Insight Database

On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022.

Image source: Enterprise official website

EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2.

In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates.

On July 28, 2022, Jushi Biology, a subsidiary of Shijiazhuang Pharmaceutical Group, and Elevation Oncology anti Claudin 18.2 antibody drug conjugate SYSA1801 entered into an exclusive licensing agreement for the development and commercialization of the drug conjugate outside the Greater China region (including Chinese Mainland, Hong Kong, Macao and Taiwan).

Shiyao Giant Stone Biotechnology will receive a down payment of $27 million and has the right to receive up to $148 million in potential development and regulatory milestone payments, as well as up to $1.02 billion in potential sales milestone payments. Shiyao Giant Stone Biotechnology also has the right to charge a sales commission of up to double-digit percentage based on the annual net sales of the product in the region. Shiyao Giant Stone Biotechnology reserves all rights to this product in the Greater China region.

According to the Insight database, Shijiazhuang Pharmaceutical Group has launched Phase I clinical application of the drug for pancreatic cancer and gastric cancer in China (NCT05009966); Elevation launched Phase I clinical trials of the drug in patients with gastric cancer, esophageal cancer and pancreatic cancer in the United States and Japan (NCT05980416).