oncology · adc

BPC-402 — EGFR-mutant non-small cell lung cancer

An antibody-drug conjugate directed at HER3, delivering a topoisomerase I inhibitor payload to EGFR-mutant tumors. Phase 2 enrollment is complete and follow-up is ongoing.

phase 2 Target: Human epidermal growth factor receptor 3 (HER3) Sample data

Investigational candidate. BPC-402 has not been approved by any regulatory authority.

Mechanism of action

How the molecule works.

BPC-402 internalizes into HER3-expressing tumor cells and releases its payload intracellularly, causing double-strand DNA breaks while sparing non-HER3-expressing tissue.

Milestones

Program timeline.

  1. 2021 ADC linker validated done
  2. 2022 Phase 1 first-patient-in done
  3. 2023 Phase 1 dose expansion done
  4. 2024 Phase 2 open done
  5. 2025 Phase 2 enrollment complete current
  6. 2026 Phase 2 topline data planned

Clinical trials

2 trials for BPC-402.

NCT-BPC402-101

Phase 1 dose escalation of BPC-402 in EGFR-mutant NSCLC

Completed phase 1 40/40 enrolled
NCT-BPC402-201

Phase 2 single-arm study of BPC-402 in EGFR-mutant NSCLC

Active, not recruiting phase 2 220/220 enrolled

Publications

3 related publications.

  • Cancer Discovery 2023

    An anti-HER3 antibody-drug conjugate with activity in EGFR-mutant non-small cell lung cancer

    Shah N, Kessler D, Watanabe K, et al.

    Preclinical and early clinical characterization of BPC-402, a HER3-directed antibody-drug conjugate with a topoisomerase I payload.

    DOI: 10.1158/2159-8290.[sample]
  • Cell Chemical Biology 2022

    A structure-guided platform for the discovery of selective kinase inhibitors

    Raman A, Fischer L, Becker T, et al.

    An overview of the structure-guided discovery platform underlying the BPC-101 and BPC-305 programs.

    DOI: 10.1016/j.chembiol.[sample]
  • PNAS 2022

    Antibody and antibody-drug conjugate discovery using engineered Fc libraries

    Hoffmann P, Shah N, Watanabe K, et al.

    Description of the Fc engineering library used to discover BPC-203 and to assemble the BPC-402 linker-payload.

    DOI: 10.1073/pnas.[sample]