Lactiga Inc. Company Profile

Background

Overview

Lactiga Inc. is a biotechnology company specializing in the development of novel mucosal antibody therapies derived from human breast milk. Founded in 2017, the company is headquartered in North Brunswick, New Jersey, with additional offices in Toronto, Canada. Lactiga's mission is to harness the therapeutic potential of secretory Immunoglobulin A (sIgA) antibodies to address conditions such as chronic respiratory disorders, gut inflammation, and immune deficiencies. By focusing on mucosal immunity, Lactiga aims to transform the treatment landscape for these conditions.

Mission and Vision

Lactiga's mission is to advance immunotherapy by pioneering sIgA antibody science, redefining mucosal immunity, and developing therapeutics inspired by human milk. The company's vision is to lead the immunotherapy revolution by creating innovative treatments that enhance mucosal immunity, thereby improving the quality of life for individuals with immune-related and mucosal conditions.

Industry Significance

Lactiga operates within the biotechnology industry, focusing on immunotherapy and mucosal immunity. The company's innovative approach to utilizing human milk-derived antibodies positions it at the forefront of developing targeted treatments for immunodeficient and inflammatory conditions. By addressing unmet medical needs in these areas, Lactiga contributes significantly to advancing therapeutic options and improving patient outcomes.

Key Strategic Focus

Core Objectives

Lactiga's primary objectives include:

Development of Mucosal Antibody Therapies: Creating novel therapeutics that target mucosal surfaces to enhance immune defense and address conditions like chronic respiratory diseases and gut inflammation.

Advancement of sIgA-Based Treatments: Utilizing secretory Immunoglobulin A (sIgA) antibodies derived from human breast milk to develop biologics that can help dysregulated immune systems in patients of all ages.

Addressing Immunodeficiencies: Focusing on treatments for immunodeficient conditions, including Common Variable Immunodeficiency (CVID) and other rare immune diseases, to improve patient quality of life.

Areas of Specialization

Lactiga specializes in:

Mucosal Immunity: Developing therapies that enhance mucosal immune responses to prevent infections at the point of entry.

sIgA Antibody Science: Harnessing the therapeutic potential of sIgA antibodies derived from human breast milk.

Immunodeficiency Treatments: Creating biologics for patients with compromised immune systems.

Key Technologies Utilized

Lactiga employs proprietary technologies to develop sIgA-based therapeutics, focusing on:

Antibody Isolation and Purification: Extracting and purifying sIgA antibodies from human breast milk.

Formulation Development: Creating stable and effective formulations for mucosal delivery.

Preclinical and Clinical Testing: Conducting rigorous studies to evaluate safety, efficacy, and pharmacokinetics.

Primary Markets Targeted

Lactiga targets the following markets:

Immunodeficient Populations: Individuals with conditions like CVID and other rare immune diseases.

Chronic Respiratory Disease Patients: Individuals suffering from chronic respiratory disorders.

Inflammatory Bowel Disease (IBD) Patients: Individuals affected by conditions such as Crohn's disease and ulcerative colitis.

Financials and Funding

Funding History

Lactiga has secured multiple funding sources to support its research and development efforts:

Pre-Seed Funding (September 2022): Raised $1.6 million, including over $350,000 in research grants, led by 1517 Fund.

Seed Investment (November 2020): Received an investment from Checkmate Capital Group, LLC, providing essential financial support for product development and regulatory engagements.

NIH Grants: Secured multi-year, multi-million dollar grants from the National Institutes of Health (NIH) to advance mucosal-targeted secretory IgA therapies for immunodeficient patients.

Total Funds Raised

While specific total funds raised are not publicly disclosed, Lactiga has attracted significant investment from both private and public sources, including venture capital and government grants.

Notable Investors

Checkmate Capital Group, LLC: Provided seed investment in November 2020.

1517 Fund: Led the pre-seed funding round in September 2022.

National Institutes of Health (NIH): Through the National Institute of Allergy and Infectious Diseases (NIAID), awarded multi-year, multi-million dollar grants to support Lactiga's research programs.

Utilization of Capital

The funds raised are allocated towards:

Research and Development: Advancing preclinical and clinical studies for sIgA-based therapeutics.

Regulatory Affairs: Engaging with the U.S. Food and Drug Administration (FDA) for Investigational New Drug (IND) applications and other regulatory processes.

Operational Expansion: Enhancing infrastructure, including establishing partnerships with breast milk banks and expanding the team.

Pipeline Development

Key Pipeline Candidates

LCTG-001: A mucosal antibody replacement therapy comprised of polyclonal Immunoglobulin A (IgA) for nasal administration in patients with Common Variable Immunodeficiency (CVID).

LCTG-002: A therapeutic targeting COVID-19 and its variants, developed in response to the global pandemic.

Stages of Development

LCTG-001: In preclinical studies, with plans to file an IND application and initiate human clinical trials in 2023.

LCTG-002: In preclinical studies, with ongoing collaborations to advance development.

Target Conditions

LCTG-001: CVID and other rare immune diseases.

LCTG-002: COVID-19 and its variants.

Anticipated Milestones

LCTG-001: IND application filing and initiation of human clinical trials in 2023.

LCTG-002: Advancement through preclinical studies and preparation for clinical trials.

Technological Platform and Innovation

Proprietary Technologies

sIgA Antibody Extraction: Developing methods to extract and purify sIgA antibodies from human breast milk.

Mucosal Delivery Systems: Formulating nasal sprays and other delivery methods for effective mucosal administration.

Significant Scientific Methods

Immunological Assays: Utilizing assays to evaluate the efficacy of sIgA antibodies in neutralizing pathogens.

Nanotechnology: Employing nanotechnology for drug delivery and enhancing therapeutic efficacy.

Leadership Team

Executive Profiles

Rikin Mehta, PharmD/JD: Co-founder and CEO. Dr. Mehta has a background in healthcare policy and regulatory affairs, having served at the U.S. FDA and in the private sector.

Viraj Mane, PhD: Co-founder and Chief Scientific Officer. Dr. Mane holds a PhD in Human Genetics and has experience in immunology, virology, and nanotechnology.

Board Members and Advisors

Navneet Puri, PhD: Board member with over 25 years of experience in the life sciences industry, including roles at InnoPharma and Pfizer.

Reena Mehta, MD: Medical advisor, board-certified Allergist, Immunologist, and Pediatrician, founder of a clinic in New Orleans treating patients with primary immunodeficiency diseases.

Competitor Profile

Market Insights and Dynamics

The biotechnology industry, particularly in the field of immunotherapy and mucosal immunity, is experiencing significant growth.

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