Eisai is currently focusing on the development of second-line (monotherapy) and first-line therapy (in combination with IC for biliary tract cancer) of Nanbullat, as well as second-line progressive multiple sclerosis without recurrence of JPH034. In addition, we will also advance the development of KRAS-mutated colorectal cancer (Nambranrat) and glioma (JPH034).
Nanbulan lat has shown potential for expanded indications for colorectal cancer based on non-clinical and clinical data. In particular, clinical data have been reported that the effect of existing drugs is limited in the KRAS mutant type, which accounts for about 40% of metastatic colorectal cancers, while high expression of LAT! is strongly associated with poor patient prognosis. In addition, non-clinical trial results have been published showing a significant growth-inhibiting effect of Nanbulan Latin in KRAS-mutant colorectal cancer cell lines. In addition, a phase 1 clinical trial involving multiple solid tumors confirmed "stable (SD)" in 2 out of 6 patients with colorectal cancer, indicating promising signs for future clinical development. In this way, we have seen the possibility of developing nambullat for KRAS-mutated colorectal cancer, and we have received a proposal for joint development from a university in the United States, and we are currently applying for a grant to start a doctor-initiated clinical trial at the university.
On the other hand, we have started development of gliomas based on multiple reports of LAT! involvement in gliomas and the high transmutability of JPH034 in the brain in response to a proposal from a large research institute in the United States. Currently, we are providing our developed products to the research institutions concerned, and we are studying them at the preclinical stage.
Eisai will give top priority to second-line and first-line therapy for biliary tract cancer and secondary progressive multiple sclerosis without recurrence, and will proceed with other clinical development in stages under appropriate risk management based on the funding situation and costs.
Some amino acid metabolism rare diseases are caused by abnormalities in the amino acid transporter of the SLC family, including LAT!, and impaired amino acid transport function in the intestine, kidney, and liver is considered to be the main pathological factor.
We focused on a unique biodistribution of nambran latte in high concentrations in the liver, bile ducts, and large intestine, and obtained results suggesting efficacy in animal models of a rare disease. Based on this achievement, we are applying for an application patent for this indication, and are pursuing new possibilities for expanding the indications of Nanbulan Rat.