Kite Pharma, a California-based clinical-stage biopharmaceutical company, has announced that it has submitted an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to initiate a Phase 1 trial of KITE-718, an engineered T-cell therapy that targets MAGE A3 and MAGE A6 on solid tumors.
MAGE A proteins are testis-specific E3 ubiquitin ligase components whose expression is upregulated in many cancers. MAGE A3 and A6 are frequently overexpressed in common solid tumors including bladder, esophageal, head and neck, lung and ovarian cancers.
Kite’s KITE-718 trial is designed to assess the safety and anti-tumor effect of KITE-718 on these solid tumors. This investigational therapy has the potential to recognize MAGE A3 and MAGE A6 fragments on tumors and kill tumor cells through activation of the immune system.
KITE-718 is built on the proof of concept data obtained from the National Cancer Institute’s (NCI) MAGE A3 TCR program (NCT02111850), where engineered T-cells were used for the treatment of metastatic cancers, by targeting the MAGE A3 proteins. No off-target toxicity was observed in the NCI study, and evidence of tumor regression was seen in patients with multiple types of solid tumors. Kite has further optimized the manufacturing process through advanced technologies and next-generation cell manufacturing conditions.
Dr David Chang, Kite’s CMO commented: “Submission of this IND is an important milestone for our solid tumor strategy utilizing engineered T cell therapy based on both TCR and CAR platform technology. TCRs have the potential to access a broad spectrum of tumor targets and we have incorporated our next generation cell manufacturing technologies into KITE-718 to exploit targets naturally expressed in common solid tumors for which there is a great unmet medical need.”
Source: Kite Pharma Submits Investigational New Drug (IND) Application for KITE-718, an Investigational Next Generation T-Cell Receptor (TCR) Therapy Targeting Cancer Antigens MAGE A3 and MAGE A6. Press Release