Sigilon Therapeutics Provides Update on Strategic Reprioritization

Sigilon Therapeutics Provides Update on Strategic Reprioritization

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  • The company will continue to focus on platform optimization, with a particular emphasis on MPS-1 and diabetes.
  • The workforce has been reduced by approximately 38%.
  • The company’s anticipated cash runway extended into 2024.

San Francisco, California-based biotechnology firm Sigilon Therapeutics, Inc. (NASDAQ: SGTX) has announced a strategic re-prioritization to enable the business to focus on MPS-1 and diabetes. The company’s trademarked Shielded Living Therapies is a platform that aims to develop functional cures for chronic diseases.

Sigilon Therapeutics product candidates are cell-based medicines that aim to synthesize the necessary proteins, enzymes, or factors for individuals suffering from long-term illnesses such as lysosomal diseases and diabetes.

The encapsulated cells are encased by Sigilon’s Afibromer biomaterials matrix, which is intended to protect them from immune response and fibrosis. Sigilon was created by Flagship Pioneering in collaboration with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of MIT’s Massachusetts Institute of Technology.

SIG-001 Trial

In November, Sigilon disclosed that fibrosed spheres were detected during a retrieval operation for the third participant in its Phase 1/2 study of SIG-001 in severe or moderately severe hemophilia A. The patient was given the spheres as part of the study and they have fibrosed, causing cells within them to become nonviable.

The Company intends to notify regulatory authorities after the SIG-001 Safety Review Committee session in December, and it will continue to follow all three patients per study protocol.

In addition, the Company does not anticipate beginning patient dosing in the Phase 1/2 clinical study of SIG-005 for MPS-1 until further research is completed.

Dr. Rogerio Vivaldi, Chief Executive Office, commented on the trial status, “There have been key learnings in our Phase 1/2 trial of SIG-001 for Hemophilia A. While we continue to investigate the findings from our SIG-001 study to help inform our development of the platform, following a review of our programs, we have made the strategic decision to refocus our pipeline.”

Sigilon Therapeutics Layoffs

Sigilon has announced that it will reduce its full-time staff by roughly 38%. The jobs eliminated are primarily in the fields of research, manufacturing, and general and administrative services.

Rogerio Vivalidi, President and CEO of Sigilon shared his thoughts on the announcement and round of layoffs. “As part of our plan to refocus our pipeline, we will also make workforce reductions, which are expected to extend our cash runway. We believe that prioritizing our MPS-1 and diabetes programs puts Sigilon in the best position for success,” said Dr. Vivaldi. “I want to thank our valued employees who will be departing Sigilon for their important contributions to the Company.”

The significant cost savings associated with the strategic re-prioritization are expected to extend the Company’s cash runway by at least four years.

Sigilon’s future plans were also discussed with Dr. Vivaldi stating, “We will be prioritizing MPS-1—a rare lysosomal disease—with our product candidate that is designed to produce the same enzyme as the native human structure, and Type 1 diabetes, alongside our partner, Eli Lilly, with a program that utilizes iPSC-derived islets.”

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