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Fusion of Innovation: Moderna Joins Forces with CARsgen Therapeutics to Forge a Powerful Duo Against Solid Tumor Cancers

In an electrifying collaboration, Moderna and China’s CARsgen Therapeutics are teaming up to merge their groundbreaking mRNA therapeutic cancer vaccine and a formidable solid tumor CAR T cell therapy. The curtain lifted on this exciting partnership as CARsgen made the revelation on a vibrant Monday.

The partnership’s grand vision involves the convergence of Moderna’s trailblazing Claudin18.2 mRNA cancer vaccine with CARsgen’s dynamic Claudin18.2 CAR T cell contender (CT041) across the stages of preclinical exploration and Phase I studies.

With fervor, Lin Guey, Moderna’s Chief Scientific Officer of external research, declared that Claudin18.2 emerges as a beacon of promise, holding the potential to combat a spectrum of cancer types burdened by unmet medical needs. This partnership, Lin Guey affirmed, will unravel the enigmatic synergy between CAR-T and a pioneering mRNA cancer vaccine that weaves the blueprint for the Claudin18.2 protein.

Enter Claudin18.2, an isoform of its predecessor, a protein standing tall as a uniquely selective biomarker. It intricately adorns itself with limited presence in the realm of normal tissues while donning the garb of abnormal expression in a medley of malignant tumors. This enigmatic behavior has thrust Claudin18.2 into the spotlight as a solitary hero tailored for targeted therapy, particularly for cancers originating in the stomach.

The narrative unfolds further with CT041, a charismatic autologous CAR T cell creation. Its resounding potential was acknowledged by the FDA, which bestowed upon it the prestigious Regenerative Medicine Advanced Therapy (RMAT) Designation in January 2022. This recognition was extended for the treatment of advanced gastric cancer and gastroesophageal junction cancer graced by Claudin18.2-positive tumors. The accolades did not halt there – in October 2020, the candidate was granted Orphan Drug designation by the same regulatory titan for the treatment of GC and GEJ, cementing its position as a beacon of hope.

In a vibrant May of 2023, CARsgen unleashed a Phase II trial, heralding patient enrollment for CT041 in the United States. The trial unfurled its banner to address Claudin 18.2–positive advanced gastric cancer and gastroesophageal junction cancer, beckoning those who had faced defeat against two prior lines of systemic therapies.

Zonghai Li, the visionary CEO and CSO of CARsgen, cast CT041 as the shining star among solid tumor CAR-T developments. He lauded its prowess in combating gastric and pancreatic cancers. Li’s excitement was palpable as he explored the synergy of attacking tumors with the dynamic CAR T-cell therapy alongside a cancer vaccine, envisioning amplified benefits for the patients. The backdrop of this alliance painted Moderna as a stalwart leader in the realm of mRNA-based vaccines and therapeutics, solidifying its position as a harbinger of innovation.

Fast forward to July 2023, a month brimming with promise. Moderna united with Merck, embarking on a monumental Phase III high-risk melanoma trial that blended the companies’ personalized cancer vaccine built on mRNA and Merck’s formidable Keytruda checkpoint inhibitor. Having conquered a successful Phase IIb trial among stage III/IV melanoma patients harboring a high risk of recurrence post-surgery, the two giants forged ahead with a Phase III journey encompassing an expanded population, including stage IIb–IV patients. This audacious endeavor promises to enroll around 1,089 patients across 165 sites and over 25 countries, painting a global canvas of innovation.

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