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Business Wire
3 days ago
- Health
- Business Wire
Leyden Labs Lands €20 Million EIB Investment Facilitated by HERA to Advance Pandemic Preparedness Activities
LUXEMBOURG & LEIDEN, the Netherlands--(BUSINESS WIRE)--The European Investment Bank (EIB) and Dutch clinical-stage biotechnology company Leyden Laboratories B.V. have signed a €20 million financing deal to advance development of the Company's broadly-protective antibodies to defend against seasonal and pandemic viral infections. Leyden Labs' lead program is a pan-influenza nasal spray currently in clinical development (PanFlu), which has the potential to provide first-in-class influenza protection and meaningfully reduce the burden of influenza infection, including in infection from Avian Flu (H5). The venture debt financing agreement is supported under the European Commission's InvestEU programme and specifically falls under 'HERA Invest.' This €110 million initiative from the European Health Union is meant to address biodefence, pandemic readiness and antimicrobial resistance in Europe, as a top-up to the European Union's InvestEU initiative, funded by the EU4Health programme. 'The COVID-19 pandemic taught us multiple lessons, including that we should strengthen the EU's preparedness and autonomy in key areas like bio sciences,' stated EIB Vice President Robert de Groot. 'With the support of the European Commission, the EIB backs highly innovative EU companies like Leyden Labs with venture debt, enabling them to grow and thrive in Europe. Technological innovations from companies like Leyden Labs are key for European competitiveness and the well-being of our society.' Hadja Lahbib, Commissioner for Equality, Preparedness and Crisis Management, added: 'Respiratory viruses are common and affect us all, especially the most medically vulnerable. Today's agreement reaffirms our commitment to invest in innovation to strengthen preparedness and protection against respiratory viruses. HERA Invest is a prime example of Europe at the forefront of medical advancements in response to serious threats to health.' 'We are thrilled with this endorsement of our approach and support from HERA and the European Investment Bank. This will accelerate our efforts to provide broad, universal protection against current and future viral outbreaks. We are grateful that HERA and the EIB understand the urgency and significance of investing in initiatives to ensure Europe is prepared for pandemic viruses. This concern is greater than ever given the increasing threat of an avian influenza outbreak,' said Koenraad Wiedhaup, co-founder and CEO of Leyden Labs. Leyden Labs' product candidates are nasal sprays that administer broadly protective antibodies directly to the respiratory mucosa. Leyden Lab's solutions are designed to work at the earliest moment, before the virus even reaches systemic circulation. Systemically administered vaccines primarily generate systemic protection against viruses, however, this may be a limitation that contributes to suboptimal efficacy. Airborne viruses, including influenza, do not directly enter systemic circulation, but rather, they enter the body through the nose and mouth. The Company's antibodies aim to protect against full viral families, so they keep working even when a virus mutates and evolves. This intranasal strategy also has the potential to benefit people with weakened immune systems because it does not rely on the person to be able to mount an immune response in order to be protective. The Company's novel approach has the potential to transform the way the healthcare ecosystem thinks about viral prophylaxis, while also providing an innovative solution for use both in times of seasonal outbreaks as well as pandemic emergencies. HERA's responsibility is to ensure that the EU and Member States are ready to act in the face of cross-border health threats. The €20 million proceeds of this financing will support further development of Leyden Labs' novel, non-vaccine approach to fighting respiratory viruses to contribute to European pandemic preparedness efforts. Background Information: Health Emergency Preparedness and Response (HERA). The European Commission's Health Emergency Preparedness and Response Authority (HERA) supports projects that strengthen preparedness and response capacities in the field of health. HERA was established as a direct consequence of the lessons learned from the initial management of the COVID-19 pandemic, to ensure a solid Union response to serious-cross border health threats and secure ready availability and accessibility of medical countermeasures. HERA's responsibility is to ensure that the EU and Member States are ready to act in the face of cross-border health threats, and its mandate covers both the strengthening of preparedness in advance of future emergencies and the implementation of a swift