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ImStar Therapeutics is a private biotechnology company headquartered in Vancouver that is developing new approaches to treat patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.

The company is developing compounds directed at a proprietary new therapeutic target for ALS discovered by co-founder Dr. Jean-Pierre Julien called TANA (i.e. TDP-43 Associated NF-kB Activation). The lead drug candidate, IMS-088, is a novel small molecule compound targeting the NF-kB activation pathway currently in preclinical development for ALS.

IMS-088 is the first in a series of novel compounds derived from withaferin A (WA), a natural withanolide isolated from the leaves of the winter cherry plant (withania somnifera).  In preclinical animal studies, WA showed promise but lacked suitable pharmacologic characteristics to be developed as a therapeutic drug.

Therapeutics targeting the TANA pathway could treat multiple neurodegenerative diseases expressing TDP-43 pathology such as ALS, Alzheimer's, Parkinson's and Dementia.

TAR DNA-binding protein 43 (TDP-43) was recently identified as a major disease-associated protein in ALS. Under normal conditions, TDP-43 regulates RNA and is predominantly localized in the nucleus. However, in ALS-affected neuronal cells the protein is misprocessed resulting in aggregation in the cytoplasm and a loss of motor function.

A recent discovery has shown that, in patients with ALS, TDP-43 unexpectedly associates with and activates nuclear factor-κB (NF-κB), an inflammation-regulating protein. This leads to exaggerated immune responses and motor neuron destruction. Inhibition of the pathway in an ALS disease model produced substantial improvements in disease and motor function illustrating this is an important new drug target.

Novel Withanolides

ImStar chemists have designed novel withanolides related to WA that have superior drug like properties. IMS-088 is the lead drug candidate in this series that is currently being developed for ALS. These compounds are covered by a new composition of matter patent filing.

TANA Inhibitors

ImStar is also developing various approaches to block TDP-43 activity and has identified novel single chain variable domain antibody fragments (scFv) that inhibit TDP-43 and block it's associated NF-kB activation. 

IR2Dx Company Overview:

IR2Dx has developed a proprietary, breakthrough analysis and reporting system for multi-marker diagnostic test panels, to provide highly personalized treatment strategies for patients with Type 2 diabetes.  While control of glucose levels remains an important factor in the treatment of the disease, the IR2Dx platform evaluates the individual disease pathways for each patient, providing critical information regarding multiple markers and their overall pattern, all of which contribute to management of underlying disease.  This information can then be used by physicians to guide treatment decisions to deliver precision medicine in diabetes. 

Today, there are approximately 382 million people with diabetes in the world, and this number is expected to grow to 592 million by 2035.  The worldwide available market for early detection and drug response diabetes diagnostics is greater than $20 billion.  IR2Dx can enter the market within the current reimbursement and regulatory environments, and is ready to launch its first products in H1 2015 through commercial laboratories.

The IR2Dx platform provides personalized treatment information and recommendations to physicians based on a proprietary decision tree algorithm, greatly enhancing the clinical utility of a laboratory report.  Existing reimbursement levels for the panel markers in the U.S. and key international markets adequately cover the addition of the IR2Dx analysis and reporting. 

The platform is a software-based decision analysis tool. The analysis is performed on results from commercially available diagnostic tests run using standard laboratory bench top systems, requiring no tailored equipment, no custom design of the test system itself, and no capital investment.  Lab technicians upload the multi-marker panel testing results to the IR2Dx proprietary web portal to access the company’s decision support tool analysis product. In the initial commercialization phase, each laboratory will have a specific customized software product, and will pay for each report on a per-use basis. 

In the current U.S. regulatory environment for such products, with “health management IT functionalities”, such as the IR2Dx analysis and reporting system, near-term requirements for premarket review are unlikely, though the FDA may give additional guidance at any time. The IR2Dx platform is protected by a strong and broad intellectual property portfolio combining substantial data and know-how with issued patents in the U.S. and Europe. The company’s issued patents carry claims for use of its analysis platform and combination of markers for treatment guidance “with all glucose lowering drugs.”

 The company anticipates launch of the proprietary IR2Dx platform in H1 2015, introducing its first clinical decision support products through commercial laboratories. 

