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About Boundless Bio Inc. (Nasdaq: BOLD)
Boundless Bio Inc. is a clinical-stage oncology company dedicated to pioneering a transformative approach to cancer therapeutics by targeting extrachromosomal DNA (ecDNA), a key driver of oncogene amplification. Oncogene amplification is observed in over 14% of cancer patients and is associated with aggressive tumor growth, resistance to existing treatments, and poor clinical outcomes. By addressing ecDNA biology, Boundless Bio aims to unlock new therapeutic possibilities for patients with oncogene amplified tumors, a population with significant unmet medical needs.
Core Focus: Targeting ecDNA
At the heart of Boundless Bio’s innovation is its proprietary ecDNA-directed therapy (ecDTx) platform. Unlike traditional cancer treatments, which often target specific mutations or pathways, Boundless Bio’s approach focuses on the unique vulnerabilities of ecDNA, which drives oncogene amplification and replication stress in cancer cells. This novel strategy positions the company as a leader in developing therapies for previously intractable cancers.
Pipeline Overview
- BBI-355: The company’s lead candidate, BBI-355, is an oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1). CHK1 plays a critical role in managing replication stress in cancer cells with ecDNA-driven oncogene amplifications. By disrupting CHK1 function, BBI-355 induces catastrophic replication stress, selectively killing cancer cells while sparing healthy cells. It is currently being evaluated in a Phase 1/2 clinical trial (POTENTIATE) for patients with oncogene amplified cancers.
- BBI-825: This second ecDTx candidate is an oral inhibitor of ribonucleotide reductase (RNR), essential for DNA synthesis and repair. BBI-825 targets ecDNA assembly and repair mechanisms in cancers with resistance gene amplifications. While initially promising, the company has strategically decided to prioritize other programs due to the competitive landscape of BRAFV600E and KRASG12C-mutated cancer treatments.
- ecDTx 3: Currently in preclinical development, this program explores a novel kinesin-based mechanism involved in ecDNA segregation. The company expects to nominate a development candidate by mid-2025, signaling continued innovation in the ecDNA space.
Diagnostic Innovation: ECHO Platform
To complement its therapeutic pipeline, Boundless Bio has developed ECHO, a proprietary diagnostic platform designed to identify ecDNA-driven oncogene amplifications in patients. This tool ensures precise patient selection for clinical trials, enhancing the likelihood of therapeutic success and paving the way for personalized cancer treatments.
Competitive Positioning
Boundless Bio operates within the highly competitive oncology therapeutics market, where it differentiates itself through its focus on ecDNA biology. This niche specialization, supported by its Spyglass platform, positions the company as a trailblazer in targeting a root cause of oncogene amplification. While challenges such as regulatory hurdles and competition from established oncology players exist, Boundless Bio’s innovative pipeline and diagnostic capabilities provide a strong foundation for long-term growth.
Market Significance
With its focus on oncogene amplified cancers, Boundless Bio addresses a critical gap in current oncology treatments. The company’s therapies have the potential to improve outcomes for patients with aggressive, treatment-resistant tumors, offering hope to a population with limited options. As the first to develop ecDNA-directed therapies, Boundless Bio is poised to redefine the therapeutic landscape for oncogene amplified cancers.
Conclusion
Boundless Bio Inc. represents a bold and innovative force in oncology, leveraging its deep expertise in ecDNA biology to develop transformative therapies for patients with high unmet needs. Through its pioneering ecDTx platform, diagnostic advancements, and strategic focus on oncogene amplified cancers, the company is well-positioned to make a lasting impact in the fight against cancer.
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company focused on extrachromosomal DNA (ecDNA) biology research for treating oncogene amplified cancers, has announced its participation in the upcoming Leerink Global Healthcare Conference.
The company's President and CEO, Zachary Hornby, will engage in a fireside chat session scheduled for March 12, 2025, at 11:20 a.m. ET in Miami, FL. Investors and interested parties can access both live and archived webcasts of the presentation through the company's website under the Events & Presentations section in the Investors area.
Boundless Bio (Nasdaq: BOLD) has appointed Robert ('Bob') Doebele, M.D., Ph.D., as Chief Medical Officer. Dr. Doebele brings over 15 years of oncology drug development experience to the clinical-stage oncology company, which focuses on extrachromosomal DNA (ecDNA) biology for treating oncogene amplified cancers.
