The mind is like a parachute. It only works if we have it open ~ Albert Einstein
Who is Hemera?
Hemera is a biotech start-up that carries out research and clinical development in regenerative medicine applied to neurological diseases, recognized as a spin-off of the Universities of Verona and Milan.
In the 10 years preceding the establishment of the Company, Hemera’s team of scientists developed and tested a cell therapy for the regeneration of damaged neuronal tissue, the first application of which relates to the treatment of spinal cord lesions.
Which is Hemera’s corporate structure?
In addition to the 4 co-founder scientists, the corporate structure includes 1 Investor and 2 syndicate companies – Friends of Founders and Proemera – which have a total of over 100 Angel Investors.
Where does the company operate?
Hemera operates in three different locations: in Verona, in the laboratories of the University, where Research & Development activities are carried out; in Milan, in the State University laboratories, where Clinical Development and Cell Therapy production activities take place; in the laboratories of the Humanitas Clinical Institute.
How is the research team composed and what skills are represented?
Hemera has an outstanding scientific team, all Italian, with international experience and reputation, that operates in the field of personalized and precision medicine, an extremely complex sector that requires highly specialized skills and know-how.
The research team is composed by the Scientific Director, Prof. Massimo Locati, the R&D Director, Prof. Ilaria Decimo, the Director of the Therapy Development Department, Prof. Francesco Bifari, and by Prof. Guido Fumagalli, Hemera’s President and Chief Medical Officer.
The team coordinates a staff of more than 25 researchers.
What are the functions of the Advisory & Regulatory Board?
The scientific team is supported by an Advisory & Regulatory Board with regulatory and clinical skills – in particular neurosurgical and neuro-rehabilitative – as well as skills related to the quality assurance system.
The REMAST therapy
What is REMAST Therapy?
REMAST therapy is based on macrophages, a type of immune cells, generated from cell precursors obtained from the patient’s blood and their in vitro exposure to particular culture conditions. This procedure leads the microenvironment to generate a “cellular bioreactor” which we have called REMAST.
What does REMAST stand for?
The acronym stands for Regenerative Educated Macrophages Self Transplantation.
In spinal injuries, a local microenvironment that is highly unfavorable to the regeneration of the damaged nerve fibers is established in a very short time, which is the basis of the failure to recover from the motor damage.
REMAST cells are instructed in vitro to best express their reparative capacities, causing them to behave as tumor cells, by definition rapidly growing despite the hostile context in which they develop.
Furthermore, in the nautical world, “to remast” means “to reassemble the ship’s mast”, a meaning of great inspiration for Hemera, which aims to offer a therapy to people with spinal cord lesions.
Who is the therapy intended for?
What pathology could REMAST therapy cure?
The therapy that Hemera is developing is indicated for the treatment of severe acute spinal cord lesions, i.e., when the injury has just occurred and is not in a chronic form and when the injury is so serious that motor recovery, either spontaneous or by means of physical rehabilitation, is impossible.
Which patients could be treated with Hemera therapy?
The therapy must be administered in the sub-acute phases, between the 2nd and 8th week after the spinal cord injury, when the tissue repair process has not been completed.
Therefore, at present the therapy does not concern patients with chronic spinal injury.
Current stage of development of the therapy
Has Hemera started the regulatory approval process?
As with all companies in the biotech sector, Hemera operates in a highly regulated context and for this reason it has already begun the regulatory process, with a five-year development plan and the strategic goal of proving the efficacy and safety of the REMAST Therapy in humans as Orphan Drug Disease.
When will it be possible to administer the therapy to patients?
The therapy must obtain the approval from the European Medicine Agency – EMA on the basis of its safety, efficacy and standardization. To this end, Hemera need the authorization for its clinical experimentation on an estimated population of 20 spinal cord-injured patients.
Once Phases 1 and 2 Clinical Trials have been completed, the therapy can be introduced into clinical practice.
What and how many studies have been conducted?
REMAST Therapy has proven to be effective in the preclinical setting, both in vitro on human adult motoneurons and in vivo in murine models of severe spinal cord injury.
10 pre-clinical studies were performed in more than 200 mice in over 10 years of research.
What results has REMAST Therapy achieved in the preclinical phase?
REMAST therapy has shown very promising results.
In terms of effectiveness, the Therapy has shown to repair the negative effects induced by spinal cord lesions.
In terms of safety, the Therapy has shown a highly favorable profile, determined by its autologous nature combined with the fact that there is no genetic manipulation of the cells.
What were the benefits of the Therapy?
The Therapy allowed to counteract the negative effects induced by spinal cord injury, reducing the scar that causes the interruption of the neuronal connection, decreasing blood vessel impairment and inflammation, improving the survival of neuronal cells, and the regrowth of connections, also favoring the improvement of the blood vessel network.
What's the next goal?
Hemera’s goal is to start the Clinical Trial in 2025. To this end, a collaboration with the Neurorehabilitation Institute “Villa Beretta” has already been started. Likewise, a network of centers of excellence for neurosurgery and spinal cord units located in Central and Northern Italy has been activated.
Forms of investment to support the therapy development
What is the financial requirement?
The development of the REMAST Therapy pledges an estimated capital investment of 10 million euros to complete Phase 1 and 2 Clinical Trials on spinal cord-injured patients and to obtain approval from EMA.
At what stage is the raising of capital?
Hemera has already concluded six capital increases, raising over 2 million euros, thanks to the generosity and social responsibility of private investors, business angels and family offices, who have decided to invest in our extraordinary scientific and entrepreneurial initiative.
Fundraising activities continue and a further round of funding is currently underway.
Can I invest in Hemera?
We are currently preparing a bridge round. If you want to learn more about it, visit the CONTACT US section and express your interest by clicking on “I would like to finance Hemera’s research “. We will contact you to get to know you better!
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