Last update 20 Jun 2024

Glenzocimab

Last update 20 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Fab fragment

Synonyms

Immunoglobulin g1, anti-(human platetet glycoprotein vi) fab fragment (humanized monoclonal act017 .gamma.1-chain), disulfide with humanized monoclonal act017 .kappa.-chain, ACT-017

Target

GPVI

Mechanism

GPVI inhibitors(Platelet membrane glycoprotein VI inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular Diseases

Active Indication

Acute Ischemic Stroke

Inactive Indication

COVID-19Respiratory Distress Syndrome, AdultSARS-CoV-2 acute respiratory disease+ [1]

Originator Organization

Acticor Biotech SAS

Active Organization

Acticor Biotech SASFondation Ophtalmologique Adolphe de Rothschild

Inactive Organization

China Medical System Holdings Ltd.

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 616723309H

Source: *****

Sequence Code 616723310L

Source: *****

Clinical Trials associated with Glenzocimab

NCT06437431 / Not yet recruitingPhase 2/3

Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy

Until recently, acute ischemic stroke (AIS) patients with a baseline large infarct core have been generally excluded from clinical trials of endovascular therapy (EVT). A first multicenter randomized trial (Rescue Japan Limit trial) found a significant benefit of EVT in AIS patients with large infarct core (DWI-ASPECTS of 3-5). Another non-randomized multicenter prospective study found a positive association of EVT with 3-month outcome in AIS patients with a baseline CTP ischemic core volume >70mL. More recently, 2 additional randomized trials were published. They both confirmed a strong efficacy of EVT in patients with large infarct core. However, even with EVT, the proportion of good outcome (3-month mRS score of 0-3), remains low in these highly severe AIS patients ranging from 8-30%. Almost 75% of EVT-treated patients are still severely disabled or dead at 3 months. In experimental studies, we and others described the pathophysiological features of the downstream microvascular thrombosis (DMT) in AIS setting highlighting its immediate occurrence and the pivotal role of platelet activation and aggregation. In recent clinical studies, it has been shown that, even with a complete angiographic recanalization after EVT, up to 40% of patients presented no-reflow (NR), a failure of downstream microvascular reperfusion, visible on perfusion imaging performed after EVT. Some clinical studies reported the clinical impact of NR after successful EVT. We found that DMT participated to the development of neurovascular lesions in AIS with both an early ischemic lesion growth risk evolving towards a delayed hemorrhagic transformation (HT) and vasogenic edema risks and therefore worse outcome. Our results suggested that an antiplatelet therapy infused early in AIS patients could reduce both the ischemic lesion but also the risk of delayed vasogenic edema and HT. Platelet glycoprotein VI (GPVI) is a key receptor for collagen and fibrin and plays a major role in platelet activation, platelet recruitment and thrombosis. Furthermore, inhibition of the GPVI does not impair haemostasis and subjects with a genetic or acquired GPVI deficiency are not prone to excessively bleed.
Glenzocimab is a monoclonal antibody directed against the GPVI. It has been developed as an immediate antiplatelet agent with minimal bleeding risk for treating AIS. The ACTIMIS trial, a phase IB/IIA clinical study that assessed for the first time the glenzocimab IV infusion in AIS patients found very promising safety data including a significant reduce of symptomatic HT (1% vs. 7.8%) and mortality rates (7.8% vs. 18.7%), especially in severe AIS patients. Our hypothesis is that IV glenzocimab infusion would improve good functional outcome in large ischemic core AIS patients treated with EVT by reducing the DMT, ischemic lesion growth, and the HT rate.

Start Date01 Sep 2024

Sponsor / Collaborator

Fondation Ophtalmologique Adolphe de Rothschild

ISRCTN15443962 / RecruitingPhase 2IIT

A phase II, randomised, double-bLInd, placeBo-controllEd tRiAl To invEstigate the efficacy and safety of glenzocimab and the mechanism of inhibiting platelet GPVI as a treatment for ST-elevation myocardial infarction (LIBERATE)

Start Date15 Jan 2024

Sponsor / Collaborator

University of Birmingham

EUCTR2021-002148-56-DK / Not yet recruitingPhase 2/3

A RANDOMIZED, DOUBLE BLIND, MULTICENTER, MULTINATIONAL, PLACEBO CONTROLLED, PARALLEL GROUP, SINGLE DOSE, ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE - ACTISAVE

