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Understanding stroke

A new target — GPVI

GPVI is an attractive target to develop new and safe antithrombotic with the following advantages:

High efficacy

  • pivotal role in atherothrombosis
  • inhibition of thrombus growth
  • inhibition of leucocyte recruitment
  • inhibition of platelet procoagulant activity

Safety

  • preservation of physiological haemostasis
  • minor risk of bleeding

High specificity

  • no expected side effect

GPVI is a platelet membrane protein which belongs to the immunoglobulin superfamily and that is expressed exclusively by platelets and their precursor, the megacaryocytes.

GPVI is the receptor responsible for platelet activation by collagen and polymerized fibrin and as thus, it is involved in the initiation of thrombus formation.

GPVI contributes to the growth of the thrombus in two ways. First GPVI mediates platelet procoagulant activity via an initial adhesion to collagen followed by an activation leading to platelet secretion, recruitment of additional platelets and aggregation. Second GPVI behaves as a receptor for polymerized fibrin which lead to an amplification of thrombin generation and recruitment of circulating platelets.

Acticor Biotech new target GPVI in 3D
3D structure of GPVI

A striking result was to discover that GPVI deficiencies do not provoke bleeding while it contributes to protect mice from thrombosis in different models. Furthermore, the founders were the first to identify a patient with a genetic deficiency in GPVI who do not presents any bleeding disorder.

Several model of thrombosis have been evaluated with the murine antibody 9O12 which was the prototype of the humanized drug candidate ACT017. In these models, 9O12 was able to decrease the process of thrombosis in vivo or to protect animals in a lethal model.

Furthermore, elevated plasma levels of soluble GPVI in patients with stroke suggest that GPVI is activated and processed in these patients.







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  • Header illustrations: © Getty Images, © Shutterstock © Fotolia
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  • Agoranov picture, © Agoranov, via http://www.agoranov.com
  • Catalent’s Kansas City, MO facility, © Catalent
  • Mediolanum’s building © Mediolanum Farmaceutici S.p.a.






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Acticor Biotech SAS
Address :
46, rue Henri Huchard
75018 PARIS
FRANCE
Email: contact@acticor-biotech.com
SIREN: 798 483 285 RCS Paris
Publishing Director: Gilles AVENARD, CEO

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Understanding stroke

Stroke treatment

Current treatment lacks efficiency

Only one pharmaceutical treatment is presently approved by FDA and EMA for ischemic stroke: thrombolysis, which aims at dissolving the blood clot. This emergency treatment is being administered to approximately 15% of patients overall, mainly because it must be done within 4 hours and 30 minutes (as approved in EU, 3 hours in USA) of the onset of stroke symptoms, in a specialized neurovascular hospital unit.

Moreover, because this treatment could induce bleedings in some patients, it is subjected to some contraindications. Finally, its efficacy remains limited to an estimated 30% success rate. A meta-analysis from 5 randomised trials has shown that thrombolysis protects only around 13% of the patients treated.

Therefore a major need for a new stroke treatment capable of effectively treating a majority of ischemic stroke patients remains.

Since 2015, mechanical thrombectomy has been recognized in several clinical trials and has demonstrated efficacy based on clinical scores at 90 days. The method is based on the use of a device delivered by endovascular access proximal to the occlusion site to disrupt the clot. Although thrombectomy becomes a gold standard, the amount of patients treated remains limited.

Antiplatelet drugs (which inhibit blood platelets aggregation) proved their efficacy in ischemic diseases like myocardial infarction, but they are not recommended in the first 12 to 24 hours for stroke because they tend to induce bleedings that have catastrophic consequences in the brain.

Our innovative solution

In this context, Acticor Biotech took on the mission to develop an innovative antithrombotic compound which could be used in the first 12 hours before switching to antiplatelet agents. Considering the properties of the target GPVI our goal is to achieve an effective action against the formation and growth of the blood clot responsible for the ischemia, without increasing bleeding risks.







Understanding stroke

Stroke outcomes

The first cause of adult acquired disabilities

Despite sustained efforts worldwide to reduce cardiovascular diseases incidence and morbi-mortality, stroke or cerebral infarction remains the first cause of adult acquired disabilities and the third cause of death in industrialized countries. There is presently no effective treatment that can be safely used on most patients.

Each year, around one million patients in Europe experience a stroke and approximately 800,000 in the USA (one every 40 seconds). Worldwide, it is 15 million people who suffer stroke each year, and of these, 6 million die.

Stroke is a cardiovascular disease and is positively impacted by cardiovascular risk prevention. However the aging of the population largely compensates this and the number of stroke occurrence is still increasing in some age groups possibly due to changes of living habits.

Stroke outcomes are disastrous

  • Death: stroke is the 3rd cause of death in wealthy countries.
  • Handicaps: stroke is the first cause of serious long-term disability and the first cause of adult acquired handicap globally, and notably the 2nd cause of dementia after Alzheimer disease.

A major economic impact

In addition to being a major public health issue, stroke has a major economic impact. For instance in 2010 stroke-related medical costs and disability cost about 34 billion dollars to the USA. In the EU countries, the total annual cost of stroke is estimated at 38 billion euros, including the value of informal care. An international comparison of stroke cost studies showed that, on average, 0.27% of gross domestic product was spent on stroke by national health systems, and stroke care accounted for ∼3% of total health care expenditures.

