About Us

CORPORATE INFORMATION

TregTherapeutics Inc. is a preclinical stage company focused on the treatment and possible cure of multiple sclerosis.

The T lymphocyte is a key component in the acquired immune system, and a subset of T cells, the T-regulator cell (known as the Treg), plays an instrumental role in the control and regulation of the immune response. Named in recognition of the vital functions this cell executes, TregTherapeutics Inc. is focused on developing a tolerogenic vaccine for the treatment and possible cure of multiple sclerosis. The corporation is a North Carolina-based preclinical-stage company whose proprietary technology is based upon an exclusive license granted by East Carolina University. The technology is a transformative platform that utilizes a novel vaccine approach that harnesses the power of Tregs to dramatically alter patient outcomes in response to autoimmune disease.

The operational team consists of experienced professionals, who, through shared vision and development objectives, are preparing the way for human clinical trials. Current efforts are centered on formulation, manufacturing, and preclinical studies in preparation for filing an Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of a tolerogenic vaccine for multiple sclerosis based on this proprietary platform.

BUSINESS STRATEGY

The mission of TregTherapeutics, Inc is to provide resources to expedite the pre-clinical development, and ultimately, the availability of next-generation therapeutics in the treatment of autoimmune disease.

The technology covered under the company’s license agreement is multifaceted with several layers of complexity. First, there are two separate technologies, specified as “Vaccine Therapy” and “Adaptive Cell Therapy,” and each of these technologies has potential application to a range of autoimmune disease states and urgent target markets. Management has decided that its primary priority is to develop the Vaccine Therapy first. The vaccine approach defined by our platform technology is applicable to dozens of autoimmune diseases, each having severe debilitating symptoms and each urgently needing the kind of outcomes possible with vaccines based on our platform. The company’s strategic plan recognizes that limited financial, technical, and time resources need to be focused. Because the primary research which forms the foundation of the vaccine platform has been within EAE models of MS, it is multiple sclerosis in humans that will be the initial objective.

TregTherapeutics objectives, then, are clear. Resources must be assembled to proceed diligently toward a humanized version of its proprietary therapeutic tolerogenic vaccine through preclinical stages of IND enabling studies in order to initiate clinical trials. This process is proceeding. The details of that process are becoming clearer with each new day. Sourcing and formulation, manufacturing, assay development and application – these are the technical requirements for regulatory compliance and for demonstrating preliminary safety and efficacy.

Financial resources are critical to the success of the enterprise. Availability of funding has an impact on our ability to proceed with planned activities, and acquiring the resources to enable execution of the preclinical pathway is our highest priority. Non-dilutive funding is being pursued. Grant writing, along with methodically seeking out, identifying, and executing appropriate opportunities is an ongoing activity.

In addition to grant solicitation and other non-dilutive funding sources, we are also pursuing equity funding in the early stages of our development. Not content to solely rely on non-dilutive funding to move the technology forward, we have engaged in a well-organized and orchestrated effort to establish an equity partnership with either angel investors, venture capital concerns, or appropriate pharmaceutical/biotech firms. This is a key strategic element of the TregTherapeutics plan. Interested investors are urged to contact us for further information.

MANAGEMENT TEAM

The TregTherapeutics management team has 40+ combined years of technical and managerial experience in leading/execution of preclinical plans and Phase I clinical trials.

Individual backgrounds of the team include leadership positions within the pharmaceutical, biotech, and medical device industries, encompassing start-up and mature enterprises, IPOs, mergers, and acquisitions; in addition, the team possesses work experience within the FDA and other government agencies. Collaborative expertise, attitude, and ability, along with the licensing partnership with ECU, provide the tools needed to take this outstanding technology through the pre-clinical pathway into human trials quickly and efficiently, and the team is focused on and dedicated to this admirable mission.

Ray Holloway

CEO

Forty years’ experience in medical device and related industry. Founder: CryoLife [NYSE: CRY], Luminal Solutions, 3D Surgical Solutions. Served as hands-on CEO of start-up ventures, various funding and corporate management roles, and as C-level positions for domestic and international multimillion dollar enterprises, some of which are currently publicly traded companies.

Brent Holloway

Engineering, MBA, Director

General Electric, Renewables Industry Services; Lucideon, Director of Sales and Marketing; Markforged, Director of Application Engineering and Strategic Sales. These experiences represent the engineering and business development acumen with startup and established businesses.

Glen Smotherman

MBA, CFO-Secretary/Treasurer

CPA and Harvard MBA with an accomplished career as primary financial officer in early-stage entrepreneurial ventures. Extensive merger and acquisition experience in medical, energy, and communications industries including two Initial Public Offerings.

Angela M. Lynch

MSPH, PhD, VP, Preclinical Dev. & Scientific Strategy

Pharmacologist/Toxicologist – Founder/Principal of ToxPlus Consulting, LLC; Twenty-five years of extensive research and regulatory experience that includes pharmacology and toxicology study protocol development, study monitoring/management, GLP/non-GLP nonclinical pharmacology and toxicology data review. Extensive experience with regulatory submissions and FDA interaction. Active member of the American College of Toxicology, Society of Toxicology, and Regulatory Affairs Professional Society.

Anita O’Connor

PhD, VP Regulatory & Scientific Affairs

Biologic and biosimilar development expert; 16 years with FDA as preclinical reviewer at Center for Biologics, Center for Drugs, Office of Vaccines, and Office of Blood; extensive experience in developing cytokines, chemokines, peptides, vaccines, monoclonal antibodies, and therapeutic blood products for a wide range of indications; founder of Anita O’Connor Consulting LLC, supporting novel biologic and biosimilar development; international speaker and workshop lecturer on biosimilars; CRO experience as Senior Director for Biopharmaceutical at Celerion.

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