Date: 2016-04-18
Type of information: R&D agreement
Compound: radiopharmaceutical diagnostic programs (alpha-synuclein PET tracer and TDP-43 PET tracer)
Company: AC Immune (Switzerland) Biogen (USA - MA)
Therapeutic area: Neurodegenerative diseases - Diagnostic
Type agreement: R&D
Action mechanism: Alpha-synuclein is a presynaptic brain protein that has been associated with several neurodegenerative diseases. Misfolding, aggregation and fibrillation of this protein are involved as critical factors in Parkinson's disease, Lewy body variant of Alzheimer's disease, diffuse Lewy body disease, dementia with Lewy bodies, multiple system atrophy... No alphasynuclein PET tracer has received regulatory approval for commercial distribution. Once the alpha-synuclein PET tracer is introduced to the body, it transiently enters the brain, binds to abnormal alpha-synuclein protein structures (Lewy bodies). Through the radio-tracer on the tracer molecule, the imaging device detects the bound alphasynuclein imaging agent and creates pictures reflecting the amount and distribution of pathological alpha-synuclein in the brain.
TDP-43 is another interesting target in the area of neurodegenerative diseases. Misfolded, aggregated TDP-43 protein leads to a broad pathology that occurs in multiple neurodegenerative diseases like Alzheimer’s disease, in particular complementing Taurelated pathology. Pathologic TDP-43 also is the major disease protein in diseases as frontotemporal dementia (FTLD-TDP), amyotrophic lateral sclerosis (ALS), chronic traumatic encephalopathy and Huntington’s disease.
Disease: Parkinson's disease, amyotrophic lateral sclerosis (ALS)
Details: * On April 18, 2016, AC Immune announced it has entered into a R&D collaboration with Biogen comprising two
radiopharmaceutical diagnostic programs in neurodegenerative diseases. The companies will further research, develop and clinically validate an alpha-synuclein PET radioligand that will be used as an imaging biomarker for Parkinson’s disease and related synucleinopathies to enable the clinical development of new disease-modifying therapies. In parallel, the partners will pursue a new research program to identify and develop novel PET radioligands for TDP-43, a recently identified target of growing interest in the pathogenesis of neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (Lou Gehrig’s Disease). The primary goal of this collaboration with
Biogen aims to develop a clinically validated alpha-synuclein PET tracer and generate longitudinal data in Parkinson’s disease patients. Such an alpha-synuclein PET tracer will assist the diagnosis of neurodegenerative diseases with alpha-synuclein pathology earlier and more accurately, and enable the tracking of disease pathology over time
alongside symptomatic endpoints. In parallel the partners will seek to identifiy and develop a TDP-43-PET tracer which shall be of significant importance for future therapeutic programs targeting neurodegenerative diseases such as Amyotrophic Lateral Sclerosis.
The collaboration will last for an initial three years and is funded primarily by Biogen. Both companies will share responsibilities for the R&D program while AC Immune retains intellectual property and commercialization rights from the collaboration. AC Immune continues to benefit from a 2015 grant from The Michael J. Fox Foundation for the alpha-synuclein PET program. AC Immune will lead the chemistry and biology research for both the alpha-synuclein PET tracer and the TDP-43 PET tracer program. Biogen will lead the scientific assessment and the radiopharmaceutical development of the AC Immune compounds. The two companies will share the clinical program design.
Financial terms:
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