Mucommune LLC

Fast Dissolving Antibody Tablets for Preventing Vaginal HSV Transmission - Project Summary Despite Immense Efforts in Educational and Behavioral Interventions to Promote Safer Sexual Practices, Sexually Transmitted Infections (STIS) Such as Genital Herpes Remain Highly Prevalent, With an Estimated 12% of People Age 14-49 Infected With HSV-2 in the United States. Unfortunately, There Are No Effective Vaccines or Microbicides for the Majority of Stis, Including HSV. an On-demand, Fast-acting, Safe, Effective, and Discreet Vaginal Microbicide Would Provide a Powerful Prevention Tool to Address Gaps Not Addressed by Behavioral and Current Pharmacologic Interventions. Human Monoclonal Antibodies (MAB) Delivered Locally to Mucosal Surfaces Offer Exceptional Promise, Combining a Long History of Safety, Anti-viral Effectiveness, and Unparalleled Target Specificity. Mucommune Has Been Pioneering Mab Technologies Designed for Mucosal Applications, Including Muco-trapping Mabs That Neutralizes and Physically Traps Individual Pathogens in Mucus, Based on Carefully-tuned Affinity Between Igg-fc and Mucins. These “muco-trapping” Mabs Can Fully Trap HSV Particles in Human Cervicovaginal Mucus (CVM) Across the Menstrual Cycle and in CVM From Women With Diverse Vaginal Microflora, With ~10-FOLD Greater Potency Than Protection by Neutralization Alone. More Importantly, Trapping Viruses in Mucus With Vaginally-dosed Mabs Directly Blocked Transmission in a Mouse Vaginal Herpes Model, in the Absence of Other Immune Protective Functions. in This Phase I Sbir, We Will Build Upon Our Work to Formulate Our Pathogen-trapping Mab Into Fast Dissolving Ab Tablets (fdats), Which Will Rapidly Disintegrate and Disburse Upon Contact With CVM, Providing Rapid and Potent Immunoprotection. in Aim 1, We Will Incorporate Muco-trapping Mabs Against HSV Into Various Fdat Formulations Containing Different Types/ratios of Excipients, Binders and Disintegrants. We Will Characterize the Physical Properties of the Fdats, Measure the Dissolution Rates of Fdats in Synthetic Mucus and Mixtures of Fresh Human Cvm/semen, as Well as Verify the Binding Affinity of the Mab Pre- Post- Fdat Formulation and Dissolution. in Aim 2, We Will Evaluate Our Lead Fdat Formulations From Aim 1 in a Sheep Vagina Model to Verify Fdat Disintegration Times, Mab Pharmacokinetics and Biodistribution, Pharmacodynamics, and Safety. Successful Completion of These Studies Will Enable Us to Identify a Suitable Fdat Formulation to Advance Into Ind-enabling Preclinical and Clinical Development, and Provide the Essential Data for a Phase Ii Proposal Supporting Development of Shelf-stable Fdat That Includes Mab Cocktail Consisting of Both Anti-hsv Mab and Our Lead Contraceptive Mab (MM008), Providing Effective Multipurpose Protection Against Both Vaginal Herpes Transmission and Pregnancy.