Dr. Doebele was previously co-founder and Chief Scientific and Medical Officer at Rain Oncology (acquired by Pathos AI), where he led development of precision oncology therapies. His notable achievements include leading research at the University of Colorado that pioneered the TRK inhibitor field, contributing to the approval of Vitrakvi® and Rozlytrek®.
At Boundless Bio, Dr. Doebele will oversee the advancement of the BBI-355 Phase 1/2 POTENTIATE trial and the selection of a development candidate for the company's Kinesin program.
Boundless Bio (BOLD) announced significant updates to its pipeline and leadership team. The company has decided not to advance BBI-825 into Part 2 of the STARMAP trial due to pharmacokinetic data concerns and increasing development costs. However, enrollment continues for BBI-355's Phase 1/2 POTENTIATE trial, with initial clinical data expected in H2 2025.
The company's third ecDTx program is progressing, targeting a novel kinesin for ecDNA segregation, with development candidate nomination expected by mid-2025 and IND submission planned for H1 2026. Leadership changes include the departure of CMO Klaus Wagner and CBO Neil Abdollahian, with James L. Freddo appointed as Interim CMO. The company's operating runway has been extended into 2027.
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company focused on extrachromosomal DNA (ecDNA) biology and oncogene amplified cancers, has announced its participation in Piper Sandler's 36th Annual Healthcare Conference.
President and CEO Zachary Hornby will participate in a fireside chat on Wednesday, December 4, 2024, at 3:30 p.m. ET in New York. The session will be available via live and archived webcast through the company's website under the Investors section.
Boundless Bio (BOLD) reported Q3 2024 financial results, highlighting progress in its clinical trials. The company maintains a strong cash position of $167.1 million, providing runway into Q4 2026. Key developments include ongoing enrollment in BBI-355 POTENTIATE and BBI-825 STARMAP trials, with initial proof-of-concept data expected in H2 2025. Q3 financials show R&D expenses of $14.1M (up from $11.6M in Q3 2023), G&A expenses of $4.6M (up from $3.3M), and a net loss of $16.5M (increased from $13.2M).
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company focused on extrachromosomal DNA (ecDNA) biology for treating oncogene amplified cancers, announced its participation in the 2024 Guggenheim Global Healthcare Conference. President and CEO Zachary Hornby will participate in a fireside chat on Tuesday, November 12, 2024, at 2:30 p.m. ET in Boston, MA. The session will be available via live and archived webcast in the Investors section of the company's website under 'Events & Presentations'.
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company focused on extrachromosomal DNA (ecDNA) biology for treating oncogene amplified cancers, announced the departure of CFO Jami Rubin for personal reasons. The company does not plan to hire a successor CFO immediately. David Hinkle, Senior VP of Finance and Controller, will assume responsibility for Finance operations and the roles of principal financial and accounting officer.
CEO Zachary Hornby expressed gratitude for Rubin's contributions, particularly in the company's successful IPO and corporate strategy refinement. Rubin stated her pride in Boundless Bio's accomplishments and confidence in the company's future success, citing ongoing clinical trials for lead programs and a strong balance sheet to support their advancement.
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company focusing on extrachromosomal DNA (ecDNA) biology, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's executives, Zachary Hornby (President and CEO) and Jami Rubin (CFO), will engage in a fireside chat session on Wednesday, September 18, 2024, at 10:20 a.m. ET in New York, NY.
Boundless Bio aims to develop transformative therapies for patients with previously intractable oncogene amplified cancers. Interested parties can access a live and archived webcast of the session through the 'Events & Presentations' section of the company's website under the Investors tab.
Boundless Bio (Nasdaq: BOLD) provided business updates and Q2 2024 financial results. Key points include:
1. BBI-355 POTENTIATE trial ongoing; initial proof-of-concept data now expected in H2 2025.
2. BBI-825 STARMAP trial ongoing; initial data expected in H2 2025.
3. ECHO ecDNA diagnostic validated for use in BBI-355 trial.
4. Operations streamlined to extend runway into Q4 2026.
5. Q2 2024 financials: Cash position $179.3M, R&D expenses $14.7M, G&A expenses $4.7M, Net loss $17.0M.
The company is focusing on core ecDTx programs while scaling back early discovery efforts. Enrollment in BBI-355 combination cohorts is slower than projected, prompting initiatives to accelerate recruitment.
Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company focused on extrachromosomal DNA (ecDNA) biology, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference. President and CEO Zachary Hornby, along with CFO Jami Rubin, will represent the company in a fireside chat on June 12 at 3:20 p.m. ET in Miami, FL. The session will be available via live and archived webcast on the company’s website under the 'Events & Presentations' section.
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