CARsgen's Satri-cel: A Breakthrough in Solid Tumor CAR-T Therapy

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) has received a significant boost with the National Medical Products Administration (NMPA) of China granting Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel (satri-cel, CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy. This designation is expected to expedite the approval process and bring this innovative CAR T-cell therapy to patients more quickly.

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2, which has the potential to be the first-in-class globally for treating solid tumors. The therapy targets the treatment of Claudin18.2 positive solid tumors, with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials, a confirmatory Phase II clinical trial for advanced gastric/gastroesophageal junction cancer in China, a Phase I clinical trial for PC adjuvant therapy in China, and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America.

The pivotal Phase II clinical trial CT041-ST-01 (NCT04581473) demonstrated that satri-cel significantly improved progression-free survival (PFS) in patients with advanced gastric/GEJ cancer following progression on 2 prior lines of therapy. The study met its primary endpoint of a statistically significant improvement in PFS assessed by the Independent Review Committee (IRC) for patients treated with satri-cel infusion as compared to treatment of physician’s choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). The safety profile of satri-cel was manageable, indicating that the therapy's benefits outweigh its potential side effects.

The Breakthrough Therapy Designation (BTD) granted by the NMPA is a significant milestone for CARsgen Therapeutics, as it brings satri-cel one step closer to becoming the world's first CAR-T product for solid tumors and providing hope to more patients with advanced G/GEJ cancer. The BTD is intended for drugs that treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. As a result of this designation, the NMPA will provide intensive guidance and support to facilitate the development and review of satri-cel, potentially accelerating its approval timeline.

In conclusion, CARsgen Therapeutics' satri-cel has the potential to revolutionize the treatment of solid tumors, particularly gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). With the Breakthrough Therapy Designation (BTD) from the NMPA, the therapy is poised to enter the market more quickly, providing hope to patients and investors alike. As the company continues to develop and expand its product pipeline, CARsgen Therapeutics remains committed to exploring new technologies and bringing innovative and differentiated cell therapies to cancer patients worldwide.