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MyeloRx is a northern California based biotechnology company. Our lead compound, MRx102, is a small molecule inhibitor of RNA polymerase II. Molecules related to MRx102 have shown clinical efficacy in AML patients in Europe and China.  MRx102 is covered by issued composition of matter patents in the U.S., E.U., China and Japan.  While AML is the initial indication, MRx102 has also been found active in stringent models of pancreatic and lung cancer. Our collaborators include clinical oncologists from MD Anderson Cancer Center, JHU School of Medicine and City of Hope Medical Center. R&D activities have been funded primarily by a $2M NCI SBIR contract. Our strong scientific and management team is lead by Dr. John Musser; it has brought multiple products to market. We are seeking funding to complete an IND which is projected to take less than a year based on the extensive studies completed to date (manufacturing, formulation, toxicology/ PK in rats and dogs etc.)  and a Phase 1 clinical trial in AML patients.

EIP Pharma, LLC is a private company based in Cambridge, MA.  The company has licensed-in and is developing a phase 2 clinical-stage oral small molecule that targets neuroinflammation and dysfunction of microglia, the major immune-cell in the brain.

Human genetic and other biologic data strongly indicate inflammation & microglial dysfunction are one of the major drivers of late-onset Alzheimer’s disease (AD), and likely the major driver in patients with symptomatic disease.

VX-745 (the licensed compound) specifically inhibits intra-cellular enzyme p38 mitogen activated protein kinase alpha (MAPKa).  In the brain, p38 MAPKa is a major regulator of inflammation through effects on microglia. P38 MAPKa is also expressed in neurons, where it is directly involved in memory formation and synaptic plasticity. 

VX-745 readily enters the brain, with brain concentrations in pre-clinical studies being approximately two-fold higher than in peripheral blood.  VX-745 had previously been clinically evaluated in non-CNS disorders, where already has demonstrated anti-inflammatory activity in patients. The combination of blood-brain-barrier penetration and previous clinical experience with demonstrated anti-inflammatory activity uniquely positions VX-745 to target inflammation to treat Alzheimer’s and other CNS disorders in which inflammation plays a role.

EIP Pharma licensed VX-745 from the originator company, Vertex Pharmaceuticals, and conducted animal studies to re-position the compound towards disease of the brain, including AD.  Vertex had previously completed a full chronic toxicology program and had demonstrated significant clinical and anti-inflammatory activity in a phase 2a 12-week treatment study of VX-745 in rheumatoid arthritis (RA).  An Investigational New Drug (IND) application remains open at FDA.

The animal studies conducted by EIP Pharma have demonstrated pro-cognitive effects, anti-inflammatory and other pharmacologic effects of VX-745 in the brain.  These data combined with dose response data in prior animal and clinical studies, have been utilized to identify doses that are highly likely to have positive activity in human brain.  The predicted doses are 2- to 5- fold lower than the dose that demonstrated anti-inflammatory activity and was well tolerated in RA, consistent with VX-745 preferentially distributing to the brain in animals.  Importantly, these dose levels should minimize risks of systemic toxicity that otherwise have hampered development of p38 MAPK inhibitors for peripheral disorders.  The animal studies have also generated new intellectual property (IP), including issuance of a US patent on 15 April 2014 (#8,697,627) for the use of VX-745 to lower brain amyloid plaque load.  This IP, along with additional IP that has been filed will support commercially the development of VX-745 beyond the primary composition of matter patent expiring in 2017.

Start-up activities (IRB submissions, CRO contracting, etc.) are underway for two phase 2a clinical studies in patients with AD; both studies are anticipated to be underway in early 2015.  Combined, the studies are designed to demonstrate anti-inflammatory and microglial modulatory activity in the brain.  Once demonstrated, VX-745 should have ability to demonstrate clinical proof-of-concept in AD and/or other disease indications in which neuroinflammation plays a role in disease pathogenesis.

Company was founded and is led by experienced biotech/pharma R&D executive (John Alam; former head of Alzheimer’s R&D at Sanofi, ex-Chief Medical Officer at Vertex Pharmaceuticals, led clinical development of AvonexÒ for Multiple Sclerosis) with extensive translational and drug development experience & expertise in both inflammation and CNS disorders.

Tutela Industries is a Health IT startup developing patient-centric mHealth solutions to reduce readmissions and significantly enhance patient engagement. Tutela has developed a proprietary and breakthrough low cost, secure framework, TutelaConnect™, for hospital-based clinicians to communicate (voice, video, and data) securely to remote caregivers, both outside and inside the hospital environment. Even though a majority of hospitals have implemented electronic health records for identifiable patient data exchange within the hospital, the secure HIPAA compliant capture and exchange of unstructured patient information outside the hospital remains a challenge, impacting decision making, care coordination and informed consent.

In a recent benchmark data security report, over 90% report that their number one security risk is the unsecure exchange of patient information (phone, text. email) initiated from inside the hospital. 88% of hospitals attribute data breaches to employee negligence and the lack of mobile device security. The cost of these breaches exceeds $5.6 Billion per year, averaging $1M per year per hospital. Most hospitals are still struggling to create a unified communication strategy that meets stringent security, HIPAA compliance requirements while meeting clinical workflow and ease of use demands. Ubiquitous solutions are not cloud-based which makes the use case for patient engagement costly, complicated and difficult to scale. Ultimately, restricting the use to the few and not the many. The worldwide available market for interactive patient engagement solutions exceeds $2.3B and the initial target market, the high-risk Neonatal Intensive Care is estimated at $160 Million. The TutelaConnect™ Platform, can enter the market within current reimbursement and regulatory environments, and is ready to launch H2 2015 through sales to the first  pilot hospitals.

The competitive landscape includes large players in adjacent markets; Cisco/PolyCom for enterprise video solutions; Phillips, medical device manufacturer for remote monitoring, and electronic health record companies, Cerner and EPIC. Small niche players, Mommy’s Ear, Angels Eye and NICView offer limited pieces of a unified patient engagement communication tool.  None to date provide a cloud-based, platform agnostic, secure and HIPAA compliant method that eliminates costly licenses, expensive hardware and ongoing endpoint configuration and IT support requirements.

A strong competive position, highly differentiated use cases, a clear Freedom to Operate and patent potential, as well as, a highly experienced management team, early traction and favourable regulatory trends provide a great opportunity for success.

Twin Cities Angels is an angel group that was founded in 2006 that is based in Minnesota. The group has raised two funds that are The Twin Cities Angels Fund I and II. The second fund is currently looking to invest in emerging companies. The group typically provides seed and venture capital ranging from $ 25.000 to $2 million to life science companies. The group plans to invest in 4 to 6 companies per year. Twin Cities Angels seeks to invest in companies based in the Twin Cities Area of Minneapolis/St. Paul, the state of Minnesota and within a reasonable distance, such as Western Wisconsin, Northern Iowa, and Eastern Dakotas.