PRESS RELEASE

October 13, 2022

BrainEver and 3P Biopharmaceuticals collaborate on development of recombinant human homeoprotein Engrailed-1

[Noáin, Spain, Octuber 13, 2022] 3P Biopharmaceuticals (3P), a leading contract development and manufacturing organization (CDMO) specializing in the process development and cGMP manufacturing of biological products and BrainEver a French biotechnology company focusing on discovering and developing First-in-Class therapies for the treatment of neurodegenerative diseases have entered into a long term collaboration to develop hEng1 a recombinant homeoprotein to treat pathologies such as Amyotrophic Lateral Sclerosis (ALS) or Parkinson’s disease.

June 08, 2022

BrainEver announces the award of €2.5M funding from the European Innovation Council for its project on the use of homeoproteins as novel therapies for neurodegenerative diseases

BrainEver’s project has been awarded a grant by the Horizon Europe funding program – the ultra-competitive instrument EIC Accelerator. BrainEver is one of the 74 companies to win this award at the March 2022 cut-off, selected amongst the 1092 projects filed. The project aims at developing and validating a revolutionary therapy using the homeoprotein Engrailed-1, to treat patients with Amyotrophic Lateral Sclerosis (ALS) and Parkinson’s Disease (PD). BrainEver will first receive €2.5M in grant to complete the regulatory preclinical toxicity studies and is eligible to further negotiate up to €15M in equity from the EIC to lead the clinical validation on ALS and PD.

Alain Prochiantz, co-founder and CSO, is the researcher that laid the foundation for BrainEver’s technology, commented: “This award by the European Innovation Council illustrates how a disruptive counter-dogmatic discovery, unveiling previously ignored physiological pathways, can lead to the finding of therapeutic molecules with disease-modifying activities”.

November 23, 2020

BrainEver Receives FDA Orphan Drug Designation for BREN-02, (human recombinant Engrailed 1) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

BREN-02 is expected to be administered in clinical trials in ALS patients in the second half of 2021, subject to preclinical toxicity results and regulatory review. Preclinical studies have shown that the homeoprotein hEN1 is essential for the survival and maintenance of spinal cord alpha motor neurons that innervate muscles throughout the body.

The FDA grants orphan drug status to encourage the development of therapies to treat, prevent or diagnose diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation in the United States recognizes the therapeutic potential of BREN02 in ALS and allows BrainEver to benefit from specific measures and advantages, including a seven-year marketing exclusivity period if hEN1 is approved for the treatment of ALS.