July 27, 2016 4:43 PM ET

Biotechnology

Company Overview of MORPHOTEK INC.

Company Overview

MORPHOTEK INC. researches and develops a pipeline of preclinical and clinical stage monoclonal antibodies for the treatment of ovarian cancer, nonsmall cell lung cancer, melanoma, colorectal carcinoma, sarcoma, mesothelioma, inflammatory disease, and rheumatoid arthritis. The company’s products pipeline includes Farletuzumab, an investigational humanized IgG1 antibody that targets folate receptor alpha; Amatuximab, an investigational chimeric IgG1 antibody that targets mesothelin; Ontuxizumab, an investigational monoclonal antibody that recognizes endosialin; MORAb-022, an investigational human IgG1 monoclonal antibody that is investigated for its potential in the treatment of various inflam...

210 Welsh Pool Road

Exton, PA 19341

United States

Founded in 1999

Phone:

610-423-6100

Fax:

610-423-6199

Key Executives for MORPHOTEK INC.

Co-Founder, Chief Executive Officer, President and Director
Age: 50
Co-Founder, Chief Scientific Officer and Senior Vice President of Research & Development
Chief Finance Officer and Vice President of Project Management
Vice President of Pilot Plant Operations
Compensation as of Fiscal Year 2016.

MORPHOTEK INC. Key Developments

Morphotek Announces Publication of Phase 3 Results from MORAb-003-004 Trial in Platinum-Sensitive Ovarian Cancer Patients

Morphotek Inc. announced that the results from the Phase 3 MORAb-003-004 trial were recently published in the Journal of Clinical Oncology. The MORAb-003-004 clinical trial (also known as FAR-131) was a randomized, double-blind, placebo-controlled, Phase 3, global study of the safety and efficacy of weekly farletuzumab (MORAb-003) in combination with a platinum standard chemotherapy regimen (carboplatin plus taxane) in platinum-sensitive ovarian cancer patients in first relapse. Farletuzumab is an investigational, humanized, monoclonal antibody that binds to folate receptor alpha (FRA), which is highly expressed in epithelial cancers, such as ovarian, but mostly absent from normal tissue. All subjects received carboplatin plus paclitaxel or docetaxel (for six cycles combined with randomized test product 1:1:1 farletuzumab 1.25 mg/kg, farletuzumab 2.5 mg/kg, or placebo), and single-agent test product was continued weekly until disease progression. Neither farletuzumab dose met the study's primary progression-free survival (PFS) endpoint when compared to placebo, with PFS of 9.0, 9.5 (hazard ratio [HR] = 0.99) and 9.7 months (HR = 0.86) for the placebo, farletuzumab 1.25 mg/kg, and farletuzumab 2.5 mg/kg arms, respectively. There was no difference in overall survival. Prespecified subgroup analyses demonstrated that subjects with a low CA125 level (less than three times the upper limit of normal) correlated with longer PFS (HR=0.49) and OS (HR=0.44) for farletuzumab 2.5 mg/kg versus placebo. Subjects with higher farletuzumab exposure also showed superior PFS and OS compared to placebo. CA125 is a tumor-produced protein elevated in the blood of some ovarian cancer patients that has been previously reported to reduce natural killer (NK) cell function; therefore, higher CA125 levels may interfere with the immune response associated with farletuzumab's potential activity. The most common adverse events were those known to be associated with chemotherapy, including: alopecia; nausea; neutropenia; fatigue; thrombocytopenia; and neuropathy. Based on the encouraging results from the prespecified subgroup analyses, Morphotek has initiated a Phase 2 trial, MORAb-003-011, to further investigate the potential clinical benefit observed in the MORAb-003-004 patients with a low CA125 level. This global study will assess the safety and efficacy of farletuzumab, using a modified dosing schedule guided by exposure-response analysis from the Phase 3 study, in combination with a platinum doublet in first-relapsed, platinum-sensitive ovarian cancer patients with low CA125 blood levels.

Morphotek Eliminates 27 Jobs

Morphotek announced that, the company has trimmed its workforce by 27 positions. The jobs cuts at Morphotek are connected to Eisai's recently announced strategic plan, called ‘E-Way 2025’, which includes the company's ‘transformation’ to a global business structure for oncology and neurology.

Morphotek, Inc. Announces License Agreement with Biocare Medical, LLC to Develop, Commercialize Diagnostic Kit for Detection of Mesothelin in Malignant Tissues

Morphotek Inc. announced that it entered into a second collaboration and license agreement with Biocare Medical, LLC (Biocare) to develop and commercialize an immunohistochemical (IHC) diagnostic kit utilizing Morphotek's proprietary monoclonal antibody to specifically detect mesothelin with Biocare's intelliPATH Automated Stainer. The agreement provides Biocare with a worldwide non-exclusive license to develop, manufacture and commercialize an IHC kit for detection of mesothelin on formalin-fixed paraffin-embedded (FFPE) tumor tissues. This is the second such agreement between Morphotek and Biocare; the first a license agreement signed in 2011 to develop kits, now commercially available, to detect folate receptor alpha in malignant tissues. Mesothelin is a cell-surface protein that is over-expressed in a variety of cancers including mesothelioma, non-small cell lung adenocarcinoma, pancreatic and ovarian carcinoma. Studies have found its expression variable among different cancer types; therefore, diagnostic assays that can identify patients with mesothelin-positive cancers may enable better diagnosis and treatment options for patients affected with mesothelin-expressing cancers. Mesothelin is the target of Morphotek's investigational therapeutic candidate, amatuximab, which is currently being assessed in a randomized, double-blind clinical trial in patients with newly diagnosed malignant pleural mesothelioma.

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