Ganymed's IMAB362 Shows Strong Evidence of Single-Agent Activity in Phase IIa Trial in Gastroesophageal Cancer

Trial Results Demonstrate Safety and Therapeutic Benefits of Antibody

(PresseBox) ( Mainz, Germany, )
Ganymed Pharmaceuticals AG announced today that its Ideal Monoclonal Antibody IMAB362 demonstrated significant safety and therapeutic benefits in a Phase IIa trial in gastroesophageal cancer (GEC). The trial involved 54 patients who had exhausted all other therapeutic options.

"This study establishes IMAB362's high potential as novel treatment for patients with advanced gastroesophageal cancers," commented Professor Martin Schuler, West German Cancer Center, Essen, who coordinated the study. "The clinical activity seen in this heavily pretreated study population is very promising for an antibody monotherapy."

In the trial, patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced GEC (NCT01197885) received 600 mg/m2 IMAB362 as a monotherapy every 2 weeks for 5 cycles. Final analyses indicate that partial response and stabilization of disease was achieved following IMAB362 treatment. A per protocol set of 21 patients showed a Disease Control Rate of 48%: Of these patients, 19% underwent partial remission and 29% achieved stable disease state according to the Response Evaluation Criteria In Solid Tumors (RECIST).

The median Progression Free Survival (PFS) was 102 days (95% CI), ranging from 70 to 146 days. Patients with clinical benefits had a median PFS of 262 days as compared to a median PFS of 70 days for patients with disease progression. Nine patients continued treatment beyond 5 cycles due to clinical benefit and one patient has been benefiting from treatment for over 16 months.

IMAB362 was safe and well tolerated during the study with nausea and vomiting being the most frequent drug related adverse event.

"I find it exciting that even as single agent, IMAB362 brought therapeutic benefits to patients to whom we have no other therapeutic options to offer," said Professor Emeritus Christoph Huber, Co-founder and Supervisory Board member of Ganymed. "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."

About IMAB362

IMAB362 is a first-in-class antibody that is selective and specific for the tight junction protein CLDN18.2. This unique target is present only on differentiated cells of the stomach mucosa and is absent from all other healthy tissues. CLDN18.2 is however expressed in up to 80% of gastrointestinal adenocarcinomas, 60% of pancreatic tumors as well as in subsets of lung, ovarian and bile duct cancers. This makes IMAB362 the first antibody that is cancer cell selective while having little or no effect on healthy cells, thus reducing the risk of side effects. This represents a great advantage over other anticancer therapies that target both cancerous and healthy cells resulting in unwanted side effects.

About Gastroesophageal Cancer

More than a million individuals worldwide are diagnosed with gastroesophageal cancer each year. The majority of cases are diagnosed at an advanced stage which drastically reduces the effectiveness of current therapies resulting in a five year survival rate of less than 25%. Major unmet medical needs include lack of safe and effective systemic first-line therapy, poor control of metastatic tumors and a complete absence of second-line treatment options. Consequently, the need for earlier diagnosis and more effective therapies is extremely high.
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