3D Medicines (3DMed) was founded in 2010 in Shanghai, China.
When Dr. John Gong arrived at 3DMed in 2014, the company only had preclinical drug discovery capabilities based on a platform of cancer cell bank consisting of over 1500 primary liver cancer cells, and a team of just over ten researchers.
The platform was validated when 3DMed had its first internally discovered drug candidate, 3D011, which resulted in a global PCT patent application.
In February 2016, 3DMed signed an agreement with Alphamab Co. Ltd to acquire the global rights for clinical development and commercialization of envafolimab (KN035) in oncological indications. Envafolimab is a first-in-class, novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc, formulated for subcutaneous injection owing to its high solubility.
On February 14, 2017, the first-in-human phase I study enrolled the first patient in the US. On March 1st, 2017, the first patient in China was enrolled. In August 2017, a phase I study was launched in Japan. All three phase I studies have reported initial, promising efficacy and safety results in major global conferences in 2018 and 2019.
In April 2018, 3DMed launched a randomized phase III study in advanced biliary tract cancer (BTC) in China for envafolimab, rendering envafolimab the first among PD-1/PD-L1 antibodies globally to be investigated in a randomized pivotal study for this indication.
In August 2018, a pivotal phase II study of envafolimab in previously treated, MSI-H/dMMR advanced cancers was commenced, positioning envafolimab to become the first PD-L1 antibody to be approved in China and the first subcutaneously administered PD-1/PD-L1 antibody globally to have entered a pivotal study.
In 2018, 3DMed obtained exclusive global development rights for 3D185 from Haihe Biopharma for treatment of cancer and pulmonary fibrosis. The first patient was enrolled in Q1 2019.
In the same period, following completion of its safety evaluation assessments, 3D011 has entered the process optimization and large-scale production stage.
Over the past three years, the company has attracted global talents to acquire global R&D capabilities with the establishment of a professional clinical team supported by a quality system and organisational framework for its clinical operations. Key functions including Clinical Research, Clinical Operation, Data Management and Biostatistics, IP management, Pharmacovigilance, Quality Assurance, Regulatory Affairs, Legal Affairs, and Government Affairs are all operating efficiently.
Building on the momentum, 3DMed is poised to make greater strides in bringing its innovative treatments to cancer patients by initiating registration studies globally in 2020 and beyond.