Innovation ADC Therapy for Breast Cancer with Remission Rate over 50%

1. Innovation ADC Therapy for Breast Cancer with Remission Rate over 50% www.creative-biolabs.com/adc

2. 01 Background Recently, Daiichi Sankyo announced its clinical safety and efficacy data based on a long-term I phase clinical trial for 241 HER2-positive breast cancer patients. These results were announced at the 2018 American Society of Clinical Oncology (ASCO) annual meeting. About one-fifth of breast and gastric cancers have overexpressed HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of certain invasive cancer cells. After the progression of many HER2-positive tumors, some existing approved therapies have been unable to continue to effectively control the disease and have not been available after treatment with trastuzumab, pertuzumab, and T-DM1. The standard of care for HER2-positive tumors. These patients are faced with unmet medical needs.

3. 02 What is DS-8201 DS-8201 is the first Tri-Commercial primary ADC product. ADC is a type of cancer targeting drug that can deliver cytotoxic chemotherapy (payload) to cancer cells by attaching monoclonal antibodies that bind to specific targets on cancer cells. The DS-8201 is designed with the first three proprietary ADC technologies and is a smart chemotherapy solution. It connects a humanized HER2 ADC antibody to a novel topoisomerase I inhibitor payload through a four-tire ADC linker. Compared to traditional chemotherapy, it can target and deliver chemotherapy within cancer cells, thereby reducing systemic exposure to cytotoxic payload (or chemotherapy).

4. 03 Phase 1 study The Phase 1 study announced this time is a two-part open-label study evaluating the efficacy of DS-8201 in patients with advanced/unresectable or metastatic solid tumors who are resistant or intolerant to standard treatment. The primary end point of this study dose escalation phase was the safety and tolerability of DS-8201 and the determination of the maximum tolerated dose. The results of this update are as follows. A subgroup analysis of 34 patients with HER2 low-expressing metastatic breast cancer showed that the overall response rate (ORR) was 50.0% and the disease control rate was 85.3% in patients using DS-8201; A subgroup analysis of 99 HER2-positive metastatic breast cancer patients treated with T-DM1, trastuzumab, and pertuzumab demonstrated an ORR of 54.5% with DS-8201 and a disease-free rate of 93.9. %; The remission and disease control of DS-8201 was also observed in HER2-positive gastric cancer and other solid tumors including colorectal cancer and non-small-cell lung cancer.

5. What is DS-8201 DS-8201 is the first Tri-Commercial primary ADC product. ADC is a type of cancer targeting drug that can deliver cytotoxic chemotherapy (payload) to cancer cells by attaching monoclonal antibodies that bind to specific targets on cancer cells. The DS-8201 is designed with the first three proprietary ADC technologies and is a smart chemotherapy solution. It connects a humanized HER2ADC antibodyto a novel topoisomerase I inhibitor payload through a four-tire ADC linker. Compared to traditional chemotherapy, it can target and deliver chemotherapy within cancer cells, thereby reducing systemic exposure to cytotoxic payload (or chemotherapy).

6. The Professional Said: "These latest results further support the extensive and comprehensive R&D projects we are conducting to explore the potential of DS-8201 in HER2 low-expression breast cancer, which represents approximately half of breast cancer, and at the same time explore the potential of DS-8201 in HER2 positive for metastatic breast cancer, of which the medical need for this type of cancer have not yet been met,” said Dr. Antoine Yver, executive vice president and global head of the First Triad’s Cancer R&D Department. “We are conducting the key to HER2-positive metastatic breast cancer. Phase 2 trial and a phase 3 trial in HER2 low expression and HER2-positive metastatic breast cancer are planned to determine whether the use of DS-8201 intelligent delivery of chemotherapy is an effective treatment option for breast cancer with different levels of HER2 expression. A similar phase 2 study of DS-8201 is also being conducted in gastric cancer and colorectal cancer."

7. The Professional Said: "HER2-targeted therapy has historically been ineffective in treating metastatic breast cancer with low levels of HER2 ADC expression," said Dr. Hiroji Iwata, deputy director of breast cancer at the Aichi Cancer Center Hospital. "Although HER-2 results in the expression subgroup also need to be further confirmed in a larger clinical setting, but preliminary data are interesting because we may need to start rethinking how to use HER2 as a cell surface target in the precise treatment of metastatic breast cancer."

8. Established in 2004, Creative Biolabs is highly specialized in advanced antibody biochemistry and engineering, including ADC customs products. With more than a decade of exploration and expansion, our current research and service capacity covers the entire new drug discovery and antibody conjugation service, which ranges from early discovery, pre-clinical evaluations, cGMP manufacturing, dar conjugation to clinical trials. As an international cooperation, Creative Biolabs has established multiple offices all around the globe with more than 200 well-trained full-time scientists and technicians, who work closely with our customers and research partners to develop new medicines for a better, healthier world. Creative Biolabs

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