# The First LANCL2-based therapeutic for influenza

> **NIH NIH R43** · BIOTHERAPEUTICS, INC. · 2021 · $300,000

## Abstract

The First LANCL2-based therapeutic for influenza
Biotherapeutics, Inc (BTI) is a clinical-stage biotech company that synergistically combines the power of
advanced computational modeling with translational experimentation to accelerate the development of novel
products for precision medicine and health. This Phase 1 SBIR application emerges from substantial preclinical
data showing the potential of lanthionine synthetase C-like 2 (LANCL2) agonists as host-based therapeutics for
viral diseases.
Our Product: BT-63, a novel lead LANCL2 agonist ligand, selectively binds to LANCL2 and exerts promising
therapeutic efficacy in mouse models of influenza A virus (IAV). In this Phase I we will focus on influenza virus
to characterize the role of LANCL2 as therapeutic target with broad antiviral effects.
Background: infectious diseases caused by emerging and re-emerging viruses are a significant public health
challenge. Influenza remains a significant public health threat despite available antivirals and vaccines. The
absence of effective universal vaccines and antivirals coupled with the rising rates of antiviral resistance justifies
the need to develop novel host-based antivirals. BTI identified LANCL2 as a novel target during viral infections.
LANCL2 agonistic drugs down-regulate viral entry and replication while protecting against the virus-induced
cytokine storm, mortality, pathology and disease.
The Specific Aims of this SBIR Phase 1 application are to:
AIM 1. Validate LANCL2 as a new host target for treating influenza infections: we will to optimize dosing
and therapeutic window and validate LANCL2 as the molecular target of BT-63.
AIM 2: Evaluate the antiviral mechanisms and spectrum of BT-63: we will test the hypothesis that BT-63
exerts broad spectrum antiviral effect by modulating metabolic responses of the host cell.
Mayor expected outcomes: BT-63 offers at least a 50% protection against mortality, suppresses by 10-fold the
expression of proinflammatory markers IL-6 and TNFα, the mechanism is LANCL2-dependent, and BT-63 has
broad antiviral spectrum against pH-dependent viruses.
.
SBIR Phase II will assess the potential for synergism with and comparison against current antivirals and
vaccines, expand LANCL2 efficacy and antiviral knowledge into other viruses and advance lead derivatives along
the FDA regulatory pathway through ADME-Tox and safety assessments with a key milestone of submitting an
IND application within 1 year of funding.
Commercial Application: Technology generated by this R&D project could disrupt a $50B annual market.

## Key facts

- **NIH application ID:** 10325782
- **Project number:** 1R43AI165190-01
- **Recipient organization:** BIOTHERAPEUTICS, INC.
- **Principal Investigator:** Raquel Hontecillas
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2021-06-11 → 2022-12-10

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325782

## Citation

> US National Institutes of Health, RePORTER application 10325782, The First LANCL2-based therapeutic for influenza (1R43AI165190-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10325782. Licensed CC0.

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