|21/08/18||GEM246||Anti-SARS-Cov-2 IgY antibody||COVID-19||Intra-nasal or inhalation||Antibody||Preclinical||・IgY antibody extracted from egg yolk of hens immunized with SARS- Cov-2 virus
・The highest concentration of antibodies in the animal kingdom is found in a single egg yolk
・Faster and lower cost in manufacturing vs monoclonal antibody
・Could be used for both therapeutic and prophylactic purposes (passive immunization)
・Looking for partner in Japan
|21/06/04||GEM185||GLP-1/GIP dual agonist||Obesity, Diabetes, NAFLD/NASH||s.c.||Peptide||Phase 1||1) GEM185 demonstrated the improvement of hyperglycemia in a clinical trial
- Dual agonist for GLP-1R/GIPR is a validated target in treating diabetes and obesity
- GEM185 is a potent dual agonist for GLP-1R/GIPR
- GEM185 decreased glucose levels in patients with diabetes
- Safe and well-tolerated
- Once daily dosing potential via injection
- Weekly formulation is ongoing
2) R&D status
- Phase 1 on-going
- No longer available for licensing to Asia/Pacific excluding Japan.
|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||Intraーnasal, Intraーvenous 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.