Sigilon Gets $80.3M to Support Trial of Hemophilia A Candidate SIG-001

Sigilon Gets $80.3M to Support Trial of Hemophilia A Candidate SIG-001
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Some $80.3 million in financing will support the first clinical trial of Sigilon Therapeutics’ new hemophilia A cell therapy candidate, SIG-001, the company said.

The trial is expected to begin by June. Last August, the U.S. Food and Drug Administration (FDA) granted the potential cell therapy orphan drug status, a designation that promotes rare disease treatment development through benefits including a tax credit for trial expenses, waived user fees, and marketing exclusivity.

The company said it will also use the funds to advance and expand its programs in rare blood disorders and other diseases. The programs are based on the biotechnology company’s proprietary Shielded Living Therapeutics platform.

New investors including Canada Pension Plan Investment Board, Longevity Vision Fund, and funds managed by BlackRock joined founding investor Flagship Pioneering and other investors, including Eli Lilly and Company, in the Series B financing round. To date, total Sigilon funding exceeds $195 million.

“Sigilon is driven to liberate patients from the fear of living with serious chronic diseases, and from alternative therapeutic approaches,” Rogerio Vivaldi, MD, president and chief executive officer at Sigilon, said in a press release.

“Our Shielded Living Therapeutics platform is designed to give patients who have chronic diseases a convenient, safe, long-term therapeutic benefit,” Vivaldi said. “We believe encapsulating engineered human cells in our proprietary matrix will enable us to deliver controlled doses of therapeutic proteins without the need for immunosuppression and without the risks associated with modifying patients’ genomes.”

SIG-001 is made up of human cells engineered to incorporate artificial DNA-encoding therapeutic proteins into cells, specifically human FVIII, which is missing in people with hemophilia A.

The modified cells are protected from immune rejection and tissue scarring (fibrosis) by Sigilon’s Afibromer artificial biomaterials matrix. In addition, the biomaterial improves the optimized delivery and long-term stability of the cells in the body. After a single implant, it is expected the modified cells can foster long-term creation of therapeutic proteins.

In preclinical studies, delivery of SIG-001 into a mouse model of hemophilia A resulted in a steady production of FVIII, and controlled bleeding. This was also the case with animal models of hemophilia B and factor VII deficiency.

The studies demonstrated that delivery of different doses of the therapy to an animal’s abdomen led to a dose-dependent production of FVIII. SIG-001 also helped curb bleeding and blood loss following a bleeding test, and kept FVIII levels stable for more than six months.

“Sigilon’s Shielded Living Therapeutics platform offers patients with chronic disease the prospect of relief without disrupting their lives,” said Douglas Cole, MD, Sigilon chairman. “The near-term transition to clinical development and the platform’s breadth and progress reflect the power and productivity of Sigilon’s approach.”

Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
Total Posts: 38
Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
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Mary M. Chapman began her professional career at United Press International, running both print and broadcast desks. She then became a Michigan correspondent for what is now Bloomberg BNA, where she mainly covered the automotive industry plus legal, tax and regulatory issues. A member of the Automotive Press Association and one of a relatively small number of women on the car beat, Chapman has discussed the automotive industry multiple times of National Public Radio, and in 2014 was selected as an honorary judge at the prestigious Cobble Beach Concours d’Elegance. She has written for numerous national outlets including Time, People, Al-Jazeera America, Fortune, Daily Beast, MSN.com, Newsweek, The Detroit News and Detroit Free Press. The winner of the Society of Professional Journalists award for outstanding reporting, Chapman has had dozens of articles in The New York Times, including two on the coveted front page. She has completed a manuscript about centenarian car enthusiast Margaret Dunning, titled “Belle of the Concours.”
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