ISOMA Diagnostics
A medical device development company.
Monday, September 11, 2017
Embassy Suites, Chesterbrook, Pennsylvania (directions) |
About
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Isoma Diagnostics has developed a diagnostic tool to stratify Glioblastoma patients into one of four known subtypes: Proneural, Neural, Classical, and Mesenchymal.
Their molecular classifier uses the differential expression of key transcript variants (isoform-level gene expression) as a prognostic and diagnostic tool for GBM. Each one of the four subtypes react differently to treatments and can change.
Every year 18,000 people in the U.S. are diagnosed with Glioblastoma (e.g. John McCain, Ted Kennedy, Beau Biden). The median survival of GBM is fifteen months, and the five year survival is less than 5%. Over the past twenty years survival rates have not improved. There are billions spent every year treating the disease and over one hundred companies currently developing therapeutics to treat it. However, none of the companies are using subtyping as a factor in development of a cure.
Isoma's technology holds promise as a robust diagnostic assay for patient stratification and prognosis assignment in a number of cancers. In addition to prognostic value, the isoform-based classifier has identified novel targets for pharmacotherapies and tailored treatments for GBM. Their classifier is platform-independent and has been validated on RT-qPCR in a cohort of 206 GBM samples with 92% accuracy.
Market Potential: Isoma's diagnostic test can help pharmaceutical companies learn which Glioblastoma subtype their therapeutic is most effective with. It can also provide a companion diagnostic to those companies seeking FDA approval. In addition, it will eventually enable physicians to know which therapeutic strategy to choose based on factors such as age, tumor location, and tumor subtype.
3 Major Issues
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- Companion Dx: Our assay can accurately subtype Glioblastoma into one of the four known TCGA subtypes. It has been independently validated with 92% accuracy using RT-qPCR in an independent cohort of 206 brain tissue samples. We have been trying to get the attention of pharmaceutical companies developing therapeutics to subtype the patients during clinical trials. This would demonstrate which subtype their therapeutic is most effective with. We can even subtype tissue samples from previously failed trials like: CellDex, Immunocellular, Bristol Meyers Squib, NW Bio, etc. None of those companies have shown any interest.
Q: Are we approaching this correctly, or do pharma companies not care / want to know which subtype their drug works best with? What are we missing?
- Funding: We only need $50k to validate our assay on NanoString (a more commercially viable platform for our diagnostic). We were hoping to bootstrap the validation and then try to get a customer such as a pharmaceutical company to pay us to subtype their tissue samples because with just one or two customers, it would fund our growth.
Q: Should we just head toward VC funding at this point and go for the $1M+ range to really accelerate our development?
- Europe and Canada: We have had feedback that Europe and Canada have more interest in knowing which patients drugs work on using diagnostic tests than in the U.S.
Q: What steps are required to get clearance to market our diagnostic in European countries such as Germany, and then get reimbursement?
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Steve Davis, CEO, will deliver Greene Street's "Elevator" Pitch to the Group
8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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