DURHAM – The Council for Entrepreneurial Development’s annual Life Science Conference will feature a host of new and returning companies as well as many first-time participants. And today six of the first-time firms are profiled in the first of a series that will feature these ventures ahead of the two-day event set for Feb. 27-28 in Raleigh.

WRAL TechWire and the CED are partnering to present the profiles.

The six featured today:

  • Esanex, Inc.
  • Dignify Therapeutics
  • Kepley BioSystems Inc.
  • Plakous Therapeutics
  • MVTRAK
  • Cellective BioTherapy, Inc.

Each profile features the firm’s website, contact information, a link to a detailed profile at CED, and responses by CEOs to three essential questions about each:

  • What is the driving mission of your firm?
  • What makes your company unique and therefore of interest to investors?
  • What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

The profiles:

Esanex, Inc.

What is the driving mission of your firm?

Development of novel therapeutics for patients with refractory cancers

What makes your company unique and therefore of interest to investors?

Esanex is leading the revival of Hsp90 inhibitors for the treatment of cancer with patent protection out as far as 2036.

What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Esanex is laser focused on the development of SNX-5422, an oral anti-cancer medication.  Esanex operates as a virtual company with a small team of highly experienced drug developers, allowing it to be extremely capital efficient.

Dignify Therapeutics

What is the driving mission of your firm?

Dignify Therapeutics is focused on developing novel bladder and bowel therapies to restore voluntary control of bladder and bowel function, eliminate bladder catheter use, and eliminate episodes of urinary and fecal incontinence.

What makes your company unique and therefore of interest to investors?

The inability to voluntarily control emptying of the bladder and bowel is a common problem in adult individuals with neurological disease, and urinary/fecal incontinence is a primary reason for institutionalization of the elderly.  Current management products representing a >$6B market include bladder catheters and adult diapers which are cumbersome, stigmatizing, and lead to secondary complications and infections. There are no safe and efficacious drug therapies available for inducing urination or defecation.  Dignify is unique in its focused approach to provide an “on-demand, drug-induced” voiding therapy to this niche, but large, patient population.

What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

  1. Dignify is a team of experienced pharmaceutical entrepreneurs that are internationally recognized for urology and gastrointestinal drug discovery/development. Dignify has raised over $12M in the last four years, primarily from the NIH and institutional investors.
  2. With an increase in the worldwide aging population, additional demands will be placed on institutions and caregivers to manage incontinence associated with impaired bladder and bowel function in the elderly. Restoring the dignity of voluntary voiding, reducing the daily demands of incontinence management by caregivers, and reducing overall healthcare costs associated with voiding dysfunction will be a significant advancement in treatment of this unmet medical need.

Kepley BioSystems Inc.

What is the driving mission of your firm?

Kepley BioSystems Incorporated (KBI) is dedicated to disruptive innovation and global solutions in marine ecology and life-sciences. The KBI team is bringing academic and scientific discipline to business with focus on stewardship and unmet demands to address pressing social and environmental challenges. Current projects include: synthetic crustacean and fish bait using naturally occurring molecules; a unique, enriched “fish-free” aquaculture feed; a novel nutritional foraging supplement for migrating shorebirds; and a patent-pending approach to ranch and protect horseshoe crabs to sustainably produce the substance vital to ensuring global pharmaceutical, vaccine, and medical device safety, which is unmatched in detecting endotoxins.

What makes your company unique and therefore of interest to investors?

Since it was founded in 2013, KBI has identified disruptive opportunities and developed patent-pending, global solutions addressing multi-billion dollar markets while adhering to scientifically sound ecological practices.

Developed with National Science Foundation (NSF) support and rigors, OrganoBait™ is the KBI patent-pending, synthetic bait poised to disrupt a $20 billion market and conserve billions of wild baitfish (forage fish) every year. Forage fish, a fundamental species essential to humans and marine life, yield the greatest value when left in the ocean to propagate and feed more valuable species and marine wildlife.

Well received in field tests against a backdrop of increasingly erratic baitfish availability and prices, additional funding would allow full optimization and at-scale raw materials investments for commercialization. KBI is also seeking to ranch and protect horseshoe crabs (HSCs) to sustainably produce the natural substance vital to ensuring global pharmaceutical, vaccine, and medical device safety; it supplies a $110-115 million raw materials market that supports an LAL (Limulus Amebocyte Lysate) kit sector in excess of $1 billion in annual revenues.

Employing a novel catheter and methods to ensure HSC wellbeing, the ranch would work to avert the random, annual capture of over 600,000 wild crabs with a mortality rate approaching 30% from current harvesting practices.

Given successful ranching, increased production of LAL could lead to further innovation, such as bedside septicemia screening for early diagnosis to alleviate a global impact approaching $1 trillion in healthcare costs due to sepsis and its sequela.

What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

KBI has built on a commitment to interventional marine ecology with a mission to identify and address global challenges and make a difference in conservation and preservation of keystone species by developing alternatives beyond the scope of simple quotas and regulatory efforts.

