Pipeline

Pipeline

Our leading program is in microbiome based therapeutic candidates in the field of immuno-oncology, skin diseases and autism. Also, we are focused on researching immuno-oncology in own therapeutic candidate in monoclonal antibody of immune checkpoint inhibitor. Along with the clinical pipelines, we are developing in the areas of cosmetics and supplementary foods based on our microbiome research.

1. Immuno-oncology Microbiome (GEN-001)

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors (ICIs).

GEN-001 consists a single-strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T-cell response.

In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with ICIs by enhancing the effect of suppressing the growth of both ICIs sensitive and resistant tumor models.

Recently, the U.S. FDA has accepted the IND application for GEN-001 for combination treatment with avelumab (BAVENCIO®) in patients with solid cancers. The phase 1/1b clinical trial will be initiated at the US clinical sites and the first patient is expected to be enrolled within this year.

2. Skin Microbiome Therapeutics (GEN-501)

GEN-501 is targeting the non-responders of dupilumab drugs with atopic skin diseases.

GEN-501 is an inhibitor of Staphylococcus aureus (S. aureus) biofilm. It can be applied to all patients with any type of skin disease caused by S. aureus dominance. Also, it is safe microbiome as it is free from genetical modification. The patient application of GEN-501 has been filed.

3. Autism Microbiome Therapeutics (SB-121): Lactobacillus reuteri (L. reuteri)

G&C holds a partnership with US Scioto Biosciences since September 2020, and G&C will continue to support clinical development of Scioto’s lead drug candidates (SB-121).

SB-121 is Lactobacillus reuteri therapeutic from breast milk bacteria. It serves as a “pioneer” bacteria that promotes GI microbiome development and prevents GI damage. Its safety and efficacy have been proven in over 25 clinical studies (zero adverse events). It shows remarkable effects on the gut with a single dose.

SB-121, which targets disorders related to the gut-brain axis like Autism Spectrum Disorder (ASD) as well as disorders related to gut-injury such as Necrotizing Enterocolitis (NEC) which affects premature infants.

4. Novel target directed immune checkpoint inhibitor (GENA-104)

GENA programs cover novel IO targets to induce tumor cell death that can be targeted by mAb candidates. The patents application has been filed.

Novel targeted ICIs, GENA programs are designed for a broader patients population: (1) patients who are either non-responders to existing PD-1/PD-L1 inhibitors or (2) PD-L1 non-expressed who are not treatment eligible by the existing immunotherapies.

Leading ICI candidates in the pipeline, GENA-104 lead optimization is currently in progress, and IND-enabling studies are ongoing. Early studies show that lead candidate have a potent T cell inhibiting effect, and indicated strong binding affinity by the receptor.