FDA Places CARsgen Therapeutics’ CAR-T Cell Therapies on Clinical Hold, Impacts Global Expansion Plans

CARsgen Therapeutics, a Chinese biotech company, is facing a significant setback as the US Food and Drug Administration (FDA) imposes a clinical hold on three of its Chimeric Antigen Receptor T-cell (CAR-T) therapy candidates. The regulatory intervention follows an inspection of CARsgen’s manufacturing facility in North Carolina, raising concerns about the company’s global expansion plans and competitive position in the rapidly evolving CAR-T therapy landscape.

The FDA’s decision, communicated this week, puts a pause on the development of CARsgen’s three CAR-T therapies, which target BCMA, Claudin18.2, and GPRC5D receptors. The manufacturing facility in North Carolina, where clinical manufacturing began over a year ago, had been touted as fully operational, with improved overall manufacturing efficiency, according to a corporate presentation released by CARsgen earlier this month.

Investors reacted swiftly to the news of the FDA’s clinical hold, causing CARsgen’s share prices to plummet by 30% to 6.57 Hong Kong dollars. This sharp decline underscores the perceived significance of the setback and the potential ramifications for CARsgen’s competitiveness in the highly competitive CAR-T therapy space.

CARsgen responded by stating its commitment to conducting a comprehensive review and improvement of its current good manufacturing practices. However, the lack of specific details regarding the FDA’s findings and the timeline for resolution leaves stakeholders in a state of uncertainty.

The affected CAR-T therapies include a BCMA candidate, which had entered a phase 1b/2 multiple myeloma clinical trial in the US and Canada back in 2019. The clinical hold has now cast doubts on the projected primary completion date at the end of next year, prompting the need for a reassessment.

Similarly, the Claudin18.2 candidate, CT041, is currently in phase 1b/2 and is subject to a clinical collaboration with Moderna. While CARsgen views CT041 as a potential first-in-class CAR-T, the regulatory hold introduces challenges as the company competes against others employing different modalities targeting the same receptor.

The third CAR-T, CT071, targeting GPRC5D, puts CARsgen in direct competition with major pharmaceutical players such as AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, and Roche. The regulatory hold introduces uncertainty regarding the fate of CT071 and its potential impact on CARsgen’s global expansion plans.

CARsgen had strategically established its North Carolina facility to compete globally, aiming to treat 700 patients annually and support clinical trials and early launch activities in North America and Europe. However, the FDA’s intervention disrupts these plans, raising questions about CARsgen’s ability to navigate regulatory landscapes outside its native China.

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