MAINZ, Germany I July 22, 2014 I Ganymed Pharmaceuticals AG, a biopharmaceutical company developing Ideal Monoclonal Antibodies (IMABs) for the treatment of cancer, announced today that it has completed recruitment of 210 patients for its Phase 2 FAST clinical trial to evaluate the combination of IMAB362 and chemotherapy as first-line therapy in patients with gastroesophageal cancer (GEC). Top line results from this trial are expected end 2015/early 2016.
“Completion of recruitment of this clinical trial represents a key achievement towards our mission of providing cancer patients with safe and effective new therapies. 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% of GEC tumors, but is not targetable in healthy cells,” said Dr. Özlem Türeci, Chief Executive Officer of Ganymed.
“I would like to thank every patient who is participating in this study as well as congratulate all our investigators and clinical sites for completing recruitment on time. The Ganymed team did an excellent job,” added Prof. Rolf Krebs, Chairman of the Supervisory Board.
Details of Phase 2 FAST Clinical Trial
The randomized three-arm Phase 2 FAST (First-line treatment of patients with CLDN18.2-positive advanced Adenocarcinomas of the STomach, the esophagus or the gastroesophageal junction) clinical trial aims to evaluate the efficacy and safety of IMAB362 in combination with the chemotherapy agents epirubicin, oxaliplatin, and capecitabine (EOX) in 210 patients with CLDN18.2-positive, advanced, unresectable, recurrent or metastatic GEC. CLDN18.2 expression in patients is being determined using Ganymed’s Claudetect™18.2 diagnostic test. The primary endpoints are progression-free survival and safety of IMAB362 in combination with EOX while median overall survival, time to progression, and objective tumor response rate are among the secondary endpoints. For more details on this trial, see www.clinicaltrials.gov/ct2/show/NCT01630083.
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 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 in non-hematological cancers 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.
About Ganymed Pharmaceuticals AG
Ganymed Pharmaceuticals AG is a biopharmaceutical company with the mission of revolutionizing cancer treatment by developing a new class of therapeutic drugs called Ideal Monoclonal Antibodies (IMABs). IMABs are unique in that they are highly selective for proteins which are present on tumor cells, but do not bind to healthy cells. This unmatched tumor cell specificity makes IMABs cancer cell selective allowing them to efficiently kill tumor cells without harming normal healthy tissues. They can thus be administered at optimal dose and have a broad therapeutic window with reduced risks of side effects.
Ganymed’s lead program, IMAB362, is in advanced Phase 2 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 1/2 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.
SOURCE: Ganymed Pharmaceuticals
Post Views: 227
MAINZ, Germany I July 22, 2014 I Ganymed Pharmaceuticals AG, a biopharmaceutical company developing Ideal Monoclonal Antibodies (IMABs) for the treatment of cancer, announced today that it has completed recruitment of 210 patients for its Phase 2 FAST clinical trial to evaluate the combination of IMAB362 and chemotherapy as first-line therapy in patients with gastroesophageal cancer (GEC). Top line results from this trial are expected end 2015/early 2016.
“Completion of recruitment of this clinical trial represents a key achievement towards our mission of providing cancer patients with safe and effective new therapies. 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% of GEC tumors, but is not targetable in healthy cells,” said Dr. Özlem Türeci, Chief Executive Officer of Ganymed.
“I would like to thank every patient who is participating in this study as well as congratulate all our investigators and clinical sites for completing recruitment on time. The Ganymed team did an excellent job,” added Prof. Rolf Krebs, Chairman of the Supervisory Board.
Details of Phase 2 FAST Clinical Trial
The randomized three-arm Phase 2 FAST (First-line treatment of patients with CLDN18.2-positive advanced Adenocarcinomas of the STomach, the esophagus or the gastroesophageal junction) clinical trial aims to evaluate the efficacy and safety of IMAB362 in combination with the chemotherapy agents epirubicin, oxaliplatin, and capecitabine (EOX) in 210 patients with CLDN18.2-positive, advanced, unresectable, recurrent or metastatic GEC. CLDN18.2 expression in patients is being determined using Ganymed’s Claudetect™18.2 diagnostic test. The primary endpoints are progression-free survival and safety of IMAB362 in combination with EOX while median overall survival, time to progression, and objective tumor response rate are among the secondary endpoints. For more details on this trial, see www.clinicaltrials.gov/ct2/show/NCT01630083.
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 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 in non-hematological cancers 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.
About Ganymed Pharmaceuticals AG
Ganymed Pharmaceuticals AG is a biopharmaceutical company with the mission of revolutionizing cancer treatment by developing a new class of therapeutic drugs called Ideal Monoclonal Antibodies (IMABs). IMABs are unique in that they are highly selective for proteins which are present on tumor cells, but do not bind to healthy cells. This unmatched tumor cell specificity makes IMABs cancer cell selective allowing them to efficiently kill tumor cells without harming normal healthy tissues. They can thus be administered at optimal dose and have a broad therapeutic window with reduced risks of side effects.
Ganymed’s lead program, IMAB362, is in advanced Phase 2 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 1/2 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.
SOURCE: Ganymed Pharmaceuticals
Post Views: 227
