IconOVir Bio has dosed the first patient in its Phase I dose escalation and expansion clinical trial of ICVB-1042 to treat advanced solid tumours.
The open-label study intends to assess the pharmacodynamics and pharmacokinetics, as well as the safety, biological, and clinical activity, of the chimeric oncolytic adenovirus ICVB-1042 in patients with relapsed or refractory solid tumours.
It also aims to establish a maximum tolerated dose (MTD) or a recommended Phase 2 dose (RP2D).
Upon establishing the MTD or RP2D, IconOVir plans to initiate open expansion cohorts in advanced solid tumours.
Biological activity of the therapy will be measured by viral replication in the tumour while clinical response will be evaluated using the immune Response Evaluation Criteria in Solid Tumours (iRECIST).
IconOVir Bio chief medical officer Julie Maltzman said: “Leveraging our proprietary platforms, we engineered and combined novel mutations to create ICVB-1042, the first oncolytic virus (OV) with the potential to be delivered systemically, without sacrificing potency or tumour selectivity.
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“Preclinical data suggest that ICVB-1042 offers a highly differentiated profile relative to currently marketed or OVs in development, which may translate into more effective anti-cancer activity across a range of difficult-to-treat tumors.
“We look forward to reporting initial safety data later this year, with potential biological proof-of-concept in the first half of 2024, and we are pleased that our first patient tolerated ICVB-1042 therapy well.”
ICVB-1042 is designed with genomic changes, enabling it to provide enhanced tumour cell killing, broad tropism, and tumour selective replication, thereby allowing it to be delivered either through IV or intratumoral routes.