FDA lifts remaining partial ban from Curis’ late-stage leukemia trial

The Food and Drug Administration (FDA) in the U.S. has completely lifted the partial clinical hold it had placed on Curis’s clinical trial called TakeAim Leukemia, which began in April 2022. This lift allows Curis to proceed from the phase 1/2 trial to the phase 2 trial, for which investigators have decided on a 300 mg BID dosing in the monotherapy phase.

The trial aimed to test the efficacy of the company’s lead clinical candidate, emavusertib, and focused on patients suffering from recurring or non-responsive acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Curis CEO James Dentzer explained that patients enrolled in the new trial must have a certain type of AML and must have received two or more previous treatments for their condition to qualify.

The phase 1/2 trial was put on hold following a serious adverse event: the death of a patient. This incident initially caused a hold on the trial, and a week later, the FDA issued another hold against Curis in a trial meant to test the drug in patients with relapsed or refractory B-cell malignancies.

After a request for further information regarding the death of the AML patient who experienced rhabdomyolysis, a known dose-limiting toxicity of the drug that causes the breakdown of skeletal muscle, the hold provided the FDA with an opportunity to investigate the efficacy and safety of the IRAK4 kinase inhibitor.

Although the hold has been in place since April, in August, the Lexington, Massachusetts-based biotech was able to remove some of the restrictions, allowing it to resume enrollment for the dose-finding phase of the study.

The lifted hold now focuses on the combination therapy portion of the trial, which aims to evaluate doses of emavusertib alongside other drugs such as Venclexta from AbbieVie and azacitidine. Not only have the partial holds been entirely lifted, but the previously held up phase 2a expansion part of the trial is also free for the firm to proceed with.

However, the initial investor reaction to the news has not been favorable, with shares of the biotech trading 14% lower in the pre-trading market. Despite this, on the same day the ban was lifted, 18.4 million shares of common stock were sold for 82 cents apiece in a registered direct offering. Gross proceeds are expected to exceed $15 million, as these shares were purchased by existing investors. The raised funds will be allocated to further R&D efforts as well as any additional corporate expenses.

In the future, the focus will be on a front-line combination study of emavusertib with other drugs, and by 2024, Curis hopes to update data for the TakeAim Leukemia monotherapy study, incorporating initial data from the additional drugs and clarifying the study design.

According to Securities and Exchange Commission filings from a couple of months ago at the end of last year, Curis has approximately $72 million in cash and other investments, which is expected to sustain the firm until 2025.

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