A world-class atherosclerosis R&D company,
part of Karolinska Development portfolio.
Athera has a unique and in-depth understanding of the immunological components in atherosclerosis, the inflammatory process leading to cardiovascular disease (CVD). The lead product candidate, the fully human antibody PC-mAb, is in late preclinical development. In addition, Athera has developed a biomarker and companion diagnostic CVDefine® kit. The biomarker, anti-PC, is linked to increased risk for cardiovascular disease and could in the future be used for identification of patients that benefit from Athera’s novel therapeutics.
PC-mAb is a fully human monoclonal antibody which neutralizes a key driver of vascular inflammation, phosphorylcholine (“PC”). Naturally occurring antibodies to phosphorylcholine (anti-PC) have anti-inflammatory properties and prevent the uptake of oxidized LDL in macrophages. Low endogenous levels of antibodies to phosphorylcholine (“anti-PC”) have been linked to a higher incidence of secondary events in CVD.
Athera’s PC-mAb is targeting the market of reducing secondary cardiovascular events, focusing on high-risk patients with low anti-PC levels. This program is in IND-enabling studies and the start of Phase I studies is expected in 2014. According to plan, the data will enable a business agreement with Athera and a partner. PC-mAb could then be launched on the market as a new drug, with clear block-buster potential, by year 2020.
To enhance clinical success by properly selecting the target population, Athera has developed a proprietary companion diagnostic CVDefine® kit to identify patients with low anti-PC levels in need of receiving PC-mAb therapy. The kit is CE-approved.
Athera is a biopharmaceutical company focused on developing targeted anti-inflammatory biological candidate drugs and companion diagnostics for the prevention and treatment of cardiovascular disease (“CVD”). The Company initiated its current program in 2005, harnessing breakthrough innovations made at the world-renowned Karolinska Institutet, Solna, Sweden. The company currently has a proprietary pre-IND program, PC-mAb, supported by an approved proprietary companion diagnostic kit. Future development costs for the antibody therapy will be co-financed by the EU FP7 program, in the project CARDIMMUN. Athera has an exclusive option agreement with Boehringer Ingelheim. Karolinska Development AB (publ) owns 65% of Athera Biotechnologies AB. Athera is managed by a core team of senior professionals from the pharmaceutical and diagnostics industries in a semi-virtual organization.
Carina Schmidt, CEO
Knut Pettersson, VP Preclinical development
Tommy Abrahamsson, Senior Advisor CVD pharmaceuticals
Anders Bergman, VP IP/Legal
Iréne Agerkvist, Project Management
board of directors.
Gunnar Olsson, MD, PhD
Chairman, former head of CV/GI in AstraZeneca
Otto Skolling, MSc
VP Business Development Karolinska Development AB
Tomas Odergren, MD, PhD
VP Clinical development Karolinska Development AB
Athera elects new Chairman of the Board and moves to new premises
Sep 19, 2013.
Athera and Boehringer Ingelheim enter into an option agreement on a novel therapy for Atherosclerosis
Jun 19, 2013.
EU grants EUR 6m to the clinical development of Athera´s cardiovascular disease antibody therapy
Jun 17, 2013.
Low levels of anti-PC predict vein graft failure
Okt 25, 2012.
Study linking outcome in acute coronary syndromes to anti-PC published in International Journal of Cardiology
Feb 7, 2012.
Athera is the leading SME partner in the FP7 EU-project CARDIMMUN. The project involves 5 partners, also including Smerud Medical Research International AS, Clinical Trial Consultants AB, Turku Pet Center and Leiden University Medical Center. LUMC is the project coordinator and will be leading the project together with Athera.
CARDIMMUN aims to pursue development of the scientific findings from the FP6 project CVDImmune. Based on patented discoveries in Athera Biotechnologies AB, that low levels of anti-PC (phosphorylcholine) indicate risk for future development of cardiovascular disease, we have developed both a diagnostic test (a marker to identify cardiovascular disease patients that are at high risk of secondary events) and a candidate drug – an innovative fully human monoclonal antibody antibody, PC-mAb – that can block vascular inflammation. Together, this forms a unique opportunity for a personalised medicine approach, with a companion diagnostic and a targeted intervention in an area that is still in great medical need, despite recent advances in therapy. PC-mAb is now ready for clinical development.
The project will be progressed, by a structured plan that brings together SMEs and selected academic partners, and integrates preclinical and clinical studies into a commercially viable and mature therapeutic modality. The 5 work packages will embrace concept testing in preclinical models using biomarkers applicable also in human disease, coronary flow reserve and glucose uptake in inflamed arteries, as well as required toxicity studies. Additionally, studies in man are planned that explores safety, pharmacokinetics, pharmacodynamics and indices of clinical efficacy, including a placebo-controlled Proof of Activity trial in patients.
CARDIMMUN receives funding from the European Union, Seventh Framework Programme.
Carina Schmidt, CEO
Reg. No. 556620-6859
Telephone: +46 76 1938 190
Athera Biotechnologies AB
Sankt Eriksgatan 117, 4th floor
113 43 Stockholm, Sweden
Athera is located at Business Center Bilpalatset, next to Hagastaden and the new Karolinska Hospital.