# Preclinical toxicology and pharmacology evaluation of a newTNFR2 antagonistic monoclonal antibody for CTCL therapy

> **NIH NIH R44** · BOSTON IMMUNE TECHNOLOGIES AND THERAPEUTICS, INC. · 2024 · $776,973

## Abstract

PROJECT SUMMARY 
Cancer has killed over 600,000 people in US in 2020. The cost for healthcare and society is unbearable: because 
of cancer, $180B healthcare expenditure and $134B lost productivity are recorded every year. This is happening 
despite recent advancements in therapy and the emergence of an ever expanding array of new therapeutics for 
the over 1.8M new cancer patients every year. Indeed, because of the multitude and redundancy of mechanisms 
contributing to cancer growth, therapies are often ineffective. Several components should be targeted at the 
same time in order to maximize therapy outcome. However, this is particular hard to attain because of 1) the 
striking variability among cancers and the limited number of cancer specific targets 2) the ability of cancer cells 
to orchestrate a microenvironment of healthy tissue and cells around them, that promote cancer growth and 
therapy resistance. Boston Immune Technologies and Therapeutics (BITT) is developing BITT-1492, able to 
target both cancer cells and their microenvironment. BITT-1492 is an antagonist antibody against TNFR2 – a 
receptor highly expressed in cancer tissue and immune suppressive cells in the microenvironment, where it 
mediates pro-survival signaling. Thanks to BITT’s proprietary antibody design platform, BITT-1492 is the first 
and only antibody able to dominantly shut down TNFR2 signaling. Due to selective expression and key role of 
TNFR2 for a variety of cancers and tumor microenvironment cells, BITT-1492 will find application in the therapy 
of several cancers, starting with Cutaneous T cell Lymphoma (CTCL), where TNFR2 is known to act as an 
extremely potent oncogene. BITT has already completed extensive pre-clinical validation for BITT-1492, 
demonstrating potent activity in CTCL, colon and ovarian cancers. In the proposed Fast-Track project, BITT will 
complete a pre-clinical toxicology and pharmacology assessment of BITT-1492 to obtain relevant data for an 
Investigational New Drug (IND) application. This will be accomplished by performing, in line with ICH guidelines, 
an exploratory small-scale toxicology study to be carried out in Phase I, that will demonstrate the safety of use 
of BITT-1492 for a wider IND-enabling toxicology and pharmacokinetic studies in Phase II. As part of the PhaseII 
BITT will also test the suitability of BITT-1492 production process for cGMP standard compliance. At the end of 
the SBIR project, BITT will be ready to advance BITT-1492 to clinical testing for which a combination of Venture 
Capital seed funds and SBIR PhaseIIb are expected to be leveraged. The successful completion of this project 
and initial clinical testing evidence will help to secure the already expressed interest of pharmaceutical 
companies with whom BITT will engage to complete late-stage clinical testing and launch BITT-1492 into 
international markets.

## Key facts

- **NIH application ID:** 10832702
- **Project number:** 5R44CA265510-03
- **Recipient organization:** BOSTON IMMUNE TECHNOLOGIES AND THERAPEUTICS, INC.
- **Principal Investigator:** Kenneth Olivier
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $776,973
- **Award type:** 5
- **Project period:** 2021-09-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10832702

## Citation

> US National Institutes of Health, RePORTER application 10832702, Preclinical toxicology and pharmacology evaluation of a newTNFR2 antagonistic monoclonal antibody for CTCL therapy (5R44CA265510-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10832702. Licensed CC0.

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