SAN DIEGO, May 19, 2022 (GLOBE NEWSWIRE) — Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotechnology company reinventing therapeutics, today announced a new patent related to its Drug Delivery System (DDS) platform in development.

The USPTO has issued US Patent No. 10,835,152 titled “Electromechanical Pill with Tracking Capabilities” and allowed US Application No. 15/940,407 titled “Tracking Systems and Methods for an Ingestible Device.” Their European counterparts, European patent numbers EP3197336 and EP3600009, also issued. The three patents and one authorized application relate to ingestible devices capable of automatically localizing themselves in the gastrointestinal (GI) tract using reflected light emitted from the device. The technology is broadly applicable to any ingestible device, whether the device is for sampling, diagnostics, or drug delivery.

“We believe, as recent data has shown, that targeted delivery of treatments has the potential to improve outcomes for patients with IBD. There is currently no way to deliver appropriate therapeutic doses directly to the site of disease, and systemic dose escalation is limited by toxicity issues,” said Adi Mohanty, CEO of Biora Therapeutics. “Therefore, it is essential to have a technology that allows the delivery of targeted therapies directly into the gastrointestinal tract, and we have created a precise and autonomous localization technology for ingestible devices that is unique and exclusive.

Biora’s intellectual property covers the use of reflected light for self-tracking by an ingestible device. This technology, as used in Biora’s DDS capsule for its core program, is designed to deliver a therapeutic dose to predefined locations in the lower gastrointestinal tract, while simultaneously limiting systemic breakdown or absorption in the upper gastrointestinal tract. Proprietary auto-localization technology is based on consistent anatomical characteristics between humans and operates independently of physiological conditions such as pH, motility, pressure, and bacterial enzymes, which can vary widely between individuals and disease states. The device auto-locator is designed to operate autonomously, without reliance on external devices or magnets, and is economical to build, without cameras or other complex electronics.

The DDS platform can provide liquid drug formulations, including peptides and proteins, which are difficult to formulate into orally available forms. The device has been successfully used in a human trial, and a clinical study of device performance in patients with active ulcerative colitis is currently being recruited.

Biora Therapeutics has developed a strong patent portfolio relating to its ingestible device localization technology, including 29 granted or cleared patents and applications and 10 pending applications in major jurisdictions around the world, including the United States, Europe, China , Japan, South Korea, Israel, Australia and Mexico. These patents are part of Biora’s corporate portfolio of 82 patent families, including approximately 170 issued patents and 170 pending applications. The portfolio includes patents and applications for drug delivery methods and devices, gastrointestinal sampling and diagnostic methods and devices, disease treatment methods and compositions, and molecular and protein tools, analyzes and diagnostics.

About the Drug Delivery System (DDS) and PGN-600

Biora Therapeutics’ targeted therapy platform uses a novel approach that may improve outcomes for patients with IBD by maximizing the dose available to the site of disease while reducing systemic toxicity. For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing treatments offer less than ideal efficacy, likely due to difficulties in achieving safe levels. sufficient drug in the affected tissues.

Biora’s drug delivery system is an ingestible capsule designed for the targeted delivery of therapeutics to improve the treatment of IBD. It is approximately the size of a fish oil capsule and provides a payload of up to 500µl of liquid or solid formulation. Once swallowed, the capsule is designed to autonomously identify specific locations in the gastrointestinal tract and release a therapeutic dose. In normal healthy volunteers, DDS has been shown to be safe and accurate in identifying entry into the colon. Biora is a recipient of the IBD Ventures development grant from the Crohn’s and Colitis Foundation to, in part, support the development and continued clinical evaluation of the DDS platform, which aims to improve the quality of life of patients with diseases inflammation of the intestine.

Biora is developing the PGN-600 program, which consists of a liquid formulation of tofacitinib delivered into the colon via the DDS capsule, for the treatment of ulcerative colitis. The company has shown preclinically in dogs that successful targeted administration using PGN-600 can lead to reduced blood drug levels and increased tissue drug levels at least 25-fold. elevated over the entire length of the colon compared to the equivalent standard oral dose. Biora plans to initiate a Phase 1 safety clinical trial of PGN-600 in late 2022.

About Biora Therapeutics

Biora Therapeutics is the biotechnology company reinventing therapeutics. By creating innovative smart pills designed for targeted drug delivery to the gastrointestinal tract and needle-free, systemic delivery of biotherapies, the company is developing therapies to improve the lives of patients. Biora envisions a world where patients have access to needle-free drug delivery and better treatment outcomes.

For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.

Safe Harbor Statement or Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. . All statements, other than statements of historical facts included in this press release, including statements regarding the progress and future expectations of our research and development efforts, are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “may”, “could”, “will”, “aim”, “intend”, “should”, “could”, “may” , “expect”, “believe”, “design”, “estimate”, “predict”, “potential”, “plan” or the negative form of these terms, and similar expressions intended to identify forward-looking statements . These statements reflect our plans, estimates and expectations as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. These risks, uncertainties and other factors include, among others, our ability to innovate in the field of precision medicine, our ability to obtain and maintain regulatory approval or clearance of our products on schedule or otherwise everything from our plans to research, develop, and bring new products to market, the unpredictable relationship between the results of preclinical studies and the results of clinical studies, our expectations regarding future revenue generation opportunities with current or future pharmaceutical collaborators, our ability to raise sufficient capital to achieve our business objectives, the ongoing COVID-19 pandemic, and the risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC and other subsequent documents, including quarterly reports, that we file with the SEC.

Biora Therapeutics expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contact Investor

Chuck Padala

Managing Director, LifeSci Advisors

[email protected]

(646) 627-8390

Media Contact

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