|20/06/18||GEM192||Selective PI3Kα inhibitor||Slow-flow vascular malformations||Oral||Small molecule||IND||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|
|20/06/18||GEM191||Potentiation of detrusor contraction||Underactive bladde||Oral||Small molecule||Phase 1||Detrusor underactivity is a main cause of underactive bladder, which causes multiple lower urinary tract symptoms such as residual urine and urinary tract infection. GEM191 potentiates detrusor contraction and shows no impact on bladder storage function or urethral function. Stratified analysis clearly indicates efficacy to reduce residual urine in patients with detrusor underactivity.||問合せ|
|20/06/15||GEM190||Lipase inhibition, α-amylase inhibition, aldehyde dehydrogenase (ALDH) activation and anti-oxidant capacity increase||Overweight and obesity Alcohol and tobacco smoke toxicity||Oral||Natural product||Clinical||GEM190 is a combination of two purified plant extracts in a form of oral liquid food supplement developed for appetite and weight control. Also, it reduces alcohol and tobacco smoke toxicity by activation of aldehyde dehydrogenase (ALDH) and increasing anti-oxidant capacity. In overweight and obese patients, GEM190 showed significant suppression of appetite and reduction of body weight and body fat as well as it had a beneficial effect on fluid distribution during weight loss, as observed in 12-week treatment. Increased ALDH activity in PBMC was observed already after 24 hours after initiation of GEM190 administration. GEM190 may provide a salvage solution in populations known to be particularly susceptible to a build-up of excess acetaldehyde, such as having a ALDH2*2 genetic mutation. GEM190 claims are under two PCT applications.||問合せ|
|20/06/05||GEM-CVD05||Immune-modulate and slow down the hyperactive active immune system from attacking lung cells (and other solid organs)||Prevention of Respiratory Falure by Treating Acute Respiratory Disease Syndrome Resulting from COVID-19 and other viral pandemics||Refer to Note*||Protein**||Phase 3 ready***||1. Treatment of blood/MSCs, Tregs, NK cells with GEM-CVD05 to improve their homing to patients’ lungs, thereby enabling those cells to slow down the hyperactive immune attack on the lungs to help prevent deaths from respiratory failure.
2. Treatment of cells such as stem cells enabling them to home/engraft more effectively to the bone marrow and accelerating immune reconstitution with ‘younger’ immune cells for improved viral infected cell killing.
*Infusion with blood, or MSCs, Tregs, NK cells to improve efficacy, safety and cost of care outcomes
**Used to treat MSCs, Blood, Tregs, NK cells , Stem Cells to Prevent deaths from respiratory failure
***Phase 2 study for other indication has been completed.
|20/06/05||GEM189||Nanoliposome-encapsuled Radionucleotide||*Recurrent Glioblastoma，**Multiple tumor||Intra- tumoral||Radio- nucleotide||*Phase1, **Preclinical||Radionuleotide in GEM189 is ideal one for the treatment of solid Tumors. It delivers a high dose of radiation directly to the tumor while sparing normal, healthy brain tissue, stays at the tumor for several days and Effect lasts for several days and then dissipates. No serious adverse events observed to date.
Key advantages over External Beam Radiation Therapy:
-At least 500 Gy,
-Single 4-day hospitalization
-Able to more effectively treat tumor margins
- Limited toxicity
-Able to verify successful delivery with SPECT scan
|20/06/05||GEM188||Dual inhibitor of ROCK and new target kinase||Glaucoma; ocular hypertension||Small molecule||Topical eye drop||Preclinical||GEM188, a dual ROCK/new target kinases inhibitor, had shown more effective in intraocular pressure lowering than competitor netarsudil in magnetic bead-induced and hypertonic saline-induced ocular hypertensive models. Moreover, GME188 also showed lower eye irritation than netarsudil in New Zealand White rabbit. The plasma exposure by eye drops dosing was less than that by iv dosed with NOAEL. The preclinical studies including GMP-compliance production, GLP toxicology, etc., is ongoing in 2020.||問合せ|
|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||GEM185||GLP-1/GIP dual agonist||Obesity, diabetes||s.c.||Peptide||IND reaedy||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, GEM182 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|
|20/05/12||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|