Asaan Pharma Bcl-2 inhibitor APG-2575 won two IB/ ...

On November 23rd Asahan Pharma announced that it had obtained two consecutive clinical trial licenses for CDE in the study of the new class 1 drug Bcl-2 inhibitor APG-2575, which will be conducted as a single drug or in association with Ibrutinib/Ritxi monoanti Ib/II studies for the treatment of Fahrenheit globulinemia (WM), and Ib/II studies for the treatment of multiple myeloma (MM) as a single drug or in a single drug or in a joint Lenalidomide/Dexamethasone.
APG-2575 is a new oral Bcl-2 selective small molecule inhibitor developed by Asaan Pharmaceuticals to restore the tumor cell program death mechanism (apoptosis) by selectively inhibiting Bcl-2 protein, thereby killing tumors and intended to be used to treat a variety of blood malignancies.
APG-2575 is the first locally developed Bcl-2 selective inhibitor to enter the clinical phase in China, and its two adaptive disorders (WM, chronic lymphocytic leukemia) have been qualified as orphan drugs by the FDA.
APG-2575 is currently licensed for multiple Phase Ib/II clinical trials in the United States, China and Australia and is advancing the clinical development of multiple blood tumor adaptations worldwide simultaneously.
The Phase Ib/II clinical trial of WM as a single drug or joint Ibrutinib/Rituximab treatment is a global multi-center study involving the United States, Australia and China.
Ib/II study of WM patients treated with APG-2575 monodrative or combined Ibrutinib/Rituximab was conducted for the Global Multi-Center, Open Ib/II Study Dosage efficacy exploration studies designed to assess the safety, tolerance, PK characteristics and preliminary efficacy of APG-2575 monodratives or combined Ibrutinib/Rituximab treatment of WM patients.
WM is a rare inert mature B-cell lymphoma, which accounts for 2% of non-Hodgkin's lymphoma (NHL).
The objective remission rate of WM treatment recommended in the current guidelines can reach 80%, but the deeper remission rate above VGPR is very low (around 20% or less), and more patients will eventually relapse or progress.
, the middle age of WM is around 70 years old, and the patient's physical condition is often insatiable with intense treatment.
the improvement of the effectiveness of WM therapy is an urgent clinical problem to be solved.
preclinical data confirm that APG-2575 can overcome Ibrutinib's insensitive drug-resistant WM model, and has significant synergies with Ibrutinib in NHL models including fable lymphoma, diffuse large B-cell lymphoma, and WM.
Ib/II study of MM patients treated with APG-2575 monodramine or Lenalidomide/Dexamethasone is a multi-center, open Ib/II study to be conducted in China Incremental clinical studies aimed at assessing the safety, pharmacodynamic and pharmacological properties of APG-2575 monodramines or Lenalidomide/Dexamethasone, as well as preliminary observations of clinical efficacy.
study will be conducted in patients with relapsed/difficult MM.
MM is a plasma cell cloning disease, can lead to hypercalcemia, anemia, kidney damage, bone damage and other symptoms, still can not be cured.
statistics, MM accounts for 1.8% of all cancers, 18.2% of blood system malignancies, has exceeded acute leukemia, ranking second in the incidence of malignant tumors in the blood system.
of MM age in the United States is about 6.9 per 100,000 per year.
epidemiological research data show that in recent years, the incidence of MM in China has increased significantly, and the mortality rate of patients over 60 years of age is significantly higher than that of young patients.
mm patients with the median age of onset in the United States is 69 years old, while in China is 59 years old, younger than abroad.
mm incidence increases gradually with age, and with the increasing aging of China's population and the gradual enhancement of disease diagnosis capacity, the number of cases in China will increase further.
preclinical study found that APG-2575 monodrative drug had obvious induced apoptosis ability and anti-proliferation activity in mm cell line with t(11; 14) chromosomal subpopation.
In non-t(11; 14) chromosomal-positioned MM cell lineages, APG-2575 showed significant synergy with immunomodulants (lenadamine or pomeranide) and dexamymide to enhance apoptosis and anti-proliferation activity.
"APG-2575 is an important product in the company's apoptosis product pipeline, is the first domestic Bcl-2 selective small molecule inhibitor into the clinic, single or combined with other drugs for WM, MM and other blood tumors have a very good therapeutic potential."
drug use is the future trend of cancer treatment, we will actively promote clinical trials to provide patients with new treatment options as soon as possible.
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