VANCOUVER, BC, Oct. 9, 2020 /PRNewswire/ — Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that the first patient for the company’s Phase 1b oncology clinical trial has been enrolled at the Cross Cancer Institute (Edmonton, Alberta) under Principal Investigator Dr. Jennifer Spratlin. This trial investigates the safety and tolerability of Bold Therapeutics’ first-in-class anti-cancer agent, BOLD-100, in combination with the current standard-of-care, FOLFOX (5-fluorouracil, leucovorin, oxaliplatin), for the treatment of patients with advanced gastric, pancreatic, colorectal and bile duct cancers. Five additional hospitals across Canada will also be enrolling patients: Princess Margaret Cancer Centre in Toronto, Ontario (PI Grainne O’Kane); Ottawa General Hospital in Ottawa, Ontario (PI Rachel Goodwin); Juravinski Cancer Centre in Hamilton, Ontario (PI Elaine McWhirter); and Jewish General Hospital and Royal Victoria Hospital in Montreal, Quebec (PIs Petr Kavan and Jamil Asselah, respectively).
BOLD-100 is a first-in-class ruthenium-based therapeutic that selectively inhibits stress-induced upregulation of GRP78 and alters the unfolded protein response (UPR), mitigating resistance, survival and proliferation, with additional synergistic direct anti-cancer activity.
“Bold Therapeutics has achieved another key clinical development milestone. The current trial will provide data on not only the safety and tolerability of BOLD-100 in combination with FOLFOX, but also important efficacy measures to evaluate patient outcomes,” stated Jim Pankovich, EVP of Clinical Development. “Bold Therapeutics is working with an experienced team of investigators across Canada – and, later, in the United States and South Korea – for this groundbreaking clinical trial. The dose-escalation portion of this adaptive-design study will enroll approximately 12 patients in cohorts of three after which the expansion-cohort portion will enroll up to 80 patients, with 20 patients in each arm.”
In a previously completed 46-patient Phase 1 monotherapy study, BOLD-100 was well-tolerated with minimal hematological and neurological side effects, suggesting it could be combined favorably with other anti-cancer therapies. Preclinical data shows profound synergy in combination with numerous drug classes ranging from traditional chemotherapies to newer targeted therapies and immune-oncology agents. The company received a No Objection Letter (NOL) from Health Canada earlier this year and has an open Investigational New Drug (IND) and an Orphan Drug Designation (ODD) in pancreatic cancer in the United States, with additional ODDs expected over the next six months.
“Cancer drug resistance remains a significant challenge for patients and physicians. We have deliberately chosen some of the most difficult-to-treat indications with the shortest mean survival times for this trial because this is where there is the greatest unmet medical need,” said E. Russell McAllister, CEO. “Preclinically, BOLD-100 significantly improves outcomes in a wide range of different indications and combinations, acting through both anti-resistance but also direct anti-cancer pathways. We are now actively evaluating additional development options, some in partnership with other pharmaceutical companies, and we expect to initiate at least one additional oncology clinical trial in 2021. Areas of particular interest include triple-negative breast cancer; neoadjuvant therapy; first-line combinations with immuno-oncology agents; sarcomas; and various liquid tumors, including multiple myeloma – all of which are potentially viable development indications and combinations based on preclinical data and/or relevant literature.”
Additional information on this study is available at www.clinicaltrials.gov/ct2/show/NCT04421820.
For more information, please visit the Company’s website at www.bold-therapeutics.com
E. Russell McAllister, CEO