# Humanization, Production, and PK/PD Characterization of anti-TIP1 antibody against Non-Small Cell Lung Cancer

> **NIH NIH R44** · MEDICAL GUIDANCE SYSTEMS, LLC · 2020 · $978,235

## Abstract

The proposed developmental activity will result in a humanized monoclonal antibody, Tiptuhumab,
which acts as a radiomodulator/immunotherapeutic. This antibody targets the cancer
neoantigen, Tax Interacting Protein-1 (TIP-1), and is cytotoxic to non-small-cell lung cancer cells,
NSCLC. For patients with NSCLC, the 5-year overall survival rate is 14.9% with a median survival
time of 4 months. The challenge in treatment outcomes is partly due to tumor genetic
heterogeneity, patient heterogeneity, tumor-induced immunosuppression, and limited drug
bioavailability to cancer cells. The impact of current cytotoxic chemotherapies on NSCLC is limited
by resistance to therapy and disease recurrence. In addition to the limited survival rates, some of
the major problems with the current treatment modalities of NSCLC include their lack of specificity
and the attendant cytotoxicity to normal cells.
 The proposed research is the development of our lead antibody, towards IND enabling
studies. We identified TIP-1 through the use of bacteriophage displayed peptide libraries and
subsequent affinity purification of surface proteins from lung cancer. TIP-1 is a scaffold protein
that binds to cellular proteins that regulate cancer cell viability and invasiveness. TIP-1 expression
is elevated in cancer cells including NSCLC and localizes to the cell surface. TIP-1
overexpression correlates with the poor outcomes in terms of both overall survival and
progression-free survival. Our anti-TIP-1 antibody binds to and sensitizes NSCLC cells to
radiation. Anti-TIP-1 mAbs are internalized and trigger apoptosis. In addition, we have
demonstrated the specificity of this antibody to implanted NSCLC cells in animal tumor models.
We will humanize our lead mouse monoclonal antibody and measure the efficacy of Tiptuhumab
as an effective immunotherapeutic agent in preclinical / PDX / humanized model systems of
NSCLC. Furthermore, we will study the pharmacokinetics and pharmacodynamics using
established methods in rats and monkey, and determine the human dosage for planned first in
human clinical trials. The goal of this research is to develop and demonstrate the efficacy of
Tiptuhumab and prepare for a pre-IND meeting with FDA.

## Key facts

- **NIH application ID:** 10020906
- **Project number:** 5R44CA210687-03
- **Recipient organization:** MEDICAL GUIDANCE SYSTEMS, LLC
- **Principal Investigator:** Sapna Deore
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $978,235
- **Award type:** 5
- **Project period:** 2016-09-19 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020906

## Citation

> US National Institutes of Health, RePORTER application 10020906, Humanization, Production, and PK/PD Characterization of anti-TIP1 antibody against Non-Small Cell Lung Cancer (5R44CA210687-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10020906. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*