On June 1, 2023 Bold Therapeutics, a clinical-stage biopharmaceutical company developing first-in-class oncology therapeutics, reported that it will be presenting positive interim results in advanced gastric and biliary tract cancer at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2-6, 2023 in Chicago, Illinois (Press release, Bold Therapeutics, JUN 1, 2023, View Source [SID1234632367]).

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These results will be presented in the Gastrointestinal (Gastroesophageal, Pancreatic and Hepatobiliary) Cancer session on June 5, 2023 from 8:00AM – 12:00PM CT as Poster 4098: "BOLD-100-001 (TRIO039): A Phase 1b/2a Study of BOLD-100 in Combination with FOLFOX Chemotherapy in Patients with Pre-Treated Advanced Gastric and Biliary Tract Cancer: Efficacy and Safety Analysis." This poster includes progression-free survival (PFS), overall survival (OS), and overall response rate (ORR) data in gastric and biliary tract cancer and expands on data in metastatic colorectal cancer presented earlier this year at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 conference. With compelling interim Phase 2 data in three different difficult-to-treat oncology indications (colorectal, gastric, and biliary tract), BOLD-100’s disruptive therapeutic potential is becoming increasingly evident.

BOLD-100 is currently being studied in a global Phase 1b/2 trial for the treatment of advanced gastrointestinal cancers, with 110 patients successfully treated to date. 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. Interim Phase 2 data in metastatic colorectal cancer presented at AACR (Free AACR Whitepaper) 2023 indicated that patients treated with BOLD-100 and FOLFOX showed a median PFS of 4.7 months, OS of 9.8 months, ORR of 13%, and DCR of 87%, substantially higher than standard-of-care data (Bayer’s Stivarga and Taiho’s Lonsurf) for a similar patient population which showed a median PFS of up to 2.0 months, OS of up to 7.1 months, ORR of up to 1.6%, and DCR of up to 44%. In addition, BOLD-100 in combination with FOLFOX proved to be exceptionally well-tolerated, with no new safety signals, and with patients remaining on therapy for up to 15 treatment cycles. Data from the full Phase 2 trial, which will include an additional 20 patients with advanced colorectal cancer, should be available in late 2023.

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.

BOLD-100 was previously granted orphan drug designations (ODDs) in gastric and pancreatic cancer and expects additional ODDs and/or breakthrough therapy designations (BTDs) expected in 2023 and 2024. Bold Therapeutics is preparing to initiate a pivotal Phase 3 trial for BOLD-100 in the treatment of advanced colorectal cancer in 2024 and is currently evaluating potentially synergistic development and commercialization partnerships to support these efforts. Concurrently, Bold Therapeutics is exploring additional development indications for BOLD-100 while also advancing its pipeline of other novel metallotherapeutics.