Relapsed-refractory cancer treatment gets first-in-human clinical trial

Mundipharma Early Development in Oncology (EDO) has announced the initiation of a first-in-human clinical trial of its investigational drug candidate EDO-S101 for relapsed-refractory (RR) cancer treatment

The fusion molecule - S101 is currently being developed for the treatment of RR haematological malignancies. Mundipharma’s phase 1 study is designed to evaluate the safety and tolerability of ascending doses of EDO-S101 and will be conducted at several sites across the United States and Europe.

EDO-S101 is the first representative of the A-DAC principle, a new approach in chemotherapy that uses fusion technology to combine an alkylating agent with a pan-histone deacetylase inhibitor (HDAC) to simultaneously damage DNA and block damage repair.

The combination of the two different modes of action has the potential to overcome resistance towards other conventional chemotherapies, according to Mundipharma.

EDO-S101 combines the active structures of bendamustine and vorinostat, two molecules that the company said have been well established in the treatment of haematological malignancies, to produce a novel single agent with efficacy characteristics superior to those of the parent compounds given in combination.

Thomas Mehrling, CEO, Mundipharma EDO said: “EDO-S101 is making significant progress in its clinical development journey and we are passionate about its potential to treat patients with relapsed-refractory haematological malignances, who are in dire need of new treatment options.

“The primary goal of this first clinical trial is to evaluate the safety and tolerability of EDO-S101 and its pharmacokinetic profile.

“These data will be used to establish the recommended dose which will then be further evaluated for safety and efficacy.”

Mundipharma said that preclinical experiments demonstrated that EDO-S101 exerts significant activity against haematological malignancies including multiple myeloma, acute myeloid leukemia,^, mantle cell lymphoma, ABC type diffuse large B-Cell lymphoma as well as hodgkin lymphoma. In addition, the molecule is active in primary resistant cells as well as in cells that have acquired resistance.