and efficient response once crisis hits. HERA Invest is a €110 million top-up to the InvestEU programme, funded by the EU4Health programme. It is implemented by the EIB and supports projects that focus on pathogens with pandemic potential, chemical, biological, radiological, nuclear threats, and antimicrobial resistance. Together with HERA, the EIB assesses whether an operation meets HERA Invest's criteria. The InvestEU programme provides the European Union with crucial long-term funding by leveraging substantial private and public funds in support of a sustainable recovery. It also helps mobilise private investment for EU policy priorities, such as the European Green Deal and the digital transition. InvestEU brings together under one roof the multitude of EU financial instruments previously available to support investment in the European Union, making funding for investment projects in Europe simpler, more efficient and more flexible. The programme consists of three components: the InvestEU Fund, the InvestEU Advisory Hub and the InvestEU Portal. The InvestEU Fund is deployed through implementing partners who will invest in projects using the EU budget guarantee of €26.2 billion. The entire budget guarantee will back the investment projects of the implementing partners, increase their risk-bearing capacity and thus mobilise at least €372 billion in additional investment. The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. The Netherlands owns a 5,2% share of the EIB. It makes long-term finance available for sound investment in order to contribute towards EU policy goals and national priorities. More than 90% of its activity is in Europe. Over the last ten years, the EIB has made available more than €27 billion in financing for Dutch projects in various sectors, including research & development, sustainable mobility, drinking water, healthcare and SMEs. In 2024 the EIB Group, which also includes the EIB's subsidiary, the European Investment Fund (EIF), made available more than €3 billion for Dutch projects. Leyden Laboratories B.V. (Leyden Labs), founded in 2020, is a clinical-stage biotechnology company based in the Netherlands. Leyden Labs is working to free people from the threat of respiratory viruses, by leveraging its Mucosal Protection Platform to develop a portfolio of candidates aimed at providing protection against influenza, coronaviruses, and other respiratory viruses through a new class of broadly protective nasal sprays. Leyden Labs is supported by a strong syndicate of investors and ambassadors; VC investors include GV (formerly Google Ventures), Casdin Capital, F-Prime Capital, ClavystBio (a life sciences venture investor established by Temasek), Polaris Partners, Qiming Venture Partners, Invus, SoftBank Vision Fund 2, Byers Capital / Brook Byers and Bluebird Ventures. To learn more, visit CR9114, Leyden Labs' lead product candidate for the PanFlu program, is a human monoclonal antibody that protects against influenza in preclinical models. Leyden Labs holds an exclusive license from Janssen Pharmaceuticals Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize CR9114.
Yahoo
08-04-2025
- Health
- Yahoo
Leyden Labs Publishes New Data Confirming Potential of Intranasal Antibody Approach
In vivo influenza protection was achieved at a significantly lower antibody dose with intranasal compared to systemic administration In contrast to what is observed with systemic administration, Leyden Labs' lead influenza antibody CR9114 has a unique mechanism of protection when administered intranasally The unmatched breadth of CR9114 is further supported by the discovery of binding to influenza C and D alongside A and B viruses – an essential attribute for durability of protection against new, emerging strains LEIDEN, Netherlands, April 08, 2025--(BUSINESS WIRE)--Leyden Laboratories B.V. (the "Company" or "Leyden Labs") today announced the publication of new findings that showcase the advantages of intranasal administration of monoclonal antibodies over systemic administration for protection against airborne viruses. The studies reported in this paper demonstrate the uniqueness of intranasal administration of broadly protective antibodies as a novel, non-vaccine approach to protect against respiratory viral infection. These new insights pave the way towards intranasal antibody delivery to provide protection against influenza and other airborne viruses. Key Findings: Intranasal antibody administration is effective at significantly lower dosages compared to systemic administration. Central to the strategy of Leyden Labs is to deliver broadly protective antibodies directly at the gate of viral entry, namely, to the respiratory mucosa. With these in vivo data, it is demonstrated that intranasal administration of CR9114 is efficacious at significant lower dosages than required for systemic administration. CR9114 is the monoclonal antibody