Ganymed's Reports Positive Results For Lead GEC Antibody Trial
Ganymed Pharmaceuticals reported that its Ideal Monoclonal Antibody IMAB362 showed meaningful safety and therapeutic benefits in patients with gastroesophageal cancer in a Phase IIA trial.
Fifty-four patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced gastroesophageal cancer, and with no other available therapeutic option, participated in the trial. Final analyses of the trial results suggest that treatment with IMAB362 led to partial response and stabilization of the disease. Twenty-one patients showed a Disease Control Rate of 48 percent, with 19 percent of these patients undergoing partial remission and 29 percent reaching stable disease state based on the Response Evaluation Criteria In Solid Tumors (RECIST).
Professor Martin Schuler, West German Cancer Center in Essen and study coordinator, said, “This study establishes IMAB362’s high potential as novel treatment for patients with advanced gastroesophageal cancers. The clinical activity seen in this heavily pretreated study population is very promising for an antibody monotherapy.”
Over a million people worldwide are diagnosed with GEC every year, the majority of which are diagnosed when the disease has reached an advanced state. As a consequence, therapy effectiveness is radically reduced, which results in a five year survival rate of less than 25 percent.
IMAB362 is a first-in-class antibody designed to be selective and specific for the tight junction protein CLDN18.2, which is present only on differentiated cells of the stomach mucosa. The protein is expressed in up to 80 percent of gastrointestinal adenocarcinomas and 60 percent of pancreatic tumors, while remaining absent in other healthy tissues. With CLDN18.2 as its target, IMAB362 is the first antibody to be cancer cell selective while having minimal impact on healthy cells. The antibody is undergoing advanced Phase II testing for gastroesophageal cancer.
Professor Emeritus Christoph Huber, Co-founder and Supervisory Board member of Ganymed, said that IMAB362’s demonstration of therapeutic benefits offers a promising treatment option to patients who have no other therapeutic alternative for GEC. “We are looking forward to seeing the results of the ongoing randomized Phase IIb study that includes 210 patients with gastroesophageal cancer receiving IMAB362 as first-line therapy in combination with chemotherapy. Based on preclinical data a synergistic effect of adding IMAB362 to best standard care is expected.”