Clinical readiness of a live biotherapeutic for treatment of Non-Small Cell Lung Cancer (NSCLC)

Introduction

Non-small-cell carcinomas (NSCLC) represent 80-85% of the worldwide lung cancer cases, which are the leading cause of cancer-related death. Several clinical trials have indicated better survival rates in NSCLC patients treated with immune checkpoint inhibitor (ICI) antibodies targeting PD-1/PD-L1 or CTLA4.

Need for New Solutions

However, since many patients display innate or acquired resistance to these therapies, there is a pressing need to discover methods to help them overcome the resistance.

Pulmobiotics Overview

Founders of Pulmobiotics, a spin-off created as a result of an ERC PoC project, have shown their ability to engineer and produce a non-pathogenic strain of the mild human lung pathogen Mycoplasma pneumoniae (the MycoChassis). This strain is used to stimulate the immune system to promote T cell infiltration in the tumor.

MycoChassis Development

The developed MycoChassis also secretes different immunomodulators (IL2, IL12, and Flt3L) in a sustained and local manner directly to the lung tumor, overcoming their high systemic doses of toxicity in patients.

Optimization and Regulatory Compliance

Pulmobiotics has further optimized the MycoChassis to meet safety requirements, engineered a development candidate product (PB_LC) for lung cancer treatment, and developed analytical methods to analyze its replication and biodistribution in vivo, which are critical regulatory requirements.

Project Objectives

The specific objectives of this EIC Transition proposal are to:

1. Establish processes for manufacturing, formulation, and inhalation delivery of the product that meet GMP standards.
2. Conduct preclinical regulatory activities (including efficacy, safety, and pharmacokinetics/pharmacodynamics).
3. Advance the market and business preparation for the commercial exploitation of the first product of the company, PB_LC.

Expected Outcomes

Achieving the project objectives will pave the way to take PB_LC into first-in-human clinical trials and license the product to reach the market. The use of PB_LC will positively impact the quality of life of NSCLC patients by increasing the efficiency of currently used immunotherapies.