# A polymeric biomaterial-based vaccine utilizing immunomodulatory agents and antigen for the amelioration of type 1 diabetes.

> **NIH NIH R44** · INSPIRA THERAPEUTICS, INC. · 2021 · $993,629

## Abstract

Immune-mediated diseases such as type 1 diabetes (T1D), multiple sclerosis, rheumatoid arthritis, and
systemic lupus erythematosis are reaching epidemic proportions in the US. T1D affects an estimated 1.25
million Americans, with more than 30,000 new patients diagnosed annually, resulting in an estimated $15
billion in health care costs in the US by 2024. T1D is an autoimmune disease characterized by effector T-cell
mediated destruction of insulin-producing β-cells, which renders the patient unable to produce insulin and
forces the patient to constantly monitor their glucose levels and manually administer insulin for the remainder
of their life. Ultimately, glucose metabolism is interrupted, resulting in the development of life-threatening
complications such as heart disease and renal failure. Clearly, the cost associated with treatment and care of
T1D in the US is significant, both to society and the individual, and a novel therapy is desperately needed to
thwart this aberrant autoimmune activity. This is a need that OneVax is committed to fulfilling.
 The biomedical research community has sought better ways to induce specific immune tolerance for
nearly 50 years. Clinical intervention trials using immunomodulatory agents (e.g., anti-CD3) have failed to
meet clinical endpoints, despite positive results in phase I/II trials. Moreover, traditional vaccine strategies
providing auto-antigen or peptides alone failed to adequately block ongoing beta cell immunity. Thus, a new
treatment strategy that is both potent and durable is required to effectively halt the ongoing attack in T1D.
Therapeutic vaccination approaches for T1D utilizing dendritic cells (DCs) hold promise to correct antigen-
specific autoimmune responses, but current strategies involving exogenous manipulation of DCs are unstable,
inefficient and expensive. OneVax has developed a novel in vivo tolerogenic vaccine using GMP-compatible
components (designated OV-01) to administer immuno-modulatory factors to phagocytic DCs, the most
efficient antigen presenting cell type of the body and key regulator of the immune system. OV-01 is minimally
invasive, requires no costly cell isolation and storage, and, due to its stable composition, has an extended shelf-
life, simplifying manufacturing and shipping. Preliminary data strongly suggests that this biomaterial-based,
microparticle vaccine system holds great promise for correcting autoimmune responses in T1D. The
overwhelmingly positive and extensive data collected thus far merits the submission of this Direct-to-Phase II
SBIR proposal wherein OneVax will establish scalability and stability parameters for OV-01, determine the
minimum effective dose in preventing diabetic onset, determine its capacity for reversing established diabetes,
and satisfy the FDA mandated pre-clinical safety assessment. Most importantly, strategic collaborations
between OneVax and the Sid Martin Biotechnology Incubator, the Biomedical Engineering Department, the
College...

## Key facts

- **NIH application ID:** 10169435
- **Project number:** 6R44DK125156-02
- **Recipient organization:** INSPIRA THERAPEUTICS, INC.
- **Principal Investigator:** Benjamin Michael Looney
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $993,629
- **Award type:** 6
- **Project period:** 2020-06-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10169435

## Citation

> US National Institutes of Health, RePORTER application 10169435, A polymeric biomaterial-based vaccine utilizing immunomodulatory agents and antigen for the amelioration of type 1 diabetes. (6R44DK125156-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10169435. Licensed CC0.

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