|21/04/30||GEM243||Known and available under CDA||Mucositis Prevention and Treatment, Fibrotic Disease Treatment||Injectable or Oral||Small molecule||Phase 2||Small molecule drug for the prevention and treatment of chemotherapy and radiation therapy induced mucositis. Also shows activity intreating fibrotic diseases such as pulmonary fibrosis and NASH. GEM243 has successfully completed POC human clinical studies in head and neck cancer patients for chemotherapy-induced mucositis prevention with excellent results. GEM243 has shown to be extremely safe and highly effective in P1a, P1b, and P2a human clinical studies.
Potentially useful in preventing and treating chemotherapy-induced pulmonary fibrosis and as a direct treatment for diseases such as Covid-19-induced pulmonary fibrosis, idiopathic pulmonary fibrosis, and NASH.
|21/04/28||GEM242||Anti-Globo H x CD3 bispecific antibody||Breast Cancer||i.v.||Antibody||Discovery||GEM242 has high correct pairing property (>95%)
It also possesses target cell-dependent T cell activation property.
Anti-cancer efficacy has been demonstrated in the breast cancer animal model through T cell-mediated cytotoxicity. (>83%, 10mg/kg)
|21/04/02||GEM241||Analyzer of EEG algorithm by AI||Prediction of seizures in epilepsy patients||Ear wearable||Medical device||On Market||・A personalized ear-wearable non-invasive small medical device which detects changes in EEG pattern by AI algorithm that alerts seizure minimum one minute before it occurs to patients and caregivers.
・It records brain activities through the ear canal and uses Big Data.
・By predicting the seizure before it occurs, the device will prevent accidents and reduce injuries, emergencies, and deaths.
・Also, it reduces emotional impact such as anxiety/depression and increases de quality of life.
・Big Data treatment can help doctors and medical society to better understand the illness and perform patinets' follow-up.
|21/03/26||GEM117||Induction of apoptosis in adipocyte||Lipolysis, non-surgical fat reduction, Diabetes||s.c.||Small molecule
||Phase 2a completed||· GEM117 specifically induce apoptosis on local injection site adipocyte
· Phase 1 showed great safety without drug-related SAE in 40 healthy volunteers
· In the Phase 2a study (n=39), GEM117 showed significant dose-dependent lipolysis effects and reduced an average of 24% local fat volume. The safety profile was similar as observed in the Phase 1 study.
|21/03/24||GEM240||Genetically modified adipocytes||Genetic diseases and intractable diseases||Transー plant||Gene and Cell therapy||Phase 1||Genetically modified adipocytes for gene therapy and regenerative therapy.
It is developed for the treatment of various genetic diseases and metabolic disorders. It shows sustainable and stable efficacy or secretion of transduced gene products from the implant of GEM240.
GEM240 is incomparable and patient-friendly.
|21/02/26||GEM-CVD08||An anti-SARS-COV-2 S1 RBD antibody||COVID-19||i.v.||Protein||Phase-1||> 10 fold higher binding affinity and >50 fold more potent blocking potency than soluble hACE2-Fc.
Neutralize authentic SARS-COV-2 virus infection of Vero E2 cells at IC50 = 0.012 - 0.062 µg/ml.
Showed binding and blocking activity against South Africa and UK mutants.
Engineered Fc to reduce potential ADE risk.
Obtained CHO-K1 CMC clone with high expression titer.
Showed potent prophylactic and desired therapeutic efficacy in rhesus monkey disease model.
|21/02/03||GEM155||FPR2-specific ligand||Atopic dermatitis/ Psoriasis, Dry eye disease, IBD （Inflammatory bowel disease）, Asthma, Rheumatoid arthritis||Topical, Eye drop, s.c.||Peptide||Phase 1||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|
|21/01/29||GEM067||c-Kit inhibitor||Diabetic macular edema & Retinopathy||Oral||Small molecule
||Phase 2a completed||-Inhibits stem cell factor-induced hyperpermeability
-Reverses retinal vascular leakage in STZ-induced diabetic rats
-Improved compliance to administration (oral) than anti-VEGF therapy (intra-vitreal injection)
-Applicable to non-responders to anti-VEGF therapy
-Repositioning of a marketed drug
|21/01/29||GEM105||Viscosupplementation||Knee osteoarthritis||Intra-articular||Poly- saccharide
||Marketing authorization||Cross-linked sodium hyaluronate hydrogel with sodium hyaluronate fluid. Long-lasting and sustainable efficacy due to unique rheology of the cross-linked hydrogel. Injected only once and single injection shows comparable efficacy to a multiple-injection treatment. Obtained marketing authorization as a drug.||問合せ|
|21/01/13||GEM239||Activation of Treg and downregulating pro-inflammatory cytokines||Psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Ankylosing spondylitis, Crohn's and colitis||Oral||Small molecule||Human POC completed||Microbiomes are important for regulating human immune systems. GEM239 is a small molecule known as a gut microbial metabolite. It downregulates pro-inflammatory cytokines, and promotes differentiation of anti-inflammatory Treg cells. Human POC study in small number of psoriasis patients has been done and significant treatment effects have been seen. FDA IND approved. Clinical trial starting in 30 patients. Formulation-science has been applied.||問合せ|