New Drug
Disease Area
Code
Indication
Research
Preclinical
PhaseⅠ
PhaseⅡ
PhaseⅢ
NDA
Remark
Metabolic
Diseases
Type 2
Diabetes
Type 2
Diabetes
Type 2
Diabetes
Type 2
Diabetes
Gout
NASH
NASH
NASH
Genetic
Obesity
Obesity
Obesity
Oncology
HNSCC
NSCLC
Solid Tumor
Oncology
Oncology
Oncology
Oncology
Oncology
Immunology
LR19025
LR19019
LR19024
LR21004
LR19025
Degenerative Disease
Atopic Dermatitis
Osteoarthritis
Osteoarthritis
Osteoarthritis
Combination Drug (Korea)
Combination Drug (Thailand)
USA
USA
USA /
In partnership with
(China)
USA
USA
In partnership with
(USA)
In partnership with PDC*line Pharma (Europe)
In partnership with G&Co (USA)
In partnership with
(USA)
In partnership with
In partnership with
(Korea)
Korea /
In partnership with
(China)
Korea
Korea /
In partnership with
ICM (Australia)
Vaccine
Vaccine
LR19114
LR20062
6-in-1 Vaccine
(Diphtheriae,
Tetanus,
Pertussis,
Hepatitis B,
Meningitis,
Polio)
aP Vaccine
Funded by the
Bill & Melinda
Gates Foundation
Received export license from MFDS**
Funded by BMGF*
Medical Device
Dermal Fillers
LR19094
LR20024
LR20008
HA Filler
HA Filler
Next
Generation
Filler
(HA Filler)
Botulinum Toxin
LR20023
HA Filler
(Moderate to
Severe Glabellar Lines)
Y-solution
(China)
Y-solution
(Europe)
In partnership with
(Korea)
LR19052
Type 2 Diabetes
LR19051
Type 2 Diabetes
LR19123
Type 2 Diabetes
LR20022
Type 2 Diabetes
Gout
NASH
LR19018
NASH
LR19131
NASH
Genetic Obesity
LR19020
Obesity
LR19156
Obesity
Oncology
HNSCC
NSCLC
Solid Tumor
LR19129
Oncology
LR20009
Oncology
LR19023
Oncology
LR19128
Oncology
LR19155
Oncology
Immunology
LR19025
Degenerative Disease
LR19019
Atopic Dermatitis
LR19024
Osteoarthritis
LR21004
Osteoarthritis
LR19025
Osteoarthritis
Vaccine
LR19114
6-in-1 Vaccine (Diphtheriae, Tetanus, Pertussis, Hepatitis B, Meningitis, Polio)
LR20062
aP Vaccine
Dermal Fillers
LR19094
HA Filler
LR20024
HA Filler
LR20008
Next Generation Filler (HA Filler)
Botulinum Toxin
LR20023
HA Filler (Moderate to Severe Glabellar Lines)
Gout is a common and complex form of inflammatory arthritis, resulting from the deposition of monosodium urate monohydrate crystals. With persistent urate crystal deposition, gout may progress from acute episodic attacks to a disabling chronic deforming arthropathy, with destructive deposits of urate crystals (tophi) in bones, joints, subcutaneous tissue, and other organs. LC350189 is a novel non-purine selective inhibitor of Xanthine Oxidase (XO). XO is needed to successively oxidize both hypoxanthine and xanthine to uric acid. Hence, this agent reduces uric acid concentrations in serum by inhibiting the production of uric acid by XO inhibition. The proposed indication of LC350189 is a treatment for chronic management of hyperuricemia in patients with gout.
While the global gout therapeutics market is expected to reach a value of USD 8.5 billion by 2025 (CAGR: 16.1%), current therapies for chronic management of hyperuricemia in patients with gout either may not be used effectively due to titration requirement or potential safety issues. LC350189 has the potential to address the unmet clinical needs for safety and efficacy in gout treatment. LC350189 showed good systemic exposures and sUA lowering effects with no significant safety concerns in Korean and the U.S. healthy volunteers. The Phase II trial is currently on-going in the U.S.
Melanocyte-stimulating hormones, neuropeptides induced by Pro-opiomelanocortin (POMC) in the hypothalamus, act as the endogenous ligands of Melanocortin 4 receptor (MC4R). They decrease appetite by MC4R activation, leading to weight loss. Dysfunction of genes in MC4R pathway is known to cause rare genetic obesity such as POMC deficiency, leptin receptor deficiency, Bardet-Biedl syndrome and Alström syndrome. Therefore, MC4R agonists have the potential to be therapeutic agents for such genetic obesities.
LB54640 is a first orally available, small molecule MC4R agonist. LB54640 has shown to be safe and well-tolerated in GLP toxicity studies. The efficacy and safety profiles of LB54640 observed in preclinical studies suggests that LB54640 can be a safe and effective drug for the patients with genetic obesity. The U.S. Food and Drug Administration has granted Orphan Drug Designation for LB54640 for the treatment of leptin receptor deficiency obesity. Currently, LB54640 is being evaluated in a first-in-human study in healthy, non-diabetic, obese volunteers with body mass index ≥ 27 kg/m2 in the US. This randomized, double-blind, placebo-controlled, single ascending dose and the multiple ascending dose design will assess the safety, tolerability, PK and PD of LB54640.
