Sigilon Therapeutics, Inc., a biotechnology company developing cures for patients with chronic diseases through its Shielded Living Therapeutics Platform, announced it completed a $80.3 million Series B financing. This money will be put to use supporting the first-in-human clinical trial of their novel encapsulated cell therapy for hemophilia A, which is expected to commence in the first half of 2020. The funds will also support the advancement and expansion of programs, including their rare blood disorder program, lysosomal diseases, and endocrine and immune disorders. Sigilon Therapeutics falls under TrialSite News’ ‘Investor Watch.

Who are their Investors (most recent and prior)?

The most recent investor entrants include Canada Pension Plan Investment Board (CPP Investments), Longevity Vision Fund, and funds managed by BlackRock joined existing investors such as Flagship Pioneering and others, such as big pharma Eli Lilly and Company. The company has now raised a total of $195 million in just two rounds. This substantial amount of money evidences the growing big stakes world of biotech investing.

Why was the Company Founded?

Sigilon was founded to develop immune-protected, bio-engineered cells to restore normal physiology in a wide range of diseases without immune rejection, liberating patients from the challenges associated with existing treatments for serious chronic diseases. Treatments based on Sigilon’s Shielded Living Therapeutics platform combine advanced cell engineering with cutting-edge innovations in biocompatible materials to pioneer a new class of medicines that have been designed to provide durable, redosable, controllable, and safe potential treatment for chronic diseases.

Massachusetts Institute of Technology (MIT) Spinoff

The company’s proprietary intellectual property was developed in conjunction with researchers from MIT. The MIT spinoff seeks to commercialize cutting-edge technology developed at the elite academic research institution with a focus on an implantable, insulin-producing device that one day could make injections obsolete. In the case of their SIG-002 product (in partnership with Eli Lilly), the venture seeks to develop “living drug factories” consisting of encapsulated, engineered cells that can be safely implanted in the body, and hence produce insulin over the course of months or even years. In the future, they envision a time when cells could be engineered to secrete other hormones, proteins, and even antibodies.

The technology platform is based on MIT research over the last decade, and that led to the creation of a device that actually encases cells and protects them from the patient’s immune system. Hence if combined with engineered cells could produce therapeutic targets such as insulin. If the company is successful at some point in the future, they could deliver “living drug factories” inside the body that distribute therapeutics at the right amount in the right location reported co-founder Daniel G. Anderson.

Who are the Co-Founders/Inventors?

Daniel G. Anderson, Professor, Chemical Engineering and Institute for Medical Engineering and Science

Robert Langer, David H. Koch Institute Professor at MIT

Jose Oberholzer, researcher/surgeon, director of the Charles O. Strickler Transplant Center; professor of surgery and biomedical engineering, University of Virginia

Arturo Vegas, former MIT postdoc and now professor of chemistry, Boston University

Omid Veiseh, former MIT postdoc and now professor of bioengineering, Rice University

What does their Pipeline look like?

Sigilon’s Pipeline presently covers three main areas, including 1) Rare Blood Disorders, 2) Lysosomal Storage Diseases, and 3) Endocrine & other Chronic Disorders. Powered by their Shielded Living Therapeutics Platform, first on the priority list is the Rare Blood Disorders, where their investigational product SIG-001 (Hemophilia A) is going through the IND process in preparation to commence clinical trials—planned for First Half of 2020 (e.g., prior to June 2020). Of note, SIG-001 received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA).

Other targets are in the “lead optimization” stage, and hence are not ready for IND (investigational new drug) application in regard to Rare Blood Disorders. Both their Lysosomal Storage Diseases and Endocrine & other Chronic Disorders pipeline all include the investigational product in Discovery or Lead Optimization stages—so they are still an early-stage biotech company. They have partnered with Eli Lilly for their SIG-002 product targeting diabetes.

What are the Core Principles Underlying their ‘Shielded Living Therapeutics Platform?

The company seeks to design medical products targeting the ever-growing numbers of patients with chronic diseases. With a focus on producing a safer, more beneficiary long-term impact, they focus on “encapsulating engineered human cells” in a “proprietary matrix” that they hope will enable more “controlled doses of therapeutic proteins without the need for immunosuppression” and lessen the risks associated with the modification of the patients’ genomes, reported Rogerio Vivaldi, MD, President, and CEO of Sigilon Therapeutics. In what can be a hint as to how products will eventually be marketed if approved, Dr. Vivaldi noted that the company “is driven to liberate patients from the fear of living with serious chronic diseases and for alternative therapeutic approaches.”

Company Background

Founded in 2015 and based on technology developed at MIT, Sigilon Therapeutics is developing functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s therapeutics consists of novel human cells engineered to produce the crucial proteins, enzymes, or factors needed by patients living with chronic diseases such as hemophilia, diabetes, and lysosomal disorders. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.

Source: Sigilon

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