Ganymed's first-in-class monoclonal antibody IMAB362 has been awarded orphan drug designation by the US Food and Drug Administration and European Medicines Agency for the treatment of pancreatic cancer.
IMAB362 is currently being developed by the German drugmaker, a spin off from the Universities of Mainz and Zurich, for the treatment of both gastroesophageal and pancreatic cancer.
According to the firm, the drug represents a unique opportunity to transform solid cancer treatment by benefiting a far higher proportion of patients (up to 80%) than other anticancer antibodies while mitigating treatment side effects.
This is because IMAB362 is highly selective and specific for the tight junction protein Claudin-18.2, which is over-expressed in up to 80% of gastrointestinal adenocarcinomas (primary and metastasised) and 60% of pancreatic tumours in addition to other solid cancers.
This makes it the first antibody that is cancer cell selective while having little or no effect on healthy cells, thus reducing the risk of toxicity, offering a "a great advantage over other anticancer therapies that target both cancerous and healthy cells resulting in unwanted side effects," Ganymed says.
IMAB362 has also received orphan drug designation on both sides of the Atlantic for gastric cancer and is currently in Phase II clinical development for gastroesophageal cancer.
Preliminary results of a Phase IIa safety and efficacy study in CLDN18.2 positive patients with metastatic, refractory, or recurrent advanced gastroesophageal adenocarcinomas showed a disease control rate of 48% with about 20% of patients undergoing partial remission and 28% achieving stable disease state, and the drug was found to be well tolerated.