OSE stock tumbles on trial pause
- OSE Immunotherapies has called a temporary halt on the Phase 3 advanced non-small cell lung cancer (NSCLC) study with its lead immunooncology product Tedopi, a combination of 10 optimized neoepitopes designed to induce T cell activation. This has left the share price spiraling down over 26%.
- The study, Atalante 1, is underway in the U.S. and EU, and recruitment was paused after recommendations from a team of independent experts "due to an emerging benefit/risk balance of the experimental treatment".
- Treatment is continuing for those patients already enrolled. OSE will now have to make a decision about trial continuation or amendment once more data is available.
The recommendation from the independent data monitoring committee to pause the study follows a previous recommendation in January 2017 to continue the trial without amendment, suggesting the issue cropped up in the last six months.
The company's statement isn't explicit about why the study is being paused. It appears, however, that the therapy simply isn't working fast enough for the patient population in Atalante 1, who have advanced disease and have failed a first-line treatment with chemotherapy or second-line therapy with checkpoint inhibitors, and enter the trial when their disease progresses.
"This cancer progression may be difficult to control for some patients in the near-term due to the generally longer-term activity observed with a combination of neoepitopes, which differs from chemotherapy’s generally near-term activity," said Dominique Costantini, CEO of OSE.
The next step is for OSE to "assess the study’s current patient profile in relation to the potential benefit of Tedopi with more mature data." Submission for approval had been expected in 2019, but it now remains to be seen whether that timeline is still going to be feasible. Plans were also in progress for the combination of Tedopi and a checkpoint inhibitor in NSCLC; it's not yet clear whether this is going ahead.
Work on other drugs in the pipeline is ongoing, although extremely early. This includes OSE-172 and OSE-703, in preclinical development in cancer; FR-104, which has been licensed to Janssen Biotech and is in Phase 1 for autoimmune disease and transplantation; and OSE-127, in preclinical development for inflammatory bowel disease under a license option agreement with Servier.
Amgen and Advaxis are also working in the neoepitopes area for immunooncology-based treatment of cancer. The two companies are collaborating on ADXS-NEO, part of Advaxis' MINE (My Immunotherapy Neo-Epitopes) program, which creates a personalized therapeutic based on a cocktail of neoantigens.
- OSE Immunotherapies Statement
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