On April 13, 2023 Bold Therapeutics, a clinical-stage biopharmaceutical company developing first-in-class oncology therapeutics, reported that it will present two posters – a clinical poster (#CT149) and a translational research poster (#2259) – at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 on April 14 – 19, 2023 in Orlando, Florida (Press release, Bold Therapeutics, APR 13, 2023, View Source [SID1234630060]).

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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 (Free AACR Whitepaper) 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 (Free ASCO Whitepaper) 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 larger sample 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 (Free ASCO Whitepaper) 2023 in June.