ICVB-1042 is an oncolytic adenovirus for the treatment of advanced solid tumors —

— Initial safety data expected in 2H 2023, followed by proof-of-concept data in 2024 —

SAN DIEGO, CA, USA I July 11, 2023 I IconOVir Bio, Inc. (IconOVir), a clinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, today announced that the first patient has been dosed in a Phase 1 dose escalation and expansion clinical trial evaluating intravenously (IV) administered ICVB-1042 for the treatment of advanced solid tumors.

“We are delighted to begin clinical evaluation of ICVB-1042, our potentially best-in-class OV and the first product candidate to emerge from our portfolio,” said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir. “We founded IconOVir to pioneer the next generation of OVs to improve the care and treatment of people living with solid tumors, with the ultimate mission of curing cancer and restoring life to patients everywhere. The initiation of this Phase 1 trial marks an important step toward achieving that goal and I look forward to working with our clinical partners to enroll and execute this study.”

ICVB-1042 is a chimeric oncolytic adenovirus, rationally designed with genomic modifications to confer tumor selective replication, broad tropism and enhanced tumor cell killing, as well as allow for either IV or intratumoral delivery. In preclinical studies, ICVB-1042 has been shown to infect and kill a broad range of tumor cells, including head and neck, bladder, lung and breast, suggesting that it could have potential utility in a wide range of solid tumor indications.

“Leveraging our proprietary platforms, we engineered and combined novel mutations to create ICVB-1042, the first OV with the potential to be delivered systemically, without sacrificing potency or tumor selectivity,” said Julie Maltzman, M.D., Chief Medical Officer of IconOVir. “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 expect to know from early data whether ICVB-1042 can be effectively delivered IV to drive viral replication in the tumor, which would provide strong mechanistic support for our approach. 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.”

About the Phase 1 Clinical Trial

IconOVir’s Phase 1 clinical trial is an open-label study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and biological and clinical activity of ICVB-1042 in patients with relapsed or refractory solid tumors. The goal of the study is to establish a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Once the MTD is reached, or a RP2D is established, IconOVir intends to open expansion cohorts in advanced solid tumors. Biological activity will be measured by viral replication in the tumor. Clinical response will be assessed by immune Response Evaluation Criteria in Solid Tumors (iRECIST) version 1.1. To learn more about the first-in-human trial of ICVB-1042, please visit www.clinicaltrials.gov (NCT05904236).

About IconOVir

IconOVir is a clinical-stage biotechnology company pioneering the next generation of OV therapy to improve the treatment of patients with cancer. IconOVir’s proprietary OV platform is based on technology developed by scientific founder Clodagh O’Shea, Ph.D., of the Salk Institute. It is designed to address key limitations of first- and second-generation oncolytic viruses and provide a personalized therapy for cancer patients. For more information, please visit www.iconovir.com and follow IconOVir on LinkedIn.