Drug Candidate Marketplace

Drug Candidate Marketplace lists the information of drug candidates, therapeutic targets and drug discovery technologies. Visitors can use search functions based on the interests and needs and download the list. If you have a drug candidates, therapeutic targets and drug discovery technologies that you are interested in and would like to gain more information, please contact us by clicking the inquiry button. Additional information will be provided to you.

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Date Candidate Mechanism of action Indication Route Modality Development stage Note
04/10/20 GEM169 Novel mechanism of action in anti-viral drug Herpes zoster*, Genital Herpes** and Herpes Labialis** Oral Small molecule Launch*, Phase 3** GEM169 is a herpes viral enzyme inhibitor, that exhibits higher in vitro antiviral activity against both VZV and HSV than existing nucleic acid analogs.
-Once daily dosing to support adherence
-No cross-resistance with existing nucleic acid analogs
-Low emergence of GEM169-resistant virus strains
-No major safety concerns to date
-No need to adjust dosage for renal-impaired patients (Hepatic excretion type drug)
Contact
04/10/20 GEM168 Heat-killed mycobacterium vaccae Tuberculosis (TB) Oral Vaccine Phase 3 First-in-class tuberculosis immunotherapy to be used as an oral adjunct to standard TB drugs. In a 1-month phase 2 trial, the mycobacterial clearance in sputum smears was observed in 72% and 19% of patients on GEM168 and placebo, respectively. Contact
04/08/20 GEM167 Elimination of MADD protein Solid tumors i.v., intra-tumoral Gene therapy Preclinical A systemically deliverable oncolytic viral vector to target and eliminate the MADD protein overexpressed in a wide range of human cancer cell lines and involved in resistance. Systemic delivery demonstrated to colon, breast, liver, and ovarian tumors with no liver or kidney damage. Our parental vector infects and replicates only in cancer cells and has undergone extensive distribution and toxicity studies in mice and baboons and was previously approved for human trials. Breast, liver, and anaplastic thyroid cancer using siRNA achieved 41-60% TGI as mono or combo therapy. Contact
03/31/20 GEM166 Anti-Nodal antibody Melanoma, Breast cancer, Pancreatic cancer and Hepatocellular carcinoma i.v. Antibody Preclinical The first anti-Nodal antibody drug targeting cancer stem cells and aggressive tumors.
Nodal is a secreted protein in the embryo. The expression is lost in most adult tissues, but is reactivated in aggressive tumor cells. Expression level is highly correlated with invasion, metastasis, drug resistance and cancer prognosis.
Combination of anti-Nodal Ab with current therapies is more effective than monotherapy. A companion diagnostic Nodal ELISA kit is also being developed which can be used as a biomarker for patient selection and disease monitoring.
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03/25/20 GEM035 An anti-ENO1 antibody Immune diseases, various cancers s.c. Protein US FDA IND cleared GEM035 is a humanized antibody against unique ENO1 target. This therapeutic antibody is first-in-class to target inflammatory macrophage and demonstrates efficacy in animal models of MS, IPF, and IBD. It also showed efficacy in animal models of lung, pancreatic, and prostate cancer, most likely by targeting tumor associated macrophage (TAM). GEM035 may be developed for treatment of COVID-19 induced ARDS based on its capability to suppress macrophage related immune response. GEM035 has a worldwide patent protection. US IND of GEM035 is approved and active now for treating MS. Contact
03/13/20 GEM165 Intratumoral production of 5-FU and reduction of T-reg in the tumor Colorectal cancer, Esophageal cancer, Gastric cancer i.v. Bacteria Phase 2 ready GEM165 is recombinant Bifidobacterium modified to express cytosine deaminase (CD). Bifidobacterium is anaerobic bacteria constituting human intestinal flora. Intravenously administered GEM165 colonizes to hypoxic solid tumor specifically and converts orally administered 5-FC to a high concentration of 5-FU only inside the tumor. The preclinical data of GEM165 in combination with anti-PD-1 antibody demonstrate synergistic anti-tumor efficacy accompanied by drastic Treg reduction.

Note:
・First-in-class, patented, strong preclinical data of GEM165 alone and in combination with PD-1 blocker.
・Clinical experiences in over 30 patients in the Phase 1 study in the US.
・The design of Phase 2 combination therapy with anti-PD-1 antibody has been already consulted with FDA. The study is ready to start after completion of the Phase 1 study.
Contact
03/11/20 GEM164 Anthracycline topoisomerase II inhibitor Breast cancer, Bladder cancer, Kaposi's sarcoma, lymphoma, and Acute lymphocytic leukemia i.v. Small molecule Bioequivalence study completed Generic pegylated liposomal doxorubicin hydrochloride. Doxorubicin is well known to cause cardiotoxicity and develop congestive heart failure. Cardiotoxicity of GEM164 is expected to be substantially lower than non-liposomal doxorubicin. Bioequivalence with CAELYX has been demonstrated.
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03/02/20 GEM163 Reduction of virus-replication and reduction of inflammation Virus diseases (incl. coronaviruses)** Oral Oligo-saccharides NDIN** ready A novel, intestinally absorbable derivative (pat. pend.) of GRAS αCD (α-cyclodextrin) to reduce virus entry (endocytosis) and replication/assembly of virueses (availability of lyso-phospholipids). βCDs have been effective in vitro against many virus infections, incl. coronaviruses, and topically against influenza and HSV2. αCDs avoid the ototoxicity of βCDs and were more effective (tested in HIV-1 cells).
**New dietary ingredient notification as a nutritional supplement/FSMP
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03/02/20 GEM162 Restoration of autophagy and reduction of inflammation Age-related diseases** Oral Oligo-saccharides NDIN** ready A novel, intestinally absorbable derivative (pat. pend.) of GRAS αCD (α-cyclodextrin) as an intermittent fasting mimetic. βCDs have been effective in vivo against many age-related diseases, including cancer, AD, and PD. αCDs are more effective against endocytosis than βCDs and lack the βCDs' ototoxicity. In the EU, oral αCD may claim to "reduce post-prandial glycemic response", but has low and variable bioavailability.
**New dietary ingredient notification as a nutritional supplement/FSMP
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03/02/20 GEM161 Restoration of autophagy and reduction of inflammation Cardiovascular and Metabolic Diseases Oral Oligo-saccharides Phase 2b/3 ready A novel derivative (pat. pend.) of hydroxypropyl-α-cyclodextrin (HPαCD) that down-regulates the PI-system by controlling serum phospholipids and, thereby, reduces endocytosis. βCDs have been shown to be effective in vivo against atherosclerosis (AS), NAFLD, but can cause permanent hearing loss (not applicable to αCDs). Oral αCD is clinically effective against metabolic syndrom, but has low and variable bioavailability. 505(b)(2) is applicable. Contact