U.S. FDA Reviewing Stem Cell Pioneer Celularity’s IND for Cell-Therapy-based COVID-19 Therapy

Apr 1, 2020 | Cell Therapy, Celularity, Coronavirus, COVID-19, Investor Watch, News, Regenerative Medicine, Stem Cell

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New Jersey cell therapy startup venture Celularity, founded by a cell therapy pioneer Bob Hariri, is among the first ventures to recognize the human placenta as an untapped resource for innovation—and, in fact, the foundation of their science is built on innovations in this segment involving immuno-oncology, hematology and regenerative medicine. The company recently announced they filed an investigational new drug (IND) application to target their cell-based therapy against COVID-19.

The Company

Founded in 2017, Celularity has already raised a staggering $290 million in one round, according to Crunchbase. The company’s seminal discovery involves a unique stem, progenitor, and immune cells from the placenta—with proprietary platform technology and operational expertise to harness the power of the placenta, they have developed a robust pipeline across a broad range of implications.

The company’s platform purports to “amplify the body’s ability to regeneration. What does this mean? Well, Celularity combines innovative assets and research in cell therapy, functional regeneration, and biosourcing to develop leading therapeutic products and services that treat serious, life-threatening diseases. They are harnessing the unique cells and biomaterials from the postpartum placenta to offer therapies that amplify the body’s ability to fight disease, heal and regenerate itself.

Impact Platform

The Immuno-Modulatory Placenta-derived Allogeneic Cell Therapy) IMPACT®platform is the foundation of a disruptive clinical development model that materially reduces the time and cost to market for advanced cell therapies. Underlying IMPACT is a Natural Killer (PNK) and cryopreserved PNK (CYNK) cells, along  with genetically modified NK cells and allogeneic CAR-engineered placental T cells. They claim on their website that thier demonstrated timeline from therapeutic discovery to Investigational New Drug (IND) application is less than 24 months. Now the company has set its sights on treatments to help COVID-19 patients.

Investors

Reported investors include Section 32Celgene, Peter Diamandis,Tony RobbinsBill MarisUnited TherapeuticsHuman LongevitySorrento Therapeutics

Founder

The company was founded by Bob Hariri, an accomplished surgeon, biomedical scientist, high performance aviator and serial entrepreneur, operating in both biomedicine and aerospace. Dr. Hariri founded stem cell venture Anthogenesis Corporation, which was acquired by Celgene Corporation for about $45 million. He also founded Human Longevity, Inc.

Stem Cell Pioneer

Dr. Hariri has pioneered the use of stem cells to treat a range of life-threatening human diseases, and till this day seeks to make transformative contributions in the fields of immuno-oncology and cell therapeutics along with tissue engineering and functional regeneration. He is widely acknowledged for his discovery of pluripotent stem cells and novel immune cells derived from the human placenta and during that discovery identified the physiological activities of tumor necrosis factor (TNF). Dr. Hariri holds over 170 issued and pending patents for discoveries including placenta-derived stem cells; Nature recognized as one of the ten most important patent estates in the field.

Conclusion

The FDA cannot declare what the status of the IND currently is but they can declare that they are attempting to fast-track INDs and, of course, the U.S. Department of Health and Human Services (FDA parent executive branch agency) is motivated to streamline COVID-19 treatments.

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