CARsgen Therapeutics Achieves Breakthrough Therapy Designation
CARsgen Therapeutics Celebrates Breakthrough Therapy Designation
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a pioneer in innovative CAR T-cell therapies targeting hematologic malignancies and solid tumors, has exciting news. The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation for satricabtagene autoleucel, commonly referred to as satri-cel, designed for Claudin18.2-positive advanced gastric and gastroesophageal junction cancer.
Significance of Breakthrough Therapy Designation
This designation is a remarkable achievement for CARsgen as it accelerates the clinical development and approval processes for drugs designed to treat serious conditions where non-innovative treatments have failed. Dr. Zonghai Li, the Founder, Chairman, and CEO of CARsgen, expressed enthusiasm regarding this recognition, stating that the designation will help facilitate a timely NDA (New Drug Application) submission for satri-cel.
Next Steps for Satri-cel
The company is gearing up to submit the NDA in the first half of the upcoming year. This initiative underlines CARsgen's commitment to bringing this significant therapy to patients who have not seen success with previous treatments.
Exploring Satri-cel
Satri-cel is an autologous CAR T-cell product that specifically targets Claudin18.2, a protein implicated in various cancers. Aiming to be a first-in-class treatment option, satri-cel mainly focuses on tackling advanced gastric cancer and pancreatic cancer. The development of satri-cel includes a series of ongoing clinical trials designed to validate its efficacy:
- Investigator-initiated trials (CT041-CG4006, NCT03874897)
- A confirmatory Phase II trial for advanced gastric and gastroesophageal junction cancer in China (CT041-ST-01, NCT04581473)
- A Phase I trial looking into pancreatic cancer adjuvant therapy (CT041-ST-05, NCT05911217)
- A combined Phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595)
Previously, in January 2022, satri-cel was awarded the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA, further solidifying its anticipated impact in the medical field.
About CARsgen Therapeutics
CARsgen Therapeutics is committed to being at the forefront of biopharmaceutical innovation, operating across key regions including China and the U.S. The company’s core focus is on advancing CAR T-cell therapies to tackle both hematologic malignancies and solid tumors. CARsgen has developed a thorough research and development platform within CAR T-cell technology, which encompasses everything from target discovery to clinical trials and large-scale production.
Notably, CARsgen has introduced novel technologies aimed at addressing significant challenges faced by current CAR T-cell therapies, including enhancing safety profiles, increasing treatment efficacy for solid tumors, and reducing associated costs. The overarching mission of CARsgen is to emerge as a global leader in biopharmaceuticals, delivering innovative and distinct cell therapies to cancer patients around the world.
Frequently Asked Questions
What is the significance of the Breakthrough Therapy Designation for satri-cel?
This designation speeds up the development and review process for drugs that aim to treat serious conditions and have the potential to address unmet medical needs.
What conditions does satri-cel aim to treat?
Satri-cel is focused on treating Claudin18.2-positive advanced gastric and gastroesophageal junction cancers, as well as pancreatic cancer.
Who leads CARsgen Therapeutics?
Dr. Zonghai Li serves as the Founder, Chairman, and CEO of CARsgen Therapeutics, guiding the company’s strategic directions.
What is the anticipated timeline for the NDA submission?
CARSgen plans to submit the New Drug Application for satri-cel within the first half of the next year.
Where does CARsgen operate?
CARsgen Therapeutics operates in both China and the U.S., focusing on the development of advanced cancer therapies.
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