Full Press Release Details
Therapeutics Announces First Patient Dosed with Camidanlumab Tesirine (Cami) in Combination with Pembrolizumab in Ongoing
Phase 1b Clinical Trial in Selected Solid Tumors
Lausanne, Switzerland, November
3, 2020 - ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering
the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological
malignancies and solid tumors, today announced that the first patient has been dosed with camidanlumab tesirine (Cami, formerly
ADCT-301) in combination with pembrolizumab, a checkpoint inhibitor, in an ongoing Phase 1b clinical trial in patients with selected
advanced solid tumors.
"We are pleased to have
dosed our first patient in an additional arm of our Phase 1b trial of Cami in solid tumors, which is intended to identify an appropriate
dosing regimen for Cami in combination with pembrolizumab and detect signals of clinical activity in expansion cohorts using the
identified dosing regimen," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics.
"The preliminary pharmacokinetic and biomarker data from the Phase 1b trial that we presented at the European Society for
Medical Oncology (ESMO) Virtual Congress 2020, as well as a preclinical study recently published in the Journal for ImmunoTherapy
of Cancer, support the evaluation of Cami in combination with other immune-modulating therapies. We look forward to the continued
evaluation of our CD25-targeted ADC, as monotherapy and in combination with a checkpoint inhibitor, as a novel immuno-oncology
approach for the treatment of solid tumor cancers."
Cami targets CD25, which is expressed
on regulatory T cells (Tregs) that infiltrate the local tumor microenvironment. In preclinical models, a single dose of the CD25-targeted
ADC induced strong and durable anti-tumor activity against established CD25-negative solid tumors with infiltrating Tregs both
as monotherapy and in combination with a checkpoint inhibitor.
The ongoing, multicenter, open-label,
dose-escalation and dose-expansion Phase 1b trial is evaluating the safety, tolerability, pharmacokinetics and antitumor activity
of Cami as monotherapy or in combination with pembrolizumab in patients with selected advanced solid tumors. Approximately 95
patients will be enrolled in the trial. For more information about the Company's Phase 1b clinical trial of Cami in solid
tumors, please visit www.clinicaltrials.gov (identifier NCT03621982).
About Camidanlumab Tesirine
Camidanlumab tesirine (Cami, formerly
ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax -TAC, licensed
from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell,
ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing
tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing
of neighboring tumor cells. PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance
immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or
refractory Hodgkin lymphoma (HL) and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.
About ADC Therapeutics
SA (NYSE:ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization
of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The
Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD)
technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and
substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline
of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical
trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs
Loncastuximab tesirine (Lonca,
formerly ADCT-402), the Company's lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial
for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR),
which exceeded the target primary endpoint. In September 2020, ADC Therapeutics submitted a Biologics License Application to the
U.S. Food and Drug Administration seeking accelerated approval for Lonca for the treatment of patients with relapsed or refractory
DLBCL. Camidanlumab tesirine (Cami, formerly ADCT-301), the Company's second lead product candidate, is being evaluated
in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having
shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating
Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.
is based in Lausanne (Biop le), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For
more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.
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including statements regarding our future results of operations and financial position, business strategy, product candidates,
research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable
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