Start Date15 Nov 2023

Sponsor / Collaborator

Acticor Biotech SAS

100 Clinical Results associated with Glenzocimab

100 Translational Medicine associated with Glenzocimab

100 Patents (Medical) associated with Glenzocimab

Literatures (Medical) associated with Glenzocimab

01 Feb 2024·The Lancet. Neurology

Safety and efficacy of platelet glycoprotein VI inhibition in acute ischaemic stroke (ACTIMIS): a randomised, double-blind, placebo-controlled, phase 1b/2a trial

Article

Author: Grouin, Jean-Marie ; Molina, Carlos A ; Lemmens, Robin ; Grotta, James C ; Plétan, Yannick ; Richard, Sébastien ; Toni, Danilo ; Binay, Sophie ; Köhrmann, Martin ; Avenard, Gilles ; Meilhoc, Adeline ; Comenducci, Andrea ; Lyrer, Philippe A ; Mazighi, Mikaël ; Sari, Anouar ; Jandrot-Perrus, Martine

BACKGROUND:

Antagonists of glycoprotein VI-triggered platelet activation used in combination with recanalisation therapies are a promising therapeutic approach in acute ischaemic stroke. Glenzocimab is an antibody fragment that inhibits the action of platelet glycoprotein VI. We aimed to determine and assess the safety and efficacy of the optimal dose of glenzocimab in patients with acute ischaemic stroke eligible to receive alteplase with or without mechanical thrombectomy.

METHODS:

This randomised, double-blind, placebo-controlled study with dose-escalation (1b) and dose-confirmation (2a) phases (ACTIMIS) was done in 26 stroke centres in six European countries. Participants were adults (≥18 years) with disabling acute ischaemic stroke with a National Institutes of Health Stroke Scale score of 6 or higher before alteplase administration. Patients were randomly assigned treatment using a central electronic procedure. Total administered dose at the end of the intravenous administration was 125 mg, 250 mg, 500 mg, and 1000 mg of glenzocimab or placebo in phase 1b and 1000 mg of glenzocimab or placebo in phase 2a. Treatment was initiated 4·5 h or earlier from stroke symptom onset in patients treated with alteplase with or without mechanical thrombectomy. The sponsor, study investigator and study staff, patients, and central laboratories were all masked to study treatment until database lock. Primary endpoints across both phases were safety, mortality, and intracranial haemorrhage (symptomatic, total, and fatal), assessed in all patients who received at least a partial dose of study medication (safety set). The trial is registered on ClinicalTrials.gov, NCT03803007, and is complete.

FINDINGS:

Between March 6, 2019, and June 27, 2021, 60 recruited patients were randomly assigned to 125 mg, 250 mg, 500 mg, or 1000 mg glenzocimab, or to placebo in phase 1b (n=12 per group) and were included in the safety analysis. Glenzocimab 1000 mg was well tolerated and selected as the phase 2a recommended dose; from Oct 2, 2020, to June 27, 2021, 106 patients were randomly assigned to glenzocimab 1000 mg (n=53) or placebo (n=53). One patient in the placebo group received glenzocimab in error and therefore 54 and 52, respectively, were included in the safety set. In phase 2a, the most frequent treatment-emergent adverse event was non-symptomatic haemorrhagic transformation, which occurred in 17 (31%) of 54 patients treated with glenzocimab and 26 (50%) of 52 patients treated with placebo. Symptomatic intracranial haemorrhage occurred in no patients treated with glenzocimab compared with five (10%) patients in the placebo group. All-cause deaths were lower with glenzocimab 1000 mg (four [7%] patients) than with placebo (11 [21%] patients).

INTERPRETATION:

Glenzocimab 1000 mg in addition to alteplase, with or without mechanical thrombectomy, was well tolerated, and might reduce serious adverse events, intracranial haemorrhage, and mortality. These findings support the need for future research into the potential therapeutic inhibition of glycoprotein VI with glenzocimab plus alteplase in patients with acute ischaemic stroke.

FUNDING:

Acticor Biotech.

