Boundless Bio provides portfolio update

The company said, “Boundless announced the following updates to its portfolio of novel ecDTx programs for a range of aggressive and difficult-to-treat cancer indications: Enrollment is ongoing in Boundless’s Phase 1/2 POTENTIATE clinical trial, which is evaluating BBI-355 both as a single agent and in combination with targeted therapies for patients with oncogene-amplified solid tumors. BBI-355 is a novel, oral, and potent CHK1 inhibitor specifically designed to target replication stress in oncogene-amplified cancers. The company has reaffirmed its expectation to report preliminary clinical proof-of-concept safety and antitumor activity data in the second half of 2025. Boundless has been evaluating BBI-825, an oral RNR inhibitor, in the Phase 1/2 STARMAP clinical trial for patients with solid tumors, including those with BRAFV600E or KRASG12C mutated colorectal cancer that has developed resistance oncogene amplifications. To date, BBI-825 has been generally well-tolerated. 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. Boundless has progressed its ecDTx 3 program targeting a previously undrugged kinesin essential for ecDNA segregation and expects to select a development candidate by mid-2025. The company has reaffirmed that it expects to submit an Investigational New Drug (IND) application in the first half of 2026.”