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Bold Therapeutics to Present Best-in-Class Phase 2 Metastatic Colorectal Cancer Data at AACR 2023

VANCOUVER, BC, April 13, 2023 -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing first-in-class oncology therapeutics, announced that it will present two posters – a clinical poster (#CT149) and a translational research poster (#2259) – at the American Association for Cancer Research (AACR) Annual Meeting 2023 on April 14 - 19, 2023 in Orlando, Florida. 

The clinical poster (#CT149) is entitled "BOLD-100-001 (TRIO039): a Phase 1b/2a Dose-Escalation Study of BOLD-100 in Combination with FOLFOX Chemotherapy in Patients with Pre-treated Advanced Colorectal Cancer: Interim Efficacy, Safety and Tolerability Analysis," and will be presented April 17, 2023 at 1:30PM. 

The translational research poster (#2259) is entitled "Novel Metallotherapeutic BOLD-100 Induces Circulating Cytokine Changes When Administered in Combination with FOLFOX in Advanced Gastrointestinal Cancer Patients," and will be presented April 17, 2023 at 9:00AM. 

"We are thrilled to share these posters, showcasing the profound progress we've made with BOLD-100 over the last year,” said Jim Pankovich, EVP Clinical Development. “This robustly positive interim clinical data is a testament to the hard work and dedication of our team, collaborators, clinical sites, investigators and patients. We look forward to continuing development of this innovative therapeutic." 

Bold Therapeutics' 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. Collectively, these effects result in cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to significantly improve outcomes in a wide range of both solid and liquid tumors in combination with other anticancer therapies ranging from traditional chemotherapies to targeted therapies and immuno-oncology agents. Earlier preclinical data showed that BOLD-100 has potential immune modulating capabilities, including the induction of immunogenic cell death pathways. The translational data to be presented at AACR shows that BOLD-100 in combination with FOLFOX induced short-term plasma level changes in multiple cytokines, including IL-10 and IL-27. 

BOLD-100 is currently being studied in a global Phase 1b/2 trial for the treatment of advanced gastrointestinal cancers, with more than 100 patients successfully treated to date. Previous Phase 1b trial results, presented at ASCO 2022, demonstrated that BOLD-100 in combination with FOLFOX was generally safe and well-tolerated. This data release expands on the prior data with a much largersample size and includes progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) data that positions BOLD-100 as a potentially best-in-class therapy for mCRC. 

Additional Phase 2 safety and efficacy results in advanced gastric and bile duct cancer have been accepted for presentation at ASCO 2023 in June. 

Additional information on AACR