New Drug
Disease Area
Code
Indication
Research
Preclinical
PhaseⅠ
PhaseⅡ
PhaseⅢ
NDA
Remark
Oncology
Renal Cell Carcinoma following prior Checkpoint Inhibitor (CPI)
Head and Neck Squamous Cell Carcinoma
HNSCC
NSCLC
Solid Tumor
Oncology
Oncology
Cachexia
Oncology
Oncology
Oncology
Oncology
Immunology
LR19019
LR19024
LR20061
Atopic Dermatitis
Osteoarthritis
Atopic Dermatitis
In partnership with Bristol Myers Squibb
In partnership with
Cue Biopharma
(USA)
In partnership with PDC*line Pharma (Europe)
In partnership with G&Co (USA)
In partnership with
Cue Biopharma
(USA)
USA, Korea
USA
In partnership with Avacta Group
In partnership with TransThera Biosciences (China)
(China)
Korea
USA, Europe, Korea
In partnership with
Rhythm Pharmaceuticals (USA)
USA
USA
Vaccine
Vaccine
LR19114
LR20062
6-in-1 Vaccine
(Diphtheriae,
Tetanus,whole
cell Pertussis,
Hepatitis B,
Meningitis,
Polio)
6-in-1 Vaccine
(Diphtheriae,
Tetanus,acellular
Pertussis,
Hepatitis B,
Meningitis,Polio)
Funded by the Ministry of Health and Welfare of South Korea
Medical Device
Dermal Fillers
LR19094
LR20024
HA Filler
HA Filler
Y-solution
(China)
Y-solution
(Europe)
Oncology
TiNivo-2
Renal Cell Carcinoma following prior Checkpoint Inhibitor (CPI)
AV-299
Head and Neck Squamous Cell Carcinoma
HNSCC
NSCLC
Solid Tumor
LR19129
Oncology
LR19155
Oncology
AV-380
Cachexia
AV-203
Oncology
LR19023
Oncology
LR19128
Oncology
LR19157
Oncology
Immunology
LR19019
Atopic Dermatitis
LR19024
Osteoarthritis
LR20061
Atopic Dermatitis
Vaccine
LR19114
6-in-1 Vaccine (Diphtheriae, Tetanus, whole cell Pertussis, Hepatitis B, Meningitis, Polio)
LR20062
6-in-1 Vaccine (Diphtheriae, Tetanus, acellular Pertussis, Hepatitis B, Meningitis, Polio)
Dermal Fillers
LR19094
HA Filler
LR20024
HA Filler
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.
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.
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.