Last update 14 Nov 2024

Glenzocimab

Last update 14 Nov 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 DiseasesRespiratory Diseases

Active Indication

Acute Ischemic StrokePulmonary Embolism

Inactive Indication

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

Originator Organization

Acticor Biotech SAS

Active Organization

Acticor Biotech SAS

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 616723309H

Source: *****

Sequence Code 616723310L

Source: *****

Clinical Trials associated with Glenzocimab

NCT06437431 / Not yet recruitingPhase 2/3IIT

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

NCT05070260 / CompletedPhase 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 un the 4.5 Hours Following an Acute Ischemic Stroke

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study.
The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.

Start Date23 Sep 2021

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 Dec 2024·THROMBOSIS RESEARCH

Platelet collagen receptors and their role in modulating platelet adhesion patterns and activation on alternatively processed collagen substrates

Article

Author: Cosemans, J.M.E.M. ; Wenzel, P. ; Luo, Q. ; Koenen, R R ; Luo, Q ; Lemmens, T.P. ; Koenen, R.R. ; Wielders, S J H ; Wenzel, P ; Scheijen, J.L.J.M. ; Scheijen, J L J M ; Al-Nasiry, S ; Cosemans, J M E M ; Lemmens, T P ; Al-Nasiry, S. ; Wielders, S.J.H.

This study examines the roles of platelet collagen receptors glycoprotein VI (GPVI), α2β1, and the GPIb-IX-V complex in platelet activation and thrombus formation on various collagen sources from different species. Type I collagens standardly used in haematology testing, i.e. collagen type I derived from equine tendon (HORM) and rat tail collagen were evaluated. Moreover, acid soluble collagen from human umbilical cord was tested. To inhibit platelet-collagen interactions, combinations of monoclonal antibodies 6B4 and 6F1, targeting GPIbα and α2β1, respectively, were used, along with the therapeutic collagen receptor GPVI antibody glenzocimab. Our findings reveal distinct dependencies on these receptors: platelet aggregation of washed platelets to HORM collagen relied on both α2β1 and GPVI, to acid soluble collagen mainly on GPVI, and to rat tail collagen solely on α2β1, respectively. In whole blood perfusion assays under non-coagulating conditions, the acid soluble collagen surface triggered a more homogenous platelet adhesion when compared to the HORM collagen surface, whilst platelet adhesion on rat tail collagen varied considerably. The GPIb-IX-V complex was shown to play a key role in initial platelet adhesion and activation across all collagen surfaces at a shear rate of 1600 s^-1. At 1600 s^-1, inhibiting platelet α2β1 interaction with collagen by 6F1 antibody did not affect platelet thrombus formation on acid soluble collagen, while it did reduce platelet surface coverage and P-selectin expression on HORM collagen without changing the overall thrombus morphology or contraction. Inhibiting GPVI interaction with collagen significantly reduced all thrombus parameters and abolished PS exposure and P-selectin expression on all three collagen surfaces, at both 1600 s^-1 and 150 s^-1. Interestingly, upon investigating combined inhibition of GPIb and α2β1, an additive inhibitor effect of 6F1 was observed on P-selectin expression and PS-exposure on acid soluble collagen but not HORM collagen at 1600s^-1, suggesting that the acid soluble collagen is well suited to study reinforcing functions of collagen receptors. Overall, this study highlights the potential advantages of using alternative collagen surfaces beyond the conventional HORM collagen to detect nuanced collagen receptor dependencies, which may prove valuable in evaluating anti-platelet medication.

13 Aug 2024·Blood Advances

Affimer reagents as tool molecules to modulate platelet GPVI-ligand interactions and specifically bind GPVI dimer

Article

Author: Naseem, Khalid M ; Cheah, Lih T ; Adams, Thomas L ; Webb, Beth A ; Duval, Cédric ; Yates, Daisie M ; Herr, Andrew B ; Slater, Alexandre ; Tomlinson, Darren C ; Hindle, Matthew S ; Gauer, Julia S ; Ariëns, Robert A S ; Calabrese, Antonio N ; Watson, Steve P ; Xu, Rui-Gang ; Tiede, Christian

Abstract:

Glycoprotein VI (GPVI) plays a key role in collagen-induced platelet aggregation. Affimers are engineered binding protein alternatives to antibodies. We screened and characterized GPVI-binding Affimers as novel tools to probe GPVI function. Among the positive clones, M17, D22, and D18 bound GPVI with the highest affinities (dissociation constant (KD) in the nanomolar range). These Affimers inhibited GPVI-collagen-related peptide (CRP)-XL/collagen interactions, CRP-XL/collagen-induced platelet aggregation, and D22 also inhibited in vitro thrombus formation on a collagen surface under flow. D18 bound GPVI dimer but not monomer. GPVI binding was increased for D18 but not M17/D22 upon platelet activation by CRP-XL and adenosine 5′-diphosphate. D22 but not M17/D18 displaced nanobody 2 (Nb2) binding to GPVI, indicating similar epitopes for D22 with Nb2 but not for M17/D18. Mapping of binding sites revealed that D22 binds a site that overlaps with Nb2 on the D1 domain, whereas M17 targets a site on the D2 domain, overlapping in part with the glenzocimab binding site, a humanized GPVI antibody fragment antigen-binding fragment. D18 targets a new region on the D2 domain. We found that D18 is a stable noncovalent dimer and forms a stable complex with dimeric GPVI with 1:1 stoichiometry. Taken together, our data demonstrate that Affimers modulate GPVI-ligand interactions and bind different sites on GPVI D1/D2 domains. D18 is dimer-specific and could be used as a tool to detect GPVI dimerization or clustering in platelets. A dimeric epitope regulating ligand binding was identified on the GPVI D2 domain, which could be used for the development of novel bivalent antithrombotic agents selectively targeting GPVI dimer on platelets.

