Osel Sees Immunotherapy-Like Trajectory For Oncology Microbiome Candidate
Depending on financing, the company could start a Phase III trial of CBM588 as early as this year, but it’s looking to develop the microbiome therapeutic for a potentially broad array of cancers.
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After years of halting progress in its microbiome-based pipeline, 4D Pharma has produced promising early data from its cancer immunotherapy combination.
The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.
The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.