Boundless Bio’s freshman year on the public markets hasn’t been easy, with “modest” layoffs in the summer followed by news this week that the company is dropping a clinical-stage candidate and shaking up its C-suite.
After reviewing data from the first part of a phase 1/2 trial of its oral RNR inhibitor BBI-825, the extrachromosomal DNA biotech said it has made the “strategic decision” not to continue with the trial. The drug has been “generally well-tolerated” in the colorectal cancer study, the company pointed out in a postmarket release Dec. 12.
“Following an assessment of preliminary pharmacokinetic data from the part 1 portion of the trial showing a lack of dose-proportional exposure, and the increasing complexity and associated development costs related to the evolving BRAFV600E and KRASG12C mutated cancer treatment landscape, Boundless has made the strategic decision not to continue dose escalation of part 1 or to proceed into the part 2 portion of the STARMAP trial,” the company explained.
This pipeline change is combined with a C-suite shakeup that will see Chief Medical Officer Klaus Wagner, M.D., Ph.D., and Chief Business Officer Neil Abdollahian leaving the company. James Freddo, M.D., a current adviser to Boundless, will step in as interim chief medical officer while the biotech searches for a permanent replacement.
Top of Boundless’ priority list remains the CHK1 inhibitor BBI-355, with a phase 1/2 trial in patients with oncogene-amplified solid tumors still on track to read out in the second half of 2025.
“With this strategic decision, we are prioritizing resource allocation to BBI-355, which remains on-track for initial clinical proof-of-concept data in 2025, and our novel ecDTx 3 program, where we’ve made substantial preclinical progress and expect to nominate a development candidate by mid-2025,” CEO Zachary Hornby said in yesterday’s release.
“It also extends our operating runway into 2027, well beyond the anticipated milestones for both BBI-355 and ecDTx 3,” Hornby added.
Boundless, which has described itself as “the world’s leading ecDNA company,” went public via a $100 million IPO in March. But, within five months, the biotech had already run into issues, blaming “lower than originally projected” enrollment in the BBI-355 study for its decision to “streamline our operations.”
In practice, this meant narrowing the company’s discovery work and “modestly” reducing its head count by less than 15 employees, representing just under 20% of the biotech's workforce.