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Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers

Vancouver BC - March 1, 2022- Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that  they have successfully completed the Phase 1b (dose-escalation) portion of its seamless adaptive oncology trial  of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers (colorectal,  pancreatic, gastric and bile duct). 

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  solid and liquid cancers and in combination with a wide range of existing anti-cancer therapies. The FDA  previously granted BOLD-100 Orphan Drug Designations (ODDs) in both Gastric and Pancreatic cancers, and  Bold Therapeutics anticipates leveraging clinical data from the Phase 1b portion of its trial for one or more  Breakthrough Therapy Designations (BTDs) in 2022. 

The Phase 1b data – which Bold Therapeutics anticipates presenting at an upcoming cancer conference – indicate that (1) BOLD-100 can be safely combined with FOLFOX chemotherapy at a dose of 625 mg / m2 (the highest dose level tested), with no new Grade 3 or 4 treatment-emergent adverse events; and (2) patients can safely remain on treatment for an extended number of treatment cycles. Based on this strong safety and tolerability profile, the Study Steering Committee unanimously endorsed proceeding immediately into the Phase 2 (dose-expansion) portion of the study. 

“Completing our Phase 1b trial with a strong safety profile for BOLD-100 is a significant achievement for Bold  Therapeutics – and while it is too early to say anything definitive, preliminary efficacy data is undoubtedly  encouraging,” said Jim Pankovich, EVP, Clinical Development. “Despite substantial headwinds from the ongoing  COVID-19 pandemic, we were nevertheless able to successfully enroll and treat patients at our six clinical sites  in Canada, and I wish to recognize the patients for their contribution to this study as well as the persistent and  resilient efforts of our investigators.” 

The Phase 2 (dose-expansion) portion of the seamless adaptive trial of BOLD-100 will enroll 80 additional  patients at 13 investigational sites worldwide: 6 sites in Canada; 2 sites in the U.S.; and 5 sites in South Korea.  Interim and complete Phase 2 data is expected by year-end 2022 and late 2023, respectively.

“As BOLD-100 advances into Phase 2, Bold Therapeutics crosses another significant value inflection point,”  stated Glenn Walthall, Chief Investment Officer of Gaston Capital and Chairman of the Board of Bold  Therapeutics. “As Bold Therapeutics’ largest institutional investor, we are encouraged with the results that  we’ve seen thus far and optimistic that BOLD-100 may significantly improve outcomes in these difficult-to-treat  cancers that are often refractory to conventional treatment options. Consistent with preclinical observations, a  number of patients in the study who had previously failed on FOLFOX alone suddenly responded when BOLD 100 was added to the treatment regimen – a result that can only be described as remarkable.” 

Bold Therapeutics executed a regional option agreement with Hana Pharm in South Korea in 2020 and is  actively seeking development partners in other territories. Bold Therapeutics is also seeking investors for a  data-driven institutional Series B round to be closed later in 2022, likely concurrent with interim Phase 2 results. 

“I am exceptionally proud of the agile and industrious Bold Therapeutics team without whom this success would  not be possible,” added E. Russell McAllister, CEO of Bold Therapeutics. “Through innovative programs like NRC IRAP, the Canadian government has provided Bold Therapeutics with substantial support in advancing our  scientific understanding of BOLD-100 that not only allowed us to advance in the treatment of gastrointestinal cancer indications, but also opened up promising areas for future development. As a result, they share this win  with us. The strong results from this Phase 1b trial and the overall accumulation of data on BOLD-100 continue  to excite support for the development of this innovative therapeutic for patients with a wide range of advanced  cancers. 

Additional information on this study is available at For more information, please visit the Company’s website at 

Source: Bold Therapeutics Inc.  

Contact: E. Russell McAllister, CEO 

(604) 262-9899