Season 1 (2011-2020)

Completed project

(KDDF-201706-04) Phase I clinical study of HER2-positive breast cancer by an antibody-drug conjugate ALT-P7

Oncology, Protein
  • Development and Market Objectives

    Completion of clinical phase 1 trial of the best-in-class next-generation NexMabTM technology-based HER2-positive breast cancer target drug ALT-P7 with expectation to have a better anti-cancer effect than Kadcyla

     

  • Unmet Medical Need & Target Patients

    1. Unmet medical needs

     

    - Kadcyla, an antibody-drug conjugate of Trastuzumab and a cytotoxic drug maytansine for Herceptin-resistant or metastatic HER2-positive breast cancer, has high cancer cell specificity and cytotoxicity.

     

    - However, Kadcyla failed to show a significant superiority of drug efficacy compared to reference drugs in clinical trials.

     

    - Therefore, a target-specific anti-cancer drug with a broad therapeutic window that can be used for Herceptin-resistant or metastatic HER2-positive breast cancer with superior anti-cancer effect than Kadcyla is required.

     

    2. Target patients: Patients with HER2-positive breast cancer which are resistant to Herceptin (Trastuzumab) or metastasic

     

  • Current Progress

    Clinical phase I trial

     

  • Intellectual Property

    - Core technology of this project NexMabTM: patent for antibody modifications with peptide motif introduced into an antibody which is exclusively protected until 2033

     

    - Registration: Korea (2015), Japan (2016), Russia (2016), Australia (2016), United States (2017)

     

    - Under rebodyview: EU, Canada, China, Mexico, Brazil etc.

     

  • Competitive Advantages

    - Drug conjugation at a specific site of the antibody allows ALT-P7 a structural stability and low in vivo toxicity, compared to non-specifically conjugated Kadcyla.

     

    - Cleavable linker permits ALT-P7 the bystander killing effect and shows superior efficacy than non-cleavable linker-adopted Kadcyla in Herceptin-resistant in vivo models.

     

  • Disease Target

    breast cancer

  • Project duration

    2017.10.01-2020.06.30

  • Organization

    Alteogen, Inc.

  • Phase of Development

    Phase 1

  • Contact

  • Related Projects