# Novel biologic to treat chemotherapy-induced neuropathic pain

> **NIH NIH R44** · RAFT PHARMACEUTICALS, LLC · 2022 · $999,967

## Abstract

PROJECT SUMMARY
Chemotherapy-induced peripheral neuropathy (CIPN) has a profound negative impact on quality of life of nearly
70% of cancer patients receiving chemotherapy. While systemic administration of opiates, NSAIDs, and
anticonvulsants can relieve pain for short intervals, they are not suitable for chronic therapy. Aside from efficacy,
many of the potent agents are beset with limiting side effects and issues related to dependence and addiction.
RAFT Pharmaceuticals (RAFT) proposes a Direct-to-Phase 2 SBIR proposal presenting a novel approach to
reversal of preexisting neuropathic pain via regulation of lipid rafts in spinal and dorsal root ganglia (DRG) cells.
Our lead candidate, RFT1081, which is a modified apoA-I binding protein (AIBP), promotes removal of
cholesterol selectively from the plasma membrane of activated and inflammatory cells. This targeting is due to
AIBP binding to Toll-like receptor 4 (TLR4), which is highly expressed on the surface of inflammatory microglia,
macrophages and activated DRG nociceptors. RFT1081-mediated disruption of lipid rafts harboring activated
TLR4 abrogates the facilitatory cycle of neuroinflammation and nociceptors’ spontaneous activity and alleviates
chronic pain phenotypes. In a prior project, we developed a non-GMP scaled-up upstream and downstream
manufacturing process for RFT1081 and conducted its detailed characterization; conducted pharmacokinetics
studies of spinally delivered RFT1081 in mice and designed pharmacodynamics assays to evaluate RFT1081
target engagement; established dose-dependent efficacy profile for AIBP treatment in CIPN mice; and conducted
a non-GLP dose-range tolerability study of RFT1081 in rats. These data provide support and justify further
development of RFT1081 in the proposed Direct-to-Phase 2 SBIR studies. In this milestones-driven project, we
plan to manufacture a RFT1081 drug product lot for toxicology studies using a cGMP-compatible process and
analytical assays. The RFT1081 drug product lot, conforming to RAFT’s specifications and in optimized
formulation will be thoroughly characterized for storage and in-use stability. The initial single-dose toxicology
studies will be performed in rats. We will then also evaluate the pharmacology, local and systemic toxicity, and
immune response to repeated i.t. administration of RAFT1081 in rats, dogs and non-human primates to further
study the safety of the drug and to select a pharmacologically relevant non-rodent species for further IND-
enabling preclinical evaluation. RFT1081 will also be evaluated in a model of cisplatin cancer therapy to ensure
it does not interfere with chemotherapy action. The project will conclude with developing a detailed synopsis of
an integrated first-in-human study and an overall indication-supporting clinical strategy, followed by preparation
for and conducting a pre-IND meeting with the FDA. We expect that this Phase 2 SBIR project outcomes will
include: 1) successful scale-up of RFT1081 suit...

## Key facts

- **NIH application ID:** 10546418
- **Project number:** 1R44CA271904-01A1
- **Recipient organization:** RAFT PHARMACEUTICALS, LLC
- **Principal Investigator:** Yakov Kogan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $999,967
- **Award type:** 1
- **Project period:** 2022-09-19 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10546418

## Citation

> US National Institutes of Health, RePORTER application 10546418, Novel biologic to treat chemotherapy-induced neuropathic pain (1R44CA271904-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10546418. Licensed CC0.

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