Amgen Leaps Into the World of Regenerative Medicine With New Investment

Published: Nov 08, 2017

Backed by Amgen Ventures, privately-held regenerative medicine company Fortuna Fixsecured $25 million in funding to push its autologous stem cell treatments for Parkinson’s disease and spinal cord injuries into the clinic.

Fortuna Fix is part of a wave of personalized medicines companies using state-of-the art methods to harness the power of a patient’s own body to treat a serious medical issue. The Canadian company has its eyes set on being the first company to enter the clinic using a patient's own neural stem cells (autologous) produced by direct reprogramming ("drNPCs") to replace lost neuronal tissue due to neurodegeneration and neurotrauma.

Fortuna said its neural stem cell therapies, set to begin Phase I/IIa trials, will be able to treat patients by providing functional integration without immunosuppression or ethical issues. Fortuna made a point of noting that its therapies do not use fetal or embryonic stem cells. Additionally, the company’s product does not involve any genetic engineering, pluripotent stem cells or use of immune-suppression. The company said its treatment is expected to have a high safety profile and are also expected to replace dead neural cells, something no other product can effectively do.

In addition to its drNPC program, Fortuna’s other flagship technology is its Regeneration Matrix (RMx), which will be developed as an off-the-shelf product used in acute settings to support regeneration and prevent secondary damage after neurotrauma. RMx is a bio-scaffold that promotes neural tissue regrowth that can also be used in combination with the drNPCs to help with grafting, the company said in its statement.

"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,” said Jan-Eric Ahlfors, who serves as both chief executive officer and chief scientific officer of Fortuna.

Fortuna’s therapies have sparked significant enough interest for Amgen to become involved. This backing of Fortuna marks the first time Amgen has invested in cellular regenerative medicines. Philip Tagari, head of therapeutic discovery at Amgen, said the backing of Fortuna underscores the California-based company’s commitment to advancing novel neuroscience research for serious brain diseases that include Parkinson’s.

"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,” Tagari said in a statement.

As part of the backing of Fortuna, Amgen’s John Dunlop, head of Neuroscience Discovery Research, and Tagari will take the roles of Scientific Advisory Board member and Board observer at Fortuna, respectively.