The all-stock asset acquisition is valued at $58.7m.
AC Immune - a Swiss biopharmaceutical company working on precision medicine for neurodegenerative diseases - says the acquisition will make it ‘a leader in the development of therapeutics and diagnostics for Parkinson’s disease’. It will immediately launch a Phase 2 study for the newly acquired vaccine candidate.
Meanwhile, AC Immune has also announced a $25m private share placement with a group of investors led by Athos Service GmbH (one of the lead investors in BioNTech).
PD01: vaccine candidate for Parkinson's
Under the terms of the agreement, AC Immune is acquiring all of Affiris’ assets and underlying intellectual property related to active vaccine candidates targeting a-syn and $5m in cash for 7.1 million shares based on a price of $8.26 per common share. This share price represents a 10.7% premium compared to the closing price of AC Immune shares as of July 23, 2021.
Affiris is an Austrian clinical stage biopharmaceutical company, working across neurodegenerative diseases such as Parkinson’s, multiple system atrophy, dementia with Lewy Bodies and Huntington’s disease.
Affiris PD01 is a vaccine designed to generate a target-specific antibody response against pathological oligomeric a-syn (Parkinson’s disease is causally linked to pathological aggregation and deposition of a-syn, a drug target that has been validated in clinical studies using monoclonal antibodies).
Phase 1 results published in The Lancet Neurology showed that PD01 generated substantial, long-lasting and boostable antibody responses against pathological forms of a-syn that were accompanied by target engagement and signals of clinical efficacy.
Having acquired Affiris PD01, AC Immune will take ACI-7104, the optimized formulation of PD01, into an adaptive, biomarker-based Phase 2 study. This trial will evaluate an initial dose-response of the optimized formulation focusing on immunogenicity against a-syn and pathological a-syn species. Additionally, progression of motor and non-motor symptoms of Parkinson’s disease will be monitored, together with digital, imaging and fluid biomarkers.
Prof. Andrea Pfeifer, CEO of AC Immune SA, said: “We believe very strongly that active vaccination will play an important role in the long-term management and possible prevention of neurodegenerative diseases. By acquiring a clinically validated vaccine program against a-syn, we are advancing AC Immune to the forefront of Parkinson’s disease drug development, with a wholly-owned a-syn portfolio that now covers a full spectrum of treatment modalities addressing this well-characterized target.”
The acquisition is subject to customary regulatory approval in Austria and expected to complete at the beginning of Q4 2021.
New shareholders
The Strüngmann Family’s Athos Service, First Capital Partner GmbH and MIG Fonds will become AC Immune shareholders, the company also announced today. Gross proceeds from a private placement will be $25m (Athos Service and First Capital Partner), while MIG Fonds becomes a new AC Immune shareholder via its prior ownership of the anti-a-syn assets required.
“As the lead investors in BioNTech, they have a globally recognized track record of identifying and supporting successful vaccine technologies,” said Pfeifer.
“Their support of Affiris and now AC Immune serves as an endorsement of an active immunization approach for Parkinson’s disease, and provides key external validation for AC Immune’s unmatched expertise in the development of vaccines for neurodegenerative diseases.”
Aduhelm approval spurs Abeta vaccine development
AC Immune already has its own SupraAntigen-V vaccine platform, which has been shown to generate antibody responses akin to that of therapeutic monoclonal antibodies.
Earlier this year, it reported ‘highly encouraging’ readouts from ongoing Alzheimer’s disease vaccine programs targeting phospho-Tau and pathological amyloid beta (Abeta) including the most toxic oligomeric and pyroglutamate Abeta species.
“With the recent accelerated approval of the passive immunotherapy Aduhelm based on Abeta biomarker data and encouraging clinical results for the anti-Abeta antibody donanemab that demonstrate the potential benefit of targeting pyroglutamate Abeta species, AC Immune is positioned to greatly accelerate the potential time-to-market for its optimized Abeta vaccine,” says the company.
AC Immune is also leveraging its vaccine expertise to accelerate the development of ACI-7104 for Parkinson’s disease and other a-synucleinopathies.