01 Nov 2023·Journal of thrombosis and haemostasis : JTH

Amplified inhibition of atherosclerotic plaque-induced platelet activation by glenzocimab with dual antiplatelet therapy.

Article

Author: Price, Joshua ; Alenazy, Fawaz O ; Kirchhof, Paulus ; Hargreaves, Oscar ; Tiwari, Alok ; Harbi, Maan H ; Slater, Alexandre ; Connolly, Derek L ; Kavanagh, Dean P ; Mangin, Pierre H ; Harrison, Paul ; Brady, Paul ; Watson, Steve P ; Kalia, Neena ; Thomas, Mark R ; Jandrot-Perrus, Martine ; Nicolson, Phillip L R

BACKGROUND:

Aspirin and platelet P2Y₁₂ inhibitors, such as ticagrelor, suboptimally inhibit microvascular thrombosis during ST-elevation myocardial infarction. Glycoprotein (GP) IIb/IIIa inhibitors may further inhibit this but cause excessive bleeding.

OBJECTIVES:

We investigated whether combination of glenzocimab, a GPVI inhibitor, with aspirin and ticagrelor provides additional antithrombotic effects, as GPVI has a critical role in atherothrombosis but minimal involvement in hemostasis.

METHODS:

We investigated the effects of glenzocimab (monoclonal antibody Fab fragment) using blood from healthy donors and patients with acute coronary syndrome treated with aspirin and ticagrelor. Platelets were stimulated with multiple agonists, including atherosclerotic plaque, from patients undergoing carotid endarterectomy.

RESULTS:

Aspirin and ticagrelor partially inhibited atherosclerotic plaque-induced platelet aggregation by 48% compared with control (34 ± 3 vs 65 ± 4 U; P < .001). Plaque-induced platelet aggregation, adhesion, secretion, and activation were critically dependent on GPVI activation. Glenzocimab alone reduced plaque-induced aggregation by 75% compared with control (16 ± 4 vs 65 ± 4 U; P < .001) and by >95% when combined with aspirin and ticagrelor (3 ± 1 vs 65 ± 4 U; P < .001). Glenzocimab reduced platelet aggregation, adhesion, and thrombin generation when added to blood of aspirin- and ticagrelor-treated patients with acute coronary syndrome. Glenzocimab shared several antithrombotic effects with the GPIIb/IIIa inhibitor eptifibatide with less effect on general hemostasis assessed by rotational thromboelastometry. In a murine intravital model of ST-elevation myocardial infarction, genetic depletion of GPVI reduced microvascular thrombosis.

CONCLUSION:

Addition of glenzocimab to aspirin and ticagrelor enhances platelet inhibition via multiple mechanisms of atherothrombosis. Compared with a GPIIb/IIIa inhibitor, glenzocimab shares multiple antithrombotic effects, with less inhibition of mechanisms involved in general hemostasis.

01 Jun 2023·Thrombosis and haemostasis

Pharmacological Inhibition of Glycoprotein VI- and Integrin α2β1-Induced Thrombus Formation Modulated by the Collagen Type

Article

Author: Farndale, Richard W. ; Heemskerk, Johan W. M. ; Poulter, Natalie S. ; Jooss, Natalie J. ; Gawaz, Meinrad P. ; Henskens, Yvonne M.C. ; Watson, Steve P. ; Jandrot-Perrus, Martine

