Preclinical study supports a therapeutic role for the immunovascular antibody PC-mAb to preserve cardiac function following heart attack

Press Releases   •   Apr 23, 2018 12:00 CEST

Stockholm April 23, 2018 Scientists report a study of the effect on cardiac remodeling and function, following treatment with the fully human antibody PC-mAb from Athera, at the 5th congress of Frontiers in Cardiovascular Biology (FCVB). The congress was organized in Vienna by the European Cardiovascular Society (ESC). The group of scientists, from Leiden University Medical Center and the biotech company Athera, concluded that treatment with PC-mAb attenuates the post-ischemic inflammatory response, leading to reduced adverse cardiac remodeling and to preserved cardiac function in this study.

The clinical stage antibody PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against oxidized phospholipid, phosphoryl choline (PC), and act to alleviate the immune response to vascular inflammation challenges and thereby reduce the risk for complications. Heart attack (Myocardial infarction) is preceded by atherosclerosis in the vessels of the heart. During a myocardial infarction there is restricted blood flow (ischemia) in the infarcted areas of the heart. Even if a successful intervention to restore blood flow is performed, the damage may lead to a post-ischemic inflammatory process and related complications, including heart failure. This study supports that PC-mAb may have a therapeutic role to reduce the risk for heart failure complications in myocardial infarction patients.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB
Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. Development of PC-mAb has been co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se

Scientists report a study of the effect on cardiac remodeling and function following treatment with the fully human antibody PC-mAb from Athera. PC-mAb is designed to alleviate the immune response to vascular inflammation challenges. This preclinical study supports that PC-mAb may have a therapeutic role to reduce the risk for heart failure complications in myocardial infarction patients.

Read more »

Immunovascular antibody PC-mAb reduces vein graft remodeling in preclinical study

Press Releases   •   Apr 23, 2018 11:00 CEST

Stockholm April 23, 2018 Scientists from Leiden University Medical Center and the biotech company Athera report study data at the 5th congress of Frontiers in Cardiovascular Biology (FCVB). The congress is organized in Vienna by the European Cardiovascular Society (ESC). The preclinical in vivo study concluded that PC-mAb effectively inhibits adverse vein graft remodeling and intraplaque angiogenesis. They suggest that the fully human PC-mAb holds promise as a new therapeutic approach to prevent vein graft disease.

The clinical stage antibody PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC (phosphorylcholine) and act to alleviate the immune response to vascular inflammation challenges and thereby reduce the risk for complications. Revascularization by vein graft surgery in the legs of patients with severe peripheral arterial disease, PAD, is done to restore blood flow, to reduce pain and restore mobility. However, the risk for subsequent amputation of the affected limb is still high, as well as severe events like heart attack and stroke. The potential to inhibit inflammation after vein graft surgery in PAD patients by PC-mAb treatment is supported by the conclusions in this preclinical study.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB
Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. Development of PC-mAb has been co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se

Scientists report preclinical study data at Frontiers in Cardiovascular Biology, concluding that PC-mAb effectively inhibits adverse vein graft remodeling. PC-mAb is designed to alleviate the immune response to vascular inflammation challenges. The potential to inhibit inflammation after vein graft surgery by PC-mAb treatment is supported by the conclusions in this preclinical study.

Read more »

Athera allowed European composition of matter patents for therapeutic antibodies

Press Releases   •   Feb 28, 2018 09:04 CET

Athera today announced that a composition of matter patent covering antibodies with binding to phosphorylcholine, PC has been allowed by the European Patent Office. The therapeutic antibodies are designed to reduce vascular inflammation. The EPO allowance is following the previous grant of corresponding US, Japanese and Australian patents covering the lead candidate PC-mAb and a second candidate.

​Athera initiates Phase 2a trial on arterial inflammation with its antibody PC-mAb

Press Releases   •   Oct 11, 2017 09:00 CEST

Stockholm October 11, 2017 Athera Biotechnologies AB today announced that screening has started for a Phase 2a prospective, double-blind, randomised, placebo-controlled multicentre study to investigate the effects of treatment on arterial inflammation with PC-mAb. The study population consists of individuals with elevated levels of lipoprotein a or Lp(a), a plasma lipoprotein with high capacity to carry phosphorylcholine, PC, the pro-inflammatory target for PC-mAb.

Professor Erik Stroes of Department of Vascular Medicine at AMC Amsterdam Medical Center is Principal Investigator of the study. “We are pleased to initiate this study with PC-mAb” says Professor Stroes. “This study is very well positioned in the expected wave of new therapy developments in the inflammatory field, following the recent positive results from the large CANTOS study which was targeting the residual risk after cardiovascular events, caused by inflammation.”

