On April 11, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s TakeAim Lymphoma study (NCT03328078) (Press release, Curis, APR 11, 2022, View Source [SID1234611973]). The TakeAim Lymphoma study is a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies.

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This notification from the FDA Division of Hematologic Malignancies 2 (DHM2), which regulates clinical studies in lymphoma, is separate from the notification previously received from the FDA Division of Hematologic Malignancies 1 (DHM1), which regulates clinical studies in leukemia.

This week’s notification extends the partial hold across both studies. This is not unexpected, as both studies treat patients with emavusertib. And, as previously announced, the Company had already voluntarily paused enrollment in the TakeAim Lymphoma study in connection with its announcement on April 4, 2022 of the FDA’s partial clinical hold on the TakeAim Leukemia study.

"We reiterate our previous comments: we are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients’ lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with B-cell cancers, AML, or MDS."

While the partial hold on the TakeAim Lymphoma study is in place, no new patients will be enrolled in that study, and current study participants benefiting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower after being reconsented.

Consistent with the previous notification, FDA is requesting additional safety, efficacy, and other data relating to emavusertib, including data related to rhabdomyolysis and the Company’s determination of the Recommended Phase 2 Dose for emavusertib.

Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical holds are resolved and the related impact on the trials can be determined.