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Biora Therapeutics Shares Progress on Smaller BioJet™ Clinical Device with Largest Payload of any Ingestible Injectable at the 14th Annual PODD Meeting

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Biora Therapeutics (BIOR) announced progress on its BioJet™ Oral Delivery Platform at the 14th Annual PODD meeting. The company has successfully developed a smaller, 00-size BioJet device that can autonomously deliver medications to the small intestine. The technology has demonstrated >30% oral bioavailability versus intravenous administration in over 30 in vivo studies. The device can deliver doses >50mg, making it the largest payload among ingestible injectables, with capacity now increased to >300 microliters. Testing with existing pharma collaborators is planned for Q4 2024, with molecule-specific feasibility testing in Q1 2025.

Biora Therapeutics (BIOR) ha annunciato progressi sulla sua BioJet™ Oral Delivery Platform durante il 14° incontro annuale del PODD. L'azienda ha sviluppato con successo un dispositivo BioJet di dimensioni più piccole, di 00 dimensioni, che può somministrare autonomamente i farmaci all'intestino tenue. La tecnologia ha dimostrato una bio disponibilità orale superiore al 30% rispetto alla somministrazione endovenosa in oltre 30 studi in vivo. Il dispositivo può somministrare dosi superiori a 50 mg, rendendolo il payload più grande tra gli iniettabili ingeribili, con una capacità ora aumentata a oltre 300 microlitri. Sono previsti test con i collaboratori farmaceutici esistenti per il quarto trimestre del 2024, con test di fattibilità specifici per le molecole nel primo trimestre del 2025.

Biora Therapeutics (BIOR) anunció avances en su Plataforma de Administración Oral BioJet™ en la 14ª reunión anual de PODD. La compañía ha desarrollado con éxito un dispositivo BioJet de tamaño más pequeño, tamaño 00, que puede administrar medicamentos de forma autónoma al intestino delgado. La tecnología ha demostrado una biodisponibilidad oral superior al 30% en comparación con la administración intravenosa en más de 30 estudios in vivo. El dispositivo puede administrar dosis superiores a 50 mg, lo que lo convierte en la carga más grande entre los inyectables ingeribles, con una capacidad ahora aumentada a más de 300 microlitros. Se prevén pruebas con colaboradores farmacéuticos existentes para el cuarto trimestre de 2024, con pruebas de viabilidad específicas de moléculas en el primer trimestre de 2025.

Biora Therapeutics (BIOR)는 제14회 PODD 연례 회의에서 바이오젯™ 경구 전달 플랫폼에 대한 진전을 발표했습니다. 이 회사는 약물을 소장에 자율적으로 전달할 수 있는 더 작은 00 크기의 BioJet 장치를 성공적으로 개발했습니다. 이 기술은 30개 이상의 in vivo 연구에서 정맥주사에 비해 30% 이상의 경구 생체이용률을 입증했습니다. 이 장치는 50mg 이상의 용량을 전달할 수 있어 경구 주입제 중 가장 큰 화물로, 현재 용량이 300마이크로리터 이상으로 증가했습니다. 기존 제약 협력사와의 테스트는 2024년 4분기로 계획되어 있으며, 분자 특정 타당성 테스트는 2025년 1분기에 예정되어 있습니다.

Biora Therapeutics (BIOR) a annoncé des avancées concernant sa Plateforme de Livraison Orale BioJet™ lors de la 14e réunion annuelle du PODD. L'entreprise a réussi à développer un dispositif BioJet de taille plus petite, de taille 00, qui peut administrer des médicaments de manière autonome dans l'intestin grêle. La technologie a démontré une biodisponibilité orale supérieure à 30 % par rapport à l'administration intraveineuse dans plus de 30 études in vivo. Le dispositif peut délivrer des doses supérieures à 50 mg, ce qui en fait la plus grande charge parmi les injectables ingérables, avec une capacité désormais augmentée à plus de 300 microlitres. Des tests avec des collaborateurs pharmaceutiques existants sont prévus pour le quatrième trimestre 2024, avec des tests de faisabilité spécifiques aux molécules au premier trimestre 2025.

Biora Therapeutics (BIOR) hat auf dem 14. jährlichen PODD-Treffen Fortschritte bei seiner BioJet™ Oral Delivery Platform angekündigt. Das Unternehmen hat erfolgreich ein kleineres BioJet-Gerät in Größe 00 entwickelt, das Medikamente autonom an den Dünndarm abgeben kann. Diese Technologie hat in über 30 in vivo Studien eine orale Bioverfügbarkeit von über 30 % im Vergleich zur intravenösen Verabreichung gezeigt. Das Gerät kann Dosen von über 50 mg abgeben, wodurch es die größte Ladung unter den einnehmbaren Injektables darstellt, während die Kapazität auf über 300 Mikroliter erhöht wurde. Tests mit bestehenden Pharma-Kooperationspartnern sind für das 4. Quartal 2024 geplant, während tests spezifischer Moleküle für das 1. Quartal 2025 anstehen.

Positive
  • Successfully reduced device size while increasing payload capacity to over 300 microliters
  • Demonstrated >30% oral bioavailability vs. intravenous administration in over 30 in vivo studies
  • Achieved 60-80% oral bioavailability compared to subcutaneous injection
  • Largest drug payload capacity among ingestible injectables (>50mg)
  • Expanded collaborations with mega-cap pharma companies
Negative
  • None.

