Therapeutics

FCDI believes that cell therapies can provide a comprehensive approach to address unmet needs and improve healthcare. Our current therapeutics efforts are Together with our partners, FCDI is focused on developing off-the-shelf allogeneic cell therapies in the areas of ocular diseases, heart disease, cancer and Parkinson’s disease.

Interested in Partnering?

Partnering with FCDI provides access to FCDI's iPSC platform to advance the progress of therapeutic candidates.

Cellular Therapeutics Pipeline

The FCDI therapeutics program is leveraging our expertise in induced pluripotent stem cell technology, differentiation, engineering and cGMP manufacturing at industrial scale to take on some of the most important health challenges we face today. Our programs are aimed at therapeutics interventions in Parkinson’s Disease, heart disease and heart failure, cancer, and blinding eye diseases. FCDI’s approach combines an extensive suite of stem cell technologies with some of the most skilled stem cell researchers to advance human health and regenerative medicine.

Neurodegenerative Disease Therapeutics

Parkinson’s disease is the second most common neurodegenerative disease, affecting approximately 6 million people worldwide. Existing treatments do not prevent the progressive loss of dopaminergic neurons. At FCDI, we are harnessing our technologies and know-how to generate midbrain dopaminergic neural progenitors for an “off-the-shelf” cell replacement therapy, which has the potential for long-term patient improvement.

  • Therapeutic approach based on iPSC-derived midbrain dopaminergic progenitor cells (FCDI DAPC-1)
  • Modes of action demonstrated in preclinical models include engraftment, innervation, and reversal of functional deficits
  • Established cGMP manufacturing and cryopreservation process
  • Robust scale-up and scale-out
  • In-depth cell characterization and assay development
  • World-class scientific team and advisors

Immunocytochemistry stain of dopamine progenitor cells (DAPC-1) matured in vitro. Red (FoxA2); green (Map2).

Transplanted iPSC-derived cardiac progenitor cells after 1 month in a Nude rat acute myocardial infarction model. The human cells were detected by ISH for hAlu, followed by IHC for cardiac troponin T and DAPI. Red (hAlu, all human cells); Green (cardiac troponin T); Blue (DAPI, all nuclei)

Cardiac Therapeutics

Heart disease is the number 1 cause of death globally. Cardiac differentiation has been a core technology of FCDI for more than 10 years. Our aim is to develop a novel, effective cell therapy for severe heart failure using iPSC-derived cardiac progenitor cells. These extraordinary cells have the capacity to remuscularize the heart and are being developed as a universal treatment for this unmet global health crisis.

  • iPSC-derived Cardiac Progenitor Cells
  • Large-scale cGMP cell manufacturing platform
  • In-depth cell characterization and assay development
  • In vivo experience with small and large animal infarct models
  • World-class scientific team and advisors

Extracellular Vesicle Therapeutics

Extracellular Vesicles (EV; exosomes, microparticles, apoptotic bodies, etc.) are naturally occurring, non-replicative, lipid-membrane-bound, particles that are released by all cell types. They are formed by bubbling off of or out of their “mother” cells. This sophisticated delivery system allows for complex biological cargo to be packaged, exported, transported and delivered to specific target cells. Receipt of their cargo can improve the health and function of their target cells. At FCDI, we are interested in harnessing the power of EV to deliver therapeutic cargo released from iPSC-derived therapeutic cells to damaged tissues, such as to cardiac tissue in heart failure patients.

  • cGMP, scalable production of iPSC-derived therapeutic cells
  • cGMP, scalable EV isolation platform development
  • Molecular and functional characterization of therapeutic EV (in vitro, in vivo)
  • Collaboration with internationally recognized leaders in the field of regenerative medicine

Immuno-Oncology Therapeutics

Cancer claims about 10 million lives, globally, every year. New immunotherapies using autologous T cells expressing Chimeric Antigen Receptors (“CAR-T” cell therapy) represent a major breakthrough in treating blood cancers. Century Therapeutics LLC, collaborating with FCDI via a license and strategic scale up, manufacture, and supply relationship, is taking the next step forward in CAR immunotherapy, by engineering induced pluripotent stem cells (iPSC) and differentiating them into immune cells designed to eliminate hematologic and solid tumors. The engineered cells will possess several features to enhance persistence, overcome suppressive conditions within the tumor microenvironment, and specifically eliminate malignant cells. The engineered iPSCs generate allogeneic T, NK, or other immune cell products that will be available “off-the-shelf” and can be manufactured with scalable processes, thereby reducing cost, increasing capacity, and improving patient access.

century_therapeutics_logo

Ocular Therapeutics

Retinal degenerative diseases cause irreversible vision loss in tens of millions of patients worldwide. Our mission, in partnership with Opsis Therapeutics, is to advance a pipeline of best-in-class cell replacement therapies targeting Age Related Macular Degeneration (AMD) and inherited retinal diseases including Retinitis Pigmentosa (RP). Our technology platform builds upon recent advances that enable scalable manufacture of authentic human retinal cells from iPS cells.

  • Purified, authentic iPSC-derived retinal cell types, including retinal pigment epithelium (RPE) and photoreceptor precursor cells (PRP)
  • Large-scale cell manufacturing platform
  • In-depth cell characterization and assay development
  • In vivo expertise in small and large animal retinal degeneration models
  • Clinical knowledge and surgical expertise
  • World-class scientific team and advisors

Transplanted human iPSC-derived photoreceptors after 6 months in the S334ter rat model of retinal degeneration. Blue (DAPI, all nuclei); Green (RP1, human photoreceptors).

Partnerships

We are actively pursuing partnerships that leverage our unique reprogramming and GMP grade iPSC capabilities, coupled with our new state of the art cGMP manufacturing facility to address major human health problems. Example partnerships include Cynata Therapeutics. We have partnered with Cynata Therapeutics regarding our unique reprogramming IP and GMP grade iPSC platform for therapeutic use.

Interested in Partnering?

If iPS cell technology and cGMP cell manufacture can provide your therapeutics program with an advantage, please contact us. All contacts are handled with complete confidentiality.