👉 Why It Matters: ALA-101 signals a shift beyond conventional CAR-T toward invariant NKT-powered immune engineering.

⚡️ Special Designations

⭐ Eureka’s next-gen ARTEMIS® CAR-T ECT204 earned FDA RMAT status for Liver Cancer (Ref)

The FDA granted RMAT designation to Eureka Therapeutics, Inc' ECT204 ARTEMIS® (an autologous anti-GPC3 CAR-T) for advanced HCC, based on promising Ph 1/2 ARYA-3/NCT04864054 data.

👉 Why It Matters: If successful, ARTEMIS could unlock a modular CAR-T platform adaptable across multiple solid tumor indications.

⭐ FDA breakthrough designation accelerates Wugen’s allogeneic CD7 CAR-T Sofi-cel (Ref)

Wugen received FDA Breakthrough Therapy Designation for Sofi-cel (off-the-shelf; anti-CD7 CAR-T) which is being evaluated in patients with R/R T-ALL and T-LBL in the Ph2 T-RRex/NCT06514794 trial.

👉 Why It Matters: Sofi-cel could become the first off‑the‑shelf CAR‑T option for R/R T‑ALL/T‑LBL, addressing a critical unmet need.

⭐ FDA granted Orphan Drug Designation to Imviva’s off-the-shelf CD7 CAR-T CTD402 for R/R T-ALL/LBL (Ref)

Imviva Biotech's CTD402 (an off-the-shelf, anti-CD7 CAR-T) received ODD from the US FDA for R/R T-ALL/LBL, with early CR rate of 64.1% in the ongoing Ph1/2 TENACITY-01/NCT07070219 trial.

👉 Why It Matters: CTD402’s early CR and MRD negative rates highlight the clinical potential of off-the-shelf CAR-T in aggressive T-cell malignancies.

🔬 Clinical Outcomes

⭐ Immunofoco has advanced its solid tumor CAR-T program as IMC002 demonstrated strong clinical activity in GC/GEJ (Ref)

Immunofoco presented results from the IMC002-RT01/NCT05946226 trial in which IMC002 (VHH-based anti-CLDN18.2 CAR-T) showed 66.7% ORR and 7.0m PFS in heavily pretreated GC/GEJ patients.

👉 Why It Matters: Durable complete responses beyond 60 weeks highlight CAR-T’s potential for long-term control in advanced gastric cancer, while VHH-based CAR design signals safer, more precise targeting in solid tumors.

🤝 Deals & Collaborations

 

⭐ India’s indigenous CAR-T therapy Talicabtagene Autoleucel has entered into African markets via Cipla (Ref)

Cipla licensed ImmunoACT's Talicabtagene autoleucel (an autologous anti-CD19 CAR-T) for exclusive commercialization in South Africa, Algeria and Morocco to address unmet needs in R/R B-NHL and B-ALL.

👉 Why It Matters: This collaboration could establish Africa’s first large‑scale CAR‑T footprint, reshaping hematology treatment standards across the continent.

⭐AdAlta linked major CAR-T deal for global development outside China (Ref)

AdAlta Ltd secured exclusive global rights (ex-China) to co-develop SHcell's promising BZDS1901 (PD1-armored Anti-MSLN CAR-T) therapy, validating its East-to-West strategy with AdCella funding Ph1 trials in Australia.

👉 Why It Matters: The deal gives AdAlta control of a high-value CAR-T in Western markets, anchors early development and manufacturing in Australia, and positions it as a gateway for Asian cell-therapy innovation into global oncology pipelines

⭐Nona Biosciences and Link Cell Therapies partnered to discover next-gen CAR-Ts (Ref)

Nona Biosciences partnered with Link Cell Therapies to discover novel fully human HCAb-based CAR-T candidates using HCAb Harbour Mice® and NonaCarFx™ platforms for solid and hematologic malignancies.

👉 Why It Matters: By pairing Nona’s antibody platforms with Link’s logic-gated CARs, the partnership could redefine precision therapy for solid tumors.

⭐CARsgen and Dispatch Bio team up to unlock CAR-T potential in Epithelial Solid Tumors (Ref)

CARsgen Therapeutics & Dispatch Bio have planned to launch Phase 1 China trial combining Dispatch's Flare platform (DV-10 tumor virus) + CARsgen's Zevor-cel (anti-BCMA CAR-T) for epithelial solid tumors in 2026.

👉 Why It Matters: If DV‑10 successfully primes epithelial tumors, CAR T could finally break through the barrier of antigen scarcity in solid cancers.

🚀 Product Launch

⭐ Immuneel launched Qartemi® India’s first globally benchmarked CAR-T therapy, redefining treatment for  NHL (Ref)

Immuneel Therapeutics Pvt. Ltd. launched Qartemi®, India's first globally benchmarked CAR T-cell therapy for R/R B-NHL which demonstrated 83.3% ORR in the IMAGINE trial.

👉 Why It Matters: Qartemi® is India’s first globally benchmarked CAR-T therapy for R/R NHL, delivering world-class personalized treatment at an accessible cost through local manufacturing redefining precision oncology in India.

A Request

We’d love your feedback, what did you find most interesting? If you have any questions or insights, feel free to reply or reach out. We look forward to exploring more breakthroughs with you in our next newsletter.

Until next time,

The CGT Watch Team