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 |
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