SaiYuan Bio's SY001, China's First CAR-Macrophage Therapy, Completes Initial Patient Dosing

Recently, the first CAR-Macrophage therapy product (CAR-M) in China —— SY001 Cell Injection from SciCell Biotech (Hangzhou) Co., Ltd. —— has completed the first batch of patient dosing.

Exploratory Clinical Trial of SY001 Injection by Saayon Biotech: The First Investigator-Initiated Clinical Study in China for a CAR-M Cell Therapy Product Officially Launched, Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SY001 in Advanced Solid Tumor Patients Using a Single-Center, Single-Arm, Dose-Escalation Design. To date, the clinical study of SY001 injection has yielded preliminary data: All patients demonstrated good safety and tolerability, with no dose-limiting toxicity (DLT) observed. None of the patients experienced cytokine storms or related syndromes, indicating the excellent safety profile of macrophage-based immunotherapy. The successful completion of the first cohort dosing in the SY001 injection trial validated the advanced nature of the company’s R&D platform technology and the maturity of its manufacturing process. Currently, this clinical study is actively recruiting participants to further advance the dose-escalation trial, with preliminary results expected to be announced in 2024.

Saiyuan Biotech looks forward to this innovative drug proving its safety and efficacy in clinical trials, providing new hope for the treatment of solid tumors, thereby improving patients' quality of life and extending their lifespan. It also anticipates developing better cell therapies that benefit patients with solid tumors.

About CellOrigin Bio:

Saiyuan Biotech is dedicated to the research and clinical transformation of engineered innate immune cells such as CAR-iMac. The company utilizes technologies like gene editing and synthetic biology to obtain engineered immune cells derived from peripheral blood or iPSC, with several core patents already authorized both in China and internationally.

CellOrigin Bio fully leverages the characteristics of macrophages, which can easily enter the tumor microenvironment (TME) and survive readily, and is actively developing CAR-iMac products primarily targeting various types of recurrent/refractory solid tumors. The company has completed the establishment of a clinical-grade iPSC cell bank, independently developed a scalable production process for CAR-iMac cells, and built a complete GMP quality system along with corresponding quality testing methods. In collaboration with multiple hospitals, the company is advancing the application for an IND registration certificate.

Editor: Bai Ji

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