Overland ADCT BioPharma Announces First Patient Dosed in China with ZYNLONTA® in Pivotal Phase 2 Clinical Trial for Diffuse Large B-cell Lymphoma
September 29 2021 - 7:15AM
Business Wire
Overland ADCT BioPharma, a joint venture created by Overland
Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), today
announced the first patient has been dosed with ZYNLONTA® in a
pivotal Phase 2 clinical trial in patients with relapsed or
refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in China. In
April 2021, ZYNLONTA was granted accelerated approval by the U.S.
Food and Drug Administration (FDA) as the first and only
CD19-targeted antibody drug conjugate (ADC) as a single-agent
treatment for adult patients with r/r DLBCL after two or more lines
of systemic therapy. This local pivotal study mirrors ADC
Therapeutics’ ongoing global pivotal Phase 2 clinical trial of
ZYNLONTA and its results are intended to support the potential
registration of ZYNLONTA in China.
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“After receiving early FDA approval of ZYNLONTA in April, we are
pleased that our colleagues at Overland ADCT BioPharma have rapidly
initiated a pivotal study to potentially benefit patients in
China,” said Chris Martin, PhD, Chief Executive Officer of ADC
Therapeutics. “We are eager for this bridging study to be
completed, and we hope that ZYNLONTA will ultimately be available
to all patients who can benefit from it globally.”
“Dosing the first patient in this pivotal trial is a key
milestone for Overland ADCT BioPharma as we collaborate to expand
the clinical reach of ZYNLONTA in greater China and Singapore,”
said Eric Koo, Chief Executive Officer of Overland ADCT BioPharma.
“With many patients in China affected by r/r DLBCL, we remain
committed to addressing this unmet medical need and delivering
promising antibody drug conjugates for underserved patients around
the world. Together with ADC Therapeutics, we look forward to the
continued development and commercialization of ZYNLONTA in
Asia.”
ZYNLONTA, Overland ADCT BioPharma’s lead product candidate, is
an ADC composed of a humanized monoclonal antibody directed against
human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer
cytotoxin. In clinical trials, ZYNLONTA has demonstrated
significant single-agent clinical activity across a broad
population of patients with r/r DLBCL, mantle cell, and follicular
lymphomas.
The China Phase 2, multi-center, open-label, single-arm study
will evaluate the efficacy and safety of ZYNLONTA used as
monotherapy in patients with r/r DLBCL.
About ZYNLONTA® (loncastuximab tesirine-lpyl)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once
bound to a CD19-expressing cell, ZYNLONTA is internalized by the
cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.
The potent payload binds to DNA minor groove with little
distortion, remaining less visible to DNA repair mechanisms. This
ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) has approved
ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult
patients with relapsed or refractory (r/r) large B-cell lymphoma
after two or more lines of systemic therapy, including diffuse
large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL
arising from low-grade lymphoma and also high-grade B-cell
lymphoma. The trial included a broad spectrum of heavily
pre-treated patients (median three prior lines of therapy) with
difficult-to-treat disease, including patients who did not respond
to first-line therapy, patients refractory to all prior lines of
therapy, patients with double/triple hit genetics and patients who
had stem cell transplant and CAR-T therapy prior to their treatment
with ZYNLONTA. This indication is approved by the FDA under
accelerated approval based on overall response rate and continued
approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.
ZYNLONTA is also being evaluated as a therapeutic option in
combination studies in other B-cell malignancies and earlier lines
of therapy.
About Overland ADCT BioPharma
Overland ADCT BioPharma, a joint venture created by Overland
Pharmaceuticals and ADC Therapeutics, is developing and
commercializing four of ADC Therapeutics’ antibody drug conjugate
(ADC) product candidates for difficult-to-treat hematologic and
solid tumors – ZYNLONTA, ADCT-601, ADCT-602 and ADCT-901 – in
greater China and Singapore.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of cancer patients with
its next-generation, targeted antibody drug conjugates (ADCs). The
Company is advancing its proprietary PBD-based ADC technology to
transform the treatment paradigm for patients with hematologic
malignancies and solid tumors.
ADC Therapeutics is based in Lausanne (Biopôle), 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.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
About Overland Pharmaceuticals
Overland Pharmaceuticals is building a fully integrated
biopharma company with a mission to bring innovative medicines to
underserved patients in Asia and around the world. By leveraging
its resources, global network, and local expertise across the
biopharma ecosystem in Asia, Overland is establishing a portfolio
of differentiated therapeutic candidates in a few carefully
selected therapeutic areas. Through formative partnerships,
Overland will move forward the development and commercialization of
the most promising advances in medicine. www.overlandpharma.com
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Overland ADCT BioPharma Arkin Feng arkin.feng@rfcomms.com
+86 15626068334 Overland Pharmaceuticals Kari Watson or
Madeline Davidshofer MacDougall kwatson@macbiocom.com or
mdavidshofer@macbiocom.com +1 781-235-3060 ADC Therapeutics
Investors Eugenia Litz ADC Therapeutics
Eugenia.Litz@adctherapeutics.com Tel.: +44 7879 627205 Amanda
Hamilton ADC Therapeutics amanda.hamilton@adctherapeutics.com Tel.:
+1 917 288 7023 EU Media Alexandre Müller Dynamics Group
amu@dynamicsgroup.ch Tel: +41 (0) 43 268 3231 USA Media Mary
Ann Ondish ADC Therapeutics maryann.ondish@adctherapeutics.com
Tel.: +1 914 552 4625
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