Sigilon Therapeutics Inc.

• Sigilon Therapeutics Inc.
• Health-Care

SGTX

 We are a clinical-stage biotechnology company pioneering a new class of therapeutics and seeking to develop functional cures for patients with chronic diseases by providing stable and durable levels of therapeutic molecules to patients. We have developed our SLTx platform, which combines advanced cell engineering with cutting-edge innovations in biocompatible materials and enables our product candidates to produce a wide range of therapeutic molecules that may be missing or deficient, such as proteins, antibodies and enzymes. We are designing our product candidates to be off-the-shelf, durable, controllable and redosable, without requiring modification of the patient's genes or immunosuppression.

Our lead product candidate, SIG-001, is designed to prevent bleeding episodes in patients with moderate-severe to severe Hemophilia A by continuously secreting human FVIII. We received acceptance of our IND submission in the United States in August 2020 and our CTA in the United Kingdom in May 2020. We have initiated our Phase 1/2 clinical study of SIG-001 in Hemophilia A, with the first patient dosed in October 2020.

        Our SLTx platform is comprised of two primary elements: the cells and the sphere. We engineered cells to express the therapeutic molecule of choice, which are subsequently encapsulated in our proprietary spheres. Our human cell line was selected for its safety, durability, scalability and engineerability, which has been extensively tested in preclinical and clinical settings. The spheres are composed of an Afibromer outer layer, an alginate conjugated with a novel, proprietary anti-fibrotic small molecule, which was derived from 10 years of work in the MIT labs of Professors Robert Langer and Daniel Anderson. This work culminated in a series of patents and patent applications to which we obtained exclusive rights through our license agreement with MIT. We developed an inner compartment consisting of a proprietary conjugation of alginates and peptides to enhance cell survival and productivity. We have observed robust in vivo preclinical results in which Afibromer alginate prevents the generation of an immune response against the biocompatible spheres and prevents fibrosis, while enabling nutrient influx and therapeutic protein efflux.

        Modularity, a key attribute of our SLTx platform, is comprised of three pillars: the cells, the sphere, and the manufacturing process. In addition to the cells and the sphere described above, we have also spent significant time and resources over the last three years to create a state-of-the-art manufacturing platform that is modular for all potential product candidates developed using our cell and sphere components.

This cost-effective manufacturing platform is designed to provide a true "off-the-shelf" product for patients. Furthermore, virtually all aspects of the platform are shared across our development programs, enabling a potentially streamlined path from discovery to clinical trials. With our modular platform, the only significant change amongst our internal product candidates is the expression cassette used in the cells, which we customize to express the desired therapeutic molecule. This modularity has created an efficient engine for generation of product candidates, allowing us to build a diverse pipeline. 

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