Ganymed Completes Recruitment For Phase 2 IMAB362 Cancer Trial

Biopharmaceutical firm Ganymed announced that it has completed patient enrollment for the Phase II combination trial of its investigational therapy IMAB362 for gastroesophageal cancer (GEC). This news comes shortly after Ganymed announced positive data for the antibody as a single agent in a Phase IIA trial in GEC in May.

IMAB362 is a first-in-class antibody designed to be specific and selective for the tight junction protein CLDN18.2, a unique target found only on differentiated cells of the stomach mucosa. The protein is expressed in up to 80 percent of gastrointestinal adenocarcinomas, 60 percent of pancreatic tumors, and in subsets of several other cancers. This allows the antibody to target cancerous cells while sparing the body’s healthy cells. The company received Orphan Drug status from both the FDA and EMA for the IMAB362 in October 2013.

The three-arm, randomized, Phase II FAST (first-line treatment of patients with CLDN18.2-positive advanced adenocarcinomas of the stomach, the esophagus or the gastroesophageal junction) trial will investigate IMAB362 in combination with chemotherapy agents in patients with CLDN18.2-positive, advanced, unresectable, recurrent or metastatic GEC. The trial’s primary endpoint is progression-free survival and safety. Secondary endpoints include time to progression, overall survival, and objective tumor response.

Dr. Özlem Türeci, CEO of Ganymed, said that the completion of patient enrollment is a step towards developing new therapies for GEC. “Current therapies show limited effectiveness in only a small fraction of GEC patients and are linked to side effects. By contrast, IMAB362 has the potential of benefiting a much larger segment of patients than current therapies with fewer side effects since its target is expressed in up to 80 percent of GEC tumors, but is not targetable in healthy cells.”

GEC affects more than a million people around the world every year, most of which are diagnosed at an advanced stage of cancer. The disease represents an area of unmet medical need with widespread lack of effective and safe systemic first-line therapy and zero second-line treatment options, resulting in poor control of metastatic tumors.

The company said it expects trial results at the end of 2015 or early 2016.