# A novel non-toxic preconditioning regimen for cancer cell therapy

> **NIH NIH R43** · AVM BIOTECHNOLOGY, LLC · 2020 · $224,770

## Abstract

PROJECT SUMMARY
Cellular immunotherapy has the potential to become the definitive solution for cancer. However, toxic
chemotherapy is currently required as preconditioning treatment to impair graft rejection and maintain therapeutic
cells in the bloodstream where they can target cancer cells. Chemotherapy is hardly tolerated by frail cancer
patients, and it fuels the side effects of immunotherapy such as toxic cytokine releases (CRS) and neuroedemas.
AVM Biotechnology (AVM) is working towards a novel safe pre-conditioning regimen, named AVM0703, which
could be easily administered to increase efficient delivery of adoptive cellular immunotherapy. AVM0703 induces
safe lymphodepletion in only 24 hours, sparing platelets, stem cells and red blood cells. Interestingly, AVM0703
can safely deplete monocytes, known to be a key inducer of CRS. CRS toxicities occur as frequently as 90%
with half of them determined as severe. Severe CRS complications can be life threatening if not treated in a
timely manner. Levels of IL-6 are elevated during CRS and animal studies have demonstrated that monocytes
are the primary source of IL-6. Depletion of IL-6 producing monocytes protected mice from CRS-induced lethality.
Unlike chemotherapy, AVM0703 can safely deplete monocytes reducing the risk of CRS and making cellular
immunotherapy accessible to high-risk individuals like older/frail patients. AVM0703 mode of action could offer
an exemplary preconditioning regimen.
To establish feasibility for this product, we propose the following two specific aims. Aim 1. Evaluate the efficacy
of AVM0703 as preconditioning for T-cell transfusion in an immunocompetent Multiple Myeloma (MM) mouse
model. The level of lymphodepletion, improvement in T cell circulation, and the level of cytotoxicity induced by
AVM0703 will be monitored and compared to standard chemotherapy. Finally, the ability to guarantee the
therapeutic effect of allogeneic T-cells will be validated. Aim2. Demonstrate improved safety of AVM0703 and
its ability to decrease risks of CRS associated with the injection of immunotherapeutic cells. The successful
outcome of this project will provide the solid clinical foundation for the use of AVM0703 as preconditioning drug
with current and future adoptive cellular therapies, to remove the need for chemotherapy. During an SBIR
Phase II project, AVM will collaborate with Cancer Centers of Excellence for the generation of novel cancer cell
therapies based on the use of AVM0703 to demonstrate their potential improved clinical outcomes. Ultimately,
the tolerable regimen offered by AVM0703 might disrupt the future “cancer concept” becoming a simple chronic
disease treated with repeated administrations of non-toxic therapies.

## Key facts

- **NIH application ID:** 10011600
- **Project number:** 1R43CA246896-01A1
- **Recipient organization:** AVM BIOTECHNOLOGY, LLC
- **Principal Investigator:** Theresa Deisher
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $224,770
- **Award type:** 1
- **Project period:** 2020-07-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10011600

## Citation

> US National Institutes of Health, RePORTER application 10011600, A novel non-toxic preconditioning regimen for cancer cell therapy (1R43CA246896-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10011600. Licensed CC0.

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