In recent years, Biopharmaceutical is one of the most vigorous fields in pharmaceutical industry. In the next decade, gene therapies and innovative drugs will be launched. Chinese capabilities in R&D and industrialization of biopharmaceuticals will be greatly improved. Chemicals, Traditional Chinese Medicine and biopharmaceuticals will stand like the legs of a tripod. A new era of the rapid development biopharmaceutical in China has just arrived!
PD-1 monoclonal antibody is a negative co-stimulatory molecule which has been discovered recently, which can block PD-1 signal pathway, activate the immune system to remove cancer cells and treat cancer. It has potentials for the treatment of a variety of tumors.
Compared with the traditional treatment methods such as the radiation and chemotherapy, representing by PD - 1 monoclonal antibody, a cluster of immune checkpoint antibody drugs has sparked a revolution of antitumor drugs. It is the highly anticipated new type of antitumor immune therapy, because of its significance in efficacy and less side effects. It is promising especially in combination therapy with other antitumor drugs.
In May 2015, Gloria enter the cooperative development agreement with Wuxi AppTec on PD - 1, which has achieved two milestones: on the one hand, it is the first time in China to use the world leading transgenic animal technology developed solely and having independent intellectual property rights; on the other hand, with Wuxi AppTec's platform of cell lines and cell culture, the expression quantity can reach up to 10 g/L, and significantly reduce the production cost.
In April 2016, submission of IND application of PD-1
In March, gets the IND Approval
In August 2017, Out-licensed the development and commercialization rights of GLS-010 Program (PD-1) to Arcus Biosciences, Inc. in designated overseas territory.
GLS-010 Program (PD-1) now is ongoing in phase I study, which included several kinds of advanced solid tumors such as gastric cancer, esophagus cancer, and non-Hodgkin's lymphoma. By the end of 2017, everything goes well with study and it s expected to have the result of efficacy and safety by 2018 H1.
LAG3 is a type of immune checkpoints, which is different from PD - 1. Lymphocyte-activation gene 3 (LAG-3) is an immune checkpoint receptor protein found on the cell surface of effector T cells and regulatory T cells (Tregs) and functions to control T cell response, activation and growth. Preclinical studies suggest that inhibiting LAG-3 allows T cells to regain their cytotoxic function and potentially affect tumor growth. LAG-3 expression is also being evaluated as a biomarker to predict response to treatment. Early research suggests that targeting the LAG-3 pathway in combination with other potentially complementary immune pathways may be a key strategy to more effectively activate the antitumor immune response. So far, MNCs such as Novartis, Bristol-Myers Squibb, is in the process of clinical trials and there's no one yet in China who submitted any IND application.
In November 2017， Gloria entered another agreement with Wuxi AppTec on the co-development of Anti-LAG3.
Ipilimumab (trade name Yervoy) is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that down-regulates the immune system. In the study of combination use of Ipilimumab andAnti-PD-1, it demonstrated superiority over single therapy.
There's only one company, BMS, has launched Ipilimumab for the treatment of unresectable or metastatic melanoma. This is the first immune checkpoint inhibitor drug approved by FDA. The global sales of Ipilimumab in 2014-2016 reached up to $3.487 billion. There are several Chinese companies developing Anti-CTLA 4 drug.
In December 2017, Gloria and Genscript entered an agreement on the development of Ipilimumab (trade name Yervoy). In addition to PD-1 and LAG3, it is a further step of Gloria to lay a solid foundation in biologics field.