Beijing China, March 15, 2022 - 3D Medicines, a commercial-stage, oncology-focused Bio-pharmaceutical company, and Merck, a global leading science and technology company, today announced a partnership on clinical research. Under the collaboration, a clinical trial is designed to evaluate the combination of envafolimab, the subcutaneously injected PD-L1 antibody drug, and Erbitux® (cetuximab), an epidermal growth factor receptor (EGFR) inhibitor in the treatment of patients with RAS/BRAF wild-type, non-MSI-H/pMMR metastatic colorectal cancer (mCRC) who previously failed the treatment with fluorouracil, oxaliplatin, irinotecan and bevacizumab

Dr. Zhaolong Gong, Chairman and CEO of 3D Medicines, said, “We are delighted to have reached this clinical collaboration with Merck, a leading global science and technology company. Envafolimab is a safe, effective, and differentiated subcutaneously injected PD-L1 inhibitor. The combination of immune checkpoint inhibitors and EGFR inhibitor has shown some synergistic effects in some clinical studies. The combination of envafolimab and cetuximab, therefore, is expected to demonstrate therapeutic effects across various types of tumors. We expect the combination treatment to provide a more effective treatment option for patients with metastatic colorectal cancer.”

Rogier Janssens, Managing Director and General Manager of Merck China Healthcare, said, “Merck is committed to becoming a Global Specialty Innovator. The partnership combines the strengths of both Merck and 3D Medicines to explore the effects of combining targeted and immuno-oncology therapies with the purpose of providing better and more effective cancer treatment options for patients with mCRC in China.”

Envafolimab is the and only subcutaneously injected PD-L1 inhibitor approved for previously treated patients with advanced MSI-H/dMMR solid tumors. Meanwhile, envafolimab has demonstrated anti-tumor activity against multiple types of cancer, and it has the potential to achieve better therapeutic effect in combination with other therapies. 3D Medicines has launched a number of clinical studies to explore envafolimab-based combinations in several cancer indications, including combinations with chidamide, lenvatinib and 3D229 (a differentiated GAS6-AXL signaling pathway inhibitor) in patients with advanced solid tumors of different types.

Erbitux® (cetuximab) is a monoclonal antibody of the immunoglobulin G1 (IgG1). It specifically targets epidermal growth factor receptor (EGFR), blocks the activity of EGFR, and thereby inhibits the proliferation and invasion of tumor cells. It also exhibits antibody-dependent cell-mediated cytotoxicity, which can induce anti-tumor immune effects. In addition, cetuximab can stimulate CD8+ T cells, thus increasing the efficacy of immune checkpoint inhibitors (PD-1/PD-L1). Cetuximab has been approved in China for the treatment of RAS wild-type mCRC and for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

About Envafolimab 

Envafolimab is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology. A Co-Development Agreement was reached between 3D Medicines and Alphamab in February 2016 when Envafolimab was in pre-clinical stage. 3D Medicines has been conducting clincial trials in multiple indications in the US, China and Japan. On March 30, 2020, 3D Medicines, Alphamab Oncology, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3D Medicines is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China. 

At present, Envafolimab (KN035) is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of previously treated MSI-H/dMMR advanced solid tumors.  

About Erbitux® (Cetuximab)

Cetuximab is the IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, cetuximab targets and binds to the EGFR, which inhibits the activation of the receptor and the subsequent signal-transduction pathway, and results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. According to in vitro studies, cetuximab also achieves antitumor immune effects through antibody-dependent cell-mediated cytotoxicity (ADCC).

To date, Erbitux® has been approved in more than 100 countries/regions worldwide for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) and recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

About 3D Medicines, Inc.

3D Medicines Inc. is a commercial-stage biopharmaceutical company with a mission to help people with cancer live longer and better. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines focuses on the development of differentiated immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with both biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.

For more information, please visit http://www.3d-medicines.com

About Merck

Merck, a global leading science and technology company, operates across healthcare, life science and electronics. Around 60,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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