The first patient administration was completed in the Phase 1b study of AXA Mdm2-p53 inhibitors in China.

On July 22, AXA Pharmaceuticals announced that it had completed its first phase 1clinical clinical study of patient syllabelet (MDS) in China as a single drug and co-treatment of adult recurrence or difficult treatment of acute myeloid leukemia (AML), recurrence or progression of high-risk/extremely high-risk myelogenic abnormal syndrome (MDS).
the first MDM2-p53 inhibitor to enter clinical phase in China for the treatment of solid tumors, this is the first clinical study of APG-115 to develop a blood tumor indication, according to a press release.
the study as a national multicenter Phase 1b clinical study designed to assess the safety, pharmacokinetics, and pharmacodynamics characteristics of patients with blood tumors such as APG-115 as a single and combined aarcycoside or alyginside treatment for recurrence or difficult treatment of AML, recurrence or progression of high-risk/extremely high-risk MDS.
AML is a cloned proliferative disease of bone marrow, the incidence increases with age, is the most common leukemia in China, about 1.62 to 2.32 people / 100,000 people.
treatment for AML has been based on a "7-plus-three" combination (7-day glycosine plus 3-day cyclogenous drugs) as the standard induction-induced remission treatment, but up to 40% of newly diagnosed AML patients are still unable to achieve full remission (CR) during initial induced palsy treatment, i.e. refracthard, or relapse within 6 months of obtaining CR.
MDS is a group of heterogeneous hematopoietic diseases derived from abnormally pluripotent stem cells, characterized by low hematopoietic function, bone marrow failure, reduction of peripheral blood cells and decreased survival rate.
in China, the incidence of MDS is about 5 per 100,000 people.
demethylation drugs have a high response rate for Treatment of MDS, many patients end up developing resistance to the effects of demethylated drugs.
once drug resistance occurs, the overall prognosis becomes very poor.
in high-risk MDS patients, the failure of demethylation drugs was associated with an average survival of less than 6 months.
so there is an urgent need for new treatments and more effective treatments for AML or MDS patients with relapse progression.
APG-115 is an oral bioavailable, highly selective small molecule MDM2 inhibitor in The Pharmaceuticals of Axa, which has a high binding affinity for MDM2 and restores p53 tumor inhibition by blocking MDM2-p53 interactions.
currently, APG-115 has started a single drug clinical phase 1 in the United States, a clinical 1b/2 trial for the treatment of advanced solid tumor/metastatic melanoma, single drug or combination chemotherapy treatment of salivary gland cancer in the United States As the first MDM2-p53 inhibitor to enter clinical phase in China, APG-115 has also been approved in China for clinical trials including single-drug Phase 1 studies, single-drug or joint treatment AML/MDS phase 1b studies. "There is still a large and unmet clinical need for the treatment of blood tumors such as AML and MDS, " said Dr. Yifan Yin Yifan, Chief Medical Officer of
Axa.
we also note that the development of drugs targeting MDM2-p53 is receiving increasing attention from the industry. As
the first MDM2-p53 inhibitor to enter clinical phase in China, aPG-115 has shown good safety and initial efficacy in clinical studies on solid tumors.
we will further explore the potential of APG-115 in blood tumors to provide more treatment options for AML and MDS patients in China and around the world.
" References to the first clinical study of The First Clinical Study of The Axa Pharmaceutical MDM2-p53 Inhibitor APG-115 Single Drug or Combination Drug Treatment of Blood Tumors in China Ib. Retrieved Jul 22, 2020, from.