R1507 (formerly called Roche 1) is a fully human antibody created by Genmab under a collaboration with Roche. R1507 was selected from a large panel of antibodies and targets the Insulin-like Growth factor-1 Receptor (IGF-1R).  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.  Roche filed an Investigational New Drug application with the US FDA for the antibody in December 2005.

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 extrosseous 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 percent.

Ongoing Clinical Studies

Phase II Study
A Phase II study of R1507 for the treatment of recurrent or refractory sarcoma was initiated by Roche in December 2007.

Previous Clinical Studies

Phase I Results
Positive results from a Phase I study of R1507 in patients with solid tumors conducted by Genmab's partner Roche were announced in October 2007.  Nine of 34 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.

Based on these initial results, Roche plans to conduct additional trials and work with a global consortium of sarcoma experts, including the Sarcoma Alliance for Research through Collaboration (SARC).

Pre-clinical Studies

In pre-clinical studies, R1507 was shown to block binding of IGF-1 and IGF-2 and to potently inhibit IGF-1R signaling.  In addition, R1507 was found to effectively stop tumor cell growth in animal models.