# Development of a tumor-retentive immunostimulant as adjunct therapy for solid tumor cancers

> **NIH NIH R41** · KINIMMUNE, INC. · 2022 · $395,595

## Abstract

PROJECT SUMMARY/ABSTRACT
Cancer immunotherapy activates the host immune system to seek and destroy cancer cells. Checkpoint
inhibitors block immunosuppressive signals, thereby ‘releasing the brakes’ of the immune system. Solid tumors,
however, typically do not respond well to checkpoint inhibitors. They are only effective in the 20-30% patients
with an already immunologically ‘hot’ tumor. Thus, novel immunostimulant therapies aim to recruit immune cells
to tumor tissue, turning cold tumors hot and working synergistically with checkpoint inhibitors.
Immunostimulants that induce local immune-cell infiltration may induce an Abscopal effect and may increase
responsiveness in patients that are resistant to checkpoint inhibitors. Unfortunately, immunostimulants often
induce systemic immune-related adverse events (e.g., cytokine release syndrome), even when administered
locally to tumor tissue. Most immunostimulants exhibit molecular properties promoting diffusion and systemic
absorption (e.g., small molecular size, negative charge, high water solubility), This presents a major limitation
as it leads to limited immune activation in the target tumor tissue after administration and immune-related
adverse events. In this project, we will advance KIN-001 – a tumor-retentive formulation of the immunostimulant
CpG designed to persist in tumor tissue thereby mitigating systemic immune-related adverse events and
potentiating immune activity in the tumor microenvironment and draining lymph nodes. KIN-001 is a small
volume nanosuspension for intratumoral injection comprised of commercially available glatiramer acetate (GA)
(Copaxone®, approved for multiple sclerosis) complexed with CpG (immunostimulant). Through preliminary
studies of KIN-001, our group has demonstrated its efficacy in recruiting immune cells to the tumor without
inducing significant systemic cytokines, and we have identified the optimal mass ratio of GA to CpG. This Phase
I STTR study has three Specific Aims: In Specific Aim 1, we will complete an in-use stability study of different
formulations of KIN-001 to demonstrate that KIN-001 is a stable composition and quality is maintained between
preparation and injection into the tumor under anticipated conditions of use. Specific Aim 2 will focus on
identifying the maximum tolerated dose of KIN-001 compared to CpG in a predominant immunotherapy mouse
model. In Specific Aim 3, we will establish proof of mechanism by elucidating KIN-001’s tumor retention and
synergy potential when combined with anti-PD1, a checkpoint inhibitor. The long-term goal of this project is to
commercialize KIN-001 as the first and only tumor-retentive immunostimulant with low toxicity for cancer
patients that have palpable (i.e., injectable) solid tumors and are refractory to checkpoint inhibitors. KIN-001
will improve efficacy of standard treatment (e.g., checkpoint inhibitors) with minimal side effects, leading to
improved outcomes and survival.

## Key facts

- **NIH application ID:** 10602219
- **Project number:** 1R41CA272024-01A1
- **Recipient organization:** KINIMMUNE, INC.
- **Principal Investigator:** Marcus Laird Forrest
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $395,595
- **Award type:** 1
- **Project period:** 2022-09-07 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10602219

## Citation

> US National Institutes of Health, RePORTER application 10602219, Development of a tumor-retentive immunostimulant as adjunct therapy for solid tumor cancers (1R41CA272024-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10602219. Licensed CC0.

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