On September 21, 2021 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported completion of the Phase 1/2 dose expansion studies evaluating its lead asset VT1021 in recurrent glioblastoma (rGBM) and pancreatic cancer (Press release, Vigeo Therapeutics, SEP 21, 2021, View Source [SID1234590109]).
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VT1021 is a first-in-class, dual-modulating compound that both blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis and inhibit angiogenesis. In the completed open-label, multicenter Phase 1/2 study (NCT03364400), the safety and preliminary anti-tumor efficacy of single-agent VT1021 was evaluated in subjects enrolled in both dose escalation and dose expansion cohorts. The escalation cohort included all-comers, and the expansion cohorts focused on rGBM and pancreatic cancer, among other indications.
Phase 1/2 Results in Recurrent Glioblastoma and Pancreatic Cancer
In the rGBM expansion cohort, single-agent VT1021 demonstrated complete tumor regression in multiple subjects and partial response in other subjects, with multiple subjects remaining on trial for well over 9 months. While the expansion study has concluded, these subjects will continue to receive VT1021 in an open label extension study.
In the pancreatic cancer expansion cohort, single-agent VT1021 demonstrated tumor reduction in multiple subjects with measurable disease. Moreover, VT1021 was able to reprogram the tumor immune microenvironment from immune-suppressive to immune-responsive.
Vigeo plans to present the results of both of these studies at medical meetings during the fourth quarter of 2021. The company is expected to initiate a global, Phase 2/3 registration study evaluating VT1021 in newly diagnosed and recurrent GBM patients by the end of 2021. In parallel, Vigeo plans to initiate efficacy studies in additional solid tumor indications, including pancreatic cancer, during the first half of 2022.
Jim Mahoney, Chief Executive Officer of Vigeo, commented, "VT1021 is a first-in-class anti-cancer agent that works by stimulating the expression of Tsp-1 which then binds with high affinity to CD47, blocking the "do not eat me" signal, and to CD36, which leads to a cascade of beneficial changes within the tumor microenvironment (TME) that further enhance anti-tumor effects. We, along with the PI’s who conducted the trials, are very excited by what we have observed to date in the two expansion studies."
Mr. Mahoney was appointed Chief Executive Officer in February of this year. Jing Watnick, PhD, MBA, Vigeo founder and previous CEO, is remaining on as the COO and will focus her efforts on developing the clinical and preclinical assets.
Prior to joining Vigeo as CEO, Mr. Mahoney served as a member of the Vigeo Board of Directors since 2015. In his new role, Mr. Mahoney will lead the development of Vigeo’s corporate strategy and will drive a disciplined growth strategy as Vigeo executes on its clinical programs.
Mr. Mahoney has over 30 years of senior executive experience at various biotechnology, healthcare and specialty chemicals companies. Most recently, he was an Operating Partner at Ara Partners, a private equity investment firm. Prior to that he served as CEO and President at Novomer Inc., Surface Logix Inc., and Prolinx Inc. and was a founding senior executive at Dade Behring Inc. Earlier, he held executive positions at Baxter International and FMC Corporation. Mr. Mahoney received his BS degree from the University of Massachusetts, Amherst, and holds an MBA from Northwestern University’s J.L. Kellogg School of Management and an MMA in international economics from the University of Southern California.
About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.