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: Masjuan, Jaime ; Grotta, James C ; de Raedt, Sylvie ; Plétan, Yannick ; Toni, Danilo ; Binay, Sophie ; Sibon, Igor ; Reiner, Peggy ; Hemelsoet, Dimitri ; Alonso, Angelika ; Köhrmann, Martin ; Avenard, Gilles ; Macian-Montoro, Francisco ; Meilhoc, Adeline ; Albucher, Jean François ; Lyrer, Philippe A ; Segura, Tomas ; Obadia, Michael ; Grouin, Jean-Marie ; Peeters, André ; Molina, Carlos A ; Lemmens, Robin ; Desfontaines, Philippe ; Zuber, Mathieu ; Doche, Emilie ; Richard, Sébastien ; Serena, Joaquin ; Cordonnier, Charlotte ; Comenducci, Andrea ; Pelz, Johann ; Mazighi, Mikaël ; Berrouschot, Jörg ; Sari, Anouar ; Vannier, Stéphane ; Tembl, Jose I. ; 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.

News (Medical) associated with Glenzocimab

26 Jul 2024

·www.fiercebiotech.com

Acticor halts phase 2/3 stroke trial for blood thinner over futility

Results from a phase 2b trial in myocardial infarction are expected at the end of next year. Acticor Biotech is discontinuing a phase 2/3 study of a blood thinner given alongside heart surgery based on the results of a futility analysis.The French company had been testing the drug, glenzocimab, as an adjunct to mechanical thrombectomy in patients who have suffered an acute ischemic stroke. More than 100 patients have been enrolled in the study to date, with the futility analysis conducted on data from the first 78 participants.“In the light of the information provided to the members of the Independent Monitoring Committee (IMC), and in accordance with the futility criteria defined in the protocol, the IMC recommends that the GREEN study be discontinued,” Acticor said in a Friday release.Glenzocimab, which is Acticor’s sole asset, is an antibody fragment that’s directed against platelet glycoprotein VI (GPVI). The protein is critical for blood clot formation but doesn’t affect the regulation of bleeding, making it an ideal target for safely inhibiting platelet clumps.Glenzocimab is undergoing or in line for a number of clinical trials in relation to strokes or heart attacks, but this isn’t the first time the drug has come up short. In April, glenzocimab failed to hit the primary endpoint of reducing the risk of severe disability or death in the wake of a stroke across a separate phase 2/3 study. Early hopes for glenzocimab were that it could cut the risk of uncontrolled bleeding that can be a side effect of widely prescribed blood thinners such as COX-1 inhibitor aspirin and P2Y12 antagonist Plavix. This theory was back up by a small first-in-human study of the drug in healthy volunteers that read out in 2019.Those hopes continued into January 2024, when a phase 1b/2a study showed a reduction in mortality and brain bleeding among stroke patients who received the drug.Results from a phase 2b trial in myocardial infarction, a term for a heart attack, are expected at the end of next year.

Phase 2Phase 3

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

100 Deals associated with Glenzocimab

External Link

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R&D Status

10 top R&D records.

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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
Pulmonary Embolism	Phase 2	FR	Acticor Biotech SAS	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04659109 (GARDEN, Pubmed) Manual	Phase 2	COVID-19	61	Glenzocimab	zfxmxacxtx(eteinduuqc) = mgzzjepdya fmxgpitwqo (qkymcyhext ) View more	-	17 Jun 2024
				Placebo	zfxmxacxtx(eteinduuqc) = kkxxjaxcea fmxgpitwqo (qkymcyhext ) View more
NCT03803007 (ACTIMIS, Pubmed) Manual	Phase 1/2	Acute Ischemic Stroke	166	Glenzocimab (phase 1b)	slqmqzobtv(xufcigxatw) = ekaefewsqj ykvmqkohpt (iedgfcjqjm )	Positive	01 Feb 2024
				Placebo (phase 1b)	-
NCT04659109 (GARDEN, Pubmed)	Phase 2	COVID-19 PCR+	61	Glenzocimab	quubhswwod(jemqsaclts) = sajyzoiyyq orlrlfikqg (hzlbnbrccj )	Negative	01 Jan 2024
				Placebo	quubhswwod(jemqsaclts) = ambcqddwym orlrlfikqg (hzlbnbrccj )
NCT03803007 (ACTIMIS, ESOC2022) Manual	Phase 1/2	Intracranial Hemorrhages	166	Glenzocimab	tvepesxkwb(keeizcupot) = kbhmtbupfs gymwvmjwqx (iphmkxzcuw ) View more	Positive	09 May 2022
				Placebo	tvepesxkwb(keeizcupot) = yhqecrblld gymwvmjwqx (iphmkxzcuw ) View more
ESC2021	Not Applicable	Plaque, Atherosclerotic	-	Glenzocimab	tfdvuawimu(dkbxhxduqb) = xazkihlkdc kbaagkjqxb (brixpgkwai ) View more	-	28 Aug 2021
				Aspirin and ticagrelor	tfdvuawimu(dkbxhxduqb) = nszhdywyfh kbaagkjqxb (brixpgkwai ) View more

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