Sigilon focuses on type 1 diabetes, reduces spend on MPS-1 after letting CMO go (corrected)
Sigilon Therapeutics said it decreased external spend on a rare lysosomal storage disorder as the Bob Langer-founded biotech focuses its cell therapy pipeline on type 1 diabetes.
The announcement comes after the biotech terminated the position of its chief medical officer, May Orfali, last month. Orfali remains as a consultant to Sigilon. In interviews after publication, she and CEO Rogério Vivaldi said the termination was due to the portfolio prioritization.
Flagship-founded Sigilon said it plans to ask the FDA for human study clearance in 2024 for the Eli Lilly-partnered program, with a revised development strategy that keeps the lights on into 2025. The Cambridge, MA biotech previously expected to make it into 2024 after laying off 38% of its workforce in December 2021 to focus on mucopolysaccharidosis type 1, or MPS-1, and diabetes. Cash, equivalents and marketable securities stood at $69.6 million at the end of 2022, at which point the biotech had 62 full-time employees.
The off-the-shelf cell therapy maker had a Phase I/II set up to test SIG-005 in MPS-1, but the company never dosed a patient because of issues that occurred in a separate study of another candidate in hemophilia A. The biotech said it optimized the “shielded living therapeutics” platform and last November had aimed for IND-enabling studies of the MPS-1 program in the second half of 2023.
No such timeline now exists, per a quarterly and annual update after the markets closed Tuesday. The biotech said it was still working on “engineering techniques and other cell line strategies” to limit or avoid patients’ potential immune responses to the candidates and enhance the lysosomal disorder candidates’ ability to cross the blood-brain-barrier.
“Having lived with diabetes for most of my life as well as being a treating physician, I am truly excited about the direction of our program, including our early preclinical efficacy and durability data,” Sigilon president and CEO Vivaldi said in a statement.
Other companies working on diabetes cell therapies include ViaCyte, which linked up with CRISPR Therapeutics in 2018 and then was bought by Vertex last year. Vertex said it received clearance for a second-gen approach in recent weeks.
Originally supported by Flagship Pioneering, Sigilon went public in December 2020 but has seen its share price $SGTX crater to the penny stock range since the December 2021 rehashing. Prior to the quarterly update Tuesday, the stock rose nearly 65%.
Editor’s note: This story was updated to correct the status of May Orfali’s work with the company and the nature of the termination of her position of chief medical officer.