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Biora Therapeutics (formerly trading under the symbol BIOR) has generated frequent news coverage around its development of smart pill-based therapeutic delivery platforms and its corporate restructuring. Company releases describe Biora as a clinical-stage biotech focused on two main platforms: NaviCap, for colon-targeted treatment of inflammatory bowel disease, and BioJet, a swallowable autoinjector platform for oral delivery of large molecules designed to replace injection with needle-free, oral administration.
News items detail progress on the BioJet™ Oral Delivery Platform, including development of a smaller, 00-size device with increased payload capacity compared with a larger 000-size capsule. Biora reports that the 00-size BioJet device is designed to deliver standard liquid drug formulations with a capacity greater than 300 microliters and to enable doses greater than 50 milligrams. Releases also describe in vivo studies, work with collaborator molecules, and presentations at industry meetings such as the Partnership Opportunities in Drug Delivery meeting and the Peptide Therapeutics Symposium.
Another major theme in Biora’s news flow is the NaviCap™ platform and its application to inflammatory bowel disease. The company has announced Phase 1 clinical trial data for BT-600, a NaviCap-based program, presented at a leading gastroenterology conference and recognized with a Presidential Poster Award, with the results suggesting the potential for larger clinical trials in ulcerative colitis patients.
In addition to R&D updates, Biora’s news includes financing transactions, Nasdaq listing developments, and a chapter 11 filing in the District of Delaware as part of a court-supervised sale process. Subsequent news reports the completion of this restructuring, with Biora emerging as a privately held company and its existing common shares cancelled pursuant to a Plan of Reorganization. Readers following BIOR-related news can review this sequence of scientific, clinical, financial, and restructuring announcements to understand the company’s evolution and platform development.
Biora Therapeutics (Nasdaq: BIOR) announced five poster presentations at the ACG 2022 Annual Scientific Meeting, showcasing results from clinical trials on its Drug Delivery System (DDS) platform. Key findings indicate the DDS was well tolerated, effectively localized, and delivered therapeutics in patients with ulcerative colitis. The results highlight the potential of targeted drug delivery to improve treatment outcomes for the 1.8 million IBD patients in the U.S. The company is developing the PGN-600 program, which uses DDS to deliver tofacitinib for ulcerative colitis treatment.
Biora Therapeutics presented a poster at the PDA Universe Conference, showcasing their innovative delivery system for large molecules. This system employs submucosal liquid jet injection targeted at the small intestine, aiming to optimize oral drug delivery. In preclinical studies, the device demonstrated over 83% deployment accuracy in canines, with a notable oral bioavailability of 25% for a variant of adalimumab in swine. Biora is advancing its PGN-OB2 program for type 2 diabetes treatment, emphasizing the importance of oral administration for patient adherence.
Biora Therapeutics (Nasdaq: BIOR) announced its participation in the 12th annual Partnership Opportunities in Drug Delivery (PODD) Conference on October 24-25, 2022, in Boston. Chris Wahl, MD, will discuss advancements in oral drug delivery of macromolecules, highlighting challenges and innovations in the field. Biora's systemic therapeutics platform utilizes a smart ingestible capsule designed for effective oral delivery of biotherapeutics, including monoclonal antibodies and peptides, aiming to improve patient outcomes, particularly for inflammatory bowel disease (IBD) sufferers.
Biora Therapeutics has announced the issuance of a new patent by the USPTO for the oral, systemic delivery of GLP-1 receptor agonists via a specialized ingestible device. This patent, U.S. Patent No. 11,439,802, supports their PGN-OB2 program aimed at treating type 2 diabetes. With a potential market exceeding $20 billion for GLP-1 receptor agonists by 2025, Biora aims to enhance bioavailability significantly beyond the current 1% of available oral medications. The company bolsters a strong patent portfolio with 82 families, ensuring robust intellectual property for its innovative technologies.
Biora Therapeutics (Nasdaq: BIOR) announced the appointment of Dr. Bruce Sands as chair of its Clinical Advisory Board for Inflammatory Bowel Disease (IBD). Dr. Sands is a prominent figure in IBD research, joining experts like Dr. Geert D’Haens and Dr. Brian Feagan. The advisory board will offer strategic guidance for Biora’s Targeted Therapeutics pipeline, which aims to enhance drug delivery for IBD patients. Dr. Sands emphasized the potential of targeted delivery methods to improve therapeutic outcomes. Biora’s innovations aim to address the limitations of current treatment options.
Biora Therapeutics (Nasdaq: BIOR) announces its participation in the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. The management team will present and hold one-on-one meetings with investors. Biora focuses on innovative therapeutics, including smart pills for drug delivery to the GI tract and needle-free biotherapeutics. The company aims to enhance patient outcomes through accessibility to advanced therapeutic solutions. Interested investors can schedule meetings through their H.C. Wainwright contacts.
Biora Therapeutics, Inc. (Nasdaq: BIOR) announced the completion of significant human studies showcasing the effectiveness of its targeted therapeutics platform. The PM-602 study demonstrated positive results in active ulcerative colitis patients, while the PM-611 study confirmed the device's performance in healthy volunteers without food restrictions. The FDA provided constructive feedback on the PGN-600 clinical trial design, with an IND filing expected in Q1 2023. Financially, Q2 2022 revenues totaled $0.9 million, with a reduced net loss of $5.5 million, marking a significant improvement from the previous year's loss.
Biora Therapeutics has announced successful results from its study PM-602, demonstrating that its drug delivery system capsule effectively detects colon entry in patients with active ulcerative colitis. The study involved seven patients and indicated the device's ability to release its payload across the entire colon. The CEO highlighted the significance of these findings as they support the advance of the PGN-600 clinical program. The Drug Delivery System aims to improve therapeutic outcomes for inflammatory bowel disease by precisely targeting drug delivery.
Biora Therapeutics (Nasdaq: BIOR) announced that five abstracts will be presented at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting from October 21–26, 2022. The presentations focus on their Targeted Therapeutics Platform and Systemic Therapeutics Platform, including device performance studies and preclinical data. Notable presentations will be led by key researchers, including Shaoying Nikki Lee, PhD. The research aims to advance the treatment of gastrointestinal disorders and will be published in The American Journal of Gastroenterology.
Biora Therapeutics (Nasdaq: BIOR) announced participation in one-on-one meetings at the BTIG Biotechnology Conference, held virtually and at the St. Regis New York Hotel on August 8-9, 2022. The company focuses on innovative drug delivery systems, particularly smart pills for targeted gastrointestinal treatment and needle-free biotherapeutics. Interested parties can schedule meetings through BTIG representatives. Biora aims to enhance patient care through advanced therapeutic solutions.