“Our fully human antibody PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications” says Professor Gunnar Olsson, Chairman of the Board of Athera. “We are happy to have reached this important milestone and look forward to working with the cutting-edge science group at AMC in this study.”

The primary objective of the study is to assess the effects of PC-mAb dosing with once monthly intravenous injections on monocyte function by ex vivo testing of these cells. Secondarily the study aims to assess the functional effects on arterial inflammation in vivo and on arterial wall stiffness, as well as safety and tolerability of PC-mAb. The study sites include AMC Amsterdam Medical Center, the Netherlands, and CTC Clinical Trials Consultants in Uppsala, Sweden.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. Development of PC-mAb has been co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB.For more information: www.athera.se

Athera today announced that screening has started for a Phase 2a study to investigate the effects of treatment on arterial inflammation with PC-mAb. The study population consists of individuals with elevated levels of lipoprotein a or Lp(a), a plasma lipoprotein with high capacity to carry phosphorylcholine, PC, the pro-inflammatory target for PC-mAb.

Read more »

Athera allowed US composition of matter patents for therapeutic antibodies

Press Releases   •   Sep 25, 2017 09:00 CEST

Stockholm Sept 25, 2017 

Athera Biotechnologies AB today announced that two composition of matter patents have been allowed for antibodies with binding to phosphorylcholine, PC. The PC target is part of modified phospholipids and has been characterized as an active driver of vascular inflammation. The therapeutic antibodies covered by the patents are designed to target and block PC and thereby reduce inflammation.

“Our lead candidate PC-mAb is covered by these patents and we are thrilled with the progress of the project through early clinical development and towards the upcoming Phase 2a study” says Carina Schmidt, CEO of Athera.

The clinical stage fully human antibody PC-mAb from Athera is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications in immunovascular diseases.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB

Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. Development of PC-mAb has been co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB.For more information: www.athera.se

Athera announce that two patents have been allowed for antibodies with binding to phosphorylcholine, PC. The PC target is part of modified phospholipids and has been characterized as an active driver of vascular inflammation. The therapeutic antibodies covered by the patents, including the lead candidate from Athera, PC-mAb, are designed to target and block PC and thereby reduce inflammation.

Read more »

Athera completes financing to advance clinic with immunovascular antibody

Press Releases   •   Aug 29, 2017 09:30 CEST

Stockholm August 29, 2017

Athera Biotechnologies AB has completed a 57 million SEK financing from current major owners; The Foundation for Baltic and East European Studies (Östersjöstiftelsen), Industrifonden and Linc AB, together with new investor Ribbskottet AB, an investment company lead by Anders Bladh. Mr Bladh has a long background from international asset management, finance and banking as well as real estate. Additional investors include Athera´s management team and Antaros Medical AB.

The 57 million SEK will be used to fully finance the next steps in clinical development of Athera’s lead project PC-mAb, currently preparing for start of clinical Phase 2. PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications.

“This marks the start of a game-changing period for Athera, securing the necessary funding for the next Phase 2 study with our fully human antibody PC-mAb,”, says Athera CEO Carina Schmidt. “The new ownership will further strengthen our team and support the development of this exciting compound in a market with high medical need.”

For more information contact:

Carina Schmidt, CEO, Athera Biotechnologies AB
Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. Development of PC-mAb has been co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB. For more information: www.athera.se

Athera Biotechnologies AB has completed a 57 million SEK financing from current major owners, together with new investor Ribbskottet AB. The investment will be used to fully finance the next steps in clinical development of Athera’s lead project PC-mAb, currently preparing for start of clinical Phase 2.

Read more »

Athera Receives FDA Orphan Drug Designation for PC-mAb in prevention of vascular access failure in kidney disease patients

Press Releases   •   Jun 21, 2017 15:00 CEST

Athera Biotechnologies AB announced today that the the U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to the fully human antibody PC-mAb, for the treatment of patients with end stage renal disease, who are preparing for or undergo hemodialysis, to prevent vascular access failure.

“We are pleased that the FDA have granted orphan drug designation to our therapeutic candidate PC-mAb.” says Carina Schmidt, CEO of Athera. “The granting highlights the great unmet medical need for new therapies for kidney disease patients, who are dependent on a well-functioning vascular access for their hemodialysis.”

