NKP-1339

VANCOUVER, BC, June 24, 2024 /PRNewswire/ -- Bold Therapeutics, a clinical-stage metallotherapeutics company, has been invited to speak at the 2024 'Metals in Medicine' GRC held in Andover, New Hampshire between June 23 to 28, 2024. The conference program, Fostering Collaborations to Diagnose and Treat Diseases with Metal-Based Agents, features a variety of global speakers and academic experts targeting the most recent advancements in the field of metallotherapeutics to treat infectious diseases and cancer. Continue Reading Mark Bazett Yasmin Borutzki Mark Bazett, PhD, Sr Director of Preclinical Development at Bold Therapeutics, presented on Monday, June 24th, in the session titled: Clinical Advances for Metals in Medicine. Bazett's talk is titled, Clinical Development of BOLD-100, a Ruthenium-Based Therapeutic Currently in Phase 2 Studies for the Treatment of Advanced Gastrointestinal Cancers. Dr. Bazett presented positive Phase 2 clinical results of BOLD-100 in colorectal, biliary tract, and gastric cancers, as well as sharing updates on Bold Therapeutics' unique novel metallotherapeutic screening program and development strategy. Shane Harrypersad, PhD, Sr Scientist, CMC is also representing Bold Therapeutics at the Metals in Medicine conference. "Following the announcement of strongly positive Phase 2 results at the 2024 ASCO and ASCO GI Annual Meetings earlier this year, Bold Therapeutics' BOLD-100 is now the most advanced novel metallotherapeutic in development," stated Dr. Bazett. "The 'Metals in Medicine' conference represents an excellent opportunity for industry leader Bold Therapeutics to strengthen our existing academic collaborations as well as identify compelling new collaborations and potential metallotherapeutic development candidates from the top labs globally." In addition to presenting at the conference, Bold Therapeutics will be meeting with academic experts and key opinion leaders in the metallotherapeutic space. Yasmin Borutzki, BSc. MSc., a graduate student in the Meier-Menches Lab at University of Vienna, a close collaborator of Bold Therapeutics, presented a poster on translational research into BOLD-100 entitled: Of Mice and Men: Reverse Translation Investigation of BOLD-100's Mechanism-of-Action. For more information about Bold Therapeutics, please visit: For more information about the Gordon Research Conference, please visit: Contact: E. Russell McAllister, CEO +1 (604) 262-9899 [email protected] SOURCE Bold Therapeutics Inc.

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.