component of the Company's PanFlu candidate. CR9114 was shown to have a more potent (low dose) protective effect when administered intranasally vs intravenously in mice. Typically, there is a trade-off between potency and breadth in antibody activity: broadly-neutralizing antibodies often are less potent in vitro. This publication however shows that intranasal administration resolves this trade-off in vivo: by administering CR9114 intranasally, low-dose protection is effective. Intranasal antibody administration enables protection that is not dependent on Fc-mediated effector functions. CR9114 protection against influenza was shown to be Fc-independent with intranasal administration in vivo. Although Fc-mediated effector functions play a large role in the mechanism of action of systemically administered antibodies, they are not required for efficacy following intranasal administration. Intranasal CR9114 can provide protection through its front-end (Fab) alone, both against strains that are neutralized in vitro and strains that are not neutralized in vitro. Importantly, this observation further highlights the opportunity to redefine criteria for preclinical evaluation of the protective potential of an antibody based on the route of administration. Clarissa Koch, PhD, Chief Research Officer of Leyden Labs commented, "We are excited to share this great work from our team and collaborators as we continue to expand our understanding about the nuances of administration of protective antibodies directly to the respiratory mucosa. We expect to publish additional data later this year regarding intranasal antibody dynamics as well. Under our Mucosal Protection Platform, findings such as these help in important ways to inform the ongoing development of PanFlu, as well as to shape additional pipeline programs by our team." Nigel Temperton, Professor of Molecular Virology and Director of Viral Pseudotype Unit at the Medway School of Pharmacy, University of Kent and University of Greenwich UK, who collaborated with Leyden Labs on these studies, said, "These findings have the potential to meaningfully impact the field of viral prophylaxis using antibodies. Although many valuable efforts have been made over time to optimize antibody composition for prophylactic use, contribution of the route of administration may have been underappreciated." Not only does this paper report discoveries about the uniqueness of intranasal administration, it also demonstrates that the breadth of activity of CR9114 is even greater than previously recognized. In addition to its known affinity for influenza A and B subtypes, it has now been shown that CR9114 also binds influenza C and D. Although influenza C and D are less at the forefront of current healthcare concerns – they mostly circulate in cattle and other animals – this finding reinforces the unique breadth of activity of CR9114 achieved by targeting a highly conserved domain. Since it is known that breadth is important for the effectiveness and durability of antibody prophylaxis, particularly when seeking to protect against new, emerging strains, this too is a significant discovery. The article published in Scientific Reports is entitled, "Intranasal administration of a panreactive influenza antibody reveals Fc-independent mode of protection." About Leyden Laboratories B.V. Leyden Labs is working to free people from the threat of respiratory viruses. Leyden Labs is leveraging its Mucosal Protection Platform to develop a portfolio of candidates aimed at providing protection against influenza, coronaviruses, and other respiratory viruses through a new class of broadly protective nasal sprays. Systemically administered antibodies or vaccines primarily generate systemic protection. Airborne viruses, including influenza and coronaviruses, enter the body through the nose and mouth. Thus, what we need is protection right at the gate, at the respiratory mucosa, to more effectively prevent initial infection and subsequent illness. Leyden Labs is pursuing this strategy by developing nasal sprays that administer broadly protective antibodies directly to the respiratory mucosa. These antibodies aim to protect against full viral families, so they keep working even when a virus mutates and evolves. In addition, this intranasal strategy is beneficial for people with weakened immune systems because it does not require a fully functional immune response. To learn more, visit About PanFlu candidate CR9114 CR9114, Leyden Labs' lead product candidate for the PanFlu program, is a human monoclonal antibody that protects against influenza in preclinical models. Leyden Labs holds an exclusive license from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize CR9114. View source version on Contacts Investor Contact Elizabeth Goodwin+1 781-460-1784investors@ Media Contact Megan Prock McGrath+1 978-800-7468media@ Sign in to access your portfolio
