Hengrui IL-2 derivative therapeutic drugs declared clinical

Recently, Hengrui Pharmaceuticals announced that its independent research and development in the research PEG modified IL-2 drug SHR-1916 domestic declared clinical trials, has been accepted by CDE contractor, intended for the treatment of advanced malignant tumors.
it is worth mentioning that this is the first declared clinical domestic IL-2 derivative therapeutic drugs, Hengrui priority layout.
's ancient immunotherapy drug IL-2 human leukocyte interleukin-2 (interleukin-2, IL-2), also known as T-cell growth factor (TCGF), which expands the lymphocyte population in the body and improves the function of the cytopl effector makes it anti-tumor.
as an ancient immunotherapy drug, as early as 1992 and 1998, the FDA approved the IL-2 drug Aldesleukin for advanced kidney cancer and malignant melanoma.
However, IL-2 is used in clinical treatment at a high required dose, which is accompanied by severe therapeutic toxicity, such as severe hypotension and vascular leakage syndrome, and patients treated with IL-2 must be hospitalized for close observation to avoid accidental life-threatening conditions, which greatly limit the clinical application of the drug.
the structure of IL-2 drugs to further improve efficacy and reduce clinical toxicity has become the direction of development.
Cases Implemented Abroad In November 2017, MD Anderson Cancer Center in the United States released clinical data on NKTR-214 combined PD-1 monoantigens for patients with advanced tumors, and that drug use reduced 72% of tumors when used in solid tumor therapy.
NKTR-214 shines throughout the 2018 ASCO annual meeting, and its effectiveness in treating PD-1 inhibitors has attracted attention.
NKTR-214 This new IL-2 cytokine immunostidant is CD122-dependent excitement agent, a modified product of IL-2, with 6 added to each IL-2 molecule Polyglycol PEG, after injection into the tumor patient, these 6 PEG modifications will gradually fall off, forming an active form of drugs, through the isogeneous ddiogeneous IL-2 subject pathway (IL-2R beta? Provides continuous signal transductivity and can also stimulate the proliferation of CD8-plus T cells and NK cells in tumor environments through regulatory T-cells.
first declared clinical IL-2 derivative SHR-1916 Hengrui actively layout IL-2 derivative therapeutic drugs, the first time in China declared clinical trials.
SHR-1916 for injection can promote the proliferation of CD8-T and NK cells by activating the JAK1/JAK3/STAT5 signaling path, according to the announcement.
SHR-1916, a derivative that is combined with IL-2 subject α subi (IL-2R alpha), contains one or more amino acid mutations that have eliminated or decreased affinity for high affinity β/γ) and retains a good affinity for medium affinity (IL2R beta/γ).
compared to IL-2 itself, SHR-1916, an IL-2 derivative, has reduced activation of regulatory T-cells and is not affected or increased in immune-effect cell activation.
the domestic layout of IL-2 derivatives treatment drugs other players in addition to Hengrui medicine, the current domestic Lynda biology and Junshi biological also laid out IL-2 derivatives treatment drug field, the progress is fast and slow, the way taken is also different.
And Hengrui SHR-1916, Xinda Bio has also adopted an independent research and development model, in the research products have been given to reduce IL-2R alpha affinity, improve IL-2R beta affinity preferred mutation points, and established a mutant library, and through the introduction of glyco-basedization points, reduce or eliminate the binding with IL-2R alpha.
different from the above two development models, Junshi Bio has reached cooperation agreements with external companies to introduce IL-2 derivatives in the research products, while taking into account the short-term and long-term IL-2 derivatives layout.
September 2020, Regeneron signed a partnership agreement with Anwita Biosciences for an advance of $2 million and a milestone payment of $86 million, bringing in the latter's IL-2 family of products.
August 2020, Junshi Bio introduced Zhidao Bio's IL-2 drug LTC002 with an advance payment of 21 million yuan and a milestone amount of 938 million yuan.