NANTES

Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine

Retrieved on: 
星期五, 五月 31, 2024
Partnership, Aedes, Health care, Licensure, ANVISA, Marketing, Coalition, CHMP, Food, European Medicines Agency, VLA, FDA, Ageing, Disease, Iberian languages, Climate change, Vaccine, IRP, Fever Dream, Instituto Butantan, European Commission, EMA, Epidemic, Vaccination, MHRA, CEPI, MAA, Health Canada, Committee, Virus, European, Euronext Paris, Brazilian Health Regulatory Agency

If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need.

Key Points: 
  • If approved, it will become the first chikungunya vaccine available in Europe to address this unmet medical need.
  • In accordance with the International Recognition Procedure (IRP)1, Valneva is also preparing a Marketing Authorization Application (MAA) for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
  • The CHMP opinion follows the November 2023 approval of IXCHIQ® by the US Food and Drug Administration (FDA)2.
  • Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This positive CHMP opinion marks a crucial milestone toward introducing a preventative solution against chikungunya in the EU.

OSE Immunotherapeutics Provides Business and Corporate Update

Retrieved on: 
星期四, 五月 30, 2024
Partnership, Infection, Novartis, Stroke, Investment, Pfizer, Sanofi, Johnson & Johnson, GSK, Vaccine, Senior, Harvard University, Breast cancer, Pharma, Inflammation, CDMO, Ulcerative colitis, ChromeOS, Harvard Medical School, Senior advisor, Central nervous system disease, MD, AbbVie, CNS, XMF, Immunotherapy, Breast Cancer Research Foundation, Initiative, Neuroinflammation, Drug development, Colitis, MBA, Cancer, Economics, Nuclear medicine, Patient, Thrombosis, Rhône-Poulenc, Woman, Boehringer Ingelheim, Growth, Title, Acquisition, Lung cancer, MBO, Medtech

NANTES, France, May 30, 2024 – 6:15pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided business and corporate update after reinforcement of the Company’s business-model based on strategic pharmaceutical partnerships following the three recent new agreements concluded with AbbVie and Boehringer Ingelheim.

Key Points: 
  • NANTES, France, May 30, 2024 – 6:15pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided business and corporate update after reinforcement of the Company’s business-model based on strategic pharmaceutical partnerships following the three recent new agreements concluded with AbbVie and Boehringer Ingelheim.
  • Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We achieved major industrial partnerships from our differentiated immunological pipeline and our sustainable innovation engine.
  • On February 28th, OSE Immunotherapeutics and AbbVie announced partnership to develop OSE-230, a novel monoclonal antibody for the treatment of chronic inflammation.
  • On May 24th, OSE Immunotherapeutics and Boehringer Ingelheim expanded their collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases.

OSE Immunotherapeutics and Boehringer Ingelheim expand collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases

Retrieved on: 
星期三, 五月 22, 2024
Partnership, Patient, Discovery, CRM, Boehringer Ingelheim, Cancer, EUR, Death, Acquisition, Apoptosis, Boehringer, Pharmaceutical industry

Nantes, France - Ingelheim, Germany - 22 May 2024, 7:30am CET - Today OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and Boehringer Ingelheim announced a major expansion of their partnership.

Key Points: 
  • Nantes, France - Ingelheim, Germany - 22 May 2024, 7:30am CET - Today OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) and Boehringer Ingelheim announced a major expansion of their partnership.
  • Two new projects to develop first-in-class treatments will be added to the ongoing anti-SIRPα immuno-oncology programs.
  • A new preclinical program will be launched to develop immune-cell activating treatments based on OSE’s cis-targeting1 anti-PD1/cytokine platform via an asset acquisition.
  • Cancer accounts for nearly 10 million deaths and for many cancer patients there are no or only limited treatment options.