Taking a breakthrough approach to the “business of science,” the company is also uniquely grounded in academia, leveraging the institutional assets of the Joint School of Nanoscience and Nanoengineering (JSNN) for scholars and graduates to take ownership of their research and develop novel products for market.

This approach will ultimately lead to an increased output of patented inventions driven by unmet needs and market demand, while seizing entrepreneurial opportunities under the experienced guidance of the KBI leadership.

Plakous Therapeutics

What is the driving mission of your firm?

Plakous Therapeutics, Inc. is developing biotherapeutics from the term pregnancy, post-delivery placenta to promote regenerative healing for diseases including Osteoarthritis (OA) and Necrotizing Enterocolitis (NEC).

What makes your company unique and therefore of interest to investors?

Plakous is developing products for diseases for which there are unmet medical needs.  The development pathways for these products are well defined. OA is currently treated with non-medical interventions, painkillers, platelet rich plasma (PRP), injectable corticosteroids, and injectable viscosupplements.   None of these are viable options for preventing joint deterioration.  Eventually, the arthritic joint deteriorates to the point that joint replacement surgery is recommended.   The market for an effective office-based treatment that can be injected into an arthritic joint to delay or prevent the need for opioid pain medicine and joint replacement surgery is wide open to Plakous.

About 4.000 babies develop NEC in the US each year, or about 5%-7% of babies weighing less than 3 lbs. at birth.  NEC carries a 20%-30% mortality rate while consuming approximately 20% of neonatal ICU expenditures.  NEC qualifies as an orphan disease for which there are no effective treatments and which facilities the path to regulatory approval.

What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Opportunities for exit will arise relatively quickly due to the need for new therapies in these indications and the straightforward path to regulatory approval for Plakous’ products.  The earliest exit opportunity will be licensing Protego-PDTM for Necrotizing Enterocolitis upon successfully achieving Orphan Designation at the FDA.

We expect that designation to take 2.5 years with timely fundraising.  A further exit opportunity will be licensing Protego-PDTM as an OA therapeutic upon filing an IND with the FDA for a 351 BLA.  We expect that filing to take 3 years with timely fundraising.  Both milestones could be reached in 3.5 years if work on both indications was conducted in parallel.

MVTRAK LLC

What is the driving mission of your firm?

We make an in-ear sensor to detect and alert for concussions in sports, the military, and the elderly–addressing the $76B medical problem of brain injury.

What makes your company unique and therefore of interest to investors?

We outstrip the competition by 15X. We have a world-class team led by a seasoned entrepreneur, an Olympic athlete, and a head injury expert. In addition, our technology is patent-pending and was spun out of Duke University.

What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

  1. Our ability to leverage our technology in concert with a multi-$B strategic partner in a multi-$B medical monitoring market means a large potential ROI.
  2. Revenue streams from government/military research programs offer a foundation of sales and cash for the company.
  3. In addition, MVTRAK’s team is seasoned at company management and technology–a team where investors can place their bets.

Cellective BioTherapy, Inc.

What is the driving mission of your firm?

Our mission at Cellective BioTherapy is to develop novel immunotherapies for treating cancer, infectious disease, autoimmunity and immunodeficiency.

What makes your company unique and therefore of interest to investors?

We are developing first-in-class regulatory B cell-based immunotherapies; our unique platforms can either enhance or inhibit immune responses as needed for disease treatment. We believe these technologies have the potential to profoundly advance treatments for diseases where effective therapies do not exist and to complement and enhance current therapies.

We have:

  • a dominant position within the B cell and regulatory B cell space
  • novel technologies for depleting a specific human regulatory B cell (B10 cell) subset that results in an enhanced immune response, as well as technologies that can expand this regulatory B cell subset to dampen immune responses
  • know-how and a library of issued patents and provisional patent applications

We are advancing monoclonal antibodies that deplete regulatory B10 cells without destroying other essential B cells to enhance a patient’s immune response to cancer and complement current immunotherapies, accelerate immune responses to infection, and act as an adjuvant for vaccines.

Our technology also has the unprecedented ability to expand human regulatory B10 cells ex vivo for use as an autologous (patient-sourced) cellular immunotherapy for autoimmune disease, chronic graft versus host disease (cGVHD), and transplantation, as well as treatment of immunodeficiency.

Cellective’s two near-term products have applications for the treatment of diverse conditions, all of which have substantial markets. There are currently no competing technologies focused on B10 cell depletion or autologous B10 cell in vivo therapies, giving us freedom to operate across these broad disease categories.

What are the most important reasons why investors should be interested in your company beyond your product and/or technology?

Our B10 cell-directed therapies are unique in their approach, solve unmet clinical needs, and distinguish us from others working in the immunotherapy space. While the importance of B10 cells has been demonstrated in mouse models of inflammation, autoimmunity, solid tumors and infection, they have additional future applications for the treatment of human disease where effective therapies do not exist.