ADC Therapeutics Doses First Patient in Phase I Trial of ADCT-301 Trial in Acute Myeloid Leukemia
09 February 2016 - 8:34PM
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.
ENDS
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.
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Instinctif PartnersSue Charles / Gemma HoweT: +44 (0)20
7866 7860adctherapeutics@instinctif.comorInstinctif Partners –
SwitzerlandKirsten DuelliT: +41 (0) 44 280 11
86Kirsten.duelli@instinctif.com