Biomarkers for Prognosis and Monitoring of Tumor Malignancies
Link to Recent Press Release
BioMarCare’s mission is to optimize personalized treatment through early cancer detection and monitoring by providing high- value biomarker-based cancer diagnostics tests.
BioMarCare is a cancer diagnostics company developing a cluster of high value tumor biomarkers for early detection, prognosis, and monitoring of cancer as well as for companion diagnostics. 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.
SECTOR AND FIELD OF ACTIVITY
Cancer has attracted a great deal of interest as the 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 early 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.
Blood-Test Based Kits – The use of a simple, non invasive blood test offers an ideal solution for widespread early detection in the general population. Additionally, it would facilitate repeat and long – term measurements.
Novel Multi- Biomarker Panels – The company in-licensed novel biomarkers with proven efficacy and is conducting a full clinical validation.
Superior Sensitivity & Specificity – The integration of multiple, high value biomarkers promises to provide superior clinical performance in both early and recurring disease as compared to individual markers.
Breast PARpanel™ is a multiple cancer biomarker blood test based on Protease Activator Receptors (PARs) tumor markers. The PARpanel™ test is an in-vitro immunoassay (ELISA) based on cancer specific markers offering improved specificity and sensitivity of cancer prognosis, therapy selection, monitoring of therapy and disease recurrence. The PARpanel™ is minimally-invasive, economical and ideal for repeat follow-up testing.
PAR Science and Technology
PARs are a four member subfamily of the G Protein-Coupled Receptors. PARs are known as key players in thrombosis, homeostasis, aberrant growth and survival of cancer cells, as well as in tumor-induced angiogenesis 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.
PAR Receptor Activation
PARs are located on the cell membrane and are activated by circulating proteases that cleave the receptors‘ extracellular N-terminal portion. Once cleaved, these receptors induce a series of cell signaling steps affecting cell growth and proliferation. PAR1 is activated when thrombin cleaves the receptor's N-terminal extracellular domain at a specific residue sequence and releases a peptide into the blood stream.Measurable levels of PAR peptides in the blood directly reflect the extent of malignancy.
PAR1 peptide levels can be analyzed by an ELISA blood test using a mixture of polyclonal and monoclonal anti PAR peptide antibodies covering the entire peptide sequence.
Blood circulating non coding RNA can identify the presence of occult residual disease. Colon MarCarePlex™ - is a multiple, non-coding RNA biomarker-based blood test for early detection and monitoring of colorectal cancer (CRC). The MarCarePlex™ assay utilizes CCAT1- a novel colon specific marker distinguishing between colorectal cancer and other malignant diseases.
In a study of 80 colon cancer tissue biopsies, the CCAT1 RNA biomarker was significantly elevated in 95% of samples taken from patients at an early stage of the disease.
BioMarCare is developing a unique kit based on a panel of molecular markers analyzed by a simple non -invasive blood test. The assay is based on an RT-PCR test aimed at accurately identifying the presence of CCAT1, combined with additional markers expressed in patients with malignant tumors.
Routine testing for Colon MarCarePlex™ will enable alerting and referring the patients to a more comprehensive evaluation for further diagnosis.
- Statistics: In 2007 approximately 12 Million new cancer cases were diagnosed worldwide, and this number is expected to reach over 17 Million by 2020.
- Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. It should reach, a compound annual growth rate (CAGR) of 18%.
- The global market for biomarkers was $5.6B in 2007. Biomarkers are pushing the world market for in vitro diagnostic (IVD) tests toward $12.B by 2012.
- The cancer biomarker market was accounted in 2007 for around 55% of total biomarker revenues at over $3B, with the majority of revenues derived from biomarker discovery and molecular diagnostics.
- The Pharma industry is becoming increasingly interested in developing tests that can be used to guide the prescription of cancer therapies.
- Regulatory – FDA highlighted the importance of biomarkers in the drug development process and calling for more and better biomarkers to accompany clinical studies
UNMET CLINICAL NEED
- Given the fact that cancers are heterogeneous, individual biomarkers cannot adequately detect all disease subtypes.
- Classical markers of malignancy although widely utilized as diagnostic indicators 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.
SOLID SCIENTIFIC BASIS
- In 300 breast cancer tissue biopsies PAR1 or PAR2 are positive in about 85% of the patients.
- Out of 86% stage I-II patients positive for PAR1 or PAR2, only 11% are positive for the CA15-3 commercial marker of breast cancer
- Disease free survival of PAR1+/ER+ (Estrogen Receptor positive) patients was significantly lower in comparison with the ER+ patients alone.
- PAR1 & PAR2 are candidate biomarkers for therapy selection in breast cancer hormonal therapy;
Dana Cohen , CEO
Dr. Ouriel Faktor, CTO
Prof. Tamar Peretz, CMO
Prof. Rachel Bar-Shavit, Co-Founder & Scientific Advisor
Dr. Beatrice Uziely, MD, Co-Founder
INTELLECTUAL PROPERTY STATUS
- BioMarCare has an exclusive worldwide license for the use of PAR1 for the diagnosis and treatment of cancer
- The company has filed 5 patents covering its PAR and CCAT1 technologies and methods for diagnosis and treatment of cancer
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 for clinical studies and product development.
BioMarCare is part of the cluster being developed by MicroMedic Technologies (TASE: MCTC) a subsidiary of Biolight Ltd. (TASE: BOLT)