Boundless Bio Announces Pipeline and Leadership Updates
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 (BOLD) ha annunciato aggiornamenti significativi riguardo al suo portafoglio e al team di leadership. L'azienda ha deciso di non proseguire con BBI-825 nella Parte 2 della sperimentazione STARMAP a causa di preoccupazioni relative ai dati farmacocinetici e ai crescenti costi di sviluppo. Tuttavia, continua l'arruolamento per la sperimentazione di Fase 1/2 POTENTIATE di BBI-355, con i primi dati clinici attesi nel secondo semestre del 2025.
Il terzo programma ecDTx dell'azienda sta procedendo, puntando a una kinesina innovativa per la segregazione dell'ecDNA, con la nomina del candidato per lo sviluppo attesa entro metà 2025 e la presentazione dell'IND pianificata per il primo semestre del 2026. I cambiamenti nella leadership includono l'uscita del CMO Klaus Wagner e del CBO Neil Abdollahian, con James L. Freddo nominato come CMO ad interim. La capacità operativa dell'azienda è stata estesa fino al 2027.
Boundless Bio (BOLD) anunció actualizaciones significativas en su cartera y equipo directivo. La compañía decidió no avanzar con BBI-825 a la Parte 2 del ensayo STARMAP debido a preocupaciones sobre los datos farmacocinéticos y el aumento de los costos de desarrollo. Sin embargo, continúa la inscripción para el ensayo de Fase 1/2 POTENTIATE de BBI-355, con los primeros datos clínicos esperados para el segundo semestre de 2025.
El tercer programa ecDTx de la compañía está avanzando, apuntando a una kinesina novedosa para la segregación de ecDNA, con la nominación del candidato a desarrollo esperada para mediados de 2025 y la presentación del IND planeada para el primer semestre de 2026. Los cambios en la dirección incluyen la salida del CMO Klaus Wagner y del CBO Neil Abdollahian, con James L. Freddo nombrado como CMO interino. La capacidad operativa de la compañía se ha extendido hasta 2027.
Boundless Bio (BOLD)는 파이프라인과 리더십 팀에 대한 중요한 업데이트를 발표했습니다. 이 회사는 약리학적 데이터 문제와 증가하는 개발 비용으로 인해 BBI-825를 STARMAP 임상 시험의 2부로 진행하지 않기로 결정했습니다. 그러나 BBI-355의 1/2상 POTENTIATE 시험에는 계속 등록되고 있으며, 초기 임상 데이터는 2025년 하반기에 예상됩니다.
회사의 세 번째 ecDTx 프로그램은 ecDNA 분리를 목표로 하는 새로운 키네신을 대상으로 진행되고 있으며, 개발 후보자 지명은 2025년 중반까지 예상되고, IND 제출은 2026년 상반기로 계획되어 있습니다. 리더십 변경 사항으로는 CMO Klaus Wagner와 CBO Neil Abdollahian의 퇴사 소식이 있으며, James L. Freddo가 임시 CMO로 임명되었습니다. 회사의 운영 기간은 2027년까지 연장되었습니다.
Boundless Bio (BOLD) a annoncé des mises à jour significatives concernant son pipeline et son équipe de direction. L'entreprise a décidé de ne pas avancer BBI-825 dans la Partie 2 de l'essai STARMAP en raison de préoccupations liées aux données pharmacocinétiques et à l'augmentation des coûts de développement. Cependant, le recrutement pour l'essai de Phase 1/2 POTENTIATE de BBI-355 se poursuit, avec des données cliniques initiales attendues au second semestre 2025.
Le troisième programme ecDTx de l'entreprise progresse, visant une nouvelle kinésine pour la ségrégation de l'ecDNA, avec la nomination du candidat au développement prévue pour mi-2025 et la soumission de l'IND planifiée pour le premier semestre 2026. Les changements de direction incluent le départ de CMO Klaus Wagner et de CBO Neil Abdollahian, James L. Freddo ayant été nommé CMO par intérim. La durée d'exploitation de l'entreprise a été prolongée jusqu'en 2027.
Boundless Bio (BOLD) hat bedeutende Aktualisierungen zu seinem Portfolio und Team bekannt gegeben. Das Unternehmen hat entschieden, BBI-825 nicht in Teil 2 der STARMAP-Studie voranzutreiben, aufgrund von Bedenken hinsichtlich der pharmakokinetischen Daten und steigender Entwicklungskosten. Die Einschreibung für die Phase 1/2 POTENTIATE-Studie von BBI-355 läuft jedoch weiter, mit ersten klinischen Daten, die für das zweite Halbjahr 2025 erwartet werden.
