On June 24, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported that they will be attending the Metals in Medicine Gordon Research Conference focusing on Advancing the Use of Metal-Based Compounds and Nanotheranostics for Personalized Medicine (Press release, Bold Therapeutics, JUN 24, 2022, View Source [SID1234616254]). The conference will be held in Andover, New Hampshire from June 26 to July 1, 2022, bringing together over 150 academic, industry, and government experts.

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Adam Carie, Director of CMC & Nonclinical Development, will be presenting on behalf of Bold Therapeutics in the "Clinical Advances for Metals in Medicine" session. He is joined by Shane Harrypersad, Senior Scientist, CMC.

This presentation will include previously embargoed data (shown below) recently presented at the 2022 American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in a session entitled "BOLD-100-001 (TRIO039): A Phase 1b dose-escalation study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastrointestinal solid cancers: Interim safety, tolerability, and efficacy." In addition to demonstrating that BOLD-100 was safe and generally well-tolerated, this data showed remarkable outcomes in the treatment of 3rd line or later treatment-resistant metastatic colorectal cancer (mCRC) in combination with FOLFOX – including in patients that had previously failed on FOLFOX alone. In the initial six patients, Progression-Free Survival (PFS) significantly exceed expected PFS for this patient population, handily exceeding the current best-in-class approved therapies for 3rd line mCRC, Bayer’s Stivarga (regorafenib) and Taiho’s Lonsurf (trifluridine and tipiracil).

While only the earliest efficacy data from the Phase 1b portion of the study was available for presentation at ASCO (Free ASCO Whitepaper), the colorectal arm of the BOLD-100-001 Phase 2 trial has since fully enrolled (N=22) and Bold Therapeutics expects to announce additional efficacy data in mCRC by year-end.

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 to immuno-oncology agents. BOLD-100 is currently being studied in a multinational Phase 2 trial in the treatment of advanced gastrointestinal cancers actively enrolling at 13 clinical sites: six in Canada; two in the U.S.; and five in South Korea.

"Bold Therapeutics is excited to present these remarkable results at the Gordon Research Metals in Medicine Conference showcasing the cutting-edge, multi-disciplinary work being performed at Vancouver-based Bold Therapeutics" noted Dr. Carie. "With our Phase 2 clinical trial well underway at sites in Canada, the United States, and South Korea, we are excited to connect with other leaders in the development of metal-based oncology therapeutics with a goal of improving outcomes for patients. With unique expertise in metallochemistry and manufacturing, translational research and rapid and efficient early-stage clinical development, Bold Therapeutics is actively seeking additional preclinical-stage metal-based therapeutics to in-license, develop and commercialize."

In parallel, Bold Therapeutics is actively seeking global development partners to support two additional parallel Phase 2 studies: (1) BOLD-100 in combination with a proteasome inhibitor (e.g. Takeda’s Velcade (bortezomib) or Amgen’s Kyprolis (carfilzomib)) in the treatment of multiple myeloma; and (2) BOLD-100 in combination with a standard-of-care agent in the treatment of bladder cancer. Compelling preclinical data supporting these development initiatives is available under confidentiality.