 Iron Horse Diagnostics, Inc., founded in 2012, has developed breakthrough diagnostic tests in neurologic disorders where there is high-unmet medical need.  We generated and validated diagnostic tests for amyotrophic lateral sclerosis (ALS) and developed assays for traumatic brain injury (TBI) and concussion. Iron Horse Diagnostics has a significant  IP portfolio for these biomarkers in ALS and  TBI, which detects specific biomarker signatures in cerebrospinal fluid and blood in these disease states. We currently are performing a prospective validation of our ALS diagnostic in 4 sites in the US and 2 in Europe.

The ALS test will be commercially available by the end of 2015 anticipating over 300,000 test globally per year. TheTBI test is projected to be market-ready in 36-48 months with 8 Mill. concussion tests in the US alone per year.

Iron Horse Diagnostics has received a fast-track small business grant from the NIH  and funding from Biogen Idec to suppport the clinical validation and commerciliazation of the diagnostic tests in ALS.

Its management team  consists of a seasoned, internally recognized team of scientists, clinicians and business development/regulatory experts. Iron Horse is endorsed by the ALS Association and is working with an international network of clinicians to further the clinical adoption of the ALS test and support reimbursement strategies.

Iron Horse Diagnostics is seeking an investment of 1 Mill. USD to further support the commercialization of the ALS diagnostic test and product development of the TBI test.

Ischemia Care (ISC) is a clinical stage, capital efficient, venture capital backed, diagnostic laboratory company commercializing ISCDX, a blood test for cause of ischemic stroke (including atrial fibrillation or “AF”), leading to timely diagnosis and treatment, resulting in hospital cost savings and improved patient outcomes. ISC is executing on the Biomarkers of Acute Stroke Etiology (BASE) study , clinicaltrials.gov identifier NCT02014896 to support clinical adoption as an LDT through a company owned CLIA laboratory. ISC's initial focus is on the 40% (320K annually) ischemic strokes which are diagnosed as unkown cause (or "cryptogenic") as these patients typically are undertreaked and at a high risk for recurrence.

Stroke is the third leading cause of death worldwide with 20M annual events. In the US, there are 800K strokes, of which 195K are recurrent. Despite advances in imaging, cardiac monitoring, patient history assessment, and clinical examination, in 40% of ischemic strokes, the cause is unknown (or “cryptogenic”) leading to high recurrence and death.  There are no blood tests for cause of stroke. The identification of cause will change outcomes per Stroke Guidelines by adoption of “cause based” treatment regimen to prevent a more massive, debilitating, and costly recurrence. For example, identifying “undetected” AF in cryptogenic patients provides a 60% risk recurrence reduction.

JBI is a Midwest-based biotechnology company driven to develop a new class of therapies to treat patients with Alzheimer’s disease and other neurodegenerative diseases. 

JBI’s unique approach is able to lower the production of Amyloid Beta (Aβ), phosphorylated Tau (pTau) and toxic intracellular Aβ aggregates.  Our passion is to develop a therapy to restore the patient’s lifespan and improve patient quality of life.

JBI is focused on further developing its lead compound, JBI-009, based on the strength of compelling preclinical safety and efficacy results to date.

JBI’s approach represents a new wave in thinking about the treatment of AD.  Currently available drugs treat disease symptoms, rather than its suspected cause, and do so with limited success.  Most drugs in late-stage clinical development are attempting to address a likely cause of the disease, the accumulation of Aβ, by potently inhibiting the enzyme responsible for Aβ production.  As this enzyme has other important biological functions, this approach has seen early failures because of unacceptable side effects.  JBI's approach is unique in that it modulates the production of this enzyme rather than inhibits its activity.  JBI’s approach is expected to restore enzyme activity and Aβ production to normal levels with a favorable safety advantage.

JBI’s technology is also unique in that it targets cellular machinery within the Endoplasmic Reticulum (ER).  Most drug developers have focused on modifying activity that occurs either on the cell membrane or within the cell nucleus or cytosol.  JBI is one of the first, if not the first, to successfully target activity within the ER.  The discoveries employed by JBI have produced a lead compound that affects the enzyme responsible for controlling the rate-limiting step in Aβ production, penetrates the blood brain barrier, and shows no toxicity in IND feasibility safety studies.  In addition, work has begun on next generation compounds.  This ER-focused approach provides platform potential for future therapies to treat additional significant unmet medical needs.

Johnson & Johnson (J&J) was founded in 1886 and is based in New Brunswick NJ with an Innovation Center in Cambridge MA. The firm invests in a variety of fields within the life science sector including medical devices. J&J?s medical device investments are highly varied in both size and structure, the structure may involve milestone payments or may be an equity investment. J&J is interested in early stage medical device companies located globally.