Das dritte ecDTx-Programm des Unternehmens verläuft, mit dem Ziel, eine neuartige Kinesin für die ecDNA-Segregation zu entwickeln, wobei die Nominierung eines Entwicklungskandidaten bis Mitte 2025 und die IND-Einreichung für das erste Halbjahr 2026 geplant sind. Änderungen in der Führung umfassen den Rücktritt von CMO Klaus Wagner und CBO Neil Abdollahian, wobei James L. Freddo als interimistischer CMO ernannt wurde. Der Handlungsspielraum des Unternehmens wurde bis 2027 verlängert.
- Operating runway extended into 2027
- BBI-355 Phase 1/2 trial on track for data readout in H2 2025
- Third ecDTx program advancing with development candidate nomination expected by mid-2025
- Discontinuation of BBI-825 STARMAP trial due to poor pharmacokinetic data
- Departure of both Chief Medical Officer and Chief Business Officer
- No immediate plans to replace Chief Business Officer position
Insights
The pipeline update reveals significant strategic shifts in Boundless Bio's clinical development. The termination of BBI-825's STARMAP trial due to suboptimal pharmacokinetics and market dynamics signals a important portfolio optimization. However, the continued development of BBI-355, a CHK1 inhibitor targeting replication stress in oncogene-amplified cancers, maintains promise with data expected in H2 2025. The advancement of the novel ecDTx 3 program targeting kinesin for ecDNA segregation demonstrates pipeline diversification.
The extended cash runway into 2027 provides substantial operational flexibility through key clinical milestones. The departure of key executives and appointment of Dr. Freddo as interim CMO brings experienced leadership during this transition phase. These decisions reflect a pragmatic approach to resource allocation and pipeline management in the competitive oncology space.
The strategic realignment presents a mixed financial outlook. The discontinuation of BBI-825 development, while disappointing, conserves capital and streamlines R&D expenses. Most notably, the extended cash runway into 2027 significantly de-risks the company's financial position, covering important clinical readouts for BBI-355 and development milestones for the ecDTx 3 program. For a small-cap biotech with a
The leadership changes, particularly in CMO and CBO positions, may create near-term operational challenges but also present opportunities for cost optimization, as evidenced by the decision not to replace the CBO position. The focused approach on two key programs instead of three should improve capital efficiency and increase the probability of successful development outcomes.
Company elects not to advance BBI-825 into Part 2 portion of STARMAP clinical trial
Third ecDTx program advancing, with plans for development candidate nomination by mid-2025
Operating runway extended into 2027, through anticipated clinical readout for BBI-355 and key development milestones for third ecDTx program
Klaus Wagner, M.D., Ph.D., Chief Medical Officer, and Neil Abdollahian, Chief Business Officer, stepping down; James L. Freddo, M.D., to serve as Interim Chief Medical Officer
SAN DIEGO, Dec. 12, 2024 (GLOBE NEWSWIRE) -- 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 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.
- 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 BRAFV600E and KRASG12C-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.”
About Boundless Bio
Boundless Bio is a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics to address the significant unmet need of patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in more than
Forward-Looking Statements
Boundless Bio cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include but are not limited to: the timing of expected data readout for the Phase 1/2 POTENTIATE clinical trial, and new development candidate nomination and submission of an IND application for ecDTx 3; the sufficiency of our cash position to fund operations through anticipated initial clinical proof-of-concept data readout for the Phase 1/2 POTENTIATE clinical trial, nomination of a new development candidate and submission of an IND application for a new development candidate for ecDTx 3 and into 2027; the company’s plan to not advance the BBI-825 program; and the potential safety and therapeutic benefits of our ecDTx in treating patients with oncogene amplified cancers. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: we are early in our development efforts and our approach to discover and develop ecDTx directed against ecDNA in oncogene amplified cancers is novel and unproven; results from preclinical studies or early clinical trials not necessarily being predictive of future results; analytical validation of an ecDNA diagnostic not necessarily being predictive of its clinical validity and utility; potential delays in the commencement, enrollment, data readouts or completion of clinical trials or preclinical studies or submission of an IND; potential difficulty or delay in transitioning the CMO position and any resulting adverse impacts on our development programs or otherwise; our dependence on third parties in connection with clinical trials, preclinical studies, ecDNA diagnostic development, and manufacturing; unfavorable results from clinical trials or preclinical studies; we may expend our limited resources to pursue a particular ecDTx and fail to capitalize on ecDTx with greater development or commercial potential; unexpected adverse side effects or inadequate efficacy of our ecDTx that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory developments in the United States and foreign countries; efforts to streamline operations may not produce the efficiencies expected; we may use our capital resources sooner than we expect; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our quarterly report on Form 10-Q for the quarter ended March 31, 2024 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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FAQ
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