Clinical Trials

Advancing Innovation Through Clinical Development

Clinical Trials of ANG1005

B³ Pharma is validating its Angiopep platform through ANG1005, a peptide-drug conjugate that leverages the LRP-1 receptor to cross the blood-brain barrier and target lethal brain metastases. Preclinical and clinical studies have demonstrated its safety and efficacy, paving the way for a pivotal Phase III trial in patients with high unmet medical needs.

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  • ANG1005: Proof-of-Concept of the Angiopep Platform

    ANG1005 combines Angiopep-2 and Paclitaxel with succinyl linkers, demonstrating its ability to bind the LRP-1 receptor and cross the BBB. Covered by patents until 2036, it establishes the foundation for B³ Pharma’s pipeline.

  • Clinical Validation of ANG1005

    ANG1005 has shown strong clinical results, addressing unmet needs in oncology by enabling paclitaxel to effectively reach tumor cells in the brain. Published data confirm its ability to penetrate LRP-1 expressing tissues, providing proof of clinical relevance for the platform.

  • Pivotal Phase III Trial

    Scheduled to begin in Q2 2026, this will be the first randomized trial for breast cancer brain metastases and leptomeningeal carcinomatosis under FDA Special Protocol Agreement. Focusing on HER2- patients, the trial will evaluate overall survival as the primary endpoint, with an adaptive design to optimize efficiency and reduce risk.

Clinical Development Journey

From Proof-of-Concept to Phase III

B³ Pharma is advancing ANG1005, its lead Angiopep-based conjugate, through a rigorous clinical program. From demonstrating its ability to cross the blood-brain barrier, to validating efficacy in patients, and now preparing for a pivotal Phase III trial, each milestone confirms the potential of the platform to transform brain metastases treatment.

Proof-of-Concept

ANG1005 (Angiopep-2 + Paclitaxel) showed effective BBB penetration and is protected by patents until 2036.

Clinical Validation

Phase I and II studies demonstrated targeted delivery and promising outcomes in patients with brain metastases

Regulatory Recognition

Received FDA Special Protocol Agreement (SPA) and Orphan Drug Designation for brain metastases and leptomeningeal carcinomatosis.

Upcoming Phase III

First randomized trial in HER2- patients, focused on overall survival with an adaptive design, starting in Q2 2026.