|20/05/30||GEM187||Mesenchymal stem cell||Rheumatoid Arthritis （RA）, Inflammatory Bowel Disease （IBD）, COVID-19||Implant （allo- genic）||Cell||IND||GEM187 is a fresh (non-frozen) human allogenic umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) product.
- Proprietary manufacturing process with no risk of contamination.
- “Youngest” adult MSC with robust proliferation capacity.
- Highly scalable to achieve enough cells.
- Superior biological functions: optimal cell viability and biological functions maintained for therapeutic use.
|20/05/29||GEM186||Innate Immune System Activator||Solid tumor||i.t.||Microbial||Phase 1||Co-activation of multipole innate immune pathways in tumor dendritic cells.
Dose dependent anti-tumor activities in allogenic models.
Low systemic risk
|20/05/12||GEM184||GPR40 full agonist||Obesity, diabetes, NAFLD/NASH||Oral||Small molecule||Phase 1||A first-in-class GPR40 full agonist stimulating multiple islet (insulin, glucagon) and gut hormones (GLP-1, GIP, and PYY). GEM184 is much more effective in improving glucose control than DPP-4 inhibitors and in preclinical models. In addition to glucose-lowering effects, GEM184 effectively decreases body weight in overweigh condition via stimulating gut hormones. By binding to a site independent of the fasiglifam binding site, GEM184 induces a similar therapeutic efficacy with much lower exposure (~1/270) compared to fasiglifam in diabetic models. A lower plasma exposure mitigates the risk of side effects including liver toxicities reported with fasiglifam. In addition, glucagon an GLP-1 stimulation by GEM184 induces therapeutic benefits on NAFLD/NASH conditions, in which DPP4 inhibitor and SGLT2 inhibitor were almost ineffective.||問合せ|
|20/05/12||GEM183||Direct renin inhibitor (DRI)||Blood pressure control and/or prevention of heart failure in patients with chronic hemodialysis||i.v.||Small molecule||Preclinical||Injectable formulation of GEM182 (oral formulation in phase-2b), is also being developed for potential use for better blood pressure control and/or prevention of heart failure by chronic intravenous treatment three times per week via vascular access established in patients with chronic hemodialysis. Renin inhbitor may be suitable for such patients who often exhibit hyperreninemia potentially due to residual function of juxtaglomerular apparatus as well as reduced renal blood flow after start of the hemodialysis. Although dialysis patients are mostly unavoidable from hypertension, no optimal treatment has been available yet. GEM183 can fulfill such such rapid growing huge unmet medical needs.
Licensing discussion is available except for China.
|20/05/12||GEM182||Direct renin inhibitor (DRI)||Hypertension （HP）, diabetic nephropathy （DKD）, chronic hemodialysis, heart failure||Oral||Small molecule||HP : Phase 2 ready, DKD: Phase 3 ready||A 2nd generation DRI with better renoprotective effects than ACEi/ARB. Better hypotensive effects than aliskiren is expected due to higher BA, less variability and no food effect following oral treatment. Prolonged renal localization, blood pressure independent renoprotection and positive effect on renal blood flow are evidenced by DRIs. In clinical trials of GEM182 in T2DM patients with microalbuminuria, dose-dependent UACR reduction and increases in remission rate from albuminuria were also seen.
This compound have been developed as mono-therapy (not combined with ACEi/ARB). Therefore, GEM182 has no safety issues seen in aliskiren's ALTITUDE trial due to RAS dual brockade.
Injectable formalution is also developed (ref. GEM183).
Licensing discussion is available except for China.
|20/05/11||GEM181||Selective HDAC8 inhibitor||Solid tumor||Oral||Small molecule||Phase 1||Through several mechanisms exhibited tumor inhibitory activity against many cancers, especially with high HDAC8 protein expression.
Advantages of GEM181
- Able to pass the BBB
- Suppresses angiogensis
- Side effects less than those of curretly marketed drugs
- Simple synthetic method
|20/05/08||GEM180||Contrasting||MRI Contrasting||i.v.||Nano particle||Phase 2||GEM180 is a MRI contrast meium whivch can detect more small liver lesion, compared to marketed product, because of the better contrast. Biopsy confirmed the number of small nodules by GEM180. GEM180 has better imaging results (higher percent signal intensity loss (PSIL) and better consistency) from CT001. So far no obvious severe adverse events seen. Comprehensive patent portofolio exist globally.||問合せ|
|20/05/08||GEM179||Iron supply||Iron deficient anemia||i.v.||Nano particle||Phase 2||GEM179 is a PEGylated Iron oxide nano particle (IOP) with high macropharge uptake efficiency. GEM179 provide higher efficacy and better safety profiles (serum iron, ROS, hypersensitivity, iFGF23). Comprehensive patent portofolio exist globally.||問合せ|
|20/05/07||GEM178||Anti-VEGF and antibacterial activities||Acne, hypertrophic scar, dermatitis||Topical skin||Small molecule||Preclinical||- The first topical drug for treating skin redness by inhibiting VEGF.
- Skin redness originates from the neovascularization. Redness of human acne was rapidly removed in a few days with no irritation nor discomfort.
- Strongly inhibited P. acne with an effectiveness >100X clindamycin.
- A 505(b)2 path available.
- US Patent granted.
|20/05/01||GEM-CVD04||Antiviral, Immunomodulatory, Anticoagulant, Cytokine release control||Pre-Exposure and Post Exposure Prophylaxis for COVID-19||Oro- mucosal （dis- solves in the mouth）||Small molecules||Phase 1*||- Multi-targeted action
- Systemic absorption and topical exposure to upper respiratory tract. colonized by COVID-19 virus.
- *Entering Phase 2 for other indication (USA).
- Available for a large clinical trial (GMP).
- Excellent safety profile
- Worldwide patents