#China #Shanghai #CARsgen #Satri-cel #Claudin18.2

CARsgen Announces Positive Phase II Results for Claudin18.2 CAR-T Therapy

CARsgen Therapeutics Holdings Limited recently revealed significant outcomes from its pivotal Phase II clinical trial focused on satricabtagene autoleucel, known as 'satri-cel', for treating gastric and gastroesophageal junction cancers. This groundbreaking trial, referred to as CT041-ST-01 (NCT04581473), marks a crucial step in the treatment landscape for patients suffering from advanced cases of these cancers that have not responded to at least two previous therapies.

Study Overview

The study was conducted as an open-label, multicenter trial and included a group of 21 participants who expressed Claudin18.2 and had failed earlier treatment regimes. Participants were randomly assigned to receive either the satri-cel treatment or a choice of traditional therapies determined by their physician, including paclitaxel and nivolumab.

The primary goal of the trial was to evaluate progression-free survival (PFS), which was assessed by an Independent Review Committee (IRC). The results showed that those treated with satri-cel experienced a statistically significant improvement in PFS compared to the traditional treatment options. These promising findings indicate that satri-cel may offer substantial benefits to patients with challenging cancer diagnoses.

Safety and Efficacy

Early data addressing the safety profile of satricabtagene autoleucel has indicated that it is manageable, providing confidence for both healthcare professionals and patients considering this innovative therapy. Dr. Zonghai Li, the Founder and CEO of CARsgen Therapeutics, expressed excitement regarding these findings and called them a 'groundbreaking milestone' in the realm of CAR-T therapies targeting solid tumors.

Dr. Li stated, "We are thrilled to see positive outcomes in our pivotal Phase II clinical trial in China. Satri-cel not only shows efficacy but provides hope for gastric cancer patients when previous treatments have failed. We aim to submit a New Drug Application (NDA) to the NMPA in the first half of 2025 and anticipate that satri-cel could become the first CAR-T product approved for solid tumors globally."

Future Developments

In addition to the advancements made in treating gastric and gastroesophageal cancers, CARsgen is exploring further applications for satri-cel, particularly in adjuvant therapy for gastric and pancreatic cancers. The company has initiated multiple trials involving satri-cel, including a confirmatory Phase II trial for advanced gastric cancer in China and a Phase 1b/2 trial for advanced pancreatic adenocarcinoma in North America.

About Satri-cel

Satri-cel is touted as a first-in-class autologous CAR T-cell therapy specifically targeting Claudin18.2 positive tumors. The ongoing research and trials underscore CARsgen’s commitment to addressing the critical challenge of effectively treating solid tumors with CAR-T technology. The therapy previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for its endeavor in advanced gastric cancer treatment, alongside Orphan Drug designation in 2020.

The mission of CARsgen Therapeutics remains clear: to lead innovative advancements in biopharmaceutical products and ultimately transform cancer treatment paradigms for patients worldwide. Through robust research and development initiatives, CARsgen is positioning itself at the forefront of cancer therapeutics, making strides toward improved treatment options that could potentially change lives.

Conclusion

With the success of the Phase II clinical trial, CARsgen Therapeutics sets a promising trajectory for integrating satri-cel into standard treatment protocols, offering fresh possibilities for patients battling resistant solid tumors. As research progresses, the company aims to usher in a new era of cancer care that emphasizes innovation, efficacy, and accessibility.