On October 14, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported that they are attending the BIO-Europe 2022 conference in Leipzig, Germany from October 24 – 26, as well as presenting at the BIO-Europe Virtual Conference from November 2 – 4 (Press release, Bold Therapeutics, OCT 14, 2022, View Source [SID1234622034]).
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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 (bile duct, colorectal, gastric and pancreatic) cancers actively enrolling at 13 clinical sites: six in Canada; two in the U.S.; and five in South Korea.
Bold Therapeutics presented initial data from this Phase 2 trial at the 2022 American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. 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. Subsequent data has both expanded and strengthened these advantages. Consequently, Bold Therapeutics expects to receive a Breakthrough Therapy Designation in the treatment of 3rd line or later treatment-resistant metastatic colorectal cancer (mCRC) and potentially other gastrointestinal cancer indications as well. Bold Therapeutics expects to present this robust data set at a major cancer conference in early 2023. In the interim, Bold Therapeutics is meeting with interested investors as well as potential development and commercialization partners and is willing to share the full clinical data set under confidentiality.