Applying Research.

Developing Biologics.

  • ABOUT IMMUNO

Immuno Technologies, Inc (ITi) is a Memphis-TN based company focused on preclinical research in preventatives (vaccines, monoclonal antibody therapies) and diagnostic assays for Lyme disease and leptospirosis.

Funding mechanism: Non-dilutive SBIR funding since 2014.

Immuno Technologies staff

Current Research

ACTIVE PROJECTS

Intranasal Vaccine against Lyme Disease

Project Number: SBIR Phase II, 5R44AI167605-03 (Active)
Project Period: 07-12-2022 to 06-30-2025

ABSTRACT: We propose to develop intranasal, parainfluenza 5 (PIV5) viral-vector delivered vaccines against human Lyme disease (LD) to be administered using a prime-boost schedule, for the US market. A recent new estimate of LD by the CDC places the new number at 476,000 annual cases, up from 329,000 in 2015 which strongly suggests that the number of Americans affected by this vector-borne disease is increasing. Currently, there is no human Lyme Disease vaccine available in the market. A prime-boost vaccination with an intranasal immunogen is a scientific and technologic advance over best vaccination protocols in development for LD that currently rely on parenteral inoculation of a minimum of 3 doses over 1 year. Our preliminary studies show that intranasal administration of a modified OspA vaccine delivered by the laboratory strain WR-PIV5 viral vector (WR-PIV5-OspABPBPk) via prime-boost (2 doses), produces an immune response that is 100% protective against tick transmitted B. burgdorferi infection in mice challenged 4 months after the 1st dose. PIV5 is a safe delivery vector used to develop many vaccines, one of which is undergoing a human clinical trial. The commercialization potential and societal impact of developing a novel, safe and efficacious LD vaccine that can be delivered by a non-invasive method is highly significant given that it may induce more durable immune responses, it could diminish vaccine hesitancy and increase vaccine compliance, and it could enable self-administration of one or both doses. The novelty of the vaccine proposed in this Direct to Phase II SBIR application relates to: 1) the use of a modified full length OspA protein in which the putative autoantigenic epitope has been replaced; 2) a needle-free intranasal delivery method in a safe, highly immunogenic viral vector; 3) the reduced number of immunizations; 4) ease of administration; and 5) the potential to increase immunity longevity. We propose to develop a new viral vector expressing OspABPBPk based on the PIV5 vaccine strain (CPI) and evaluate intranasal vaccine efficacy in mice as compared to the WR-PIV5- ABPBPk shown in preliminary results; we will also assess immunogenicity, safety and efficacy of the best vaccine candidate in the non-human primate (NHP) model of Lyme disease; last, we will perform studies required for Investigational New Drug (IND) regulatory approval by FDA. Once the novel vaccine is shown to meet pre-set performance criteria specified in our milestones (>80% efficacy in mice and non-human primate models), it will be trademarked as LymeMist™ and the company will implement a plan to commercialize it.


Detection of B. burgdorferi antigen in biological fluids for Lyme disease diagnosis

Project Number: SBIR Phase I, 1R43AI188732-01 (Letter of Intent to Fund)
Project Period: 12-01-2024 to 11-30-2026

ABSTRACT: Lyme disease, a progressive illness caused by Borrelia burgdorferi, presents a challenge in early diagnosis due to non-specific symptoms and limitations of current serologic assays. Although the standard two-tiered approach (STT) is effective in early disseminated and late stages, early detection within 2-3 weeks post-tick bite remains below 50% sensitivity. Additionally, existing assays cannot differentiate between past and currently active infections. This Phase I SBIR proposal aims to develop a new diagnostic assay, AiCapLyme, based on electrokinetics capacitive sensing technology. The assay directly detects B. burgdorferi antigens in biological fluids, allowing for discrimination between disease stages and active versus past infections. The proposal's novelty lies in its approach: a new class of diagnostic assays that enables early disease detection and active infection status determination using technology that is ultrasensitive and simple to use. The proposal outlines two main aims: optimization of AiCap sensors for detecting four B. burgdorferi antigens in analytical samples and quantification of these antigens in clinical samples from Lyme disease patients. Sensitivity and specificity will be assessed against clinically characterized samples. Key benchmarks include achieving limits of detection in the pg/mL range and comparing AiCapLyme performance with qPCR/ddPCR and the CDC-recommended serologic MSTT (Modified Standard Two Tier). The proposed assay is highlighted for its sensitivity, specificity, simplicity, and rapid results, making it a potential game-changer in Lyme disease diagnosis. Successful completion of this project could lead to a paradigm shift in Lyme disease diagnostic technology, potentially paving the way for point-of-care antigen detection assays in future phases of development. Ultimately, this innovation could significantly improve the accuracy and efficiency of Lyme disease diagnosis, impacting both clinical practice and public health.

COMPLETED PROJECTS

(since 2014)

Low-cost Production of a Vaccine for Lyme Disease in Maize

Project Number: SBIR Phase I, R43AI152650 (Closed)
Project Period: 03/02/2021-02/29/2024

Antibody isotyping for discrimination of disease stage and diagnosis of early Lyme disease

Project Number: SBIR Phase I, R43AI155211 (Closed)
Project Period: 07/02/2020 – 03/31/2023

Point of care assay for the serodiagnosis of Leptospirosis

Project Number: SBIR Phase I, R43AI136551 (Closed)
Project Period: 12/15/2017 – 07/31/2020

Lab on a chip point of care assay for the rapid serodiagnosis of Lyme disease

Project Number: SBIR Phase II, R44AI096551 (Closed)
Project Period: 07/01/2014-04/30/2017

  • PATHWAY TO COMMERCIALIZATION

  • PATHWAY TO COMMERCIALIZATION

ITi preclinical development of biologics fits into the Proof-of-Principle (POC) and Pre-IND space (IND enabling studies). Once the IP is secured, ITi seeks strategic alliances (for example, a license) with interested parties that have the capability to commercialize the product. Each new Patent or License either becomes the foundation of a new company or, if it fits within a pipeline of products of an existing company, a licensing agreement is established between the parties.

Parties interested in Strategic Alliances please contact us.

Immuno Technologies laboratory
Immuno Technologies scientist
Immuno Technologies research
Immuno Technologies lab equipment

Partnerships