NKP-1339

VANCOUVER, BC, June 3, 2024 /PRNewswire/ -- Bold Therapeutics, the world leader in the development of novel metallotherapeutics, announced positive Phase 2 safety and efficacy results for the company's lead asset BOLD-100 in the treatment of advanced metastatic biliary tract cancer (BTC) and gastric cancer (GC) at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL. This follows positive Phase 2 results in the treatment of advanced colorectal cancer presented at the 2024 ASCO Gastrointestinal Cancers Symposium in January. Continue Reading ASCO 2024 BTC and GC data from Bold Therapeutics' ongoing multinational Phase 2 clinical trial (NCT04421820) of BOLD-100 in combination with standard-of-care FOLFOX in the treatment of patients with advanced gastrointestinal cancers at sites in Canada, the United States, Ireland, and South Korea was presented as Abstract #4115 (Poster Board #95) "A Phase 2 Study of BOLD-100 in combination with FOLFOX chemotherapy in patients with pretreated advanced biliary tract cancer: efficacy and safety analysis" and Abstract #4059 (Poster Board #39) "A Phase 2 Study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastric cancer: efficacy and safety analysis", respectively, in the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary session on June 1, 2024, from 1:30 – 4:30PM CDT. BTC Efficacy and Safety: 18 out of 22 patients treated were eligible for efficacy evaluation; Median progression-free survival (PFS) of 6.0 months [95% CI: 3.8 – 10.0] and median OS of 7.3 months [95% CI: 4.5 – 13.0], which compares extremely favorably with standard-of-care outcomes; One patient (n=1) achieving a partial response (PR) for an objective response rate (ORR) of 6% [95% CI: 1.0, 23.0], fourteen (n=14) patients with stable disease (SD), and disease control rate (DCR) of 83% [95% CI: 62.0, 95.0]; Patients received a median of 4 cycles (range: 1 – 41) of therapy; and For all treated patients (n=21), 21 had ≥ 1 TRAEs, most commonly neutrophil count decrease (n=10, 46%), nausea (n=8, 36%), fatigue (n=7, 32%), peripheral-sensory neuropathy (n=6, 27%), and pyrexia (n=6, 27%). GC Efficacy and Safety: 18 out of 21 patients treated were eligible for efficacy evaluation; Median progression-free survival (PFS) of 4.2 months [95% CI: 2.8 – 7.1] and median OS of 7.9 months [95% CI: 4.8 – 15.0], which compares extremely favorably with standard-of-care outcomes; Two patients (n=2) achieved a partial response (PR) for an objective response rate (ORR) of 11% [95% CI: 2.0, 31.0], eleven (n=11) patients with stable disease (SD), and disease control rate (DCR) of 72% [95% CI: 49.0, 89.0]; Patients received a median of 6 cycles (range: 1 – 27) of therapy; and For all treated patients (n=21), 19 patients had ≥ 1 TRAEs, most commonly neutrophil count decrease (n=7, 33%), nausea (n=6, 29%), and peripheral-sensory neuropathy (n=4, 19%), with most AEs being grade 1-2. "Driven by our dedicated and talented employees and supported by generous grants and subsidies from the government of Canada, BOLD-100 continues to exceed expectations," added E. Russell McAllister, CEO. "On top of the robustly positive Phase 2 clinical data presented at both ASCO and ASCO GI, Bold Therapeutics expects to announce intriguing nonclinical data later this year, specifically biomarker data that we think will generate significant excitement amongst both clinicians and scientists as we disrupt commonly held perceptions about how to safely and effectively treat some of the most difficult-to-treat solid tumor indications where existing therapies are largely ineffective." Later this month, Bold Therapeutics expects to begin enrolling patients into a multinational Phase 2 randomized clinical trial comparing two different doses of BOLD-100 in combination with standard-of-care FOLFOX against standard-of-care FOLFOX in patients with second-line FOLFOX-naïve colorectal cancer. Based on prior results, we expect to see significant improvements in both safety and efficacy outcomes. In addition, Bold Therapeutics is currently manufacturing drug product to support a pivotal Phase 3 trial in advanced colorectal cancer. For more information, please visit the Company's website at Source: Bold Therapeutics Inc. Contact: E. Russell McAllister, CEO +1 (604) 262-9899 [email protected] SOURCE Bold Therapeutics Inc.

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.