Value creation through
competitive pipelines

Create value and grow as a global company through competitive pipelines domestically and overseas

Pipeline Overview

The clinical development department at Genexine performs clinical planning, clinical operation, and drug surveillance in compliance with domestic and international standards, such as ICH-GCP, and conducts clinical trials in a scientific and reasonable manner.

Genexine’s vision of treating patients and improving their quality of life is being practically realized owing to faster and more accurate drug development based on clinical planning and execution, management of clinical trial institutions (hospitals), and smooth communication with regulatory authorities (MFDS).

Our clinical development department has experience with various clinical trials, both domestically and globally, and possesses its own core development capabilities to perform clinical and strategy planning, regulatory work, research design, and clinical trial protocol preparation in early stage clinical trials.

Moreover, we play a central role in collaborating with global partners through the effective use of external resources and active exchange at scientific meetings and/or academic seminars with domestic and foreign partners and joint venture partners.

Our clinical development capabilities have acted as a compass for bio-venture development strategies based our experience of conducting around 20 clinical trials, both rapidly and accurately, on healthy adults and patients over the past five years.

Immuno-oncology

Key
PRE-CLINICAL : ◆
PHASE 1 : ■□□
PHASE 2 : ■■□
PHASE 3 : ■■■
Drug Candidate Novelty or
Key Differentiation
Indication
Therapeutic Area
Regimen Development
Phase
GX-I7

  • Improvement for chemotherapy-induced lymphopenia
  • Immuno-booster that enhances Anti-tumor effect
Colorectal cancer, Breast cancer, Ovarian cancer, Cervical cancer, Small bowel cancer, Anal cancer Mono ◆ ■ □ □
Phase 1b
Rectal cancer, Bile duct cancer, Colon cancer, Gastric cancer, Duodenal cancer Combo
(Cyclophosphamide)
◆ ■ □ □
Phase 1b
Glioblastoma Mono ◆ ■ □ □
Phase 1b
Triple negative breast cancer
(TNBC)
Combo
(Keytruda®)
◆ ■ ■ □
Phase 1b/2
Recurrent glioblastoma Combo
(Avastin®)
◆ ■ ■ □
Phase 2a
Newly diagnosed glioblastoma Combo
(Temozolomide)
◆ ■ ■ □
Phase 2
Glioblastoma Mono ◆ ■ □ □
Phase 1
High grade glioma (HGG) Combo
(CCRT/Temozolomide)
◆ ■ ■ □
Phase 1/2
High-risk skin cancer Combo
(Tecentriq®)
◆ ■ ■ □
Phase 1b/2a
TNBC, Pancreatic cancer, NSCLC, SCLC, Colorectal cancer Combo
(Keytruda®)
◆ ■ ■ □
Phase 1b/2a
Gastric adenocarcinoma, GEJ, EAC Combo
(Opdivo®)
◆ ■ ■ □
Phase 2a

R/R large B-cell lymphoma Combo
(Kymriah®)
◆ ■ □ □
Phase 1b

  • Improvement for chemotherapy-induced lymphopenia
  • Enhancing cell-mediated immuno response by vaccine
Idiopathic CD4 lymphocytopenia Mono ◆ □ □ □
In preperation
Elderly cancer survivors Combo(Vaccine) ◆ ■ □ □
Phase 1/1b
COVID-19 Combo
(Standard of care)
◆ ■ □ □
Phase 1
GX-188E
  • DNA therapeutic vaccine that induces HPV-specific immune response for patients with advanced, non-resectable HPV type 16 and/or 18 positive cervical cancer
Cervical cancer
(HPV 16/18+ type)
Combo
(Keytruda®)
◆ ■ ■ □
Phase 1b/2

Rare Disease

Key
PRE-CLINICAL : ◆
PHASE 1 : ■□□
PHASE 2 : ■■□
PHASE 3 : ■■■
Drug Candidate Novelty or
Key Differentiation
Indication
Therapeutic Area
Development
Phase
GX-H9
  • Effective both weekly & twice-monthly
  • Improve patient compliance and treatment outcomes
Adult growth hormone deficiency ◆ ■ ■ □
Phase 2
Pediatric growth hormone deficiency ◆ ■ ■ ■
Phase 3
GX-G8
  • Lasting longer than a week
  • Improvement in intestinal growth and function compared to Teduglutide
Short bowel syndrome ◆ ■ □ □
Phase 1