Valneva Appoints Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer

Retrieved on: 
星期二, 五月 21, 2024
Infection, Executive Committee, COVID-19, Translational medicine, HIV, J&J, VLA, Johnson & Johnson, RSV, Vaccine, Research, Chikungunya, CSO, Saint-Herblain, Lyme disease, Viral disease, Euronext Paris, Senior

Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024.

Key Points: 
  • Saint-Herblain (France), May 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the appointment of Dr. Hanneke Schuitemaker, Ph.D. as Chief Scientific Officer (CSO) and Executive Committee member, effective June 3, 2024.
  • Valneva decided to complement its Executive Team with an accomplished R&D leader to oversee the further evolution of the Company´s R&D portfolio.
  • Specifically, Dr. Schuitemaker will focus on accelerating Valneva’s pre-clinical and translational R&D activities in support of the Company’s strategic ambition to provide first-, best- or only-in-class vaccine solutions.
  • She has a unique and solid scientific background, which is notably reflected in more than 350 scientific publications.

Valneva Reports First Quarter 2024 Financial Results and Provides Corporate Updates

Retrieved on: 
星期二, 五月 7, 2024
FDA, VLA, Bank statement, Fast Track, Research, CHMP, Trial of the century, Biologics license application, Coalition, Profit & Loss, OrbiMed, Lyme disease, Bavarian Nordic, CDC, Notifiable disease, Adolescence, Income tax, Chikungunya, Third party, ACIP, BLA, Licensure, CEPI, PRV, Safety, Travel, Indoor Living, EMA, Marketing, USD, Sale, Tropical disease, EDT, Depreciation, MAA, Profit, Euronext Paris, Zika virus, Epidemic, Adjustment, COGS, Saint-Herblain, COVID-19, Growth, Ageing

Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.

Key Points: 
  • Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates.
  • The condensed consolidated interim financial results are available on the Company’s website ( Financial Reports – Valneva ).
  • In the first quarter of 2024, IXIARO®/JESPECT® sales were €16.6 million compared to €17.4 million in the first quarter of 2023.
  • IXIARO®/JESPECT® sales were €16.6 million in the first quarter of 2024 compared to €17.4 million in the first quarter of 2023.

OSE Immunotherapeutics’ Global License to Develop a Novel Monoclonal Antibody for the Treatment of Chronic Inflammation Becomes Effective

Retrieved on: 
星期二, 四月 16, 2024
Inflammation, Partnership, AbbVie, Generic drug

NANTES, France, April 16, 2024 – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, today announced that the Hart-Scott-Rodino waiting period has expired with respect to its global license with AbbVie to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.

Key Points: 
  • NANTES, France, April 16, 2024 – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, today announced that the Hart-Scott-Rodino waiting period has expired with respect to its global license with AbbVie to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.
  • As part of the partnership agreement announced on February 28, 2024, AbbVie received from OSE Immunotherapeutics an exclusive global license and collaboration agreement to develop OSE-230, a monoclonal antibody designed to resolve chronic inflammation.
  • Under the terms of this agreement, AbbVie will now make an upfront payment of $48 million to OSE Immunotherapeutics.
  • In addition, OSE Immunotherapeutics will be eligible to receive up to an additional $665 million in clinical development, regulatory and commercial milestones and potential tiered royalties on global net sales of OSE-230.

Independent Studies Presented at ESCMID Global Demonstrate the Clinical Utility of SeptiCyte® RAPID in Patients Suspected of Sepsis, Including in Polytrauma Patients

Retrieved on: 
星期三, 四月 17, 2024
Infection, Polytrauma, Hospital-acquired infection, Trauma, Internship, Systemic inflammatory response syndrome, Animation, SIRS, VAP, ICU, Ventilator-associated pneumonia, Fungal infection, Patient, University of Nantes, Diagnosis, Sepsis, Pharmaceutical industry

SeptiCyte® RAPID accurately differentiated between nosocomial infections and systemic inflammatory response syndrome in polytrauma ICU patients suspected of sepsis.

