Apexigen has started dosing patients in a Phase Ib/II clinical trial of APX005M in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) to treat patients with advanced solid tumours.

APX005M is a humanised monoclonal antibody designed to induce anti-tumour immune response in the microenvironment of the tumour via immune system’s antigen-presenting cells (APC).

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The two part trial will assess the safety, tolerability and preliminary efficacy of the combination in second-line metastatic non-small cell lung cancer (NSCLC) patients who are not responding to prior chemotherapy.

Patients suffering with metastatic melanoma and have previously failed I-O therapy will also be enrolled.

"We are excited to dose the first patient in this clinical trial to evaluate the potential of a new treatment approach, combining our CD40 agonist APX005M with Opdivo, a PD-1 immune checkpoint inhibitor."

Apexigen president and CEO Xiaodong Yang said: “We are excited to dose the first patient in this clinical trial to evaluate the potential of a new treatment approach, combining our CD40 agonist APX005M with Opdivo, a PD-1 immune checkpoint inhibitor.

“Previously, APX005M has demonstrated safety and activity in a Phase I clinical trial and dosing the first patient in this Phase Ib/II trial is an important milestone as we advance our clinical development plans for our novel I-O agents.”

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The Phase Ib dose-escalation part of the trial will establish the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of APX005M, while the Phase II dose-expansion portion will involve administration of RP2D in combination with nivolumab.

The trial’s primary endpoints are safety and overall response rate (ORR), while secondary endpoints include the pharmacokinetic (PK) profile of APX005M, incidence of its anti-drug antibodies (ADA), duration of response (DOR) and median progression-free survival (PFS) for patients.

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