Background In secondary cardiovascular disease prevention, treatments blocking platelet-derived secondary mediators pose a risk of bleeding. Pharmacological interference of the interaction of platelets with exposed vascular collagens is an attractive alternative, with clinical trials ongoing. Antagonists of the collagen receptors, glycoprotein VI (GPVI), and integrin α2β1, include recombinant GPVI-Fc dimer construct Revacept, 9O12 mAb based on the GPVI-blocking reagent Glenzocimab, Syk tyrosine-kinase inhibitor PRT-060318, and anti-α2β1 mAb 6F1. No direct comparison has been made of the antithrombic potential of these drugs. Methods Using a multiparameter whole-blood microfluidic assay, we compared the effects of Revacept, 9O12-Fab, PRT-060318, or 6F1 mAb intervention with vascular collagens and collagen-related substrates with varying dependencies on GPVI and α2β1. To inform on Revacept binding to collagen, we used fluorescent-labelled anti-GPVI nanobody-28. Results and Conclusion In this first comparison of four inhibitors of platelet–collagen interactions with antithrombotic potential, we find that at arterial shear rate: (1) the thrombus-inhibiting effect of Revacept was restricted to highly GPVI-activating surfaces; (2) 9O12-Fab consistently but partly inhibited thrombus size on all surfaces; (3) effects of GPVI-directed interventions were surpassed by Syk inhibition; and (4) α2β1-directed intervention with 6F1 mAb was strongest for collagens where Revacept and 9O12-Fab were limitedly effective. Our data hence reveal a distinct pharmacological profile for GPVI-binding competition (Revacept), GPVI receptor blockage (9O12-Fab), GPVI signaling (PRT-060318), and α2β1 blockage (6F1 mAb) in flow-dependent thrombus formation, depending on the platelet-activating potential of the collagen substrate. This work thus points to additive antithrombotic action mechanisms of the investigated drugs.

News (Medical) associated with Glenzocimab

16 May 2024

·www.prnewswire.com

Brainomix Announces New Studies Further Validating the Impact of Brainomix 360 Stroke Platform

With these latest studies, the firmly established European market leader in stroke AI imaging adds to its growing body of evidence. The latest research reflects the company's extensive academic collaborations and its growing Life Science partnerships. OXFORD, England and CHICAGO, May 16, 2024 /PRNewswire/ -- Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, announced a series of new studies that were presented this week at the European Stroke Organisation Conference (ESOC) in Basel. The studies validated the impact of the Oxford-based company's Brainomix 360 Stroke platform, including its FDA-cleared Triage Stroke tool and its flagship e-ASPECTS software. The studies follow Wednesday's presentation at ESOC of a groundbreaking study, the largest prospective evaluation of stroke AI imaging, involving more than 80,000 patients at 26 sites over a 3-year period. This study showed that the implementation of Brainomix 360 Stroke was associated with an additional 50% increase in the number of patients receiving mechanical thrombectomy and a reduction in door-in-door-out (DIDO) time of around 50 minutes. Dr Michalis Papadakis, CEO and Co-Founder of Brainomix, said: "The studies presented this week at ESOC reflect our ongoing commitment to scientific excellence and our extensive academic collaborations with world-class research institutions, including the Mayo Clinic, the Rockefeller Institute at West Virginia University, and Boston Medical Center. These studies provide further validation that our AI-enabled technology can play a critical role in stroke care, helping clinicians make more confident decisions leading to more patients getting access to life-saving treatments. "We are also proud to showcase the growing body of research we are conducting with Life Science partners. Our unique set of imaging biomarkers and clinical trial tools, along with our world-class core lab team, are delivering real value for pharma partners, device manufacturers and biotech companies, generating insights that may guide future clinical trial design." Key abstracts accepted and presented at ESOC included: "Large Vessel Occlusion Detection in Acute Ischemic Stroke Using Non-Contrast CT" was a multisite collaboration with the Mayo Clinic, the Rockefeller Neuroscience Institute at West Virginia University, and Boston Medical Center validating Triage Stroke as a reliable tool for large vessel occlusion (LVO) detection. The authors concluded that when coupled with clinical information such as NIHSS, the tool may help centers to identify thrombectomy candidates, especially those with constrained resources and basic imaging. Brainomix and CSL Behring jointly published a retrospective observational study, "Automatically Quantified Follow-Up Imaging Biomarkers as Predictors of Clinical Outcomes after Acute Ischemic Stroke: A Real-World Evidence Study." After processing NCCT follow-up images with Brainomix 360 Stroke software, the results validated the prognostic significance of automated final infarct volume (FIV) and its components, confirming the opportunity for AI-derived imaging biomarkers at follow-up time points to improve the design and delivery of randomized controlled trials in AIS. Brainomix and Acticor jointly published a poster, "Patients Randomized to Glenzocimab Suffered Less Hemorrhagic Transformation with Greater Benefit in Larger Baseline Infarct Core," which helped to elucidate the mechanism and demonstrate the efficacy of Acticor's drug, glenzocimab, while identifying subgroups of patients who appear to benefit the most. A UK study, "WOW (With Or Without): Measuring Impact of e-ASPECTS Software on Conventional CT Reporting in Acute Ischemic Stroke," validated the impact of e-ASPECTS on reader performance. "e-ASPECTS is a valuable tool for clinicians in the speedy and accurate diagnosis of acute ischemic stroke (AIS), and has the potential to enable the identification of AIS patients in centres without neuroradiology expertise, improving access to life-saving treatment," noted Dr Anna Podlasek, lead author of the study. RESILIENT Extend IV, an ongoing randomized controlled trial assessing Tenecteplase in non-LVO AIS patients in the extended time window, will provide an update on its progress. The Brazilian trial is using Brainomix 360 e-CTP for patient selection. About Brainomix Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients. To learn more about Brainomix and its technology visit , and follow us on Twitter, LinkedIn and Facebook. Contacts Jeff Wyrtzen, Chief Marketing & Business Development Officer [email protected] M +44 (0)7927 164210 T +44 (0)1865 582730 Media enquiries Charles Consultants Sue Charles [email protected] M +44 (0)7968 726585 Logo - SOURCE Brainomix

