LAUSANNE, Switzerland & LONDON & MURRAY HILL,N.J.--(BUSINESS WIRE)--ADC Therapeutics SA (ADCT), the oncology drug development company, announces that the first patient has been dosed in a Phase I trial to evaluate its lead antibody drug conjugate (ADC) ADCT-301 in Acute Myeloid Leukemia (AML).
The two stage, Phase l open-label trial will evaluate the tolerability, safety, pharmacokinetics and activity of ADCT-301 in patients with relapsed or refractory CD-25 positive AML. 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.
ADCT-301 is composed of 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. In preclinical in vivo models, ADCT-301 exhibited strong dose-dependent anti-tumor activity against CD25-positive cell lines at single low doses.
Professor Martin Tallman, Principle Investigator of the trial and Chief of the Leukemia Service at Memorial Sloan Kettering Cancer Center, New York, said: “Acute myeloid leukemia is the most common leukemia in the US adult population and the prognosis is poor. Patients expressing CD25 on their leukemia cells have a particularly poor prognosis.
ADCT-301 has shown promise in in vivo studies and we believe that this important trial could help us to improve patient outcomes.”
Dr Chris Martin, CEO of ADC Therapeutics, added: “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.”
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.
Notes to Editors
About ADC Therapeutics (www.adctherapeutics.com)
ADC Therapeutics SA (ADCT) is an oncology drug development company that specializes in the development of proprietary ADCs targeting major solid and hematological cancers. The Company’s ADCs are highly targeted drug constructs which combine monoclonal antibodies specific to surface antigens present on particular tumor cells with a novel class of highly potent pyrrolobenzodiazepine (PBD)-based warheads. The Company has access to warhead and linker chemistries via agreements with Spirogen (a wholly-owned subsidiary of AstraZeneca’s MedImmune). It is progressing eleven ADC programs, one of these under a joint development agreement with MedImmune. During 2015 ADCT-301 and ADCT-402 entered Phase I for lymphoma and leukemia. ADC Therapeutics has its head office in Lausanne, Switzerland and has its R&D laboratories in London, UK, its clinical development team in New Jersey, USA, and its manufacturing team based in San Francisco, USA.