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Image credits: Amarna Therapeutics

Amarna Therapeutics, a Leiden-based biotech company, developing curative gene therapies for a range of rare and prevalent diseases, announced that it has secured €5M funding. 

Of this total funding, €4M was provided by existing investors C4 holding BV, and Flerie Invest AB. The Netherlands Enterprise Agency invested €1M as additional innovation credit funding from RVO.

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Fund utilisation

The funds will enable the Dutch company to advance its lead gene therapy for the treatment of hemophilia B towards a first-in-human clinical trial. 

The capital will also be used to accelerate its R&D pipeline in selected autoimmune diseases and chronic inflammation.

The announcement comes two years after raising €10M funding from the same investors and RVO. 

Gene therapies

Founded in 2008, Amarna Therapeutics is pioneering the development of gene therapies based on simian virus 40 (SV40), a macaque polyomavirus to which humans are immunologically naïve. 

The Dutch company has created a proprietary production cell line (SuperVero) to produce SV40-derived vectors suitable for therapeutic use. 

Leveraging this natural non-immunogenicity feature of its gene delivery system in humans, Amarna is developing a broad pipeline of safe, effective, and durable gene therapies focused on genetic disorders, autoimmune diseases, and chronic inflammation. 

The company’s lead product, AMA005, aims to restore the blood clotting process in hemophilia B patients. 

“Hemophilia B is an X-linked blood clotting disorder causing easy bruising and bleeding due to an inherited mutation of the F9 gene, resulting in a deficiency of coagulation factor IX (FIX) in the blood,” says the company.  

The company is currently completing IND (Investigational New Drug) enabling studies and has initiated manufacturing with the aim of starting a Phase 1/2a trial in approximately two years. 

Partnership with HALIX

Amarna has recently partnered with HALIX, a biopharmaceutical Contract Development and Manufacturing Organisation (CDMO), to produce the clinical trial material. 

Steen Klysner, CEO of Amarna Therapeutics, says, “As Amarna is entering an exciting next phase, we would like to thank both our existing investors and RVO for their continued support, which enables us to advance our lead gene therapy towards the clinic and progress our broader R&D pipeline for the treatment of autoimmune and chronic inflammation towards pre-clinical proof-of-principle.”

“Moreover, we are pleased to have partnered with renowned Dutch CDMO HALIX for the production of our first clinical batches, providing an optimal setting for process transfer and collaboration, due to its location in our close proximity in Leiden,” he added.