Other pipelines

Key
PRE-CLINICAL : ◆
PHASE 1 : ■□□
PHASE 2 : ■■□
PHASE 3 : ■■■
Drug Candidate Novelty or
Key Differentiation
Indication
Therapeutic Area
Development
Phase
GX-19N
  • Prevention for the COVID-19
  • Induction of antibody response by immune-activation function
COVID-19 preventive DNA vaccine ◆ ■ ■ ■
Phase 2/3
GX-E4
  • Long-acting EPO administered bi-weekly or monthly
CKD induced anemia ◆ ■ ■ ■
Phase 3
GX-G3
  • Advantage over current safety issues of pegylated products
  • Longer half-life than 1st and 2nd generation G-CSF
  • Once-per-cycle
  • Similar effects compared to Neulastar
Severe neutropenia, non-myeloid malignancies receiving myelosuppressive anti-cancer drugs ◆ ■ ■ □
Phase 2
GX-G6
  • Weekly or bi-weekly
  • Optimization of receptor binding affinity for improved safety
Type 2 Diabetes Mellitus ◆ ■ ■ □
Phase 2
GX-P1
  • Innovative MoA compared to conventional autoimmune drugs
  • Effective & specific suppression of activated T cells
Autoimmune disease ◆ ■ □ □
Phase 1

GX-I7

A recombinant human interleukin-7 hyFc

GX-I7 is a long-acting human IL-7 which is essential for homeostatic T cell proliferation and improves lymphopenia, typically induced by chemotherapy or radiation therapy. The safety has been proved via phase I clinical trial in healthy volunteers and phase Ib and Ib/2 Clinical trials are being conducted to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and efficacy.

Clinical Trials
  1. 1. Clinical trial of GX-I7 in healthy volunteers. NCT02860715
  2. 2. Safety and tolerability of GX-I7 in HPV-infected female volunteers. NCT03144934
  3. 3. Study to evaluate safety and tolerability of GX-I7 in patients with locally advanced or metastatic solid tumors. NCT03478995
  4. 4. GX-I7 With cyclophosphamide in patients with metastatic or recurrent solid tumors. NCT03733587
  5. 5. A dose-escalation study to evaluate the safety and tolerability of GX-I7 in patients With glioblastoma (GBM). NCT03619239
  6. 6. Study of GX-I7 in combination with pembrolizumab in refractory or relapsed (R/R) TNBC subjects. NCT03752723
  7. 7. Efficacy and safety study of GX-I7 plus adjuvant temozolomide combination in patients with newly diagnosed glioblastoma. NCT04065087

GX-188E

A DNA vaccine targeting HPV 16 and 18 types

GX-188E is a DNA therapeutic vaccine fused with encoding both E6 and E7 antigens as well as the extracellular domain of Flt3L to target and activate dendritic cells. GX-188E has ability to induce a tumor-specific CD8+ immune response and functional activity to eliminate target cells against high-grade cervical intra-epithelial neoplasms (CIN3, carcinoma in-situ). A phase 1b/2 clinical trial for the cervical cancer patients to evaluate safety, tolerability and efficacy is currently ongoing.

Clinical Trials (for Cervical Cancer)
  1. 1. A multi-national, multi-center, open-label Phase Ib-II trial of the combination of GX-188E vaccination and pembrolizumab in patients with advanced, non-resectable HPV type 16 and/or 18 positive cervical cancer. NCT03444376
Publications
  1. 1. Clearance of Persistent HPV Infection and Cervical Lesion by Therapeutic DNA Vaccine in CIN3 Patients. Nat Commun . 2014 Oct. doi: 10.1038/ncomms6317
  2. 2. A Phase II, Prospective, Randomized, Multicenter, Open-Label Study of GX-188E, an HPV DNA Vaccine, in Patients With Cervical Intraepithelial Neoplasia 3. Clin Cancer Res.
    2020 Apr. doi: 10.1158/1078-0432.CCR-19-1513
  3. 3. Efficacy and safety results of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab administration in patients with HPV 16- and/or 18- positive advanced cervical cancer: Phase Ib/II interim analysis results. 2020 AACR Virtual Meeting I. 2020 Apr. 27

GX-H9

A recombinant human growth hormone fused to hyFc

GX-H9 is expected to display the efficacy of endogenous or 1st generation recombinant growth hormone and will have a longer half-life therefore reducing the frequency of dosing. GX-H9 demonstrated safety, and efficacy both adults and pediatric patients in the previous clinical trials, and phase 3 trial with PGHD patients will be submitted in China in 2020.

