IM1240 / Purple Biotech - LARVOL DELTA

CAPTN-3 Tri-Specific Antibody Platform (GlobeNewswire) - "IM1240 is advancing toward first-in-human clinical trials, with IND submission and study initiation planned for 2026."

IND • New trial • Solid Tumor

Purple Biotech Achieves Manufacturing Milestone for IM1240, a Tri-Specific Antibody from the CAPTN-3 Platform (GlobeNewswire) - "Achieved commercially viable yield for IM1240, positioning the program competitively for future development. Validates scalability of the CAPTN-3 tri-specific antibody platform. IM1240, the first CAPTN-3 tri-specific antibody targeting the novel tumor-associated antigen 5T4, advances toward first-in-human clinical trials, with an Investigational New Drug (IND) submission planned for 2026."

Commercial • IND • Solid Tumor

Purple Biotech Highlights Significant Advantages of the Novel CAPTN-3 Tri-Specific Antibody Platform at the EACR 2025 Annual Congress (GlobeNewswire) - "The preclinical data demonstrate the potential of CAPTN-3 to re-invigorate exhausted T cells and efficiently kill solid tumor cells, largely attributed to the significant contribution of the unique anti-NKG2A arm...These activities are further supported by the in-vivo data demonstrating that both the NKG2A and CD3 arms contribute to the sustained tumor regression observed in mice models...Robust In Vivo Anti-Tumor Activity: The lead CAPTN-3 tribody, IM1240 (capped-CD3×5T4×NKG2A), induced sustained tumor regression in a triple negative breast cancer (TNBC) xenograft model...Additional CAPTN‑3 tribodies, such as IM1060 (CD3×5T4×NKG2D) and IM1065 (CD3×EGFR×NKG2A), demonstrated significant tumor regression, underscoring the platform’s modularity and customizable capabilities."

Preclinical • Triple Negative Breast Cancer

Purple Biotech Presents New Data for its Novel Tri-Specific T Cell and NK Cell Engagers Antibody Platform, CAPTN-3, at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "'Our Investigational New Drug (IND) enabling work is aimed to reach first in human clinical studies with our lead candidate IM1240 potentially by 2026.'...CAPTN-3 is a novel platform technology of conditionally activated tri-specific antibodies engaging both T cells and NK cells to target cancers expressing Tumor Associated Antigen (TAA)...to induce a strong and selective immune response against the tumor....The lead compound, IM1240 demonstrated high affinity binding towards CD3 & NKG2A proteins and CD3 & NKG2A expressing cells, while no binding was detected using the mutated versions of the tribody, indicating specificity. The synergistic effects of the αCD3 and αNKG2A arms in suppressing 5T4+ non-small cell lung cancer (NSCLC) patient-derived explant (PDE) at 10nM were demonstrated, emphasizing CAPTN-3’s potential advantage in a clinically-relevant biological assay. A dose-dependent effect of IM1240 was shown."

New trial • Preclinical • Oncology • Solid Tumor

Purple Biotech Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Phase 2 study of NT219 in combination with cetuximab as a 2nd Line treatment for R/M SCCHN is planned to commence in 2024....Lead asset, IM1240, expected to be ready for Phase 1 study by early 2026."

New P1 trial • New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Purple Biotech Reports Fourth Quarter and Full-Year 2023 Financial Results (GlobeNewswire) - "Purple Biotech Ltd...today announced financial results for the fourth quarter and full year ended December 31, 2023...NT219 as 2nd Line Treatment for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) Phase 2 is Planned...Recommended Phase 2 Dose achieved; Phase 2 study is planned to commence in H1 2024...In a Phase 1 dose escalation study (NCT04474470) of NT219, a first-in-class small molecule dual inhibitor of IRS 1/2 and STAT3, Purple Biotech determined 100mg/kg as the recommended Phase 2 dose for NT219 in combination with Erbitux (cetuximab) in the treatment of R/M SCCHN....The platform’s lead tribody in development, IM1240, which is expected to be ready for an Investigational New Drug (IND) filing with the U.S. Food and Drug Administration in approximately two years, targets the antigen 5T4..."

IND • Trial status • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck