NKP-1339

VANCOUVER, BC, April 5, 2024 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company at the forefront of developing innovative metallotherapeutics, has announced that Dr. Do-Youn Oh's group at Seoul National University College of Medicine, Seoul, South Korea, will be presenting at the AACR Annual Meeting, April 5-10, 2024, in San Diego, California on the use of BOLD-100 in combination with ATR (Ataxia telangiectasia and Rad3-related protein serine/threonine kinase) inhibitors as anticancer therapies for the treatment of Pancreatic Ductal Adenocarcinoma (PDAC). Continue Reading Bold Therapeutics announced Dr. Do-Youn Oh’s group at Seoul National University College of Medicine, Seoul, South Korea, will present at the AACR Annual Meeting, April 5-10, 2024, in San Diego, California on the use of BOLD-100 in combination with ATR inhibitors as anticancer therapies for the treatment of Pancreatic Ductal Adenocarcinoma (PDAC). Dr. Do-Youn Oh, MD, PhD, Seoul National University College of Medicine Bold Therapeutics' BOLD-100, a pioneering ruthenium-based small molecule, uniquely acts by (1) targeting GRP78 to modulate the unfolded protein response (UPR) and (2) generating reactive oxygen species (ROS) leading to DNA damage and cell cycle arrest. This dual action triggers cell death across a spectrum of cancer types, including those resistant to current treatments. As a result, BOLD-100 holds promise for significantly enhancing treatment outcomes in a diverse array of both solid and liquid tumors when used alongside a broad range of anticancer treatments, from conventional chemotherapies to cutting-edge targeted therapies and immuno-oncology agents. Our recent presentation at ASCO GI 2024 showcased positive Phase 2 clinical trial results in the treatment of advanced metastatic colorectal cancer (mCRC) in patients previously treated with FOLFOX / CAPOX. The data, highlighting patients treated with a combination of BOLD-100 and FOLFOX, demonstrated notable safety and clinical improvements, bolstering confidence in the therapeutic value of BOLD-100. Dr. Do-Youn Oh's group at Seoul National University College of Medicine, South Korea will be presenting a poster entitled, "Co-downregulation of GRP78 and ATR enhances apoptosis in pancreatic ductal adenocarcinoma," (Poster no. 12, Session: Cellular Stress Responses 1). This work underscores the significant impact of BOLD-100 in inducing GRP78 inhibition, which substantially triggers oxidative stress. Furthermore, when combined with ATR inhibition, this synergy effectively promotes cell death. Key Findings: BOLD-100 elevates ER stress and ROS, leading to activation of the UPR pathway and CHOP-dependent apoptosis, which inhibits PDAC growth; ROS accumulation activates the ATR-CHK1 DNA damage repair pathway, which NAC can abrogate; and The combination of BOLD-100 with the ATR inhibitor AZD6738 exhibits a synergistic effect, suggesting GRP78/ATR dual targeting as a promising therapeutic approach for PDAC. These findings unveil a compelling strategy for combinational targeting to inhibit PDAC growth. "DNA repair mechanisms play a crucial role in maintaining genomic integrity, leading to cell cycle arrest and thereby preventing the uncontrolled growth and progression of cancer cells. Our in-vitro and in-vivo findings indicate that combining BOLD-100 with ATR inhibition results in synthetic lethality against highly aggressive Pancreatic Ductal Adenocarcinoma. We are eager to delve deeper into this research path and its potential clinical utility," stated Dr. Oh. Mark Bazett, Sr Director, Preclinical Development at Bold Therapeutics added, "BOLD-100 has already demonstrated remarkable safety and efficacy in the treatment of metastatic colorectal cancer (mCRC). Diverging from the path of targeted therapies, BOLD-100's unique multi-modal mechanism-of-action opens avenues for potent combination therapies designed to tackle some of the most difficult-to-treat cancers including those resistant to standard treatments. The synergistic combination identified by Dr. Oh's group holds particular promise, and we look forward to further exploring this potential." Jim Pankovich, EVP, Clinical Development at Bold Therapeutics, and Mark Bazett, Sr Director, Preclinical Development at Bold Therapeutics, will also be attending the 2024 AACR Annual Meeting in San Diego and are available for in-person discussions related to BOLD-100. For additional details, visit Bold Therapeutics' website at or the AACR conference site at Contact: E. Russell McAllister, CEO [email protected] +1 (604) 262-9899 SOURCE Bold Therapeutics Inc.

