|20/03/02||GEM161||Restoration of autophagy and reduction of inflammation||Cardiovascular and Metabolic Diseases||Oral||Oligo-saccharides||Phase 2b/3 ready||A novel derivative (pat. pend.) of hydroxypropyl-α-cyclodextrin (HPαCD) that down-regulates the PI-system by controlling serum phospholipids and, thereby, reduces endocytosis. βCDs have been shown to be effective in vivo against atherosclerosis (AS), NAFLD, but can cause permanent hearing loss (not applicable to αCDs). Oral αCD is clinically effective against metabolic syndrom, but has low and variable bioavailability. 505(b)(2) is applicable.||問合せ|
|20/03/02||GEM160||Restoration of autophagy and reduction of inflammation||Neuro-degenerative diseases||Oral, Intra-thecal||Oligo-saccharides||Phase 2b/3 ready||A novel derivative (pat. pend.) of hydroxypropyl-α-cyclodextrin (HPαCD) that down-regulates serum phospholipids and prevents aging cells from accumulating Aβ/tau (AD), α-syn (PD), myelin (MS), mHTT (HD), SOD1 (ALS), ... . βCDs were effective in vivo against AD and PD, but development was abandoned (except for NPC) due to the risk of permanent hearing loss (not applicable to αCDs). In the US, αCD is generaly recognized as safe (GRAS) for oral use; in the EU, αCDs are approved for oral and parenteral use. 505(b)(2) is applicable.||問合せ|
|20/03/02||GEM159||Restoration of autophagy and reduction of inflammation||Breast cancer and other carcinomas*||Oral, intra-venous||Oligo-saccharides||Phase 2b/3 ready||A novel intestinally absolrbable derivative (pat. pend.) of hydroxypropyl-α-cyclodextrin (HPαCD) that down-regulates the Phosphoinositide-system by controlling serum phospholipids and, thereby, reduces endocytosis. βCDs were effective in vivo against breast, ovarian, lung, and colon cancer, and metastatic melanoma, but need to be infused overnight and can cause permanent hearing loss. αCDs are not ototoxic and were more effective in vivo against growth and metastases of breast cancer.
*Mono- or adjuvant treatment. 505(b)(2) is applicable.
|20/02/27||GEM158||Anti-mitotic chemotherapy||Small cell lung cancer||i.v.||Small molecule||Phase 1 completed||Proprietary innovative albumin-stabilized pegylated liposomal docetaxel formulation. Elevated exposures of docetaxel compared with free (nonencapsulated) docetaxel were confirmed in animals and humans. Acceptable tolerability and results suggesting anti-tumor efficacy were observed in Phase 1. FDA orphan drug designation was granted and confirmed with FDA that 505(b)(2) NDA pathway appears to be an acceptable approach.||問合せ|
|20/02/21||GEM157||Combined adoptive cell therapy (autologous)||Hepatocellular carcinoma （HCC）*||Infusion||Cell therapy||Launch||A combined adoptive cell therapy comprising cytokine-induced killer cells and activated cytotoxic T lymphocytes. In Phase III using patients whose tumors have been removed after curative resection for HCC, RFS was 44 months for the immunotherapy group while that of the control group was 30 months. The HR for tumor recurrence or death in the immunotherapy group vs the control group was 0.63. The mortality rate was reduced by 79% in the immunotherapy group vs the control group. Clinical trials for other solid tumors are ongoing.
*: Adjuvant therapy for patients whose tumors have been removed after curative resection for HCC.
|20/02/18||GEM156||Chromatin destabilizing||Solid and hematological tumors||Oral, i.v., i.a||Small molecule||Phase 1||A First-In-Class chromatin destabilizing agent that intercalates into DNA, and interferes with histone/DNA binding changing its spatial structure. Consequent functional inactivation of a histone chaperon FACT leads to inhibition of several previously undruggable pro-cancer transcriptional factors, activation of p53 and interferon response. Dose-dependent nonclinical antitumor activity is seen in multiple models of solid and hematological tumors. Oral and i.v. phase 1 studies demonstrated a manageable safety profile and disease control with tumor regressions and protracted stable disease.||問合せ|
|20/02/18||GEM155||FPR2-specific ligand||Atopic dermatitis/ Psoriasis, Dry eye disease, IBD （Inflammatory bowel disease）, Asthma, Rheumatoid arthritis||Topical, Eye drop, s.c.||Peptide||Preclinical||GEM155 is a small (7mer) lipidated peptide ligand for pro-resolving receptor FPR2 (N-formyl peptide receptor 2) involved in regulation of innate immune system and inhibition of ILC2 function (adaptive immune system). It also has anti-microbial effect for pathogenic bacteria through fusion with functional moiety. Efficacy is seen in animal models for the indications. CMC study is almost done. Toxicity study for topical usage and subcutaneous injection is going-on. Formulation for topical use is almost finished.||問合せ|
|20/02/18||GEM154||Collagen-inducing peptide||Dermal filler, Cosmetics||Topical||Peptide||Preclinical||Laminin-derived peptide. Boosts collagen synthesis at sub-nanomolar concentration (Wrinkle-care) & inhibits melanin synthesis (Whitening). Registered cosmetic ingredient.||問合せ|
|20/02/18||GEM153||Angiogenic peptide||Wound-care, Diabetic foot ulcer, Cosmetics||Topical||Peptide||Preclinical||Increases blood vessel formation (VEGFA/VEGFR1 expression ↑& cell proliferation/migration ↑). Boosts collagen synthesis at sub-nanomolar concentration (Wrinkle-care) & inhibits melanin synthesis (Whitening). Registered cosmetic ingredient.||問合せ|
|20/02/18||GEM152||Fat-adsorption inhibitor||Obesity, Diabetes, Fatty liver||Oral||Natural product||Preclinical||Mushroom-derived natural product.
Reduces weight gain and obesity, blood glucose and lipid contents in the liver via reduction of lipid absorption in the gut.