Clinical ResultClinical Study

07 Sep 2023

·www.biospace.com

The UK Regulatory Agency (MHRA) Approved the Protocol of LIBERATE Study, the First Clinical Trial Evaluating Glenzocimab for Heart Attacks

PARIS--(BUSINESS WIRE)-- September 7th, 2023, the University of Birmingham and Acticor Biotech (Paris:ALACT) announce the full regulatory approval of LIBERATE clinical study. In 2021, the University of Birmingham and Acticor Biotech signed a partnership agreement to evaluate glenzocimab efficacy in myocardial infarction in a new clinical trial called LIBERATE. The University has received full regulatory approvals to initiate the study. This new clinical trial is based on a long-standing collaboration between Acticor Biotech and the University of Birmingham. The publication in August of a scientific paper from Dr Mark Thomas entitled: “Amplified inhibition of atherosclerotic plaque-induced platelet activation by glenzocimab with dual antiplatelet therapy “ (link to the publication) in the Journal of Thrombosis and Haemostasis, reinforced the mode of action of glenzocimab and its major role as an antithrombotic drug. The randomised, double-blind Phase 2b LIBERATE study will recruit more than 200 patients suffering from a ST-elevation myocardial infarction (STEMI) and planned for a percutaneous coronary intervention. The study aims to assess the safety and the efficacy of glenzocimab 1000 mg versus placebo to reduce the myocardial infarct size at Day 90 post-treatment. The trial will be conducted in two acute care hospitals in the UK: the Queen Elizabeth Hospital, Birmingham and the Northern General Hospital, Sheffield. Patient recruitment is expected to start by the end of 2023. Doctor Mark Thomas, Associate Professor of Cardiology at the University of Birmingham and Honorary Consultant Cardiologist, who designed the trial and led its development, said: “Our recent studies of glenzocimab at the University of Birmingham have just been published – these explain the cellular mechanisms for why it is highly effective at reducing “blood stickiness”, particularly when combined with existing medications. We are very pleased to receive regulatory approval to launch the LIBERATE clinical trial to investigate whether glenzocimab can reduce the type of blood clotting that causes heart damage during heart attacks. This exciting collaboration with Acticor has the potential to benefit our patients in Birmingham and Sheffield, and across the world.” Professor Jon Townend, Consultant Cardiologist at University Hospitals Birmingham, Honorary Professor of Cardiology in the Institute of Cardiovascular Sciences at the University of Birmingham, and Chief Investigator of the trial said: “This new drug looks extremely promising and we are excited to be within sight of beginning recruitment for this important trial” Yannick Pletan, Chief Medical Officer, and General Manager of Acticor Biotech declared: “Glenzocimab has already delivered very promising results in the treatment of acute ischemic stroke and we hope to confirm its therapeutics potential in other cardiovascular emergency indications. LIBERATE phase 2b study extends glenzocimab development programme to myocardial infarction. We are delighted to collaborate with all the teams involved, the University of Birmingham particularly, sponsor of this study, to extend the therapeutic field of glenzocimab.” ENDS Notes to editor: The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries. The University of Birmingham is a member of Birmingham Health Partners (BHP), a strategic alliance which transcends organisational boundaries to rapidly translate healthcare research findings into new diagnostics, drugs and devices for patients. Birmingham Health Partners is a strategic alliance between five organisations who collaborate to bring healthcare innovations through to clinical application: University of Birmingham University Hospitals Birmingham NHS Foundation Trust Birmingham Women's and Children's Hospitals NHS Foundation Trust Sandwell and West Birmingham Hospitals NHS Trust West Midlands Academic Health Science Network About ACTICOR BIOTECH Acticor Biotech is a clinical stage biopharmaceutical company, a spin-off from INSERM (the French National Institute of Health and Medical Research), which is aiming to develop an innovative treatment for cardiovascular emergencies, including ischemic stroke. Acticor Biotech is developing glenzocimab (ACT017), a humanized monoclonal antibody (mAb) fragment directed against a novel target of major interest, platelet glycoprotein VI (GPVI). Glenzocimab inhibits platelet binding to the thrombus without affecting physiological hemostasis, thereby limiting the bleeding risk, particularly in the brain. The positive results from its Phase 1b/2a study, ACTIMIS, confirmed the safety pro showed a reduction in mortality and intracerebral hemorrhage in the glenzocimab-treated group in patients with stroke. The efficacy of glenzocimab is now being evaluated in ACTISAVE, an international Phase 2/3 study. In July 2022, Acticor Biotech was granted "PRIME" status by the European Medicines Agency (EMA) for glenzocimab in the treatment of stroke. This designation will allow the company to strengthen its interactions and obtain early dialogues with regulatory authorities. Acticor Biotech is supported by a panel of European and international investors (Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum farmaceutici and the Armesa foundation). Acticor Biotech is listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT). For more information, visit: Disclaimer This press release contains certain forward-looking statements concerning Acticor Biotech and its business. Such forward-looking statements are based on assumptions that Acticor Biotech considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document as approved by the Autorité des marchés financiers under number R. 22-011 on 26 April 2022 and to the development of economic conditions, financial markets and the markets in which Acticor Biotech operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Acticor Biotech or not currently considered material by Acticor Biotech. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Acticor Biotech to be materially different from such forward-looking statements.

