Exeliom Biosciences announces three Phase II immuno-oncology clinical trials

Published: 11-Apr-2024

Phase II clinical trials will investigate efficacy of lead candidate EXL01 – in gastric cancer with GERCOR, in NSCLC with CHU Lille and in hepatocellular carcinoma with Centre Eugène Marquis of Rennes


Exeliom Biosciences, a clinical-stage biotechnology company developing new therapies in immuno-oncology and immuno-inflammation, today announces the launch of three phase II clinical studies of its lead candidate EXL01 combined with immune checkpoint inhibitors to target multiple cancers. 

EXL01 will act as an adjuvant by modulating the immune system, with synergistic effects when combined with immune checkpoint inhibitors. This is the first single-strain Live Biotherapeutic Product (LBP) using Faecalibacterium prausnitzii [F. prausnitzii] to be evaluated in a clinical setting for application in immuno-oncology.

“I am thrilled to enter the immuno-oncology arena with the launch of these clinical trials, spearheaded by talented teams across France. This is a huge milestone for us, establishing the company as a leader in the development of live biotherapeutic products in this field,” said Benjamin Hadida, CEO of Exeliom.  

EXL01 is a novel drug candidate containing an unmodified single-strain of F. prausnitzii, being developed as a new immune modulating medicine. Research shows that this species plays a critical role in the body's ability to repspond to immune-checkpoint inhibitors in the treatment of cancer and that increasing levels of F. prausnitzii in patients could potentially lead to longer progression-free survival periods. 

The three phase II clinical trials, approved by the French regulatory agency ANSM (Agence Nationale de Sécurité du Médicament), will investigate the use of EXL01 in:

  • Gastric cancer – led by GERCOR, a non-profit organization with a network of over 300 centers, whose mission is to improve treatments for solid tumor cancer patients  
  • Non-Small Cell Lung Cancer (NSCLC) – led by the Lille University Hospital (CHU de Lille), one of the top five university hospitals in France for the quality of its research
  • Hepatocellular carcinoma – led by the Centre Eugène Marquis of Rennes, a university hospital associated with the university of Rennes and a member of OncoBretagne, the regional oncology network 

In these three indications, respectively only 35%, 20% and 30% of the patients respond to the standard of care even in first line treatment. Increasing the efficacy of these treatments would cater to a large group of patients with severe unmet medical needs. 

The EXL01-drug substance is formulated in gastro-resistant capsules for oral administration, designed to enable targeted delivery in the intestines. Exeliom worked extensively on the scale-up manufacturing, facilitating the supply of these phase II trials. The company expects to share results of the trials at the end of 2026, if positive there will be the potential to launch phase III studies. 

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