2014 is fleeting and a new 2015 has arrived. While appreciating the joy of victory, the elites of the pharmaceutical industry are also looking forward and thinking. What new breakthroughs will the new year have? Which new drugs will be eliminated in the approval of new drugs for the first time, and won the final victory? In the upcoming first quarter of 2015, the most eye-catching new drugs were two new anti-cancer drugs, Indoximod, a new drug for solid tumors, and HyperAcute, a new immunotherapy for lung cancer and pancreatic cancer.

Solid tumor treatment of new drugs Indoximod

Indoximod was developed by NewLink Genetics and is an indoleamine 2,3-dioxygenase (IDO) inhibitor. Indoleamine 2,3-dioxygenase is widely expressed in mammalian tissues and cells, especially in lymphoid tissue and placenta. It is the only enzyme outside the liver that can catalyze the epoxidation cleavage of tryptophan in the tryptophan molecule. The catabolic rate-limiting enzyme of the kynurenine pathway. Studies have shown that indoleamine 2,3-dioxygenase is involved in the regulation of T cell responses. Indoleamine 2,3-dioxygenase blocks T cell activation by degrading tryptophan, because T cells are particularly sensitive to tryptophan depletion, and when the tryptophan concentration is low, T cell proliferation will be static In the G1 period. The indoleamine 2,3-dioxygenase expressed in the tumor mediates tumor immune escape, antigen-presenting cells such as macrophages, indoleamine 2,3-double plus on dendritic cells (DC) Oxygenase can induce T cell immune tolerance to tumor antigen by inhibiting T cell proliferation.

Indoximod is used to treat four solid tumors of breast, brain, pancreatic, and melanoma and is currently in phase II clinical trials. Phase I clinical trials have shown that Indoximod has good oral bioavailability and that half-life is also beneficial to patients, while patients are more tolerated. NewLink Genetics expects to announce the results of clinical trials of Indoximod in breast cancer, brain cancer, pancreatic cancer, and melanoma in the first quarter of 2015.

HyperAcute, a new immunotherapy for lung cancer and pancreatic cancer

HyperAcute is NewLink Genetics' tumor immunotherapy drug. HyperAcute transfects human pancreatic, lung, and melanoma cells with alpha1, 3-galactosyltransferase genes from mouse and pig, allowing the epitope to be expressed on the cell surface. The use of natural antibodies and NK cells against the epitope present in the human body to kill tumors opens up new avenues for cancer gene therapy. Alpha-1,3-galactosyltransferase is a major heterologous antigen recognized by natural antibodies pre-stored in the human body on the surface of pig and mouse cells and expressed on animal cells such as pigs and mice, and in humans due to α1,3-galactose The transmethylation enzyme is inactivated and there is no expression of this epitope on the cell membrane surface.

Phase III clinical trials of HyperAcute for the treatment of non-small cell lung cancer (NLG0301) and phase III clinical trials for the treatment of pancreatic cancer (IMPRESS and PILLAR) will release clinical trial results in the first quarter of 2015. If the results of the HyperAcute Phase III clinical trial are optimistic, NewLink Genetics will submit a biologic drug application to the FDA.