Phase 2

31 Aug 2023

·www.biospace.com

ACTIMIS Post-hoc Results on Imaging Stroke Data Using Artificial Intelligence Reinforces Glenzocimab Mode of Action in Stroke Patients

PARIS--(BUSINESS WIRE)-- Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT), a clinical stage biopharmaceutical company developing glenzocimab, an innovative drug for the treatment of cardiovascular emergencies, announced today the results of its collaboration with Brainomix Limited, to further explore the imaging data using Artificial Intelligence (AI) from its phase 1b/2a ACTIMIS study. The ACTIMIS clinical trial evaluating glenzocimab in combination with the reference treatment (thrombolysis with or without thrombectomy) in patients presenting with Acute Ischemic Stroke (AIS) has demonstrated a favorable safety pro glenzocimab, as well as a significant reduction in the number of intracerebral hemorrhages and mortality in the group treated with glenzocimab. To explore the mode of action of glenzocimab in the reduction of intracranial hemorrhage occurrence, a collaboration has been setup with Brainomix, a UK company specialized in the creation of AI-powered imaging biomarkers, to further analyze imaging stroke results from ACTIMIS study. In a post-hoc analysis of the ACTIMIS study results, ischemic injury and hemorrhagic transformation volume measurements were quantified using AI-enabled Brainomix software. This provided an objective assessment of the evolution of the stroke brain injury which was associated with clinical outcome. First results using these biomarkers showed that patients treated with glenzocimab had smaller stroke lesion volumes compared to placebo-recipients (standard of care only), mainly due to a significant reduction in hemorrhagic transformation volumes. The benefit of glenzocimab was more pronounced in patients having undergone a mechanical thrombectomy after an initial treatment by a thrombolytic agent. Yannick PLETAN, Chief Medical Officer and General Manager of Acticor Biotech, explained: “We are delighted with this collaboration with Brainomix, which enables us for the first time to analyze in greater detail the brain images of patients in the ACTIMIS study. Preliminary results seem to show that glenzocimab not only reduces the occurrence of intracranial hemorrhages, but also their volume, compared with placebo. These results support the first analyses of the ACTIMIS study and will be submitted for publication at upcoming international congresses.” George HARSTON, Chief Medical Officer of Brainomix and Consultant Stroke Physician said: "We are excited to have partnered with Acticor Biotech to support this innovative analysis of the ACTIMIS study using our AI-powered imaging biomarkers. The Brainomix core lab analysis has helped elucidate the mechanism and demonstrate efficacy of glenzocimab. It has shown that glenzocimab reduced brain injury following thrombolysis in stroke, and identified subgroups of patients who appear to benefit most." About BRAINOMIX Limited Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke, lung fibrosis, and cancer. