Iron Horse Diagnostics partnership for ALS diagnostics on the horizon

Iron Horse Diagnostics partnership for ALS diagnostics on the horizon, raising USD 4m for TBI program

  • Two 250-patient TBI trials planned for when funding is in place
  • ALS diagnostics validation process to be complete in four months
  • Seeking CRO for ALS, and eventually TBI, diagnostics trials

BioPharm Insight05/07/2013:  © BioPharm Insight (Republished with permission)

Iron Horse Diagnostics, a US-based firm, is seeking USD 4m through private investment for a minority stake, to fund two trials investigating its mild traumatic brain injury (TBI) diagnostic, CEO Robert Bowser said. The firm is also close to securing a large pharmaceutical partner for its two amyotrophic lateral sclerosis (ALS) diagnostics and is seeking an extra USD 450K in financing for validation studies, he added.

Iron Horse has not set a timeline to close the USD 4m seed round for the TBI diagnostic, as it is in its early stage, Bowser said. He added that discussions have primarily been with private investors in the US but the company will also consider looking to the EU for investment.

Iron Horse Dx LogoThe financing will be used to launch two 250-patient multisite trials investigating blood and clinical outcome measures of patients with mild TBI, Bowser noted. The company will likely need a contract research organisation (CRO) to help run the trials, but it’s too early to initiate these discussions, he added.

ALS diagnostics

Iron Horse is waiting to receive grant funding of USD 1.1m from the National Institute of Health (NIH) to move forward with the validation of its ALS assays, and once it is received, the process should take around four months to complete, Bowser said. He explained that both diagnostic tests identify proteins involved in the disease – one through samples of patients’ cerebrospinal fluid and another through blood samples. Much of the research to develop these tests was conducted in Bowser’s academic laboratory.

Bowser said he anticipates one or two private investors providing the additional USD 450K required for the ALS validation studies, but that the project will start before these additional funds are secured. Potential TBI investors would be welcome to provide this funding, he added.

Iron Horse had planned two financing rounds worth USD 1.5m each in 2012 to get the ALS tool to market, according to previous news reports, yet these did not take place, and Bowser explained, “We revised the funding request based on advisor comments to the current amounts.”

Additional funding in the form of a partnership with a large pharmaceutical company is likely to be secured shortly to perform a multi-site prospective study of its ALS diagnostic, Bowser said. He declined to comment on the amount that will be raised from the deal, as although an agreement has been reached, it has not yet been signed.

The assay validation for the ALS diagnostics is a very traditional and defined set of experiments, and Iron Horse is the process of generating the required supply of the reagents and antibodies, Bowser said. These products are generated and the antibodies in-licensed from EnCor Biotechnology, a company founded by Iron Horse’s scientific advisor Gerry Shaw, Bowser noted, adding, Shaw also co-founded Iron Horse.

The company is also in the process of selecting between two CROs to run the ALS diagnostics clinical trial, Bowser said. He noted that although the bidding process has already begun, Iron Horse will accept additional bids for the 300-patient trial.

The trial will include four sites in the US and two in Europe and should be completed in around 14 months, Bowser said.

He explained that originally the trial was designed to only include US sites and Iron Horse was going to manage the trial in-house and select niche CROs to manage individual tasks on the trial. However, since the company recently decided to expand the trial internationally, it will now require full service CRO to manage the trial, Bowser said, adding it will likely be one of the bigger CROs that is selected for the trial.

Following the trial, he said the company will offer its diagnostic as a laboratory developed test in a Clinical Laboratory Improvement Amendments (CLIA)-waived laboratory and should have enough data to seek regulatory approval for use commercially by physicians and as a companion diagnostic in clinical trials, such as those run by its perspective partner.

Iron Horse will try to offer those companies a tool for earlier and faster diagnosis to include patients in clinical trials and the potential to use its diagnostic tools as biomarkers to monitor patients’ progress, he explained.

Iron Horse utilises the advisor Peter Allison, managing director at Biogenesis Investment Group who provides financial advice and assists in fundraising activities, as well as InVent Life Sciences for grant-writing services, the CEO said. The company is not seeking additional advisors at this time, he noted.

The company is looking to hire additional staff within the next six months which will include a chief scientific officer and two laboratory research specialists, Bowser said.


by Abigail Moss in London for BioPharm Insight


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