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

Project description

Attenuated bacteria for the treatment of lung cancer

Harnessing the power of the immune system to fight cancer is a very attractive strategy and many approaches have been developed in this endeavour. Funded by the European Innovation Council, the PB_LC project capitalises on the development of attenuated lung bacteria as a means of stimulating T cell infiltration in the tumour. These bacteria are engineered to secrete cytokines locally in the tumour for further immune stimulation. The PB_LC project will establish manufacturing and formulation processes alongside an inhalation delivery approach for the product. Researchers will evaluate the safety, pharmacokinetics and efficacy of this live biotherapeutic towards clinical use in patients with non-small cell lung carcinomas.

Objective

Non-small-cNon-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. 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. 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), used to stimulate the immune system to promote T cell infiltration in the tumor. 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. 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 analyse its replication and biodistribution in vivo, critical regulatory requirements. The specific objectives of this EIC Transition proposal are to establish processes for manufacturing, formulation, and inhalation delivery of the product that meet GMP standards; to do preclinical regulatory activities (including efficacy, safety, and pharmacokinetics/ pharmacodynamics), as well as to advance the market and business preparation for the commercial exploitation of the first product of the company, PB_LC. 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.

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HORIZON-EIC - HORIZON EIC Grants

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Call for proposal

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(opens in new window) HORIZON-EIC-2022-TRANSITION-01

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Coordinator

PULMOBIOTICS SL
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 881 875,00
Address
PASEO DE GRACIA, 54, 02 D
08007 Barcelona
Spain

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 881 875,00
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