Date: 2016-02-04
Type of information: Clinical research agreement
Compound: IMGN853 - mirvetuximab soravtansine and Keytruda® (pembrolizumab)
Company: Immunogen (USA - MA) Merck&co (USA
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: antibody drug conjugate/monoclonal antibody. Mirvetuximab soravtansine (IMGN853) is a FRalpha-targeting antibody drug conjugate (ADC) developed and wholly owned by ImmunoGen. It is the first and only ADC to this target to enter clinical testing, and comprises a FRalpha-binding antibody conjugated to DM4, a potent cancer-cell killing agent developed by ImmunoGen specifically for use in ADCs. The antibody serves to target the DM4 specifically to FRalpha-positive cancer cells which the DM4 can then kill. FRalpha is highly expressed on many cases of epithelial ovarian cancer, and on other types of solid tumors including endometrial cancer and some non-small cell lung cancers. Mirvetuximab soravtansine is currently being assessed for the treatment of FRalpha-positive, platinum-resistant ovarian cancer and for FRalpha-positive relapsed/refractory endometrial cancer, with additional assessments anticipated. Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It has received a Breakthrough Therapy designation for advanced melanoma, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. In November 2015, the FDA has granted Breakthrough Therapy Designation to Keytruda® for the treatment of patients with microsatellite instability high (MSI-H)metastatic colorectal cancer.
Disease: ovarian cancer
Details: * On February 4, 2016, ImmunoGen and Merck&Co announced that they have entered into a clinical research collaboration for the assessment of ImmunoGen's mirvetuximab soravtansine in combination with Merck's anti-PD-1 therapy, Keytruda® (pembrolizumab), for the treatment of patients with FR?-positive ovarian cancer. ImmunoGen is conducting a Phase 1b/2 clinical trial, FORWARD II, that evaluates mirvetuximab soravtansine for FR?-positive ovarian cancer used in doublet combination with other anticancer agents. The assessment of mirvetuximab soravtansine with Keytruda® will be added to this trial, with Merck&Co supplying Keytruda®. ImmunoGen expects this cohort to open for patient enrollment in the second half of 2016. The agreement is between ImmunoGen and Merck, through a subsidiary. The agreement includes a provision for potential expansion of the collaboration to include a subsequent Phase 3 clinical trial. Additional details were not disclosed.
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