NeoProgen

Neonatal stem cells for heart health, potential COVID-19 treatment


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NeoProgen, Inc. is a pre-clinical stage company developing human neonatal heart-derived stem/progenitor cells (nCPCs) and secretome-based products for tissue repair and regeneration for the treatment of heart failure (HF) and pulmonary/cardiac complications due to COVID-19.

  • Heart Failure (HF), the inability of the heart to pump blood at a rate required to oxygenate body tissues, has reached epidemic proportions afflicting nearly 40 million people around the word.
  • Approximately 0.4–2.2% of the population in industrialized countries suffer from HF, with 500,000–600,000 incident cases diagnosed each year.
  • The mortality rate for patients with HF is high with nearly 50% of the patients dying within 5 years after diagnosis.
  • The global economic burden of HF is estimated at $108 billons per annum approximately 1/3rd of which is spend by the US.
  • The major driver of HF is the irreplaceable loss of heart muscle cells following a heart attack or myocardial infarction (MI).
  • Recent clinical observations suggest that heart muscle injury occurs in more than 25% of patients with severe COVID-19 illness compared to those with non-severe disease and it is associated with worse prognosis.


The pro-angiogenic, immunomodulatory, anti-inflammatory, and anti-fibrotic properties of the InCPC secretome suggest several additional indications of medical need where these products could be effective. 


Product:

  • Interventions nCPCs for severe COVID-19 pneumonia.
  • InCPCs were cleared for safety.
  • InCPCs GMP production master cell bank was initiated on April 2020.
  • InCPC IP was filed on November 2019.
  • InCPC secretome delivery in conjunction with secretome delivery device was initiated in April 2020.
  • InCPC secretome GMP manufacturing CROs under negotiation.

Awards:
Winner of the Maryland Stem Cell Research Fund Commercialization Grant.


NeoProgen is filing a phase I/II IND application with the FDA in severe COVID-19 pneumonia patients.

In these patients, a key event leading to high mortality is the cytokine storm - an overproduction of immune cells.

Adult stem cells have recently been reported to treat or significantly improve the cytokine storm and oxygen deficit in treated COVID-19 pneumonia patients.

We are proposing to use a similar study design using our cell based therapies (nCPCs) -- which have more potent activity than adult stem cells used in other COVID-19 trials.

We will determine whether our products will block the cytokine storm by treating severe COVID-19 pneumonia patients with intravenous administration of our product. We believe our technology could save lives.


Dr. Sunjay Kaushal, M.D., Ph.D.,Founder & Chief Medical Officer

  • Professor & Chief of Pediatric Cardiac Surgery, U of Maryland School of Medicine
  • Expert in heart failure performing 200 cardiac operations per year
  • Published 100+ peer-reviewed journals, has 10-member post-doc research lab

Bill Niland, CEO

  • Serial Life sciences entrepreneur
  • Exited 4 companies including structural heart start-up, new treatment paradigm for respiratory patients, largest sleep testing company in US
  • President/CEO of Harpoon Medical Inc (sold to Edwards in 4.5 years for $250M with only $6.5M of dilutive capital generating >100% IRR for investors), founded Vapotherm (NYSE:VAPO)

Dr. Rachana Mishra, Founder & Chief Scientific Officer

  • 10 years experience in stem cells, generated progenitor cells from 500+ cardiac biopsies
  • Expert in cardiac progenitor cell biology at University of Maryland
  • Published 18 peer-reviewed journal articles, manages 10-member research lab

Dr. Sudhish Sharma, Founder & Chief Technology Officer

  • Assistant Professor in Department of Cardiac Surgery University of Maryland
  • PhD in Molecular Biology & Biotechnology, expert in data-analysis
  • 16 peer-reviewed articles

Sotirios Karathanasis, PhD, VP of Research and Development

  • Experienced Pharmaceuticals Executive at Pfizer, Eli Lilly, and AstraZeneca
  • More than 20-years experience in managing and leading R&D teams of up to 245 colleagues.
  • Delivered multiple clinical candidates several of which advanced in late clinical development.
  • Directed lab of students, postdoctoral & clinical fellows in academic and industry settings.
  • Published 100+ peer-reviewed manuscripts and book chapters.
  • Awarded Twenty-two patents.

Marie Joy Coraza, MS Quality and Regulatory Independent Consultant

  • 20 years of Manufacturing and Research & Development  experience in Regulatory Science, Policy and Quality Compliance gained at leading pharmaceutical companies.  Led both small molecule and biologic development programs from Phase I through Phase IV across multiple therapeutic areas including cardiovascular, renal, oncology, anti-inflammatory, rare-diseases and metabolism.
  • Masters of Science in Chemistry

Mark Collins, CPA, CFO

  • Background in accounting, information systems, human resources, purchasing, operations and customer service
  • VP of Finance and Operations at Harpoon Medical

Peter Boyd, JD, MBA, EVP of Business Development & Counsel (Consultant)

  • Business development executive, attorney and entrepreneur
  • Worked at Harpoon Medical and Vapotherm, Edwards Lifesciences, focusing on European commercialization efforts

Jamie Niland, VP of Operations

  • Background in project management, digital solutions, marketing and finance.

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