Earlier this month ADC Therapeutics, a Swiss-based oncology drug development company, dosed the first patient in a Phase I trial to evaluate ADCT-301, also know as HuMax®-TAC-ADC, its lead antibody-drug conjugate or ADC for the treatment of patients with Acute Myeloid Leukemia (AML). The drug, which has the potential to be a first-in-class ADC is in development for lymphoma under an agreement between Genmab and ADC Therapeutics.

The two stage, Phase I open-label trial will evaluate the tolerability, safety, pharmacokinetics and activity of ADCT-301 in patients with relapsed or refractory CD-25 positive AML. CD25 is expressed on a variety of hematological tumors and shows limited expression on normal tissues, This makes it a very attractive target for antibody-payload approaches.

The initial dose escalation phase will recruit up to 30 patients at ten clinical sites across the US and will seek to determine the recommended dose of ADCT-301 for the second stage. The second stage, which will begin once an appropriate dose is identified, will be expanded into the UK and Europe with the recruitment of up to 30 additional patients.

Strong dose-dependent anti-tumor activity
ADCT-301 is composed of Genmab’s HuMax®-TAC, a monoclonal antibody directed against CD25 (the alpha chain of the IL-2 receptor) conjugated to ADCT’s highly potent proprietary pyrrolobenzodiazepine / PBD-dimer using ADC Therapeutics proprietary linker technology. In preclinical in vivo models, ADCT-301 exhibited strong dose-dependent anti-tumor activity against CD25-positive cell lines at single low doses.

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“Acute myeloid leukemia is the most common leukemia in the adult population in United States and the prognosis is poor. Patients expressing CD25 on their leukemia cells have a particularly poor prognosis,” explained Professor Martin Tallman, the Principle Investigator of the trial and Chief of the Leukemia Service at Memorial Sloan Kettering Cancer Center, New York. ADCT-301 has shown promise in in vivo studies and we believe that this important trial could help us to improve patient outcomes.”

“Dosing the first patient in this trial with ADCT-301 is an important milestone for the Company. We look forward to the progress of this trial over the coming year and to accelerating the clinical development of our ADC pipeline,” added Chris Martin, MD, the Chief Executive Officer of ADC Therapeutics.

ADC Therapeutics currently has two PBD-based ADCs in four clinical trials, with four other ADCs in late preclinical development and further ADCs in research.

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