Leyden Labs Demonstrates Feasibility of Novel Antibody-Based Nasal Spray for Flu Prevention

• The need for more effective protection against influenza continues to grow, as the virus consistently causes significant illness and mortality worldwide
• New human clinical data from Leyden Labs show intranasal delivery of broadly neutralizing antibodies can safely achieve and maintain protective levels at the site of viral entry
• Non-human primate data confirm these antibody levels, attained by low dose administration, are sufficient to protect against influenza infection
• Published today in Science Translational Medicine, the data validate the scientific premise of the Company’s pan-influenza nasal spray in development (PanFlu) and support a first-in-class approach for immediate protection against airborne viruses

LEIDEN, The Netherlands–(BUSINESS WIRE)–Leyden Laboratories B.V. (the “Company” or “Leyden Labs”) today announced landmark preclinical and clinical data in Science Translational Medicine supporting the development of their antibody-based nasal sprays to prevent influenza infection by neutralizing virus at portal of entry.

The data directly underpin the Company’s PanFlu program, which aims to provide broad, immediate protection against influenza through intranasal antibody delivery. In two clinical studies in healthy volunteers, the PanFlu nasal spray was shown to be safe and well tolerated, and the dosing schedule achieved high, sustained concentrations of the active substance (antibody CR9114) in the nasal cavity. Importantly, the antibody retained antiviral functionality after residence in the nasal mucosa.

In a third study, intranasal administration of CR9114 protected non-human primates from influenza infection and viral replication, providing proof-of-concept that antibody levels achieved intranasally can confer meaningful protection in a highly translatable model.

“These results demonstrate the feasibility of our ongoing efforts to stop viruses at the portal of entry rather than through the traditional route of intravenous or intramuscular delivery,” said Clarissa Koch, Chief Scientific Officer of Leyden Labs. “Our lead candidate for PanFlu contains CR9114, the broadest human monoclonal influenza antibody identified to date. These new data across species provide important validation of our approach to effectively protect against respiratory viruses with our antibody-based nose sprays.”

“This study provides important proof-of-concept preclinical and clinical data for the delivery of monoclonal antibodies by the intranasal route. Administering antibodies by the mucosal route may prove particularly effective for respiratory viruses so that the antibodies can neutralize virus at the mucosal portal of entry,” said Dan Barouch, MD, PhD, of Beth Israel Deaconess Medical Center and a co-author on the paper.

Key Findings:

• Intranasal administration of the pan-influenza antibody CR9114 was safe and well-tolerated in human phase 1 studies of healthy volunteers. Two phase 1 studies were reported, including a total of 143 participants, in which doses from 0.5 to 10 mg in single and repeat dosing schedules for up to 14 days were tested.
• Repeated dosing achieves sustained CR9114 concentrations in the nose, overcoming natural clearance mechanisms. The antibody retains antiviral functionality after residence in the nasal mucosa.
• Intranasal administration of CR9114 in non-human primates provided potent protection against H1N1. In a study in non-human primates, intranasal administration of CR9114 protected against influenza H1N1 infection and replication. CR9114 administration resulted in significant reductions in viral load and replicating virus compared to placebo.

“As we once again face a challenging influenza season, there is a growing need for additional tools that complement vaccination and help people better protect themselves. Our findings show that a simple intranasal spray of the CR9114 antibody rapidly achieves effective levels, is well tolerated, and exhibits strong antiviral activity. Importantly, the same formulation intended for human use also protected animals from infection, underscoring the promise of CR9114 as an innovative strategy to stop influenza infections before they begin,” remarked Boris Juelg, MD, PhD.

Taken together, the extensive body of new data presented in this paper provides important proof-of-concept for intranasal administration of a pan-influenza antibody for prophylactic use. These data not only help advance the lead PanFlu program of Leyden Labs, but also the additional pipeline assets in development by the Company. These studies pave the way towards the introduction of prophylactic, antibody-containing nose sprays as a novel product category in the fight against respiratory viruses.

Read the article here: https://www.science.org/doi/10.1126/scitranslmed.adz1580

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 www.leydenlabs.com.

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.

Contacts

Investor Contact
Elizabeth Goodwin
+1 781-460-1784
investor.relations@leydenlabs.com

Media Contact
Megan Prock McGrath
+1 978-800-7468
media@leydenlabs.com