Asieris Pharmaceuticals has enrolled the first subject in the Phase II clinical trial of oral APL-1202 plus Tislelizumab as a neoadjuvant treatment for muscular invasive bladder cancer (MIBC).

The multicentre, open-label Phase I/II trial is designed to assess the safety of the combination therapy in MIBC patients.

It will also identify the recommended Phase II dose (RP2D) and evaluate the treatment’s efficacy as a neoadjuvant MIBC therapy.

In June, the US Food and Drug Administration (FDA) granted clearance for the investigational new drug (IND) application while the China National Medical Products Administration’s Center for Drug Evaluation (CDE) granted approval in October last year. 

The first subject in the trial was dosed in December last year and the trial concluded the Phase I dose-escalation portion. 

The study entered Phase II in November this year.

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An oral reversible MetAP2 inhibitor, APL-1202 has anti-angiogenic and anti-tumour activities.

A humanised IgG4 anti-PD-1 monoclonal antibody of BeiGene, Tislelizumab can reduce binding to FcγR on macrophages. 

Asieris chief operation officer Dr John Zhuang said: “APL-1202 in combination with Tislelizumab has shown a promising safety profile in the Phase I stage of the clinical trial. 

“We will further explore the efficacy and safety of the combination in this Phase II stage, and continue to make positive progress on the clinical development of the neoadjuvant therapy to address unmet medical needs and benefit more patients.”

In November this year, the company received US FDA clearance for its IND application of an oral drug, APL-1401, to treat moderately-to-severely active ulcerative colitis.

Asieris plans to commence subject enrolment in a Phase Ib trial of the drug in the US.