1. Halbjahr 2024
JWTCR001 JWTCR001 is a specific cell therapy product directed to MAGE-A4 (including any mutations, fragments, modifications or derivatives of the engineered TCR binding MAGE-A4). MAGE-A4 is a highly prevalent antigen in a wide variety of malignant tumors, including non-small cell lung cancer, melanoma, bladder, head and neck, gastroesophageal and ovarian cancers, and thus an ideal target indication for TCR-T therapy. We have utilized the CTBR12 TGF-beta (“FLIP”) receptor technique developed by Regeneron, which potentially increases efficacy. Early phase clinical trials6 have previously demonstrated that TCR-T cell therapies targeting MAGE-A4 can have meaningful clinical efficacy for treatment of MAGE-A4-expressing solid tumors. The biologics license application (“BLA”) for treatment of synovia sarcoma was accepted by the U.S. FDA on January 31, 2024, and priority review has been granted. In October 2022, we established a strategic alliance with 2seventy bio to develop and commercialize a cell therapy product directed to MAGE-A4 (including any mutations, fragments, modifications or derivatives of the engineered binding element for MAGE-A4) in oncology indications. The agreement is focused on the technologies and know-how possessed by 2seventy bio, and also includes future prospects for the development and commercialization of the product in Greater China based on addressable patient population and unmet medical needs. We believe that the Company may be able to secure a first mover or early-mover advantage in a highly promising market through development of such a therapy. We have established our manufacturing process for a product directed to MAGE-A4 in anticipation of commencement of an IIT, and this study has started to enroll patients from the first quarter of 2024 |