Roche Releases Positive Phase I Results for R1507
COPENHAGEN, October 23 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today positive results from a Phase I study of R1507 in patients with solid tumors, conducted by its partner Roche. R1507 is a human monoclonal antibody targeting the insulin-like growth factor receptor (IGF-1R) and was developed under Roche's collaboration with Genmab.
Nine of 34 adult patients with solid tumors experienced disease stabilization when treated with R1507. Four of the seven heavily pretreated patients with Ewing's sarcoma demonstrated clinical benefit with two of these patients achieving durable, objective partial responses.
Once a week administration of R1507 was well tolerated with few side effects. The most frequently observed side effects were fatigue, anorexia and weight loss, symptoms that are commonly observed in patients with advanced cancer. A similar side effect profile was seen in 26 patients who were treated with R1507 on a three week schedule.
The results were reported during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in San Francisco, California, USA. Further details can be found at http://www.rocheusa.com.
"These are the first clinical results to be presented from an antibody developed by Genmab under our collaboration with Roche," said Lisa N. Drakeman, Ph.D. "We are pleased with these positive results and hope it may offer a potential treatment for sarcoma patients in the future."
Based on these initial results with R1507, Roche plans to conduct additional trials and work with a global consortium of sarcoma experts, including the Sarcoma Alliance for Research through Collaboration (SARC).
IGF-1 is one of the most potent natural activators of the AKT and MAPK signaling pathways, which promote cell growth and cell survival. The IGF-1R pathway has also been shown to have an important role in mediating the resistance to cytotoxic drugs and EGFR/HER2-targeted agents. The IGF-1R molecule has been shown to be important in tumor growth and protecting tumor cells from being killed. IGF-1R is over-expressed on a variety of tumors including breast, colon, prostate, lung, skin and pancreatic cancers and is a well validated target for an antibody therapeutic approach.
About Ewing's Sarcoma
The Ewing's family of tumors (EFT) includes primary tumors of bone (classic Ewing's sarcoma, primitive neuroectodermal tumor, and Askin tumor) and extraosseous primary tumors. The estimated incidence of Ewing's sarcoma in the US is approximately 300 new cases per year. More than 50 percent of patients are adolescents with a slight predominance in males. Patients who present with metastatic disease at initial diagnosis have a survival rate of approximately 25 to 30%.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using unique, cutting-edge antibody technology, Genmab's world class discovery and development teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.
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