Key Points: 
  • SeptiCyte® RAPID accurately differentiated between nosocomial infections and systemic inflammatory response syndrome in polytrauma ICU patients suspected of sepsis.
  • SeptiScore® was elevated in ICU patients suspected of sepsis when a causative pathogen was identified.
  • A Nantes University poster #P3895 entitled, "SeptiCyte RAPID, a new biomarker for the diagnosis of ventilator-associated pneumonia in polytrauma patients," will be presented on April 27, at noon CET.
  • Samples were evaluated using SeptiCyte RAPID and compared to a standard clinical evaluation by a blinded physician in the ICU.

OSE Immunotherapeutics Announces Peer-Reviewed Publication on Novel Myeloid Immune Checkpoint CLEC-1 in Journal of Immunology

Retrieved on: 
星期二, 四月 2, 2024
Research, Journal of Immunology, Translational research, Myelocyte, Collaboration, Neutrophil, Vaccine

Nantes, France – April 2, 2024 – 7:30 am CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced the publication of novel data in the peer-reviewed Journal of Immunology (1) on a first-in-class research program with CLEC-1, its novel myeloid immune checkpoint target for cancer immunotherapy.

Key Points: 
  • Nantes, France – April 2, 2024 – 7:30 am CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced the publication of novel data in the peer-reviewed Journal of Immunology (1) on a first-in-class research program with CLEC-1, its novel myeloid immune checkpoint target for cancer immunotherapy.
  • In the new publication, the collaborative research work confirmed and reinforced the potential of CLEC-1 as a novel myeloid immune checkpoint regulating acute immune responses.
  • Dr Elise Chiffoleau, INSERM scientist, said: “We are very pleased to have these novel research data published in “Journal of Immunology”, an internationally recognized scientific journal.
  • Our collaborative work shows, for the first time, that CLEC-1 acts as an immune checkpoint for the control of acute immune responses in the context of sterile inflammation.

Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Retrieved on: 
星期二, 三月 26, 2024
Notifiable disease, Saint-Herblain, Zika virus, JE, COVID-19, VLA2001, Ageing, Public, Chikungunya, Woman, Mosquito-borne disease, VLA, Safety, Euronext Paris, Access, CpG, Food, Vaccine

Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the

Key Points: 
  • Saint-Herblain (France), March 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the initiation of a Phase 1 clinical trial to investigate the
    the safety and immunogenicity of VLA1601, its second-generation adjuvanted inactivated vaccine candidate against the Zika virus (ZIKV).
  • The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States.
  • Phase 1 results from Valneva’s first-generation Zika vaccine candidate were reported in 2018 showing a favorable safety profile and immunogenicity in all tested doses and schedules2.
  • This preference stems from the understanding that the primary recipients of a Zika vaccine are anticipated to be women of childbearing age, potentially including those who are pregnant.

Valneva Announces Filing of 2023 Universal Registration Document and US Form 20-F

Retrieved on: 
星期一, 三月 25, 2024
Saint-Herblain, URD, VLA, Euronext Paris, File, AMF, Cryptocurrency

Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).

Key Points: 
  • Saint-Herblain (France), March 25, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the filing, on March 22, 2024, of its 2023 Universal Registration Document (URD) with the French Financial Markets Authority (AMF) under the filing number D.24-0157 and its Form 20-F with the U.S. Securities and Exchange Commission (SEC).
  • Valneva’s 2023 Universal Registration Document – available in its entirety in French – includes the Company’s 2023 Annual Financial Report, the Company's Annual Management Report, the Board of Directors’ Corporate Governance Report and the Company’s Sustainability Report.
  • These documents are available on Valneva’s website ( https://valneva.com/investors/financial-reports/ ) and will also be available on the AMF ( www.amf-france.org/ ) and SEC ( www.sec.gov/ ) websites, respectively.
  • Hard copies of these documents may be obtained from the Company, free of charge, upon request at the following address: 6 rue Alain Bombard, 44800 Saint-Herblain, France.