Insights

The development of a smaller BioJet device with enhanced payload capacity represents an incremental technical advancement, though several uncertainties remain. The 60-80% oral bioavailability compared to subcutaneous injection is technically impressive, but commercial viability depends on successful molecule-specific testing in Q1 2025.

The expanded collaborations with mega-cap pharma partners and the shift from exclusive development suggests a strategic pivot to maximize licensing opportunities. However, the timeline to revenue remains distant, with functional testing scheduled for Q4 2024. The 50+ milligram delivery capacity and successful size reduction to 00-capsule while maintaining >300 microliter payload are promising technical achievements, but regulatory approval and commercial adoption hurdles remain significant.

Expanded collaborations to support rapid testing in advanced animal models in Q4 2024

SAN DIEGO, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today is sharing progress on its development of the BioJet™ Oral Delivery Platform, which is designed to replace injection with needle-free, oral delivery, at the 14th Annual Partnership in Drug Delivery (PODD) meeting in Boston, Massachusetts.

“We have now demonstrated the ability to autonomously deliver to the small intestine in canine models with our smaller, 00-size BioJet device, a size that is desired by both patients and pharma companies,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We have agreed with existing mega-cap pharma collaborators to rapidly progress development in advanced animal models. The goal of this approach is to maximize licensing potential by enabling agreements within multiple verticals using a form factor desired by all our collaborators. We believe this is preferable to an exclusive development path based on the larger, 000-size device. We anticipate completing full functional testing in Q4 2024 and molecule-specific feasibility testing during Q1 2025.”

BioJet delivery technology has been proven in over 30 in vivo studies with both internal and collaborator molecules. The BioJet platform has achieved oral bioavailability greater than 30% vs. intravenous administration for molecules including peptides, antibodies, and antisense oligonucleotides, which equates to 60–80% oral bioavailability compared to subcutaneous injection.

The BioJet delivery device is a swallowable, needle-free autoinjector that uses liquid jet injection to deliver existing liquid drug formulations into the submucosa of the small intestine. With the ability to deliver doses greater than 50 milligrams, BioJet offers the largest drug payload among ingestible injectables. Its size has been successfully decreased from capsule size 000 to size 00, while increasing payload capacity to over 300 microliters.

About the BioJet™ Oral Delivery Platform
Biora’s BioJet platform for oral delivery of macromolecules is designed to replace injection with needle-free, oral delivery. The BioJet device is a swallowable autoinjector that uses liquid jet injection to deliver drug into the submucosa of the small intestine.

The BioJet platform is designed to provide category-leading oral bioavailability for a wide range of molecules, including proteins, peptides, and nucleic acids. The 00-size BioJet device delivers standard liquid drug formulations with a capacity of >300 microliters. It offers the largest drug payload of any ingestible injectable, with the ability to deliver doses greater than 50 milligrams.

About Biora Therapeutics
Biora Therapeutics is a clinical-stage biotech company developing two smart pill-based therapeutics platforms: the NaviCap™ platform for colon-targeted treatment of IBD, designed to improve patient outcomes through treatment at the site of disease in the gastrointestinal tract, and the BioJet™ platform for oral delivery of large molecules, designed to replace injection with needle-free, oral delivery.

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

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 concerning the progress and future expectations and goals of our research and development, preclinical and clinical trial activities, and partnering and collaboration efforts with third parties, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “envision,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “anticipate,” “forward,” “believe,” “design,” “estimate,” “predict,” “projects,” “projecting,” “potential,” “plan,” “goal(s),” “target,” or the negative 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. Such risks, uncertainties, and other factors include, among others, our ability to innovate in the field of therapeutics, our ability to make future FDA filings and initiate and execute clinical trials on expected timelines or at all, our ability to obtain and maintain regulatory approval or clearance of our products on expected timelines or at all, our plans to research, develop, and commercialize new products, the unpredictable relationship between preclinical study results and clinical study results, our expectations regarding allowed patents or intended grants to result in issued or granted patents, our expectations regarding opportunities with current or future pharmaceutical collaborators or partners, our ability to raise sufficient capital to achieve our business objectives, our ability to maintain our listing on the Nasdaq Global Market, and those 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 year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) and other subsequent documents, including Quarterly Reports on Form 10-Q, 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.

Investor Contact
Chuck Padala
Managing Director, LifeSci Advisors
IR@bioratherapeutics.com
(646) 627-8390

Media Contact
Liz Robinson
CG Life
lrobinson@cglife.com


FAQ

What is the new size of Biora Therapeutics' BioJet device (BIOR)?

Biora Therapeutics has reduced the BioJet device from capsule size 000 to size 00, while increasing payload capacity to over 300 microliters.

What is the bioavailability of Biora's BioJet platform (BIOR)?

The BioJet platform achieves over 30% oral bioavailability versus intravenous administration, equivalent to 60-80% oral bioavailability compared to subcutaneous injection.

When will Biora Therapeutics (BIOR) complete BioJet functional testing?

Biora Therapeutics plans to complete full functional testing in Q4 2024, followed by molecule-specific feasibility testing during Q1 2025.

What is the payload capacity of Biora's BioJet device (BIOR)?

The BioJet device can deliver doses greater than 50 milligrams, making it the largest drug payload among ingestible injectables, with capacity over 300 microliters.

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