Humanized Anti-HER2 Antibody BSI-001 used for breast cancer

Partnering objectives
Seeking a collaborative licensing opportunity with a company that has a strategic interest in the treatment of HER positive Breast Cancer and Gastric Cancer.

Field: Treatment of Breast Cancer and Gastric Cancer.

Technology and MOA
MOA: Humanized anti-HER2 antibody BSI-001 is a Herceptin Best-In-Class Booster for Next Generation Anti-Her2 Therapy. When combined with Herceptin, it exhibits more potent and higher efficacy to inhibit the proliferation of human tumor cells that overexpress HER2 than the marketed “Pertuzumab + Herceptin” Combo.

HER2 is a member of the human epidermal growth factor receptor (HER/EGFR/ERBB) family; Amplification or over-expression of this oncogene has been shown to play an important role in the development and progression of certain aggressive types of breast cancer.

The therapeutic candidate is cytotoxic to cells expressing human epidermal growth factor receptor 2 (HER2). It binds to the HER2 protein in breast cancer cells. The binding leads to antibody mediated killing of the HER2 positive cells by multiple mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), complement dependent cytotoxicity (CDC), signaling blockage, antibody mediated HER2 internalization and protein degradation.

Marketing opportunity
Breast cancer is the most commonly occurring cancer in women, accounting for 25.1% of all cancers, and the second most common cancer overall. There were over 2 million new cases in 2018. It is increasing particularly in developing countries where most cases are diagnosed in late stages and breast cancer is now the leading cause of cancer-related deaths in women in the world’s developing countries. Furthermore, in developed countries breast cancer is second to lung cancer for cancer-related deaths in women. Early diagnosis and easy access to treatment is the key for surviving.

Global sales for targeting HER2 reached $10,973 M in 2018 and estimated to reach $19,497 M in 2025, CAGR 8.5% (GlobalData).
Pertuzumab’s net present value (NPV) is estimated about 9724 million USD (GlobalData)

Differentiable treatment with potential to be first/ best in class
Biosion has developed a best-in-class Trastuzumab’s efficacy booster BSI-001 humanized anti-HER2 monoclonal antibody with more potent and higher efficacy than benchmark – “pertuzumab + trastuzumab” combination (Roche) – approved in 2013 for metastatic or locally recurrent HER2-positive breast cancer.

Indications
• Breast Cancer and Metastatic Breast Cancer

Data
Key parameters of humanized anti-HER2 monoclonal antibody BSI-001 as compared to pertuzumab:
• Binds distinct epitope different from Herceptin or Pertuzumab
• significantly improves the in vivo efficacy of Herceptin in the treatment of HER2-positive cancers as compared to Perjeta
• Shows ~2 times internalization rate than that of Herceptin or Perjeta; Significantly promotes the internalization of the HER2/Herceptin complex, thus is likely to synergize with Herceptin-ADC drugs
• Shows comparable target binding affinity as compared to Herceptin
• PK/PD studies is on-going
• Ideal candidate for best-in-class trastuzumab booster and ADC drug development

Intellectual property
PCT patent #WO 2018/127791 A2; For discussion under CDA.