Biomarkers for Prognosis and Monitoring of Tumor Malignancies
BioMarCare is an early-stage company dedicated to the development of a cluster of high value in-vitro diagnostics for early detection, prognosis and monitoring of cancer. The company's Multi-Biomarker Panel approach, combined with its technological and clinical expertise, promises to generate molecular and serum-based diagnostic blood tests with high specificity and sensitivity as well as rigorous validation. Our mission is to minimize uncertainty through early cancer detection and monitoring.
Sector and Field of Activity
Cancer has attracted strong interest as the disease area of choice for the development of biomarker-based companion diagnostics. Until superior therapeutic treatments are developed to prevent, treat and cure cancer, the best means of reducing mortality and morbidity in a disease this complex is early detection and diagnosis. In the major solid cancers long-term survival rates drop precipitously once metastasis has occurred.
Critical to the success of oncology-targeted therapies is the use of biomarkers and diagnostics to identify the patients who are most likely to benefit from a particular therapy, allowing the right patient to be matched with the right drug.
Many patients with early cancer are cured by surgery alone. However, a significant number of patients treated with surgery will have recurrence of the disease and require adjuvant treatment. The goal of a prognostic and follow-up test is to identify those patients at risk of recurrence, those who should receive additional treatment and additionally, reduce the number of patients who receive unnecessary treatment.
BioMarCare's lead product is a multi-biomarker diagnostic blood test for breast and colon cancer based on a Protease Activator Receptors (PARs) panel. Initial scientific & clinical data suggest that both PAR-1 and PAR-2 are useful for detecting disease onset and recurrence, and may be a valuable tool both for prognosis as well as serial monitoring.
Market Opportunities
The traditional global markets for cancer diagnostics include diagnostic tests for cancer detection, monitoring, staging, and prognosis. Pharmaceutical companies are becoming increasingly interested in developing tests that can be used to guide the prescription of cancer therapies.
In 2007 approximately 12 Million new cancer cases were diagnosed worldwide, and this number is expected to reach over 17 Million by 2020. Within the diagnostics market, cancer testing is anticipated to experience some of the greatest growth over the next three to five years.
The global market for biomarkers was $5.6 billion in 2007 and is expected to reach $12.8 billion by 2012.
Unmet Clinical Need
- Given the fact that cancers are heterogeneous, individual biomarkers cannot adequately detect all disease subtypes.
- Current serum biomarkers are neither sensitive nor specific enough for early detection of cancer onset or recurrence.
- There are no biomarker-based blood tests approved today for early detection of disease onset, prognosis and recurrence. Instead, imaging modalities are used for follow-up no sooner than 12 weeks after therapy and expose the patient to radiation.
Hence, there is a critical need for a highly sensitive, multi-biomarker- based blood test for early diagnosis, prognosis and monitoring of treatment.
Science and Technology
Protease-activated receptors (PARs) are a family of 7-transmembrane G Protein-Coupled Receptors that have recently emerged as key players in tumor growth, invasion and metastasis.
In healthy individuals, none or very little PAR expression is detected in epithelial cells, whereas in malignant epithelial cells, enhanced over-expression of PAR is observed. In these cells, PARs are activated by circulating proteases that cleave the receptors' extra-cellular N-terminal and induce a series of cell signaling steps leading to tumor cell proliferation. Upon cleavage of the N-terminal, a peptide is released into the bloodstream, which can be measured in a simple blood test. This PAR-released peptide provides a "mirror image" of PAR activation in the malignant cells.
BioMarCare Technologies is currently developing a next generation, in-vitro immunoassay (ELISA), based on a PAR-1 and PAR-2 biomarker panel. We believe that our PAR multi-biomarker diagnostic test will provide improved specificity and sensitivity for detecting the onset of disease or recurrence, prognosis and monitoring of therapy.
The PAR-panel™ blood test will be economical and non-invasive, making it ideal for repeat follow-up testing.
Development Status
• Proof of concept using over 100 blood samples demonstrated significantly elevated PAR-1-released peptide levels in cancer patients as compared to marginal levels in healthy individuals, indicating high sensitivity and a potential role in early diagnosis
• Clinical data include low and high PAR-1-released peptide levels in disease stages I & II, suggesting a strong prognostic tool for disease progression and recurrence
• A sensitive ELISA kit is under development
Next Milestones
- Q3/2010 Improve assay sensitivity and specificity by incorporating new monoclonal antibodies against the PAR-released peptides
- Q4/2010 Establish clinical validation for Breast and Colon Cancer
- Q1/2011 Assay production scale-up
- Q4/2011 Establish multi-site clinical trial
Executive team
Dana Cohen , CEO
Dr. Ouriel Faktor, CTO
Prof. Tamar Peretz, CMO
Prof. Rachel Bar-Shavit, Founder & Scientific Advisor
Dr. Beatrice Uziely, MD, Founder
Intellectual Property Status
• BioMarCare has an exclusive worldwide license for the use of PAR-1 for the diagnosis and treatment of cancer
• The company has filed 3 patents covering its technology and methods for diagnosis and treatment of cancer
Investment Sought
BioMarCare's clinical activities are conducted in conjunction with the Hadassah Medical Center in Jerusalem, Israel.
The company is currently seeking a strategic alliance and/or investment funding of $2M for clinical studies and product development.
