Early data from Bold Therapeutics’ BOLD-100 mCCR to be presented at the 2022 Gordon Research Conference on Metals in Medicine

VANCOUVERBC , June 24, 2022 /PRNewswire/ — Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that it will participate in the Metals in Medicine Gordon research conference focused on advancing the use of metal-based compounds and nanotheranostics for the personalized medicine. The conference will take place at Andover, New Hampshire of June 26 to July 1, 2022bringing together over 150 academic, industry and government experts.

Adam Carie, director of CMC & Nonclinical Development, will present on behalf of Bold Therapeutics in the “Clinical Advances for Metals in Medicine” session. He is joined by Shane HarrypersadPrincipal Scientist, CMC.

This presentation will include previously embargoed data (presented below) recently presented at the 2022 American Society of Cancer Oncology (ASCO) Annual Meeting during a session titled “BOLD-100-001 (TRIO039): A phase 1b Dose Escalation Study of BOLD-100 in Combination with FOLFOX Chemotherapy in Patients with Advanced Gastrointestinal Solid Cancers: Intermediate Safety, Tolerability, and Efficacy.” In addition to demonstrating that BOLD-100 was safe and generally well tolerated , these data showed remarkable results in the treatment of 3rd treatment-resistant metastatic colorectal cancer (mCRC) online or later in combination with FOLFOX – including in patients who had previously failed FOLFOX alone. In the first six patients, progression-free survival (PFS) significantly exceeds the expected PFS for this patient population, easily exceeding current best approved therapies for 3rd mCRC, Stivarga® from Bayer (regorafenib) and Lonsurf from Taiho (trifluridine and tipiracil).

Although only the first phase efficacy data 1b part of the study was available for presentation at ASCO, the colorectal arm of the BOLD-100-001 Phase 2 trial has since been fully recruited (N=22) and Bold Therapeutics expects to announce data from additional efficacy in mCRC by the end of the year.

Bold Therapeutics’ BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) modifies the unfolded protein response (UPR) through the selective inhibition of GRP78; and (2) induces reactive oxygen species (ROS) which cause DNA damage and cell cycle arrest. Collectively, these effects drive cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to dramatically improve outcomes in a wide range of solid and liquid tumors in combination with other cancer therapies ranging from chemotherapies traditional to targeted therapies via immunotherapies. – oncology agents. BOLD-100 is currently being studied in a multinational Phase 2 trial in the treatment of advanced gastrointestinal cancers that is actively recruiting at 13 clinical sites: six in Canada; two in the United States; and five in South Korea.

“Bold Therapeutics is thrilled to present these remarkable results at the Gordon Research Metals in Medicine conference, showcasing the cutting-edge multidisciplinary work done at VancouverBold Therapeutics,” Dr. Carie noted. “With our well-advanced Phase 2 clinical trial at the sites of Canada, United Statesand South Korea, we are excited to partner with other leaders in the development of metal-based oncology therapies to improve patient outcomes. With unique expertise in metallochemistry and manufacturing, translational research, and rapid and efficient early-stage clinical development, Bold Therapeutics is actively pursuing additional preclinical-stage metal-based therapies to acquire, develop, and commercialize. »

In parallel, Bold Therapeutics is actively seeking global development partners to support two additional parallel Phase 2 studies: (1) BOLD-100 in combination with a proteasome inhibitor (e.g. Takeda’s Velcade® (bortezomib) or Kyprolis® d ‘Amgen (carfilzomib)) in the treatment of multiple myeloma; and (2) BOLD-100 in combination with a reference agent in the treatment of bladder cancer. Compelling preclinical data in support of these development initiatives is available confidentially.

For more information about Bold Therapeutics, please visit: https://www.bold-therapeutics.com/

For more information on the Gordon Research Conference, please visit:
https://www.grc.org/metals-in-medicine-conference/2022/

Contact:
E. Russell McAllisterCEO
(604) 262-9899
[email protected]

SOURCE Bold Therapeutics Inc.

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