Phase 1/2 Trial of Tinostamustine Recruiting Patients with Myeloma, Other Blood Cancers

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by Alice Melão |

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The expansion part of a Phase 1/2 clinical trial testing tinostamustine in relapsed or refractory blood cancers has begun treating the first patient.

The trial (NCT02576496), conducted by Mundipharma EDO in collaboration with Imbrium Therapeutics, is currently seeking about 111 adult patients in the U.S. and Europe with either multiple myeloma, Hodgkin’s lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, or T-cell prolymphocytic leukemia. More information on trial locations and contacts is available here.

“We are excited to see the first patient enrolled in the tinostamustine expansion study in patients with hematologic malignancies, a group of difficult-to-treat cancers,” John Renger, PhD, a vice president at Imbrium Therapeutics, said in a press release.

Tinostamustine (EDO-S101) is an inhibitor of the alkylating deacetylase enzyme, and is designed to have potent toxic effects against cancer cells by integrating multiple modes of action. Preclinical studies revealed that tinostamustine improves access to DNA strands within cancer cells, both by breaking them and counteracting the cells’ mechanisms to repair this damage.

In addition, treatment with the compound alone caused cancer cell death in myeloid and lymphoid malignancies, and in solid tumors. The treatment appears to increase the efficacy and duration of effectiveness for other myeloma treatments, such as Velcade (bortezomib, by Takeda Oncology).

The ongoing Phase 1/2 trial has two parts. In the first part, patients received ascending doses of tinostamustine which allowed researchers to assess the treatment’s safety and toxicity, and to determine the maximum tolerated dose for use in future studies.

Currently, researchers are exploring the overall efficacy and treatment impact across multiple relapsed or refractory types of blood cancer, including myeloma. The Phase 2 part of the trial is meant to determine the overall response rate, duration of response, and treatment safety in each patient group. The results will be presented in future medical meetings.

“The initiation of the expansion arms of this Phase 1/2 trial is a significant step for our work in oncology as we pursue important treatment options for people living with these types of devastating cancers,” said Paul Medeiros, president of Imbrium Therapeutics.

“We look forward to continue building on the foundation of safety data generated in the dose-escalation portion of the trial as we advance the development of tinostamustine as a potential therapy for people with limited treatment options,” he added.