Gene Therapy

Gene Therapy

HighField’s approach adds a new level of safety to gene therapy allowing it to be applied to common chronic conditions

Our lead development programs include products for treating chronic diseases such as diabetes, obesity, and autoimmune diseases

Gene-based therapeutics are considered the next generation of therapeutics in which lipids are an integral part. Our approach focuses on LNP/RNA structures that are stable and provide for long-term therapeutic effect.

We also optimize our lipid compositions, nanoparticle size, and structural features based on the mechanism of the gene products. Specific cell types may need to be targeted and specific gene products may need to stay inside the cell, to be secreted or  incorporated into the cell membrane to be effective.

Our lead development programs include products for treating chronic diseases such as diabetes, obesity, and autoimmune diseases.

HighField's Chronic Disease Pipeline

Product
Indication

API

Preclinical Development

Clinical Studies

PD

PK/PD

CMC

TOX

IND

Ph 1a

Ph 1b/2

HFG1
Diabecity

mRNA encoding GLP-1RA

HFG2
Autoimmune

Antibody RNA complex
(lipoARC)

HFG3
CNS

siRNA

Gene therapy for very long term expression of GLP-1R agonist 

HFG1 is an LNP-mRNA complex that provides expression of a GLP-1R agonist for weight loss and treating diabetes. HFG1 is presently in IND enabling studies for a U.S. IND filing scheduled for 3Q2024.

The components of HFG1’s LNP complex were selected to provide prolonged expression of the GLP-1R agonist without observable immune response. HFG1 requires fewer injections than existing GLP-1 products while providing steady-state agonist activity.

Diabetic monkeys treated with HFG1 show weight loss and significant A1C reduction over an extended period. After an initial activity peak at dosing, a steady state of GLP-1R activity and A1C control were observed for at least 60 days. This translates into therapeutic activity of about 4-5 months in humans for a single injection.  No behavior changes or toxicities were observed other than an initial loss of appetite at the time of injection.