|21/06/04||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) started in 2020 in the UK. No longer available for licensing to Asia/Pacific excluding Japan.||問合せ|
|21/06/02||GEM245||Recombinant protein based on complement inhibitor C4BP with anti-inflammatory and tolerogenic action||Autoimmune diseases including SLE, IBD and RA||s.c. injection||Protein||Preclinical （before GLP）||・Recombinant protein based on endogenous complement inhibitor C4BP exerts anti-inflammatory and tolerogenic action on dendritic cells.
・A novel biologic for immunomodulation, not immunosuppression.
・Reduces TLR-induced overproduction of proinflammatory cytokines (IL-12, TNF-alpha, IFN-gamma).
・Confirmed in vivo efficacy in SLE model, RA model, and DSS-induced colitis model.
・Global IP coverage (incl. compositions)
|21/05/24||GEM244||Recombinant human CC10 protein - multiple mechanisms, replacement therapy||Chronic rhinosinusitis* Acute lung injuries**, including Severe acute respiratory infection, Smoke inhalation, ARDS, COPD exacerbation, and Chronic Lung Diseases**, including Bronchiolitis obliterans, Asthma, and COPD||Intranasal, Intravenous and Inhaled||Protein||*Phase 2 （Phase 1 completed） **Phase 1 （Preclinical completed）||GEM244 is a recombinant version of a naturally occurring secretoglobin protein and a unique, clinical-stage, first-in-class biologic for host defense, ARDS, shock, thrombosis, chronic lung diseases, and transplant.
- Proof of pharmacology demonstrated in human infants and numerous animal models, for example, anti-inflammatory, anti-fibrotic, and disease-modifying activity, allergy, asthma, COPD, lung repair, transplant, burns, shock, and pulmonary edema/pneumonia
- Broad-spectrum use in respiratory infection such as Influenza, COVID-19, RSV, possibly bacterial pneumonia - Genetic alleles correlate with deficiencies of the native secretoglobin to identify patients most likely to benefit from this therapy as a replacement of the native protein.
|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|