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KDDF-201706-04 Phase I clinical study of HER2-positive breast cancer by an antibody-drug conjugate ALT-P7(Oncology, Protein) [2019-06-24]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

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

Status

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.

Contact & Company Overview

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