Will Curis' TakeAim Trials Hit The Mark?

(RTTNews) - Curis Inc. (CRIS), a biotechnology company developing novel therapies for slowing or preventing the progression of cancer and prolonging life, has several important clinical trial milestones lined up for the end of this year.

The company's lead drug candidate is Emavusertib, a first-in class IRAK4 inhibitor in phase I/II clinical studies in leukemia and lymphoma, dubbed TakeAim Leukemia and TakeAim Lymphoma.

IRAK4, or interleukin-1 receptor-associated kinase 4, is said to play a crucial role in triggering inflammation, oncogenesis, and survival of cancer cells. According to studies, IRAK4 inhibition has demonstrated anti-tumor effects in preclinical cancer models.

According to the company, initial phase I/II clinical data of Emavusertib demonstrated single-agent anti-cancer activity in Acute myeloid leukemia (AML) and Non-Hodgkin lymphoma (NHL), with potential for broader application in combination with standard of care.

In the TakeAim Lymphoma trial, Emavusertib is not only being evaluated as monotherapy but also in combination with AbbVie's *Ibrutinib for non-Hodgkin's lymphoma subtypes including primary CNS lymphoma (PCNSL) patients. *Ibrutinib is approved in the indications of Chronic Lymphocytic Leukemia, Waldenström Macroglobulinemia, and Graft-versus-host disease.

The initial Emavusertib/Ibrutinib combination data from the TakeAim Lymphoma study, reported last December, demonstrated a manageable and acceptable safety profile, according to the company.

The updated combination study data from the TakeAim Lymphoma trial in patients with R/R PCNSL is expected in late-2024.

A phase I trial of Emavusertib in combination with *Azacitidine and Venetoclax in Acute Myeloid Leukemia patients is also ongoing, with initial safety data from the study anticipated in late 2024. (*Azacitidine plus Venetoclax is a standard of care for newly diagnosed AML infit for intensive induction chemotherapy.

Financial Numbers

For the first quarter ended March 31, 2024, Curis reported a net loss of $11.9 million or $2.05 per share compared to a net loss of $11.6 million or $2.39 per share for the same period in 2023.

Currently, the company does not generate any revenues from its direct sale of products. But it recognizes royalty revenues related to Genentech/Roche's sales of Erivedge.

Erivedge, which was approved by the FDA in January 2012, for the treatment of patients with advanced basal cell carcinoma, is commercialized by Genentech and Roche under a 2003 collaboration agreement between Curis and Genentech. This drug is also approved in the European Union and in several other countries worldwide.

Revenues for the first quarter of 2024 were $2.1 million compared to $2.3 million in the year-ago quarter. Revenues for both periods consist of royalty revenues from Genentech/Roche's sales of Erivedge.

Cash Position

Curis ended March 31, 2024, with cash, cash equivalents and investments of $40.7 million.

CRIS has traded in a range of $0.38 to $17.49 in the last 1 year. The stock closed Friday's (July 5, 2024) trading at $6.38, up 2.08%.