(KDDF-201706-04) Phase I clinical study of HER2-positive breast cancer by an antibody-drug conjugate ALT-P7
Oncology, Protein
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
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
Clinical phase I trial
- 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.
- 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.
breast cancer
2017.10.01-2020.06.30
Alteogen, Inc.
Phase 1