Vancouver, BC – June 9, 2020 – Bold Therapeutics, a clinical-stage biopharmaceutical company, is pleased to announce that it is receiving advisory services and additional research and development funding of up to CAD$965,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support the development of BOLD-100 as a novel antiviral, bringing the total project funding to $1.46M. This funding supports preparations for a future clinical trial of BOLD-100 including (1) completion of nonclinical studies; (2) further testing of BOLD-100 against various COVID-19 variants of concern; and (3) manufacturing process development.
BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. In a previously completed Phase 1 monotherapy study in 46 patients with advanced cancer, BOLD-100 was safe and generally well-tolerated, and BOLD-100 is currently being tested in combination with FOLFOX in a Phase 1b / 2a clinical trial in advanced gastrointestinal cancers. In early 2020, a variety of academic publications suggested that GRP78 plays a critical role in viral replication – a hypothesis since validated across numerous studies completed by Bold Therapeutics’ academic collaborators including Stephen Barr, PhD (Western University); François Jean, PhD and Ted Steiner, MD (University of British Columbia); Marc-André Langlois, PhD, (University of Ottawa); and Hector Aguilar-Carreno, PhD (Cornell University).
“This project could have a significant impact on future pandemic preparedness, not just in Canada, but worldwide. Importantly, not only is BOLD-100 effective in vitro against COVID-19 and numerous variants of concern, but there is extensive evidence suggesting BOLD-100 could also be effective against a wide range of currently untreated viruses (e.g. Dengue, Ebola, West Nile, Zika),” stated E. Russell McAllister, CEO. “At last count there were more than 200 independent academic articles supporting GRP78, previously thought undruggable, as a promising antiviral target. If Canada had such a therapeutic available in early 2020, much of the early impact of the pandemic could potentially have been mitigated, significantly reducing morbidity and mortality amongst infected patients while vaccines were being developed and tested. BOLD-100 is stable and has broad spectrum activity, allowing it to be stockpiled for extended periods as part of a pandemic preparedness plan and then rapidly deployed when and where it is needed. Unlike agents such as antiviral antibodies that target virus-specific components, BOLD-100 targets a fundamental replication pathway common across viruses and therefore does not become ineffective or obsolete as viruses inevitably mutate. It is incredibly exciting to have inadvertently stumbled upon an entirely new way to fight viruses either alone or in combination with other antiviral agents. This project would not have been possible without support from NRC IRAP, and we look forward to continuing our efforts as part of Canada’s ongoing pandemic preparedness efforts.”
For more information, please visit the company's website at www.bold-therapeutics.com/COVID-19.
Source: Bold Therapeutics, Inc.
E. Russell McAllister, CEO