Date: 2013-10-21
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics meeting (abstract #A73)
Company: ImmunoGen (USA) Sanofi (France)
Product: SAR566658
Action
mechanism: antibody drug conjugate. SAR566658 is an antibody drug conjugate (ADC) targeted to CA6, which is found on many cases of ovarian, breast, and other epithelial cancers. SAR566658 was created by ImmunoGen and licensed preclinically to Sanofi as part of a broader collaboration between the companies. It comprises the Company’s huDS6 CA6-targeting antibody with one of ImmunoGen’s proprietary cell-killing agents (DM4) attached using one of its engineered linkers (SPDB). In 2003, ImmunoGen, and Aventis have concluded a collaboration agreement to discover, develop, and commercialize novel antibody-based anticancer products. The agreement included the acquisition of worldwide commercialization rights to the new product candidates created by the collaboration as well as worldwide commercialization rights to three early-stage product candidates in ImmunoGen's research pipeline: a potential new treatment for the blood cancer, acute myeloid leukemia; a potential new treatment for a number of solid tumors, including breast, lung, and prostate cancers; and a potential new treatment for certain B-cell blood cancers including non-Hodgkin's lymphoma. In 2006, ImmunoGen and sanofi-aventis have entered into an option agreement that enables sanofi-aventis to gain expanded access to the Company's Tumor-Activated Prodrug (TAP) technology.
Disease: CA6-positive cancers
Therapeutic area: Cancer - Oncology
Country: France, Spain, USA
Trial details:
Latest
news: * On October 21, 2013, ImmunoGen has announced the presentation of interim data from the ongoing Phase I trial of Sanofi’s SAR566658 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics meeting (abstract #A73) being held in Boston. The data reported support that SAR566658 is generally well tolerated and can induce objective responses and sustained stable disease in heavily pretreated patients with CA6-positive cancers. The interim findings reported are from the dose-finding part of the first SAR566658 clinical trial. A total of 34 patients received SAR566658 at doses ranging from 10-240 mg/m2 (6.5 mg/kg), administered every three weeks. Overall, SAR566658 was well tolerated, with limited adverse events typically associated with cytotoxic chemotherapy (hematologic toxicity, peripheral neuropathy). Reversible ocular corneal changes were seen at the higher doses. The recommended dose for further evaluation was determined to be 190 mg/m2, and SAR566658 is now being assessed at that dose in the extension phase of the trial. Among the 20 patients who received SAR566658 at doses of 120 mg/m2 (3.2 mg/kg) or more, there were two partial responses (PR), two unconfirmed PRs, and nine with stable disease.* On July 2, 2010, a new Phase 1 trial with SAR566658, an antibody drug conjugate (ADC) targeted to CA6, was published on ClinicalTrials.gov "First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor".
