|20/08/26||GEM208||A3 adenosine receptor (A3AR) agonist||Liver cancer* NAFLD**||Oral||Small molecule||Phase 3 in preparation* Phase 2 completed**||・A3AR is highly expressed in inflammatory and cancer cells. Specific agonists of A3AR induce apoptosis of cancer cells but not normal cells.
・Very good safety profile.
・An orphan drug status for hepatocellular carcinoma (HCC).
・In phase-2 study in HCC patients, it did not meet the primary endpoint (OS) but subgroup analysis of Child Pugh B patients showed a positive signal of efficacy for OS.
・In phase-2 study (vs placebo) in NAFLD/NASH, it met primary endpoint (liver enzyme) and reduced liver fat, fibrosis and steatosis.
|20/08/26||GEM207||A3 adenosine receptor (A3AR) agonist||Rheumatoid arthritis （RA）, Psoriasis||Oral||Small molecule||Phase 3||・A3AR is highly expressed in inflammatory and cancer cells. Specific agonists of A3AR induce apoptosis of inflammatory cells but not normal cells.
・Very good safety profile as 1st line therapy.
・In the pahse-2b study (monotherapy vs placebo) for12 weeks in naive RA patients, the endpoint was achieved.
・In the pahse-2/3 study (monotherapy vs placebo) in moderate to severe psoriasis patients, it did not meet the primary endpoint at 12 weeks, but at 32 week the improvement of PASI score was significant vs at 16 week.
・A phase-3 study (vs MTX) in moderate to severe RA and a phase-3 study (vs apremilast) are ongoing.
|20/08/24||GEM206||FLT3 Kinase Inhibitor||Acute myeloblastic leukemia （AML）||Oral||Small molecule||Preclinical||- Novel chemical structure distinguished from known FLT3 inhibitors
- Highly potent against FLT3 and FLT3 mutants (overcome FLT3-TKD mutation mediated drug resistant)
- Highly selective
- Monotherapy & orally active
- Well-tolerance in preclinical tox study
- GLP tox study is in progress.
|20/08/24||GEM205||Anti-Mesothelin (MSLN) Antibody-Drug Conjugate (ADC)||Cancer （Pancreatic Cancer, Ovarian Cancer etc.）||Injection||Antibody||Preclinical||- Mesothelin is a differentiation antigen overexpressed in many solid tumors
- GEM205 showed great tumor growth inhibition (>90%) in animal model without body weight loss.
- GEM205 also showed great efficacy in large tumor model (>500 mm3).
- Self-owned I4 technology was applied in GEM205.
- GEM205 showed uniform DAR (4), high affinity, good cytotoxicity.
|20/08/24||GEM192||Selective PI3Kα inhibitor||Slow-flow vascular malformations||Oral||Small molecule||Phase 1||Slow-flow vascular malformations including venous malformation, lymphatic malformation, Klippel-Trenaunay syndrome is abnormal clustering of blood vessels that occurs in children or young adults and are caused by PI3K pathway GOF mutation. By selectively inhibiting PI3Kα isoform, GEM192 inhibits angiogenesis, but not immune function resulting in better therapeutic effects and lower infectious risk. Phase 1/2 data for another indication demonstrate a favorable tolerability profile. Clinical development to be pursued with new pediatric formulation.||問合せ|
|20/08/24||GEM185||GLP-1/GIP dual agonist||Obesity, diabetes||s.c.||Peptide||Phase 1||GEM185 is an injectable (QD) dual agonist for GLP-1R and GIPR. Preclinical studies have shown that GEM185 is more effective in improving diabetes and obesity than GLP-1R agonism only. In addition, GEM185 has been shown to improve liver parameters in diabetic and obesity conditions in preclinical research. Hence, GEM185 may be superior to the GLP-1R agonist in improving diabetes, obesity, and non-alcoholic steatohepatitis (NASH). In a preclinical study, GEM185 showed better efficacy in improving glycemic control and an almost same efficacy in decreasing body weight compared to tirzepatide, a Lilly’s Ph3 program. A long-acting formulation, which is likely to maximize its therapeutic efficacy, are under development. A phase 1 study (first-in-human study), starting in 2020, is being organized in the UK.||問合せ|
|20/08/12||GEM204||Multi-molecular targeting including the Wnt/𝛽-catenin pathway||Hair loss, Andogenetic alopecia, Telogen effluvium, Senescent alopecia||Topical and/or oral||Plant extracts||Commercial||GEM204 is a comprehensive solution for the treatment of hair loss, targeting more than 21 hair regulating molecular pathways to promote hair growth and inhibit hair loss. Market approval and full scientific dossier available with clinical trials in women and men of all hair loss patterns, hair types and skin types.||問合せ|
|20/08/10||GEM203||FXR agonist and 5-HTR2A antagonist||NAFLD, Type 2 diabetes, obesity, dyslipidemia and hypertension||Oral||Small molecule||Preclinical||First in class single molecule having both FXR agonistic and 5-HTR2A antagonistic actions.
In DIO mice, GEM203 reduced hyperglycemia, hyperinsulinemia, insulin resistance and liver lipid contents to similar or greater extent vs metformin. GEM203 reduced the body excess weight while metformin did not.
In NASH model mice, GEM203 reduced liver excess weight, TG and TC contents, plasma ALT and AST, inflammation and collagen gene expression in the liver.
Strong IP portfolio with long expiry dates granted in major markets.
|20/08/05||GEM202||Somatostatin receptor subtype 5 (SSTR5) antagonist||Type 2 diabetes, Gallstone, Primary sclerosing cholangitis （PSC）, Inflammatory bowel disease （IBD）, short bowel syndrome （SBS）||Oral||Small molecule||IND ready||SSTR5 is primarily expressed in pancreatic ß-cells and enteroendocrine cells, and its ligand, somatostatin, negatively regulates the secretion of insulin and gut hormones (GLP-1, GLP-2, PYY, etc.). GEM202 is a selective SSTR5 antagonist and is unique owing to its dual action of elevating these hormone secretions and increasing insulin sensitivity, thereby improves glycemic control in obese and diabetic mice. In addition, GEM202 is effective in stimulating gallbladder motility and increasing bile flow, accounting for its therapeutic effects in animal models of gallstones and PSC. Thus, an additional potential application involves treatment of hepatobiliary diseases. Patents have been filed globally.||問合せ|
|20/08/01||GEM201||mRNA Vaccine Platform technology. Production of S-Protient with Immune-modulators in one construct||Coronavirus （COVID-19）; Broader Vaccine Platform||i.v.||Drug Delivery, Cell therapy||Preclinical||GEM201 utilizes TGEM055 technology loaded with antigenetic proteins as a mRNA Vaccine Platform
- Produce functional antigenetic protiens in Lymphatic organs
- Localized antigen induction at high intracellular amounts where antigen presenting cells aggregate. Co-delivery of potent Immune-modulators (GM-CSF, IL-12, etc) sumultaneously
- GEM201 is a vaccine platform
- GEM201 is critical for vaccination of elderly and immune suppresed populati