1. What is the critical gap in cancer treatment that you are addressing?
Most breast cancers – about 90-95% - occur for unknown reasons. They are called “sporadic cancers.” They are not linked to a family history and they are not the result of a genetic or environmental incident. They are entirely random - and unfortunately we have no tools to prevent them.
SilBiotech is developing a diagnostic tool to stop sporadic cancers from happening to women who are first diagnosed with benign tumors. There are many studies that have shown women who develop certain types of benign breast tumors have an increased risk of developing breast cancer later. This translates to about 40,000 women each year whose benign tumors will later develop into breast cancer.
Currently, there is no tool to help clinicians identify who these women are so that prophylactic treatments can be administered beforehand, increasing their chance of survival. This uncertainty puts enormous emotional burden on patients and clinicians and creates a treatment dilemma. Right now, treatments are administered randomly to willing patients with benign tumors who do not know their actual risk of developing breast cancer. As a result, patients who have no risk are unnecessarily subject to the side effects of prophylactic drugs or undergoing unnecessary mastectomies. On the other hand, patients who are at risk but opt out of treatment are not getting the benefit of prophylactic measures.
The fact that we do not have a diagnostic tool to identify those women at risk represents a critical gap in preventing about 20-25% of breast cancer every year. The Silbiotech’s diagnostic tool will fill this gap.
2. What is the key product development milestone you seek to fund?
The next critical milestone is to validate our diagnostic tool using hundreds of tumor biopsies that have already been removed from the patient for diagnosis. The future milestone will be to validate the diagnostic tool in a clinical trial to establish a correlation between clinical test results and prophylactic treatments and prevention.
3. How will funds be used?
Funds will be used to purchase the required supplies and to support the scientific personnel whose expertise are critical for the accomplishment the above milestone. The breakdown of use of funds is below:
• 50% of funds will be spent on personnel including pathologists, physicians and technical assistants;
• 30% of funds will be spent on facilities and administrative cost;
• 20% of funds will be spent on laboratory supplies and other related supplies for developing the test.
4. What key resources have/will you acquire to facilitate the accomplishment of the above R&D milestone?
Other sources of funding include a Phase II Small Business Innovative Research (SBIR) Award for July-August 2016. Silbiotech intends to utilize this Phase II award towards the purchase of needed equipment. The tumor samples, along with the clinical follow up information, will be acquired from various cancer centers throughout the US and abroad. If crowdfunding is successful, we would leverage these funds to access a SBIR Phase IIb bridge award. This is a matching fund mechanism that requires support from outside or third party sources, such as Sound Affects.
5. If your technology were to disappear in the Valley of Death, how might this impact society?
We are highly confident that the clinical question we have addressed and the diagnostic tool we are developing will not disappear in the ‘Valley of Death’ because we have already completed several milestones. We are 100% sure that our diagnostic tool will benefit women in stopping breast cancers but will not meet the fate of falling in the ‘Valley of Death’.
Indira Poola, Ph.D.
Chief Executive Officer
Dr. Poola has previously served as a professor in a major Medical School, and in two SBIR funded biotech companies. Dr. Poola was a winner of 25 grant awards from 7 funding agencies including NIH, Komen for Cure, NSF and DOD totaling nearly $10Million and an established leader in the field of biomarkers in breast cancer. Four NCI grants to Dr. Poola, a STTR, two SBIR and a R33, were on clinical assay development for prognostic and therapeutic breast cancer biomarkers. Dr. Poola has served in over 20 national and international grant Peer Review committees of ten funding agencies including SBIR grant review committees, regular reviewer for more than 20 cancer journals, and published extensively (30 first author papers) on breast cancer. Dr. Poola has successfully led a number of multi-institutional, multidisciplinary projects, collaborated with (ten) intra-, (fifteen) inter- institutional researchers and roduced several peer-reviewed publications from each project.
Qingqi Yue, Ph.D.
Head of Data Management
Qingqi Yue, Ph.D, a statistician and data management expert. Dr. Yue will work on data management and statistical analyses of the data needed for evaluation of the Technology in Phase II. He will continue to participate in Phase III prospective study in establishing test validity and regular updating of the Data Base. He will devote about 20% of time in Phase II and 10% beyond Phase II.
John Gallespei, M.D a Board-certified, Licensed pathologist. He will provide pathology support in Phase II in validating the Test. He has 15 plus years of experience in cancer biomarker field. Dr. Gallespei has been working with Silbiotech for the past two years will continue to work both at the technology validation stage in Phase II and in commercialization stage in generating Test reports to customers.
Providing Clinical Samples
1) Jianyu Rao, M.D., Professor of Pathology at UCLA Medical School, 2) Savitri Krishnamurthy, M.D., Professor of Pathology at MD Anderson Cancer Center and 3) Abeer Shaaban, M.B.B.S., FRCPath, Chair of translational subgroup of the NCRI Breast CSG, University
Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital at Birmingham, England. We are also negotiating with another group in Hartford, Connecticut..