CUE-101 is a fusion protein designed to activate and expand tumor-specific T cells, directly in the patient’s body, that target Human Papilloma 16 (HPV16)-driven malignancies. It contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the E7 protein of human papilloma virus 16 (HPV 16-E7). CUE-101 is the lead immuno-oncology drug developed within the IL-2 based CUE-100 framework from Cue Biopharma’s novel Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform technology. In November 2018, LG Chem Life Sciences partnered with Cue Biopharma to develop and commercialize cancer immunotherapy drugs based on the Immuno-STAT platform technology.
HPV cancers account for more than 20,000 deaths each year in the US and Europe. The majority of these cancers are driven by HPV 16 which carries the E7 antigen targeted by CUE-101. Despite treatment with current standards of care, approximately 50% of patients with advanced disease will experience recurrence and significant quality of life impact. Patients with HPV-related head and neck, cervical and genitoanal cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.
In preclinical studies, CUE-101 has demonstrated selective binding and preferential activation and expansion of antigen-specific T cells, dose-dependent effector cytokine production and inhibition of tumor growth both as a monotherapy and in combination with a PD-1 inhibitor.
The Investigational New Drug (IND) application for CUE-101 was accepted by the U.S. Food and Drug Administration (FDA) in May 2019. The open-label, multi-center Phase I trial for Head and Neck Squamous Cell Carcinoma (HNSCC) patients is currently on going in the U.S.
In addition to the CUE-101 program, CUE-102 targeting WT-1 and CUE-103 (TBD) are being developed through this partnership.
PDC* lung is an off-the shelf cancer vaccine of potent Ag-specific CD8+ T cell inducer based on a proprietary cell line of Plasmacytoid Dendritic Cells (PDC* line) originating from the French-Belgian biotech company PDC* line Pharma. PDC* lung consists of PDC* line loaded with HLA-A*02:01-restricted peptides derived from 6 antigens broadly expressed in Non-Small-Cell Lung Cancer (NSCLC). LG Chem in-licensed PDC* line’s anti-cancer vaccine in March 2019.
PDC* lung is our leading product for NSCLC. 2.1 million new cases of lung cancer were diagnosed worldwide in 2018, and it was responsible for and 1.8 million deaths (source IARC). Lung cancer is therefore the most frequently diagnosed cancer and the leading cause of cancer mortality. About 60% of patients are diagnosed with locally advanced (stage IIIb) or metastatic (stage IV) cancer; prognosis is poor (median survival of 8-13 months).
PDC* line is highly potent in priming and boosting fully functional antitumor CTL displaying a strong cytotoxic activity against tumor cells, and it is synergetic with the use of anti-PD-1 immune checkpoint inhibitors. Robust results already obtained for PDC* line provide a preclinical validation, as well as ex vivo results on blood samples of lung cancer patients. An approval was granted in May, 2019 to PDC* line Pharma to launch in France and in Belgium PDC-LUNG-101 trial, an open-label, dose-escalation, Phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC* lung01, associated with or without anti-PD-1 treatment in patients with non-small-cell lung cancer.
LR20056 (Compound name: LG00303174) is a novel, potent, selective, and irreversible inhibitor of semicarbazide-sensitive amine oxidase (SSAO, also known as vascular adhesion protein-1 (VAP-1)) intended as an oral treatment for non-alcoholic steatohepatitis (NASH). LG Chem licensed LR20056 from TransThera Biosciences Co. Ltd. to research, develop, manufacture, and commercialize globally except China and Japan.
NASH is a progressive form of non-alcoholic fatty liver disease (NAFLD) caused by the accumulation of excess fat in the liver. NASH is associated with chronic liver inflammation and liver cell injury, and can lead to fibrosis, cirrhosis, and liver cancer or liver failure. NAFLD and NASH are highly prevalent in patients with metabolic disorders such as type 2 diabetes and obesity. NASH is a medical disease of unmet therapeutic need with no approved treatments yet.
LR20056 has demonstrated high selectivity over other amine oxidases (MAO-A, MAO-B, DAO) and low BBB (blood–brain barrier) penetration. So far, safety profile shows minimal potential for clinically relevant drug-drug interactions.
The Phase 1 clinical study is currently being conducted in the U.S.
LR20011 (Compound name: GEN-001) is an oral microbiome therapeutic product which targets advanced solid tumors. It consists of Gram+ single strain bacteria isolated from a healthy human and identified to be the closest species of Lactococcus lactis. LG Chem licensed LR20011 from Genome & Company, a clinical stage biotechnology company based in Republic of Korea in December 2019 for development in Asia territory.
From the preclinical studies, LR20011 has its immune response and anti-cancer effect by enhancement of dendritic cell / macrophage maturation and bacteroidales-specific memory T cell responses which leads to increase of IL-2 & IFN-γ secretion and systemic activation of CTL.
The Phase 1/1b clinical study is currently being conducted in the U.S & KR in combination with Avelumab for PD-L1 refractory patients of solid tumors.