Annually, 15 million first-ever strokes occur in the world, causing a total of 6 million deaths.







Understanding stroke

Stroke in brief

A large spectrum of symptoms

Stroke or cerebral infarction is a sudden neurological deficit caused by an infarction (80% cases) or a hemorrhage (20% cases) in the brain. It is characterized by a quick onset (instantaneous or within minutes) and is most of the time affecting one half of the body: hemiplegia, unilateral blindness but also speech impairment.

This large spectrum of symptoms varies from patient to patient but also depending on the hemorrhagic or ischemic origin of the stroke and the location of the neurological damage. However, in all cases, the sudden onset of a deformed mouth, a weakening of one side of the body (arm or leg) and/or difficulties to speak are the indication of a neurological problem that should be considered a potentially life-threatening medical emergency.

After onset, symptoms can disappear spontaneously within seconds or hours. In this case the event is referred to as Transient Ischemic Attack (TIA). Even if no neurological trouble sustains, this is a diagnostic and therapeutic emergency. All patients experiencing this type of symptoms must visit a doctor or the closest emergency service available.

Around 30% of strokes occur after this kind of transient symptoms, which are too often neglected by patients.

It usually takes a long time for survivors to recover spontaneously, from several weeks to several months, followed by a slower recovery phase that lasts for years.

The two types of stroke

Approximately 80% of strokes are the ischemic type. They are caused by the occlusion of an artery delivering blood to the brain (brain arteries but also carotids and vertebral arteries). When this happens, a part of the brain is deprived of oxygen and nutrients. This deprivation results in a cerebral infarction, which provokes neurological damages that result in severe disabilities or death if it lasts more than several minutes or hours.

The remaining 20% of strokes are hemorrhagic, subsequent to the rupture of a cerebral artery wall.

The probability of experiencing an ischemic stroke increases with age whereas hemorrhagic strokes occurrence is age independent. However, even if the mean age for stroke is 73 years (in Europe), 25% of strokes occur in patients below 65. Stroke can occur at all age, including childhood.







Our product — ACT017

Pipeline

ACT017

In recent decades molecular engineering methods have seen impressive advances enabling the design of therapeutic antibodies and derivatives that now represent the fastest growing class of biopharmaceuticals .

Acticor Biotech product, ACT017, is a high affinity humanized antibody fragment (Fab) directed against a new therapeutic target of major interest: the platelet glycoprotein VI (GPVI). ACT017 is produced in CHO cells using the GPEx technology (Catalent).

GPVI ACT17 Blockade of GPBI binding sites
ACT17 (Acticor Biotech): monoclonal Fab

ACT017 activity has been demonstrated in transgenic mice expressing the human GPVI and in primates. The results shown an inhibition of the collagen-induced platelet aggregation with no influence on bleeding time nor platelet count. The treatment will be a new option in the therapeutic landscape of stroke: it should be suitable for use in all patients, including those eligible to thrombolysis or not and patients beneficing of mechanical thrombectomy.







Understanding stroke

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Contact Us

Contact information

map-markerHeadquarter

Acticor Biotech SAS
Hôpital Bichat - INSERM U1148
46, rue Henri Huchard
75018 PARIS
France
Email: contact@acticor-biotech.com

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Acticor Biotech
Paris Santé Cochin
27 rue du Faubourg Saint Jacques
75014 Paris France
Adresse mail : contact@acticor-biotech.com

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About Us

Company Overview

Acticor Biotech Summary

Acticor Biotech is a biopharmaceutical company developing an antithrombotic agent for the treatment of the acute phase of ischemic stroke.

Acticor Biotech is a spin-off company from Inserm (French National Institute of Health and Medical Research) founded in November 2013 and located in the Inserm U1148 building inside the Bichat Hospital in Paris.

Acticor Biotech develops a biologic drug candidate based on academic research on a platelet glycoprotein called GPVI. GPVI is a platelet receptor of collagen and polymerized fibrin. The drug candidate ACT017 is a humanized fragment of monoclonal antibody which binds to GPVI and inhibits platelet adhesion and aggregation on collagen and polymerized fibrin. The efficacy and safety of ACT017 have been demonstrated in vitro and in vivo animal models. Acticor Biotech announced, end of January 2018, the completion of its phase I clinical trial in healthy volunteers. The primary endpoint assessing safety and tolerability was achieved with no serious adverse event reported at any of the doses tested. With the results of this study, the company will be able to determine the most appropriate ACT017 dosage for phase II studies which should start Q3 2018.

Partners and awards

Concours Mondial de l’Innovation 2016

Laureate 2016, “Silver Economy” category

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Tremplin des Entreprises 2016

Laureate 2016

Acticor Biotech, lauréate du Tremplin des Entreprises 2016

Since 2015, this project received the label EIP by Medicen (Innovative Enterprise) and has been recognized by Genopole. In 2016, Acticor Biotech was laureate of the Concours Mondial d’ Innovation (World Innovation Contest) and was also laureate of the Concours Tremplin d’Entreprises du Sénat (national contest for innovative enterprises).

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Recently, Acticor Biotech signed a partnership contract with INSERM and received grants from Bpifrance (innovation support).







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