# IND-enabling toxicology studies to reach IND approval for a proprietary biologic to treat oral mucositis in cancer patients

> **NIH NIH SB1** · ALLANDER BIOTECHNOLOGIES, INC. · 2023 · $1,239,748

## Abstract

Summary
Oral mucositis, a severe oral ulceration, is a common toxic effect of radio- or chemoradio-therapy (RT or CRT)
and a limiting factor to using the optimal dose of radiation for effective cancer treatment. Intensity modulated RT
(IMRT) and stereotactic Body RT (SBRT) spare more normal tissues and lessen chronic side effects, but not
oral mucosa in head and neck cancer patients. To date, Palifermin, a protein derived from keratinocyte growth
factor, is the only targeted therapy approved by the Food and Drug Administration (FDA) for preventing oral
mucositis in patients with hematopoietic malignancy followed by bone marrow transplant (4% of the at-risk
population), but it has no effect on existing mucositis. Allander Biotechnologies has developed a proprietary
biologic that shows prophylactic and therapeutic effects on radiation-induced oral mucositis in mice and dogs
upon topical application to oral mucosa. Our biologic possesses multiple functions needed for oral mucositis
healing. Under the previous SBIR Phase II funding supporting Allander’s drug development, we have 1) identified
the lead drug and formulated it as oral gel; established the manufacture platform and quality control (QC) panels
ready to be implemented for quality assurance (QA) for certified Good Manufacture Practice (cGMP); 2)
established efficacy dose range in dogs that be scaled to the treatment dose in human oral mucositis patients;
3) defined pharmacodynamics (PD) based on mechanisms of actions; 4) de-risked toxicity and oncogenic
potential; 5) developed pharmacokinetics (PK) PK/Toxicokinetic (TK) and immunogenic assays needed for
toxicology studies and clinical trial. Under this Commercialization Readiness Program (CRP) application, we will:
a) manufacture our drug under Good Engineering Practice (GEP) conditions to supply the Good Lab Practice
(GLP) toxicology studies; b) perform in-use dose formulation tests of our drug in toxicology studies and finalize
dose-formulation analyses to be used in clinical trial; c) perform systemic GLP toxicology studies in small and
large animal species with the safety data to support future maximum clinical dose. The milestones under this
funding are to apply for Investigational New Drug (IND) of our drug and receive approval from the FDA to initiate
our Phase I clinical trial. Our ultimate goal is to complete the first-in-human Phase I trial and initiate Phase II/III
trials afterwards and file a New Drug Application (NDA) after completing clinical trials.

## Key facts

- **NIH application ID:** 10694727
- **Project number:** 2SB1DE024659-04A1
- **Recipient organization:** ALLANDER BIOTECHNOLOGIES, INC.
- **Principal Investigator:** Xiao-Jing Wang
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,239,748
- **Award type:** 2
- **Project period:** 2023-09-21 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10694727

## Citation

> US National Institutes of Health, RePORTER application 10694727, IND-enabling toxicology studies to reach IND approval for a proprietary biologic to treat oral mucositis in cancer patients (2SB1DE024659-04A1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10694727. Licensed CC0.

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