Ganymed’s IMAB362 Shows Strong Evidence of Single-Agent Activity in Phase IIa Trial in Gastroesophageal Cancer
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|Tuesday, 27 May 2014 11:30 (UTC + 2)|
Trial Results Demonstrate Safety and Therapeutic Benefits of Antibody
Mainz, Germany, May 27, 2014 / B3C newswire / - 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 Gastroesophageal Cancer
About Ganymed Pharmaceuticals AG
Ganymed’s lead program, IMAB362, is in advanced Phase II testing for gastroesophageal cancer. IMAB362 binds to the tight junction protein Claudin-18.2 which is expressed in up to 80% of gastroesophageal adenocarcinomas, 60% of pancreatic tumors as well as in other various solid tumors.
Ganymed is also developing IMAB027, a monoclonal antibody targeting Claudin-6 which is absent in healthy adult organs, but is expressed in a wide range of solid cancers, including testicular, ovarian, uterine, and lung cancers. IMAB027 is presently in Phase I/II clinical development for ovarian cancer.
Ganymed is a private company that was founded in 2001 as a spin-off from the Universities of Mainz and Zurich. Its majority shareholder is ATS Beteiligungsverwaltung GmbH. Other investors include Future Capital AG, MIG Fonds, FCPB Gany GmbH, and private individuals.
Dr. Luc St-Onge
Frank Butschbacher, CIR