Startup IntelliPanel aims to commercialize a blood test for glioblastoma after succeeding in a crowdsourcing challenge that puts winning companies on the fast track to bringing government research to market.
Glioblastoma is the most aggressive form of brain cancer, and accounts for about all cases of the disease. IntelliPanels' diagnostic would be a sharp improvement over invasive brain biopsies and unreliable MRI images.
The Neuro Startup Challenge has spawned 15 other new companies. The most promising teams in the competition were chosen to license several patents related to brain health owned by the National Institutes of Health, in a bid to overcome challenges associated with bringing the feds' innovations to market, such as rules and regulations that make it difficult for government scientists to form startups.
The competition's organizers turned the challenge model on its head. They selected the ideas and NIH patents up for licensing. Then the most promising teams were selected as the future licensees, in a bid to overcome challenges associated with bringing the feds' innovations to market like rules and regulations that make it difficult for government scientists to form startups.
IntelliPanel co-founders Joshua Warren and Keyvan Mirsaeedi-Farahani, both MD/MBA candidates at UPenn, aim to build on NIH research that suggests the transmembrane protein ATIA is a biomarker for the disease.
Glioblastoma cells express high levels of the protein. Crucially, the IntelliPanel team of four businessmen and scientists think it is detectable in the blood stream as well. ATIA is cleaved by another protein, leading to the release of a fragment into the extracellular environment. Theoretically the ATIA fragment should cross the blood-brain barrier (one of the body's most difficult-to-traverse obstacles) since it is compromised by brain tumors.
To prove that ATIA fragments exist in patients' peripheral bloodstream, and that the NIH diagnostic can detect it, the team needs about $2 million funding to conduct proof of concept experiments, though IntelliPanel scientist Richard McCloskey, a UPenn biotechnology postdoc, said a grant of $150,000 would suffice for now, since the research is still in its early stages. Commercialization is at least two years away.
The four-person company is preparing for a competition-sponsored investor conference in October. IntelliPanel also needs to license the NIH patent for the diagnostic to determine the level of ATIA expression; the company is very likely to succeed on that front because it won the competition, Warren said.
The diagnostic is an ELISA assay. "Our diagnostic would most likely capture the target protein with antibodies and then detect that protein with a second antibody that is bound to an enzymatic reporter. This type of test can optimized to have high sensitivity for the protein target to be detected and can be semiquantitative at reporting levels of those proteins in the blood," McCloskey said.
"In general, ELISA detection assays consist of two antibodies, for which we are considering both monoclonal and polyclonal. Polyclonal antibodies tend to have better sensitivity properties and lower specificity properties and monoclonal antibodies vice versa, so finding the right combination of antibodies and having a reproducible supply chain will be an important part of developing the product," McCloskey added.
Warren said the blood test could also function as a glioblastoma monitor to check for disease reoccurrence. And ATIA is also a therapeutic target for brain cancers, including not just glioblastoma but also astrocytoma, the NIH patent says.
In its current form, the diagnostic has 70% sensitivity and very high specificity, meaning the blood test would detect 70% of glioblastomas, and a positive result is almost certainly indicative of this form brain cancer, and not another condition associated with the ATIA protein biomarker.
Patients who receive a negative result on the blood test would go on to receive a more invasive biopsy.
IntelliPanel was selected over at least 6 other teams of prospective entrepreneurs. Several teams consisting of scientists, businesspeople and seasoned entrepreneurs competed for the right to license several other NIH neurological innovations.
The teams had to develop an elevator pitch and write a business plan to life science investors and domain experts. Warren said the team was warned that the diagnostic's small addressable market will be a challenge, for there are only about 15,000 to 20,000 cases of glioblastoma per year in the U.S.
"The competition forced us to look at things from a business perspective in a really rigorous way," Warren said, adding that the program also provided participants with helpful training on topics like the NIH licensing process.
Due to the Neuro Startup Challenge, 16 new companies like IntelliPanel are now on the prowl, attempting to commercialize NIH neurological innovations, including diagnostics, therapeutics and medical devices.
As always, the startups' success (or failure) will depend to on their ability to procure financing. For that, there's a critical investor meeting in October. -- Varun Saxena (email | Twitter)