VANCOUVER, BC, Jan. 22, 2024 /PRNewswire/ -- Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics, presented positive Phase 2 safety and efficacy data in advanced metastatic colorectal cancer (mCRC) patients treated with BOLD-100 in combination with FOLFOX previously treated with FOLFOX/CAPOX at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on January 18-20, 2024. Continue Reading Bold Therapeutics Inc. Bold Therapeutics Inc. Bold Therapeutics' BOLD-100 is a first-in-class metallotherapeutic with a unique multimodal mechanism-of-action that targets a critical replication and survival pathway common across all cancers. Interim results presented at AACR (April 2023) and ASCO (June 2023) showed robustly positive efficacy and safety results in advanced colorectal, biliary tract and gastric cancer patients. Bold Therapeutics' ongoing BOLD-100-001 (NCT04421820) study is a multinational Phase 2 clinical trial evaluating BOLD-100 in combination with standard-of-care FOLFOX (folinic acid / leucovorin, fluorouracil, and oxaliplatin) in patients with advanced gastrointestinal cancers. The trial has currently enrolled 109 patients with advanced biliary tract, colorectal, gastric, and pancreatic cancers at sites in Canada, the United States, Ireland, and South Korea. The primary endpoint for the trial is progression-free survival (PFS), with overall survival (OS) and objective response rate (ORR) as secondary endpoints. Disease control rate (DCR) was also captured. As of an August 31, 2023 data cutoff, data from 36 patients with advanced metastatic colorectal cancer was presented in clinical poster format (abstract #143) entitled "BOLD-100-001 (TRIO039): A Phase 2 Study of BOLD-100 in Combination with FOLFOX in Advanced mCRC Patients Previously Treated with FOLFOX/CAPOX: Efficacy and Safety Analysis." Key findings: Enrolled patients had a median of 4 [range 2-8] prior therapies including FOLFOX/CAPOX 67% of patients had progressive disease on prior FOLFOX/CAPOX Median progression-free survival (PFS) was 3.9 months [CI 2.7, 5.7] Median overall survival (OS) was 9.6 months [CI 6.0, 17] In 29 evaluable patients for response, the objective response rate (ORR) was 7.0%, with 2 partial responses (PR) and 20 stable diseases (SD) resulting in a disease control rate (DCR) of 76% These findings indicate a clinical benefit for patients treated with BOLD-100 in combination with FOLFOX and on all metrics compares favorably to existing treatment options for advanced metastatic colorectal cancer: Taiho's Lonsurf® (trifluridine / tipiracil), Bayer's Stivarga® (regorafenib), and Takeda's Fruzaqla® (fruquintinib). The table below compares this data against the data from the registration studies for these existing treatment options, all of which had less progressed (and thus healthier) patient populations. BOLD-100 in combination with FOLFOX continued to be well-tolerated, with no new safety signals. For all treated patients, treatment-emergent adverse events (TEAEs) were observed in 33 (92%) of patients, with the most common TEAEs as follows: neutrophil count decreases (all grade 47%, grade ≥3 42%), nausea (42%, grade ≥3 0%), and fatigue (19%, grade ≥3 0%). "Not only are we encouraged with BOLD-100's efficacy, but we are excited about BOLD-100's unexpectedly favorable safety profile, which has allowed patients to remain on treatment considerably longer than originally expected and thus maximizes the impact of the treatment combination," noted Jim Pankovich, EVP of Clinical Development. "More specifically, relatively few patients in our study experienced neurotoxicity, despite all patients having been previously treated with neurotoxicity-inducing oxaliplatin." Phase 2 safety and efficacy results in biliary tract and gastric cancer are currently available under confidentiality and will be presented publicly at a major cancer conference later this year. "Bold Therapeutics was founded in 2018 to improve patient outcomes in some of the most difficult-to-treat cancer indications and has rapidly advanced since then" added E. Russell McAllister, CEO. "We look forward to advancing BOLD-100 into late-stage studies in the near-future, initially targeting a 2027 FDA approval in advanced metastatic colorectal cancer." For more information, please visit the Company's website at Contact: E. Russell McAllister, CEO [email protected] +1 (604) 262-9899 SOURCE Bold Therapeutics Inc.