FREDERICK, MD, – Cartesian Therapeutics, Inc., a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced a strategic licensing agreement with WestGene Biopharma Co., Ltd. to advance the development of novel in vivo chimeric antigen receptor T-cell (CAR-T) therapies in autoimmune diseases.

“Building on our leadership in autologous cell therapy in autoimmune disease, we are partnering with WestGene to extend our mRNA payloads into in vivo delivery,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We believe that the potential for in vivo to further enhance the delivery of cell therapies in the field of autoimmune disease provides a compelling commitment to scientific innovation. This partnership provides an accelerated and efficient path to human clinical data with expected proof-of-concept being evaluated in patients with myasthenia gravis. With positive clinical data, we intend to advance programs across multiple autoimmune diseases into U.S. clinical development. We believe this collaboration has the potential to further transform the treatment paradigm for cell therapy in autoimmune diseases.”

WestGene has previously conducted clinical studies in the fields of oncology and autoimmune diseases using mRNA CAR‑T constructs delivered via its targeted lipid nanoparticle (tLNP) platform, establishing early proof of concept for its in vivo approach. Across multiple dosing regimens, including repeated administration of up to 14 doses in a single patient, the therapy demonstrated a favorable safety and tolerability profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or infusion-related reactions (IRRs) reported. Only one subject experienced Grade 1 cytokine release syndrome (CRS). Clinical data demonstrated robust in vivo CAR-T generation following administration, including high levels of circulating CD8⁺ CAR-T cells and rapid, sustained B-cell depletion. Importantly, CAR expression and biological activity were maintained following repeat dosing, supporting the potential for long-term, multi-cycle administration without evidence of diminished pharmacologic activity. The underlying ionizable lipid technology has shown preferential uptake in CD8⁺ T cells in vivo and a consistent tolerability profile, collectively reinforcing the potential of WestGene’s platform to deliver consistent biologic activity and serving as a validated vehicle for advancing additional programs, including Cartesian’s anti‑BCMA approach.

Cartesian is partnering with WestGene to conduct a Phase 1 dose-escalation study of the mRNA used in Descartes-08 delivered via WestGene’s proprietary targeted lipid nanoparticles (tLNPs) in patients with generalized myasthenia gravis. IV infusions will be administered across multiple dose levels using a Bayesian Optimal Interval (BOIN) adaptive design with a comprehensive translational assessment package including clinical response measures. The program represents a novel in vivo approach to BCMA-directed T-cell engineering that, if successful, could eliminate the ex vivo manufacturing step.

In addition to Descartes-08, Cartesian’s tested CAR construct with the potential to be evaluated initially with the WestGene LNP delivery platform, Cartesian is also planning to advance multiple internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed T-cell engager (TCE) as part of its expanding mRNA payload portfolio. The WestGene partnership is designed to provide an efficient framework to move additional Cartesian payloads into human trials, extending the platform’s potential to generate clinical proof-of-concept data across multiple programs in several disease states.

“We are thrilled to partner with Cartesian, which we believe to be the most clinically advanced mRNA CAR-T company, whose validated payloads complement WestGene’s targeted LNP delivery platform,” said Xiangrong Song, Ph.D., Co-Founder and CEO of WestGene. “WestGene brings the early clinical infrastructure to rapidly evaluate Cartesian’s constructs in vivo, and we believe this collaboration has the potential to meaningfully advance the treatment of autoimmune diseases.”

Under the terms of the agreement, WestGene will receive an upfront payment and is eligible to receive potential development and commercial based milestone payments. This clinical study is expected to initiate in 2H 2026 with in-human data expected in 1H 2027.

This strategic collaboration between Cartesian and WestGene was facilitated by Uni-Pioneers, BioMed., Inc., a Chapel Hill-based firm specializing in strategic partnership, cross-border venture creation, deal-making, and alliance building. Leveraging its expertise, Uni-Pioneers worked closely with both Cartesian and WestGene to structure a partnership that has the potential to accelerate the path to clinical proof of concept of in vivo CAR-T and TCE therapies in autoimmune diseases.

About Cartesian Therapeutics

Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis, Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2 clinical development for pediatric autoimmune diseases, including juvenile dermatomyositis. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X.

About WestGene Biopharma

WestGene Biopharma is a clinical-stage biotechnology company focused on nano-delivery (LNP/tLNP) and next-generation mRNA therapeutics. The company has developed proprietary LNP delivery platforms and RNA engineering technologies to enable applications across oncology, autoimmune diseases, infectious diseases, metabolic disorders, and in vivo cell therapies. The Company’s nano-adjuvant WGa0401 has launched under EUA. The lead mRNA asset, WGc-043, is a tumor vaccine in Phase 1 clinical development