Paris-based Exeliom Biosciences will focus Phase III efforts of its immune modulating drug EXL01 in gastric cancer if it succeeds at Phase II.
The company will be running three trials with EXL01, but the companies will be looking to focus on the gastric cancer space, Benjamin Hadida, CEO of Exeliom, told the Clinical Trials Arena.
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If successful at Phase II, Haida said that the Phase III trial will likely be in gastric cancer due to the high unmet medical need. Following the trial, the company will continue the development of the candidate in other oncological indications.
The Phase II gastric cancer trial, the BIG study, will be led by GERCOR and will enroll 120 patients who have had no prior treatment and have PD-L1 advanced gastric cancer.
Patients enrolled will be randomised on a 2:1 ratio. Patients in the treatment arm will receive FOLFOX chemotherapy, which is a combination of fluorouracil, leucovorin and oxaliplatin, Opdivo (nivolumab) and EXL01. Patients in the control arm will receive FOLFOX chemotherapy and Opdivo.
The primary endpoint is the overall response rate (ORR) at four months based on the Response Evaluation Criteria in Solid Tumor [RECIST] criteria.
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By GlobalDataSecondary endpoints will asses safety, progression-free survival (PFS), overall survival (OS) and duration of response.
Hadida said: “This study will be in first-line treatment. The unmet need is very important in gastric cancer, there’s almost no option in second-line. Currently, just 35%, of patients respond to the standard of care even in first-line treatment.”
EXL01 is a novel, oral drug candidate containing an unmodified single-strain of F. prausnitzii. Research shows that this species can assist the body’s response to immune checkpoint inhibitors and could lead to longer progression-free survival periods.
The other Phase II trials will be in non-small cell Lung cancer (NSCLC), led by the Lille University Hospital, and hepatocellular carcinoma, led by the Centre Eugène Marquis of Rennes.
The company expects to share the results from all three trials at the end of 2026.
Gastric cancer landscape
Current gastric cancer treatment options include surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy.
According to a GlobalData report, gastric cancer and gastroesophageal junction adenocarcinoma market across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and South Korea) was valued at $1.12 billion in 2019 and is forecast to grow at a high compound annual growth Rate (CAGR) of 15.5% to reach $4.72 billion by 2029.
GlobalData is the parent company of the Clinical Trials Arena.
