Kenox Pharmaceuticals Inc. and Lactiga US, Inc. have announced a strategic collaboration aimed at developing novel mucosal-targeted Secretory IgA (sIgA) therapies for patients with compromised immune systems. The partnership is backed by a multi-million-dollar Small Business Technology Transfer (STTR) grant awarded to Lactiga by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The collaboration will combine Kenox's specialized expertise in nasal and inhaled pharmaceutical development with Lactiga's pioneering work in secretory IgA-based therapeutics. Together, they aim to accelerate the preclinical development of LCTG-001, Lactiga's lead asset and the first-ever sIgA mucosally-targeted replacement therapy for immunodeficient patients.
"We are thrilled to partner with Lactiga and contribute to the development of these potentially life-changing therapies," said Sitaram Velaga, President and CEO of Kenox Pharmaceuticals. "This collaboration, combined with the prestigious NIH grant, underscores the immense potential of this innovative approach to address the unmet needs of immunodeficient patients."
The Science Behind Mucosal Immunity
Secretory IgA serves as the body's first line of defense, coating mucosal surfaces to neutralize pathogens, modulate inflammation, and maintain microbiome balance. Patients with Common Variable Immune Deficiency (CVID) and similar conditions lack the ability to maintain this critical immunological barrier, leaving them highly susceptible to chronic infections and inflammatory complications.
"Immunologists have long sought a nasal sIgA spray to reduce recurrent respiratory infections, especially in compromised individuals – a major unmet medical need costing the healthcare system billions of dollars," explained Rikin Mehta, CEO and Co-founder of Lactiga. "Through our partnership with Kenox, we are making a first-in-class intranasal sIgA therapy a reality."
Regulatory Milestones and Clinical Development
Lactiga's LCTG-001 program has already achieved significant regulatory recognition, receiving both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA). These designations highlight the therapy's potential to address serious unmet needs, particularly for pediatric CVID patients who face higher mortality rates.
The NIH funding will enable Lactiga to complete key nonclinical studies and prepare for first-in-human trials. For Kenox, the collaboration represents an opportunity to expand its capabilities in inhaled and intranasal biologic delivery systems, further strengthening its position in the specialized pharmaceutical development space.
Addressing a Critical Unmet Need
Recurrent respiratory infections in immunocompromised patients represent a substantial burden on both patients and healthcare systems. Current treatment options for conditions like CVID typically involve regular intravenous immunoglobulin (IVIG) infusions, which are costly, time-consuming, and do not adequately address mucosal immunity.
The development of a mucosally-targeted sIgA therapy could transform treatment paradigms by providing localized immune protection at the respiratory surfaces where infections typically begin. This approach has the potential to reduce infection frequency, decrease hospitalization rates, and significantly improve quality of life for affected patients.
Company Backgrounds
Established in 2018 and based in the greater Princeton area, New Jersey, Kenox Pharmaceuticals specializes in pharmaceutical aerosol product development, including soft mist inhalers, pressurized metered-dose inhalers, dry powder inhalers, nebulizers, nasal sprays, and ophthalmic products for both small and biologic molecules.
Lactiga is a biotechnology company developing novel mucosal antibodies derived from human breastmilk to improve the lives of vulnerable and compromised populations. The company specializes in secretory IgA (sIgA)-based therapeutics, utilizing proprietary technologies to develop targeted treatments for infectious and inflammatory diseases.
This collaboration marks a significant step forward in addressing the needs of immunodeficient patients through innovative, targeted immunotherapy approaches that harness the body's natural defense mechanisms.
