Boundless Bio (BOLD) Announces Pipeline and Leadership Updates

Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced updates to its portfolio of ecDNA directed therapy (ecDTx) programs and to its executive leadership team.

Pipeline Updates
Boundless announced the following updates to its portfolio of novel ecDTx programs for a range of aggressive and difficult-to-treat cancer indications:

• Initial clinical data readout for BBI-355 on track for the second half of 2025: 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.
• Decision not to advance BBI-825 into Part 2 portion of STARMAP trial: 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 BRAF^V600E or KRAS^G12C 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 BRAF^V600E and KRAS^G12C 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.
• Third ecDTx program advances, with development candidate nomination expected by mid-2025: 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.

Leadership Transitions
Boundless also announced that Klaus Wagner, M.D., Ph.D., Chief Medical Officer (CMO), and Neil Abdollahian, Chief Business Officer (CBO), will depart the company at the end of December and in early January, respectively. James L. Freddo, M.D., current advisor to Boundless with nearly 30 years of clinical leadership experience in biopharmaceutical companies, will serve as Interim CMO while the company conducts a search for a permanent hire. Dr. Freddo’s extensive background includes serving as CMO and later as a member of the board of directors at Ignyta, Inc., CMO and Senior Vice President, Development at Anadys Pharmaceuticals, and Vice President, Clinical Development, Oncology at Pfizer. Boundless does not intend to appoint a new CBO at this time.

“After a thorough assessment of BBI-825’s emerging clinical data and anticipated development costs, particularly amid the dynamic and increasingly competitive landscape of BRAF^V600E and KRAS^G12C-mutated cancer treatment, we have decided not to advance the STARMAP trial. We are grateful to our team members, patients, and investigators who contributed to the BBI-825 program,” said Zachary Hornby, President and CEO of Boundless Bio. “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. It also extends our operating runway into 2027, well beyond the anticipated milestones for both BBI-355 and ecDTx 3.”

Mr. Hornby added, “At Boundless, we are seeking to improve outcomes for high unmet need oncogene amplified cancer patients by tackling complex challenges in cancer biology. I would like to sincerely thank both Klaus and Neil for their instrumental contributions to that work over the past several years and wish them well as they move to their next professional chapters. Looking ahead, we remain diligently focused on delivering meaningful outcomes for patients and other stakeholders and look forward to reporting on our progress in 2025.”

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