Clinical Trials
  1. 1. A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9. NCT02946606
  2. 2. Dose finding study of GX-H9 in paeditaric patients with growth hormone deficiency. NCT03309891
Publications
    Long-acting FC-fusion rhGH (GX-H9) Shows Potential for Up to Twice-Monthly Administration in GH-deficient Adults. Eur J Endocrinol. 2018 Sep. doi: 10.1530/EJE-18-0185

GX-G8

A recombinant human GLP-2 fused to hyFc

GX-G8 is a GLP-2 analog fused to hyFc protein, which allows for a longer half-life and a far preferable pharmacokinetic (PK) profile, which is expected to result in increased efficacy in treating SBS patients as measured by increased intestinal weight and intestinal function as compared to Teduglutide. GX-G8 achieves greater efficacy while also reducing the number of administrations to weekly as opposed to daily for Teduglutide. In 2018, FDA was designated as an orphan drug designation and in 2019, France received a phase 1 IND approval for healthy adults.

Clinical Trials
A randomized, double-blind, placebo-controlled, single ascending dose study, to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of GX-G8 in healthy volunteers.

GX-19N

A DNA vaccine for COVID-19

GX-19N, a spike (S1, S2) and nucleocapsid protein (NP) induced plasmid for the SARS-CoV-2, activates T-cell responses and antibody responses, including neutralizing antibody responses, against SARS-CoV-2. A phase 2/3 clinical trial in healthy subjects to evaluate safety, tolerability and Immunogenicity is currently ongoing.

Clinical Trials
A Phase 1/2a, multi-center, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, and immunogenicity of GX-19N, a COVID-19 preventive DNA vaccine in healthy subjects

GX-E4

A recombinant human erythropoietin (EPO) fused to hyFc

Efepoetin alfa (GX-E4) is a novel long-acting EPO-hybrid Fc fusion protein (rhEPO hyFc), and it is intended for treatment and maintenance of anemia due to chronic kidney disease (CKD) with or without dialysis. Safety and tolerability were evaluated from phase 1 clinical trial in healthy volunteers, and phase 2 clinical trial in anemia patients with CKD have been completed.

Clinical Trials
  1. 1. Study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of GX-E2 in dealthy subjects. NCT02291991
  2. 2. Study to evaluate the efficacy and safety of GX-E2 in the anemic patients diagnosed With chronic kidney disease (CKD). NCT02044653
  3. 3. A study of Efepoetin alfa in treating anaemia associated with chronic kidney diseases patient. NCT04155125

GX-G3

A recombinant human G-CSF fused to hyFc

GX-G3 developed for severe neutrophenia caused by inhibited bone marrow production induced by chemotherapy. The G-CSF is combined with the G-CSF receptor present on the surface of the cell and increased the cell division in the bone marrow to increase the neutrophil counts in patients who the neutrophil counts are reduced. Safety, and tolerability were confirmed through phase 1 clinical trial with healthy male volunteers, and safety, tolerability and efficacy were evaluated through phase 2 clinical trial with non-hodgkin lymphoma patients. Multinational clinical trials for phase 3 are currently being prepared.

Clinical Trials
  1. 1. Phase 1 study GX-G3 in healthy male subjects. NCT01951027
  2. 2. Phase 2 study of GX-G3 in Non-Hodgkin's lymphoma. EudraCT: 2015-002693-20

GX-G6

A recombinant human GLP-1 fused to hyFc

GX-G6 is a long-acting GLP-1 fused to hyFc as a diabetes treatment. GLP-1 is secreted from L cells of the intestine and mainly stimulates the beta cells of the pancreas, thereby increasing insulin secretion, suppressing an increase in blood sugar. The hyFc was improved for optimization of receptor binding for safety, thus safety of GX-G6 was confirmed and the injection interval also was confirmed as once a week or every other week in animal data. Safety and tolerability confirmed in healthy adult males in a phase 1 clinical trial in Germany in 2018. Phase 2 IND was approved for phase 2 diabetes in Australia in 2019.

Clinical Trials
  1. 1. Safety and tolerability of GX-G6 in healthy male subjects. NCT03651466
  2. 2. A Phase 2, 12-week, double-blind, efficacy and safety of GX-G6 in patients with uncontrolled type 2 diabetes mellitus. NCT03962010
Publications:
A Glycosylated Fc-fused GLP-1 Exhibits Equivalent Glucose Lowering Effect but Lesser Gastrointestinal Side Effect Than Dulaglutide. Diabetes Obes Metab.
2020 Apr 20. doi: 10.1111/dom.14058

GX-P1

A soluble protein that consists of PD-L1 linked to the long-acting hyFc platform

GX-P1 mainly binds to PD-1, which are overexpressed in activated T cells, and induces immune tolerance by inhibiting the cell proliferation, survival and cytokine production. It is expected to have clinical benefits in various autoimmune diseases caused by T cell activation. A phase 1 clinical trial for evaluate safety and tolerability will be started in 2020.

Clinical Trials
Safety and tolerability of GX-P1 in healthy male volunteers in Korea. NCT04298749