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BioJet™ Systemic Oral Delivery Platform

Systemic oral delivery of biotherapeutics designed to improve disease management

Our BioJet™ systemic oral delivery platform (formerly the Oral Biotherapeutic Delivery System or OBDS) uses an ingestible smart capsule designed for needle-free, liquid jet delivery of large molecules to the small intestine for systemic uptake.

The platform has the potential to deliver a broad range of large molecules including monoclonal antibodies, peptides, and nucleic acids. These molecules are currently delivered by injection because they cannot survive stomach acids and they are too large to be absorbed in the intestine. 

Oral delivery can help improve patient convenience, which has been shown to improve patient compliance and associated outcomes.

Needles are associated with poor disease management

38% of people with diabetes miss 4+ injections per week.1

71% higher discontinuation rate for diabetes patients initiating treatment with an injectable GLP-1 agonist vs. those starting oral therapy.2 

42% of patients fail to maintain diabetes treatment due to injection concerns when using an injectable GLP-1 agonist.2

Video: how the BioJet platform works

  • ORAL ADMINISTRATION: Convenient oral capsule the size of a multivitamin
  • NEEDLE-FREE DELIVERY: Liquid jet injection to the small intestine to maximize systemic bioavailability
  • AUTONOMOUS FUNCTION: Enteric trigger for precise timing of drug delivery to the small intestine
 
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Therapeutic challenges

Needle-based therapy leads to poor disease management due to inconsistent dosing.

Large molecules cannot achieve systemic uptake through intestinal absorption.

Other oral delivery technologies require difficult re-formulation and lengthy approval pathways.

BioJet oral delivery approach

Needle-free, oral administration may improve patient compliance and therefore patient outcomes.

Liquid jet delivery into the small intestine maximizes systemic bioavailability.

Use of liquid formulation has the potential to deliver a range of approved large molecules, without reformulation.

BioJet Systemic Therapeutics Pipeline

We are developing a pipeline of investigational drug/device combinations designed for oral delivery of biotherapeutics. While advancing our own pipeline, we are collaborating with Ionis Pharmaceuticals to evaluate the BioJet platform for delivery of antisense oligonucleotides, and we also have collaborations with two other leading pharmaceutical companies to evaluate delivery of their molecules via the platform. 

Program Indication Design / Feasibility Preclinical Clinical

BioJet™
Systemic Oral Delivery Platform

 —
Preclinical

Ionis Collaboration
BioJet + antisense therapy

 Undisclosed
Preclinical

Large Pharma 1 Collaboration
BioJet + undisclosed drug

 Undisclosed
Preclinical

Large Pharma 2 Collaboration
BioJet + undisclosed drug

 Undisclosed
Preclinical

BT-200
BioJet + GLP-1 agonist

 Demonstration Program
Preclinical

BT-002
BioJet + adalimumab variant

 Demonstration Program
Preclinical
  • BT-200
  • BT-002

BT-200: liquid formulation of a GLP-1 receptor agonist delivered via BioJet for the treatment of type 2 diabetes

We are developing BT-200 (formerly PGN-OB2) as a combination product of a GLP-1 receptor agonist and the BioJet device for the treatment of type 2 diabetes. GLP-1 receptor agonists are a leading class of therapeutics for type 2 diabetes. We believe oral GLP-1 receptor agonists will be preferred by patients to injectables, resulting in a significant market opportunity. 

We are currently advancing development of BT-200 with key preclinical studies.

BT-002: liquid formulation of anti-TNF-alpha monoclonal antibody delivered via BioJet for the treatment of autoimmune conditions

We are developing BT-002 (formerly PGN-OB1) as a combination product of a variant of adalimumab and the BioJet device for the treatment of inflammatory conditions. Several anti-TNF-alpha antibodies have been approved to treat a range of inflammatory conditions. However, all require either intravenous or subcutaneous injection. Adalimumab is approved for a range of inflammatory disorders and is the best-selling drug globally. An oral variant of adalimumab presents a significant opportunity for the many patients who would prefer to avoid painful injections. 

BT-002 is currently in preclinical stage development with a formulation that we have developed and scaled to GMP grade material.

Systemic Therapeutics Publications

Evaluation of the pharmacokinetics of GLP-1 receptor agonist delivered through the BioJet™ oral biotherapeutic delivery platform in a porcine model: an update
#Systemic Therapeutics
Evaluation of the pharmacokinetics of GLP-1 receptor agonist delivered through the BioJet™ oral biotherapeutic delivery platform in a porcine model
#Systemic Therapeutics
Evaluation of the pharmacokinetics of PGN-OB1 following oral administration of an oral biotherapeutics delivery system (OBDS) in Yucatan swine
#Systemic Therapeutics
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References

  1. Frost & Sullivan research commissioned by Rani Therapeutics Holdings, Inc. https://ir.ranitherapeutics.com/static-files/b1f080bf-a860-4136-87cb-d6f7c49c1502
  2. Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported Barriers to Adherence and Persistence to Treatment With Injectable Medications for Type 2 Diabetes. Clin Ther. 2016;38(7):1653-1664.e1.