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Type of technology

Polymer-based particles

Administration route

Intramuscular, Intravenous

Development state and regulatory approval

Active Pharmaceutical Ingredient (API)

Isoniazid

Development Stage

Pre-clinical

Regulatory Approval

Not provided

Description

Polymeric nanobiotics are a novel nanoparticle drug-delivery system designed to treat Mycobacterium tuberculosis. They are created by covalently bonding antibiotics, like isoniazid, directly to a biodegradable polymer chain. In acidic environments—such as inside infected macrophages and granulomas—the polymer undergoes hydrolysis to trigger a sustained, targeted release of the active drug. Furthermore, these nanoparticles can encapsulate a second hydrophobic drug, like clofazimine, enabling synchronized multi-drug therapy that maximizes bacterial killing while minimizing systemic toxicity.

Developer(s)

University of Cambridge
Originator
United Kingdom

University of Cambridge

It is one of the prestigous univerisities in the UK. The University of Cambridge's drug and formulation development evolved from its 1946 Department of Pharmacology into an open-innovation ecosystem. Its infrastructure centers on the Cambridge Biomedical Campus, anchoring the Milner Therapeutics Institute and CATS. This network pairs AI-driven target discovery with advanced engineering to translat

Technology highlight

1) Core Design: Polymeric nanobiotics are nanoparticles formed by covalently bonding antibiotics (e.g., isoniazid) directly to biodegradable polymer chains. 2) Triggered Release: α-keto polyester undergo hydrolysis in acidic environments—like inside Mtb-infected macrophages and granulomas—triggering targeted, sustained drug release. 3) Multi-Drug Therapy: They can encapsulate a second hydrophobic drug (like clofazimine) for synchronized combination chemotherapy. 4) High Payload: Direct conjugation achieves a massive drug payload (up to 25% by weight) with excellent long-term structural stability. 5) Targeted Uptake: They are avidly engulfed by macrophages, delivering drugs directly to intracellular bacteria and extracellular granulomas.

Illustration(s)

Technology main components

1. α keto polyester 2. Conjugated API (eg: isoniazid (INH)) 3. Conjugated API (eg: clofazimine (CFZ)) 4. Stabilizer (eg: poly(vinyl alcohol) (PVA)

Information on the raw materials sourcing, availability and anticipated price

Not provided

Safety, Efficacy and Evidence Summary

Safety

Safety studies were not conducted yet.

Efficacy

Preclinical studies: (i) In vitro studies - indicate that Isoniazid (INH) Polymer nanobiotic showed equivalent potency to free INH against intracellular M. tuberculosis (100 μM free INH versus 100 μM INH delivered as nanodrug) for 48 hours. This was demonstrated in both THP-1 cells and primary human macrophages. Intracellular bacterial burden was assessed using relative luminescence units normalised to untreated cells. (ii) In vivo studies - In an M. marinum-infected zebrafish model, treatment with INH nanobiotics +/- clofazimine. The nanobiotics effectively trigger sustained drug release via hydrolysis in acidic environments. Nanoparticles were taken up by >70% of infected macrophages. Both Nano-INH and Nano-INH + CFZ significantly reduced bacterial burden (0.6 and 0.45-0.5).

Evidence Summary

Preclinical studies show that the Nano-INH retained INH activity intracellularly and demonstrated superior in-vivo effects versus equivalent free drug in the M. marinum zebrafish model. Further safety studies of polymer nanobiotics is required.

References and relevant studies

Not provided

APIs compatibility profile

API desired features
Water-soluble molecules

Water-insoluble molecules

Small molecules

Anti-tubercular drugs are targeted for polymer nanobiotics such as Isoniazid and clofazimine

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

10-30 wt%

API co-administration

2 different APIs : Two small molecules (hydrophilic and hydrophobic)

LogP

Min: -0.7 Max: 7.5
Polymer Nanobiotics has the capacity to encapsulate both hydrophilc and hydrophobic drugs

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Excipients & delivery device(s)

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Poly(vinyl alcohol) (PVA)

Residual solvents used

No residual solvent used

Delivery device(s)

No delivery device

Additional features

Other features of the technology
  • Biodegradable
  • Monolithic
Release properties

The nanobiotics exhibit greater and more rapid drug release in acidic environments (pH 5.0 and 6.0) bu the release is significantly slower at physiological pH (7.4), which represents systemic circulation. Invitro studies demonstrates that the drug release has a sustained release upto 30 days

Injectability

Polymer nanobiotics are intended to be adminstered through Intravenous and Intramuscular injections.

Stability

Polymer nanobiotics are stable in solution for at least 9 months at room temperature.

Storage conditions and cold-chain related features

Not provided

Therapeutic area(s)

  • TB
Use case(s)
  • Treatment

Potential associated API(s)

  • Isoniazid
  • Drugs for treatment of tuberculosis

Use of technology

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
Frequency of administration

Unknown

User acceptance
Not provided

Targeted user groups

Age Cohort
  • Adults
  • Older Adults
Genders
  • All
Pregnant individuals

Unspecified

Lactating individuals

Unspecified

Healthy individuals

Unspecified

Comment

Not provided

Isoniazid

Class(es)

Anti-tubercular antibiotics

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Mycobacterium tuberculosis (Mtb) infections

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

Drugs for treatment of tuberculosis

Class(es)

Anti-tubercular Antibiotic

Development stage

Pre-clinical

Clinical trial(s)

Not provided

Foreseen/approved indication(s)

Mycobacterial Infections

Foreseen user group

Not provided

Foreseen duration between application(s)

Not provided

Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

All sponsors

No sponsor indicated

Additional information