Biora Therapeutics Inc

Invention:	Robotic pill
Trademark:	BioJet™
Patents:	300
NASDAQ:	BIOR

The invention

BioJet is an ingestible capsule designed for the needle-free oral delivery of large molecules to achieve high systemic exposure. The BioJet device enables the oral delivery of therapeutics that traditionally require injection. This is particularly beneficial for delivering large molecules such as monoclonal antibodies, peptides, and nucleic acids, which cannot survive stomach acids or be absorbed in the intestine. 

​​Approximately the size of a multivitamin and shaped like a standard capsule, it is easy to swallow, making medication administration more convenient and less intimidating for patients. Once ingested, the BioJet capsule is designed to traverse the gastrointestinal tract and activate in the small intestine. It employs a needle-free liquid-jet release mechanism to directly inject the drug into the small intestine for optimized bioavailability.

Performance advantages

​The BioJet systemic drug delivery platform offers several performance advantages over existing solutions, primarily in the realm of biologic drug delivery, which traditionally relies on injections:

1. Needle-Free Delivery: One of the most significant advantages is the elimination of needles. This not only reduces the discomfort associated with injections but also addresses needle phobia, which is a common barrier to medication compliance among patients. Approximately 20% of adults have a fear of needles, which can significantly impact their willingness to adhere to treatment regimens.
2. Improved Patient Compliance and Outcomes: The oral delivery system of the BioJet device can lead to higher patient compliance compared to injectable treatments. For example, diabetes patients starting treatment with an injectable GLP-1 agonist reported a 71% higher discontinuation rate compared to those starting oral therapy. The ease and comfort of oral administration could lead to better long-term management of chronic diseases.
3. Optimized Bioavailability: The BioJet device is designed to protect the drug from stomach acids and release it directly into the small intestine, where it can be absorbed systemically. This targeted delivery potentially improves the bioavailability of drugs that are unstable in the gastrointestinal tract or have poor intestinal absorption.
4. Broad Applicability: The BioJet platform's ability to deliver a wide range of molecules (including monoclonal antibodies, peptides, and nucleic acids) in a liquid form without needing reformulation makes it broadly applicable for various therapeutic areas. This versatility is a significant advantage over other drug delivery methods that might be limited to specific types of molecules or require complex reformulation of drugs for oral delivery.
5. Potential for More Frequent Dosing: The platform enables dosing flexibility, potentially allowing for more frequent administration of drugs. This can help maintain drug levels within a desired therapeutic window, potentially improving efficacy and safety profiles compared to current injection regimens.

Intellectual property

Biora holds a robust portfolio of approximately 300 issued patents and pending patent applications. This portfolio includes claims directed toward a wide range of therapeutic and device methods, systems, and compositions surrounding their suite of current and future products.

Preclinical studies

​The BioJet device has undergone several preclinical studies to assess its safety, tolerability, functionality, and bioavailability of delivered drugs. Here are key highlights from the preclinical studies as outlined in the document:

1. Preclinical Studies in Swine and Canines: Biora conducted preclinical studies using the BioJet device in swine and canines to evaluate the device's potential bioavailability rates and its safety and tolerability. These studies are crucial for understanding how the device performs in a living organism and its potential for delivering therapeutic agents effectively.
2. Swine Studies for Bioavailability Assessment: In studies involving swine, Biora assessed the bioavailability of drugs such as human insulin, dulaglutide, and adalimumab delivered using the BioJet device. These studies showed average bioavailability rates of approximately 19% for insulin, 29% for dulaglutide, and 27% for adalimumab. The pig's intestinal anatomy closely resembles that of humans, making it a preferred model for bioavailability studies. However, due to differences in stomach anatomy, the device required endoscopic placement in these studies.
3. Canine Study for Safety and Device Functionality: A preclinical study with an autonomous BioJet device was conducted in canines. This single-dose study focused on evaluating the safety and tolerability of the device, in addition to its ability to activate and deliver its payload upon reaching the small intestine. The study used a contrast agent to evaluate device function, demonstrating that the BioJet device could reliably deploy in the small intestine, supporting its potential for oral administration.
4. Lead Programs and Bioavailability: Two lead programs, BT-002 (a variant of adalimumab) and BT-200 (a GLP-1 receptor agonist), have been developed utilizing the BioJet device. Preliminary results from a preclinical study for the BT-002 program showed an average bioavailability of 51.3% for a variant of adalimumab delivered via the BioJet device. For the BT-200 program, preliminary results showed an average bioavailability of 37% for semaglutide, a GLP-1 receptor agonist.

Competitive landscape

BioJet's competitors include:

1. Functional Excipients: Companies like Enteris Biopharma and Novo Nordisk are developing technologies that enhance the solubility and/or permeability of peptides and small molecules. These functional excipients are designed to improve the oral bioavailability of drugs that would otherwise be poorly absorbed through the gastrointestinal tract.
2. Enteric Coating Technologies: Firms such as Catalent, Cosmo Pharmaceuticals, Intract Pharma, Lonza, and Tillotts Pharma are mentioned as competitors in the space of enteric coating technologies. These technologies aim to protect active pharmaceutical ingredients from gastric degradation, facilitating their delivery to the gastrointestinal tract where they can be absorbed.
3. Ingestible Devices for Therapeutic Payload Delivery: Several companies are developing ingestible devices designed to deliver therapeutic payloads. Competitors in this category include Novo Nordisk, Lyndra Therapeutics (LYNX), Rani Therapeutics (RaniPill), Biograil (BIONDD), Eli Lilly, and Amgen. These devices vary in their mechanisms of drug release and targeting within the gastrointestinal tract.

Lyndra Therapeutics is an unlisted company that develops LYNX™, a robotic pill that releases a mechanism once in the stomach. The mechanism consists of arms connected to a flexible core that is designed to enable the dosage form to achieve and maintain the desired shape while in the stomach to prevent passage through the pylorus (the opening between the stomach and the small intestine). There are linkers that connect the arms of the dosage form to the core that are designed to soften and disintegrate when the dosing period is complete. The components are designed to then pass through the pylorus, safely exiting the body. For patients and caregivers, this innovative solution means medicines have the potential to last longer and perform better in terms of pharmacokinetics than current immediate-release or extended-release oral formulations.

Biograil is an unlisted company that develops BIONDD™, a robotic pill that utilises an anchor mechanism to attach itself to the inner wall of the stomach. Once attached, the drug payload is released over time, allowing the usual barriers for dosing by the oral route (degradation and poor absorption from the gut) to be circumvented. 

Rani Therapeutics (go to: Rani Therapeutics) is a listed company that develops RaniPill™, a robotic pill that utilises a self-inflating balloon to expose a syringe that injects a microneedle into the intestinal wall in order to deliver the drug payload.

This competitive landscape highlights the diverse approaches being pursued to enhance or facilitate the oral administration of therapeutic agents. The BioJet device's unique proposition lies in its needle-free liquid-jet release mechanism for delivering drugs directly into the small intestine, aiming to optimize bioavailability for large molecule therapeutics that are traditionally delivered via injection.

Addressable market

The total market for biologic drugs is estimated to be in excess of $250 billion, with monoclonal antibodies alone accounting for over $100 billion. This highlights the significant financial scale of the sector that the BioJet aims to serve, underlining the substantial economic opportunity for a device that can enhance the delivery of these therapies.

Upside

As of Feburary 2024 Biora is a small cap with a market capitalisation of USD$20m. 


Sources

Biora Therapeutics Inc annual report 2022
https://investors.bioratherapeutics.com/static-files/2f9b4adb-c300-4f77-9875-0c9a4f86e5cc