Porustobart in combination with toripalimab is intended for the treatment of hepatocellular carcinoma. Credit: KGH / commons.wikimedia.org.

Harbour BioMed has reported results from a Phase Ib clinical trial of porustobart (HBM4003) combined with toripalimab for the treatment of hepatocellular carcinoma (HCC).

The open-label, dose expansion study has been designed to assess the tolerability, safety, PK/PD and preliminary efficacy of the combined therapy in patients with advanced HCC and other solid tumours.

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Porustobart 0.45 mg/kg plus toripalimab 240 mg every three weeks was given to 28 patients with advanced HCC in both cohort 1 and cohort 2.

Cohort 1 has selected 16 patients who failed previous anti-VEGFR multikinase inhibitor treatment and did not receive treatment with anti-PD-(L) 1 while cohort 2 enrolled 12 patients who failed previous anti-PD-(L)1 and anti-VEGF(R) treatments.

Objective response rate per RECIST 1.1. is measured as the primary endpoint.

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Favorable PK/PD signature was observed in patients treated with porustobart in combination with toripalimab and no noticeable differences in PK between the cohorts were observed.

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Porustobart in combination with toripalimab also showed acceptable safety profile in HCC along with promising anti-tumour activity.

Harbour BioMed founder, chairman and CEO Dr Jingsong Wang said: “We are excited to observe the promising efficacy and safety profile of porustobart and its potential to be developed as a cornerstone therapy in immuno-oncology.

“The continuous breakthrough in clinical studies of porustobart, the first molecule entered into clinical development generated from Harbour Mice HCAb, reflected superb innovation capabilities of our team and vast value of our industry leading technology platforms.

“We are fully committed to advancing the clinical development project of porustobart to address the significant unmet medical needs in multiple solid tumour indications.”