Fortuna Fix, a private, clinical-stage Regenerative Medicine company is aiming to be the first to bring to the clinic a patient’s own neural stem cells (autologous) produced by direct reprogramming (“drNPCs”) to replace lost neuronal tissue in neurodegeneration and neurotrauma.
Fortuna announces the closing of its USD 25 million Series B financing. The proceeds will enable the company to conduct Phase I/IIa clinical trials in Parkinson’s Disease and Spinal Cord Injury. Amgen Ventures and other new investors join existing shareholders, including Salamander Invest to support the development of Fortuna’s lead programs and its neuro-regenerative technology platforms. In addition to clinical development, the financing will enable further expansion of Fortuna’s automated robotic manufacturing capabilities.
“We are excited to welcome Amgen Ventures and our other investors to Fortuna and I would like to thank them for their strong support for the development of our ethical cell therapies and for their help in bringing our novel regenerative medicine solutions to patients suffering from neurotrauma and neurodegeneration,” says Jan-Eric Ahlfors, CEO and CSO of Fortuna. “With Fortuna’s technology platform, there finally exists a tremendous opportunity to deliver autologous drNPCs that can readily replace lost neurons, do not require immune suppression, are ethically sourced, efficacious and address some of the largest unmet medical needs by fixing the underlying pathology of cell loss to enable restoration of functionality in patients.”
Fortuna’s autologous drNPCs are expected to help regenerate neural tissue with the following major benefits to patients:
- For the first time, patients suffering from neurotrauma or neurodegeneration will be able to be treated with their own neural stem cells providing functional integration without immunosuppression or ethical issues (the technology uses no fetal, embryonic-like, or other ethically challenging processes).
- The manufacturing of autologous drNPCs is accomplished with a rapid, high throughput, and fully automated process, which does not involve genetic engineering, animal components, or staged pluripotency.
Fortuna’s second neuro-regenerative technology platform – Regeneration Matrix (RMx™) – will be developed as an off-the-shelf product to be used in acute settings to support regeneration and prevent secondary damage after neurotrauma. RMx™ is a unique and highly efficient bio-scaffold that promotes neural tissue regrowth that can also be used in combination with the drNPCs to help with grafting.
In conjunction with the investment by Amgen Ventures, Dr. John Dunlop (Ph.D), Amgen Vice President, Neuroscience Discovery Research, and Philip Tagari, Amgen Vice President, Therapeutic Discovery, will take the roles of Scientific Advisory Board member and Board observer at Fortuna, respectively.
Dr. Dunlop has been with Amgen since 2016 and is leading efforts focused on neurodegenerative diseases, migraine and analgesia. Previously he was VP and Head of the Neuroscience Innovative Medicine Unit at AstraZeneca, leading discovery and early development efforts. Prior to joining AstraZeneca, Dr. Dunlop was Executive Director in the Neuroscience Research Unit at Pfizer with responsibility for the preclinical portfolios in Neurology and Psychiatry. He joined Pfizer as part of the Wyeth integration and at Wyeth held roles as head of Psychiatry and Acting Head of Neuroscience. Trained as a neuropharmacologist, his current research interests include the role of proteostasis mechanisms, innate immunity and mitochondrial dysfunction in neurodegenerative diseases such as Alzheimer’s, Parkinson’s disease and ALS, and on the emerging genetics of brain disorders. He is a member of the Executive Scientific Advisory Board for the Michael J. Fox Foundation for Parkinson’s disease, a board member of Target ALS, and serves as a scientific advisor to the ALS Association, the frontotemporal dementia biomarkers SAB, the Weston Brain Institute of Canada and the National Institute for Neurological Disorders and Stroke for translational programs in neurological disorders.
Mr.Tagari has been with Amgen for close to 20 years and has amassed 25 years of research experience in the areas of neurobiology, hematology/oncology, metabolic disease, immunology & inflammation, cell and molecular biology, peptide chemistry, analytical chemistry & biochemistry, structural biology, pharmacokinetics, safety pharmacology, laboratory automation and information technologies, that have led to several important experimental and marketed therapies and over 65 peer-reviewed publications.
“This investment in Fortuna represents Amgen’s first foray into cellular regenerative research and underscores our commitment to advancing novel neuroscience research for serious brain diseases, such as Parkinson’s,” said Philip Tagari, Amgen Vice President, Therapeutic Discovery. “Regenerative medicine is one of the most exciting fields of healthcare today, and we are delighted to participate in the advancement of these innovative solutions for patients suffering from severe neurodegenerative diseases and neurotrauma.”