Ascentage Pharma is set to initiate a Phase IIa clinical study of its novel APG-115 for treating patients with relapsed/refractory T-cell prolymphocytic leukaemia (r/r T-PLL) after it received approval from the Chinese National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).

The company already received clearance from the US Food and Drug Administration (FDA) for the study.

An orally administered, selective, small-molecule inhibitor of MDM2 protein, APG-115 is designed to trigger tumour suppression activity of p53 by blocking the MDM2-p53 protein-protein interaction.

An aggressive T-cell leukaemia, T-PLL has an incidence rate of just 0.6 cases per million with the median age of onset of the disease being 61 years.

The global, multi-centre, open-label study will analyse safety, pharmacokinetics, and preliminary efficacy of APG-115 as a single agent or in combination with the company’s new Bcl-2 inhibitor APG-2575, for treating patients with r/r T-PLL.

Ascentage Pharma chief medical officer Dr Yifan Zhai said: “Concurrent inhibition of both MDM2-TP53 and BCL-2 apoptosis pathways by the combination of APG-115 and APG-2575 has great therapeutic potential in triggering ‘synthetic lethality’ and effectively induce cell death by simultaneously blocking two important nodes of both apoptosis pathways.”

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“Second, both APG-115 and APG-2575 are orally bioavailable, targeted agents. The combination may provide a chemo-free treatment option for patients with T-PLL.”

The US FDA has granted the investigational new drug (IND) status for the Phase IIa study of APG-115 as a single agent or with APG-2575 based on T-PLL’s pathogenesis and the molecular therapy’s potential.

It is also backed by the positive preclinical results and early clinical data of APG-115 and APG-2575.

In June, Ascentage Pharma formed a strategic clinical collaboration with AstraZeneca’s haematology research and development centre Acerta Pharma.