Servier leverages Mission Bio's Tapestri® Platform to uncover AML resistance mechanisms in pivotal TIBSOVO® (ivosidenib) clinical trial

• Servier to present data at 12^th Annual World Clinical Biomarkers & CDx Summit demonstrating the utility of single-cell DNA sequencing with Tapestri^® in clinical development.
• Earlier collaboration that investigated mechanisms of TIBSOVO resistance supported clinical findings of the pivotal TIBSOVO-azacitidine combination trial in IDH1-mutant AML, and the combination was approved by FDA in May 2022.
• Partnership will continue to generate clinically relevant insights from ongoing phase 3 study and potentially inform future clinical trials in AML and other blood cancers.

SOUTH SAN FRANCISCO, Calif., Sept. 15, 2022 /PRNewswire/ -- Mission Bio, Inc., the pioneer in high-throughput single-cell DNA analysis, today announced new data supporting the use of its Tapestri^® Platform in clinical development, including clonal evolution patterns in patients with IDH1-mutated acute myeloid leukemia (AML) treated with Servier Pharmaceuticals' TIBSOVO (ivosidenib tablets) plus azacitidine. Data previously generated via single-cell DNA sequencing with Tapestri^® supported analyses for Servier's ongoing pivotal phase 3 AGILE trial, the basis for U.S. Food and Drug Administration approval of the combination in newly diagnosed patients with IDH1-mutated AML in May 2022.

AML is one of the most common and dangerous leukemias, as the majority of patients with AML eventually relapse after initial treatment – with poor prognoses. However, improving methods of molecular profiling has brought new hope by supporting the development and targeted use of precision therapies like TIBSOVO, the first FDA-approved IDH1 inhibitor. Researchers at Agios (later acquired by Servier) previously leveraged Tapestri^® to fully characterize the clonal architecture of AML at the single-cell level, revealing mechanisms of resistance to TIBSOVO monotherapy and enabling Servier to further explore the advantages of the combination therapy trial strategy.

Through their continuing collaboration, Servier has worked with Mission Bio's Pharma Assay Development (PAD) services to utilize the Tapestri^® single-cell DNA sequencing technology to serially assess hundreds of samples from patients with IDH1-mutated AML who have been treated with TIBSOVO. At the World Clinical Biomarkers & CDx Summit this month, Servier will discuss Tapestri^®-powered findings revealing differences in the clonal evolution that occurs after TIBSOVO treatment in frontline and relapsed/refractory settings, both as a monotherapy and a combination therapy. This includes new insights into acquired resistance to TIBSOVO and azacitidine and the potential for serial molecular testing using single-cell analytics to enable physicians to dynamically sequence therapies to suppress emerging clones in AML.

"Targeted therapies play a key role in the continued evolution of precision cancer treatment, but it is critical to examine disease resistance in order to maximize the impact of these medicines," said Scott Daigle, Director of Translational Medicine at Servier. "Tapestri^® has shown that it can play an important role in helping drug developers discover insights that bring the right therapies to patients at the right time."

"The latest data on TIBSOVO, as well as the collaboration with Servier itself, is a great demonstration of Tapestri^®'s utility in retrospective studies. We are excited to see how this can potentially progress to prospective use of Tapestri^® in clinical trials for patient stratification, therapy monitoring, and measurable residual disease detection," said Todd Druley, Chief Medical Officer of Mission Bio. "Servier is again leading the pharmaceutical field, showing the potential for single-cell DNA sequencing to be used to predict relapse and help impact patient outcomes."

Servier is presenting a talk entitled "Clonal evolution underlying clinical responses and relapses in patients with IDH1-mutated AML treated with ivosidenib monotherapy or ivosidenib + azacitidine" at the 12^th Annual World Clinical Biomarkers & CDx Summit at 4:15 p.m. on September 28^th in Boston, Mass.

Visit Mission Bio during the World Clinical Biomarkers & CDx Summit from September 28-29 at booth 26.

Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others.

The company's Tapestri^Ⓡ platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri^Ⓡ is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri^Ⓡ Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.

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SOURCE Mission Bio