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.
|Date||Candidate||Mechanism of action||Indication||Route||Modality||Development stage||Note|
|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.
|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 with macrophage-targeting features and showed efficacy in animal model for MS, IPF, and IBD. It also showed efficacy in animal model for liver cancer, pancreatic cancer, and lung cancer. 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.
・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.
|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.
|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
|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
|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|
|03/02/20||GEM160||Restoration of autophagy and reduction of inflammation||Neuro-degenerative diseases||Oral, Intra-thecal||Oligo-saccharides||Phase 2b/3 ready||A novel derivative (pat. pend.) of hydroxypropyl-α-cyclodextrin (HPαCD) that down-regulates serum phospholipids and prevents aging cells from accumulating Aβ/tau (AD), α-syn (PD), myelin (MS), mHTT (HD), SOD1 (ALS), ... . βCDs were effective in vivo against AD and PD, but development was abandoned (except for NPC) due to the risk of permanent hearing loss (not applicable to αCDs). In the US, αCD is generaly recognized as safe (GRAS) for oral use; in the EU, αCDs are approved for oral and parenteral use. 505(b)(2) is applicable.||Contact|
|03/02/20||GEM159||Restoration of autophagy and reduction of inflammation||Breast cancer and other carcinomas*||Oral, intra-venous||Oligo-saccharides||Phase 2b/3 ready||A novel intestinally absolrbable derivative (pat. pend.) of hydroxypropyl-α-cyclodextrin (HPαCD) that down-regulates the Phosphoinositide-system by controlling serum phospholipids and, thereby, reduces endocytosis. βCDs were effective in vivo against breast, ovarian, lung, and colon cancer, and metastatic melanoma, but need to be infused overnight and can cause permanent hearing loss. αCDs are not ototoxic and were more effective in vivo against growth and metastases of breast cancer.
*Mono- or adjuvant treatment. 505(b)(2) is applicable.
|02/27/20||GEM158||Anti-mitotic chemotherapy||Small cell lung cancer||i.v.||Small molecule||Phase 1 completed||Proprietary innovative albumin-stabilized pegylated liposomal docetaxel formulation. Elevated exposures of docetaxel compared with free (nonencapsulated) docetaxel were confirmed in animals and humans. Acceptable tolerability and results suggesting anti-tumor efficacy were observed in Phase 1. FDA orphan drug designation was granted and confirmed with FDA that 505(b)(2) NDA pathway appears to be an acceptable approach.||Contact|