End stage renal disease (ESRD) patients have a loss of kidney function and require either dialysis or a kidney transplant to survive. All patients on hemodialysis require a reliable vascular access. It has been estimated that 20% of all hospitalizations in the hemodialysis population are due to vascular access dysfunction. Creation of a well-functioning vascular access is a main concern, as complications substantially contribute to morbidity and mortality. PC-mAb reduces inflammation by targeting PC (phosphorylcholine), and therefore has the potential to prevent the neointimal hyperplasia that is the root cause of vascular access failure. The fully human PC-mAb is designed to mimic the anti-inflammatory role of endogenous antibodies against PC and act to support the immune response to vascular inflammation challenges and thereby reduce the risk for complications.

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email: c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB.For more information: www.athera.se

Athera announced today that FDA have granted Orphan Drug Designation to the fully human antibody PC-mAb for the treatment of patients with end stage renal disease, who are preparing for or undergo hemodialysis, to prevent vascular access failure. PC-mAb is designed to mimic endogenous antibodies to PC and act to support the immune response to vascular inflammation and thereby reduce complications.

Read more »

Athera presents positive First-in-Patient data with their new antibody against immunovascular disease at ESVS

Press Releases   •   Sep 28, 2016 15:00 CEST

Copenhagen September 28, 2016 Athera Biotechnologies AB, a privately held biopharmaceutical company focused on developing a new antibody against immunovascular diseases, presents data from the first study in patients with peripheral artery disease (PAD) at the annual meeting of ESVS (European Society of Vascular Surgeons) in Copenhagen. Conclusions from this Phase 1b study in PAD patients were positive, showing good safety and tolerability, as well as antibody properties supporting once monthly dosing also in patients. The study, run at Karolinska University Hospital in Stockholm, included 12 patients receiving a single dose of Athera’s lead candidate PC-mAb or placebo.

Professor Gunnar Olsson, Chairman of the Board, said “The study data confirms that there are generally low levels of endogenous antibodies to phosphorylcholine, anti-PC, in PAD patients, indicating a window for reconstitution therapy with PC-mAb. We also noted that PAD patients have markedly reduced limb arterial dynamic functionality, which was an important observation for future clinical study designs. This really give a good base for succinct definitions of clinically relevant endpoints in the planned phase 2a study in this patient group.”

“We are very pleased to have reached this important milestone and to be able to report safety data supporting next development steps, efficacy trials with PC-mAb, said Athera CEO Carina Schmidt. “We think PC-mAb has significant potential to address unmet medical needs in PAD, but also in other immunovascular diseases, and this should represent a significant value for an industrial partner.”

For more information, contact: Carina Schmidt, CEO, Athera Biotechnologies AB Phone: +46 (0)76 1938 190, email:c.schmidt@athera.se

About Athera Biotechnologies AB

The mission of Athera is to address the large unmet need for anti-inflammatory therapeutics in the treatment of immunovascular disease. Athera´s focus is on PC-mAb, a clinical stage biopharmaceutical program with block-buster potential. In addition, Athera has developed a biomarker and companion diagnostics product, CVDefine® kit. The biomarker could in the future be used for identification of patients that benefit from Athera’s novel therapeutics. PC-mAb provides an opportunity to address the need for improved secondary prevention after revascularization in severe PAD patients and reduce the associated risks for complications and new vascular disease events. PAD is a chronic disease that severely restricts the mobility of the patients and therefore their quality of life. It affects about 5% in ages 45-50 and 19% in ages 85-90. With severe PAD the disease is causing extensive pain also at rest, leading to further morbidity. The risk for severe events like heart attack and stroke is high, as well as the risk for amputation of the affected limbs. Development of PC-mAb is co-funded by EU FP7 in the CARDIMMUN project. Major shareholders are Industrifonden, The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Linc AB.For more information: www.athera.se

Athera, a biotech company focused on developing a new antibody against immunovascular diseases, presents data from the first study in patients with peripheral artery disease (PAD) at the annual meeting of ESVS. Conclusions from this Phase 1b study in PAD patients were positive, showing good safety and tolerability, as well as antibody properties supporting once monthly dosing also in patients.

Read more »

Athera strengthens board with Johan Kördel

Press Releases   •   Jul 04, 2018 09:19 CEST

Johan Kördel has been elected as board director in Athera Biotechnologies AB, replacing Lennart Hansson who recently retired from Industrifonden. Professor Gunnar Olsson, former head of AstraZeneca CVD/GI Therapy area remains Charman of the Board. Otto Skolling and Svein Mathisen remain as board directors for Athera.

Information om kallelse till ordinarie Årsstämma i Athera Biotechnologies AB (Swedish only)

Press Releases   •   Apr 09, 2018 14:26 CEST

Stockholm 9 april, 2018


Årsstämma i Athera Biotechnologies AB

Styrelsen i Athera Biotechnologies AB kallar härmed till årsstämma måndag den 7 maj 2018 kl 16.00 i bolagets lokaler på S:t Eriksgatan 117 i Stockholm.