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company that has innovated award-winning imaging biomarkers and software solutions that are used in more than 30 countries worldwide and in multiple clinical trials for patient selection and AI core lab analysis. Its first product, the Brainomix 360 platform, provides clinicians with the most comprehensive stroke imaging solution, driving faster treatment times and improving functional independence for patients. About ACTICOR BIOTECH Acticor Biotech is a clinical stage biopharmaceutical company, a spin-off from INSERM (the French National Institute of Health and Medical Research), which is aiming to develop an innovative treatment for cardiovascular emergencies, including ischemic stroke. The positive results from its Phase 1b/2a study, ACTIMIS, confirmed the safety pro showed a reduction in mortality and intracerebral hemorrhage in the glenzocimab-treated group in patients with stroke. The efficacy of glenzocimab is now being evaluated in an international Phase 2/3 study, ACTISAVE, which will include 1,000 patients. In July 2022, Acticor Biotech was granted "PRIME" status by the European Medicines Agency (EMA) for glenzocimab in the treatment of stroke. This designation will allow the company to strengthen its interactions and obtain early dialogues with regulatory authorities. Acticor Biotech is supported by a panel of European and international investors (Mediolanum farmaceutici, Karista, Go Capital, Newton Biocapital, CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited, Anaxago, and the Armesa foundation). Acticor Biotech is listed on Euronext Growth Paris since November 2021 (ISIN: FR0014005OJ5 – ALACT). For more information, visit: Disclaimer This press release contains certain forward-looking statements concerning Acticor Biotech and its business. Such forward-looking statements are based on assumptions that Acticor Biotech considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the Document de référence registration document as approved by the Autorité des marchés financiers under number R. 22-011 on 26 April 2022 and to the development of economic conditions, financial markets and the markets in which Acticor Biotech operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Acticor Biotech or not currently considered material by Acticor Biotech. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Acticor Biotech to be materially different from such forward-looking statements.

Clinical ResultClinical Study

100 Deals associated with Glenzocimab

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 3	US	Acticor Biotech SAS	23 Sep 2021
Acute Ischemic Stroke	Phase 3	DE	Acticor Biotech SAS	23 Sep 2021
COVID-19	Phase 2	FR	Acticor Biotech SAS	16 Dec 2020
Respiratory Distress Syndrome, Adult	Phase 2	FR	Acticor Biotech SAS	16 Dec 2020
Severe Acute Respiratory Syndrome	Phase 2	FR	Acticor Biotech SAS	16 Dec 2020
SARS-CoV-2 acute respiratory disease	Phase 2	BR	Acticor Biotech SAS	11 Oct 2020
Stroke	Phase 2	CH	Acticor Biotech SAS	15 Sep 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03803007 (ACTIMIS, ESOC2022) Manual	Phase 1/2	Intracranial Hemorrhages	166	Glenzocimab	zudmpeimxz(eplbktycuu) = omvpgfbory fgftfxbknb (dccbhzzfrs ) View more	Positive	09 May 2022
				Placebo	zudmpeimxz(eplbktycuu) = yfeboliztx fgftfxbknb (dccbhzzfrs ) View more
ESC2021	Not Applicable	Plaque, Atherosclerotic	-	Glenzocimab	yhoatsyghb(nghyehucmr) = haithzbdef fefcdfywgi (fjhtivxwqs ) View more	-	28 Aug 2021
				Aspirin and ticagrelor	yhoatsyghb(nghyehucmr) = gtczfeiepi fefcdfywgi (fjhtivxwqs ) View more

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