BBI-940 / Boundless Bio - LARVOL DELTA

KOMODO-1: Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Boundless Bio, Inc. | N=96 ➔ 8 | Trial completion date: May 2029 ➔ Jul 2026 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2029 ➔ Jul 2026; The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal.

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • ER

POTENTIATE clinical trial of BBI-355 and BBI-825 (The Manila Times) - "In January 2026, Boundless announced its intention to cease enrollment in the Phase 1/2 POTENTIATE trial evaluating the combination of BBI-355 and BBI-825 based on market considerations, available clinical data, and prioritization of its BBI-940 program."

Enrollment closed • Pipeline update • Cervical Squamous Cell Carcinoma • Endometrial Cancer • Estrogen Receptor Positive Breast Cancer • High Grade Serous Ovarian Cancer • Leiomyosarcoma • Pancreatic Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Undifferentiated Pleomorphic Sarcoma

BBI-940 novel Kinesin degrader program (The Manila Times) - "KOMODO-1 (Kinesin Oral Molecular Degrader for Oncology-1), a first-in-human clinical trial of BBI-940 in patients with estrogen receptor positive and human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer who have progressed following treatment with a cyclin-dependent kinase 4 and/or 6 (CDK4/6) inhibitor plus endocrine therapy, as well as patients with triple-negative breast cancer luminal androgen receptor subtype (TNBC-LAR), is open for enrollment; Boundless expects to deliver initial safety and efficacy clinical proof-of-concept data within its existing cash runway timeline."

Enrollment open • First-in-human • P1 data • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Triple Negative Breast Cancer

KOMODO-1: Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Boundless Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • ER

KOMODO-1: Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer (clinicaltrials.gov) - P1 | N=96 | Not yet recruiting | Sponsor: Boundless Bio

First-in-human • New P1 trial • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • ER

FDA accepts Boundless Bio’s IND for novel cancer drug BBI-940 (Investing.com) - "The company plans to initiate KOMODO-1, its first-in-human clinical trial of BBI-940 in patients with metastatic breast cancer, in the first half of 2026. According to the press release, BBI-940 has demonstrated anti-tumor activity in preclinical studies, including tumor regressions in mouse models."

First-in-human • IND • Breast Cancer • Oncology

BBI-940 novel Kinesin program targeting ecDNA segregation and inheritance (GlobeNewswire) - "The Company expects to submit an investigational new drug (IND) application for BBI-940 and initiate a first-in-human Phase 1 clinical trial in the first half of 2026; Initial proof-of-concept clinical data are expected within the Company’s existing cash runway timeline."

IND • New P1 trial • P1 data • Oncology

Boundless Bio Announces Portfolio Prioritization and Runway Extension (GlobeNewswire) - "Declared BBI-940 as the development candidate for novel Kinesin program; IND submission on track for the first half of 2026."

IND • Oncology

Boundless Bio Reports First Quarter 2025 Financial Results and Business Highlights (GlobeNewswire) - "Boundless expects to nominate a development candidate for its preclinical program targeting a previously undrugged kinesin by mid-2025, with an investigational new drug (IND) submission planned for the first half of 2026."

IND • Pipeline update • Oncology

Boundless Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights (GlobeNewswire) - "We are on track to nominate a development candidate for our Kinesin program by mid-year, with the intention to submit an IND in the first half of 2026. We look forward to the year ahead as we continue to advance our pipeline to address the significant unmet need in patients with oncogene amplified cancers."

IND • Oncology