Deltagande

Rätt att delta på stämman

Aktieägare som önskar delta i årsstämman ska

dels vara införd i aktieboken onsdag den 2 maj 2017,

dels anmäla sin avsikt att delta i årsstämman senast fredag den 4 maj 2018.

Anmälan om deltagande i årsstämman m.m.

Anmälan om deltagande i årsstämman ska ske skriftligen till Athera Biotechnologies AB, Carina Schmidt, S:t Eriksgatan 117, 113 43 Stockholm eller per e-post c.schmidt@athera.se.

Vid anmälan ska uppges aktieägarens namn, personnummer/organisationsnummer, adress och telefonnummer. Dessutom ska vid anmälan anges om aktieägaren ska företrädas av om- bud och om aktieägaren ska medföra biträde. Högst 2 biträden får medföras. Aktieägare som företräds genom ombud ska utfärda skriftlig daterad fullmakt för ombudet. Fullmakten bör i god tid före stämman insändas till bolaget på ovanstående adress. Om fullmakten utfärdas av juridisk person som ej är registrerad i det av Bolagsverket förda aktiebolagsregistret, ska bestyrkt kopia av registreringsbevis eller motsvarande för den juridiska personen bifogas. För beställning av fullmaktsformulär gäller samma kontaktuppgifter som för anmälan (se ovan).

Förslag till dagordning

1.Stämmans öppnande

2.Val av ordförande vid bolagsstämman.

3.Upprättande och godkännande av röstlängd.

4.Val av en eller två justeringsmän att jämte ordföranden underteckna protokollet.

5.Godkännande av dagordning.

6.Prövning av om bolagsstämman blivit behörigen sammankallad.

7.Information från bolagets verkställande direktör.

8.Framläggande av årsredovisningen och revisionsberättelsen.

9.Beslut om:

a)fastställande av resultaträkningen och balansräkningen

b)dispositioner beträffande aktiebolagets vinst eller förlust enligt den fastställda balansräkningen, och

c)ansvarsfrihet åt styrelseledamöterna och verkställande direktören.

10.Val till styrelsen och revisor.

11.Fastställande av arvoden till styrelsen och revisorn.

12.Beslut om antagande av ny bolagsordning.

13.Bemyndigande till styrelsen att genomföra nyemission av aktier.

14.Annat ärende, som skall tas upp på bolagsstämman enligt aktiebolagslagen (2005:551) eller bolagsordningen.

15.Stämmans avslutande.

Övrigt

Kallelse med styrelsens förslag och handlingar i enlighet med aktiebolagslagen finns tillgängliga hos bolaget på S:t Eriksgatan 117, 113 43 Stockholm senast två veckor innan årsstämman.

Stockholm den 9 april 2018

Styrelsen för Athera Biotechnologies AB

E-post: info@athera.se,www.athera.se

S:t Eriksgatan 117, 113 43 Stockholm Org.nr: 556620-6859

Styrelsens säte: Stockholms kommun, Stockholms län

​Årsstämma i Athera Biotechnologies AB Styrelsen i Athera Biotechnologies AB kallar härmed till årsstämma måndag den 7 maj 2018 kl 16.00 i bolagets lokaler på S:t Eriksgatan 117 i Stockholm.

Read more »

Images & Videos 3 images

Contacts 3 contacts

  • Press Contact
  • Chief Executive Officer, M.Sc.
  • Chief Executive Officer, M.Sc.
  • nuc.schmjwdbfyidt@mhrmxzkfatxehezsraeg.se
  • +46 (0)76-1938190
Carina Schmidt has nearly 30 years industrial experience, mainly in business development and management within the life science... Show more

About Athera Biotechnologies AB

Clinical stage development of anti-inflammatory antibody therapeutics for treatment of immunovascular disease

Athera is a clinical stage biopharmaceutical company focused on developing targeted anti-inflammatory biological candidate drugs and companion diagnostics for the prevention and treatment of immunovascular disease. The Company initiated its current program in 2005, harnessing breakthrough innovations made at the world-renowned Karolinska Institutet, Sweden. The company currently has a proprietary clinical development stage 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 is managed by a core team of senior professionals from the pharmaceutical and diagnostics industries in a semi-virtual organization.

Address

  • Athera Biotechnologies AB
  • Sankt Eriksgatan 117, 4th floor
  • 11343 Stockholm
  • Sweden
  • Our homepage