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    Home > Active Ingredient News > Drugs Articles > AXA is developing a new IAP inhibitor apg-1387, which has been approved in China

    AXA is developing a new IAP inhibitor apg-1387, which has been approved in China

    • Last Update: 2020-02-25
    • Source: Internet
    • Author: User
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    A clinical research and development enterprise dedicated to the development of innovative drugs in the fields of cancer, hepatitis B and aging related diseases-- Yasheng pharmaceutical announced that the company was approved by the drug review center (CDE) of the State Drug Administration (SDA) on the research of class 1 new IAP inhibitor apg-1387, and will carry out its phase Ib / II clinical research in advanced pancreatic cancer patients with its combination chemotherapy (albumin paclitaxel and gemcitabine program) in China This study is a multicenter, open phase IB dose exploration study and phase II efficacy exploration study, aiming to evaluate the safety, PK characteristics and preliminary efficacy of apg-1387 combined with albumin paclitaxel and gemcitabine in the treatment of advanced pancreatic cancer Apg-1387 is a new generation of apoptotic protein inhibitor (IAP) in the research of AXA, which can induce and accelerate the process of apoptosis by simulating the degradation of IAPs by endogenous SMAC molecules In a series of in vivo and in vitro studies, apg-1387 alone and in combination with chemotherapy drugs or targeted therapy can effectively inhibit the growth of tumor cells in different xenograft tumor models, which provides powerful data support for further exploration of anti-tumor effect of apg-1387 in clinical Apg-1387 is the first IAP inhibitor in China At present, apg-1387 has completed phase I research on advanced solid tumors in China and Australia, with good clinical tolerance Apg-1387 preliminary data of the ongoing phase I clinical study in the United States was published at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2019 This study found that apg-1387 single drug showed a certain anti-tumor activity for patients with advanced pancreatic cancer who had failed in previous multi-line treatment Among 10 patients with advanced pancreatic cancer treated with single drug, 4 patients obtained disease stability (SD), among which 1 patient in 45mg group had SD over 9 treatment cycles In general, apg-1387 was well tolerated and adverse events were controllable Pancreatic cancer is a kind of digestive system tumor with high malignancy Because of poor prognosis, the incidence rate is about 1 of the mortality rate, which has replaced liver cancer as the new generation of "cancer king" Pancreatic cancer is the ninth largest tumor type in China, and its incidence rate is increasing year by year Because of the special anatomy of pancreas, the early symptoms of pancreatic cancer are not obvious At the time of diagnosis, most patients are in the advanced stage or have metastases, so they can't operate The median survival time of metastatic pancreatic cancer was only 4-6 months Statistics in 2015 show that the 5-year survival rate of pancreatic cancer patients in China is 7.2%, which is the lowest in China In recent years, tumor treatment has made rapid progress, and the advent of targeted therapy and immunotherapy has greatly improved the survival rate of lung cancer, breast cancer and even liver cancer However, the treatment options and drugs for pancreatic cancer are still limited Chemotherapy is still the main treatment option for unresectable local advanced stage or patients with distant metastasis, but the median survival period after treatment is still less than one year Therefore, the improvement of the therapeutic effect of pancreatic cancer is an urgent problem to be solved Dr Zhai Yifan, chief medical officer of Yasheng pharmaceutical, said: "the effective treatment of pancreatic cancer, especially advanced pancreatic cancer, is an urgent clinical demand that has not been met in the world As the first IAP inhibitor to enter the clinical stage in China, apg-1387's previous clinical data showed great potential for patients with advanced pancreatic cancer We will actively promote the development of phase Ib / II clinical trial of apg-1387 in China to provide new treatment possibilities for pancreatic cancer patients " References 1 Prabhu Bray F, ferry J, soerjamataram I, et al (2018) global cancer statistics 2018: global estimates of income and mortality worldwide for 36 cancers in 185 countries CA cancer J Clin; 68 (6): 394-424 2 Hongmei Zeng, Wang Qing Chen, rongshou Zheng, et al (2018) changing cancer survival in China during 2003-15:00 A pooled analysis of 17 population-based cancer registers Lancet global health; 6: e555-67 about apg-1387 apg-1387 is a new small molecule IAP inhibitor designed and developed by AXA The company is developing apg-1387 worldwide At present, it has completed phase I dose ramp up test for solid tumors in China and Australia, and is carrying out phase Ib / II clinical test combined with pabolizumab in the United States At the same time, phase IB clinical trials for the treatment of hepatitis B are being carried out in China About Yasheng pharmaceutical, Yasheng pharmaceutical is an original new drug R & D enterprise based in China and facing the world It is committed to developing innovative drugs in the fields of cancer, hepatitis B and aging related diseases The company has a self-developed protein protein interaction target drug design platform On October 28, 2019, AXA pharmaceutical was successfully listed on the main board of Hong Kong stock exchange Yasheng pharmaceutical R & D product pipeline mainly focuses on the inhibitors of key proteins of apoptosis pathway By inhibiting Bcl-2, IAP or MDM2-p53, it can restart the apoptosis process of tumor cells; the second and third generation inhibitors for kinase mutants in cancer treatment, etc Eight new class 1 drugs have entered the clinical development stage, and 28 phase I / II clinical trials are being carried out in China, the United States and Australia.
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