ADC Therapeutics Announces Exclusive License with Mitsubishi Tanabe Pharma Corporation to Develop and Commercialize ZYNLONTA® (loncastuximab tesirine-lpyl) in Japan
18 Janvier 2022 - 11:00AM
Business Wire
ADC Therapeutics to receive $30 million upfront
payment, up to $205 million in milestones, and double-digit
royalties based on net sales in Japan
ADC Therapeutics SA (NYSE: ADCT), a commercial-stage
biotechnology company improving the lives of those affected by
cancer with its next-generation, targeted antibody drug conjugates
(ADCs) for patients with hematologic malignancies and solid tumors,
today announced it has entered an exclusive license agreement with
Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and
commercialization of ZYNLONTA® (loncastuximab tesirine-lpyl) for
all hematologic and solid tumor indications in Japan.
Under the terms of the agreement, ADC Therapeutics will receive
an upfront payment of $30 million and up to an additional $205
million in milestones if certain development and commercial events
are achieved. ADC Therapeutics will also receive royalties ranging
in percentage from the high teens to the low twenties based on net
sales of the product in Japan. MTPC will conduct clinical studies
of ZYNLONTA in Japan and will have the right to participate in any
global clinical studies of the product by bearing a portion of the
costs of the study.
“This license agreement with MTPC, a leader in the Japanese
pharmaceutical industry, expands our global footprint in an
important geography, and furthers our goal to make ZYNLONTA
available globally to patients,” said Chris Martin, PhD, Chief
Executive Officer of ADC Therapeutics. “We are excited to bring
together our expertise in ADCs with MTPC’s extensive experience in
Japan where there is significant unmet need for a safe and
effective therapy for patients with relapsed or refractory
DLBCL.”
"MTPC is delighted to collaborate with ADC Therapeutics, a
leader in the field of antibody drug conjugates, to develop and
commercialize ZYNLONTA in Japan,” said Hiroaki Ueno, PhD, Chief
Executive Officer of Mitsubishi Tanabe Pharma Corporation. “We will
try to improve the quality of life of patients suffering from
cancer with the use of ADC Therapeutics’ novel anti-CD19 ADC,
ZYNLONTA.”
In April 2021, the U.S. Food and Drug Administration (FDA)
granted accelerated approval to ZYNLONTA as the first and only
CD19-targeted ADC as a single-agent treatment for adult patients
with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
after two or more lines of systemic therapy. A Marketing
Authorization Application (MAA) for ZYNLONTA has been validated by
the European Medicines Agency (EMA) and is under review by the
EMA’s Committee for Medicinal Products for Human Use (CHMP).
ZYNLONTA has also received Orphan Drug designation in Europe for
DLBCL. In addition, Overland ADCT BioPharma, a joint venture formed
by Overland Pharmaceuticals and ADC Therapeutics, is working to
develop and commercialize ZYNLONTA in greater China and Singapore.
Overland ADCT BioPharma is now conducting a pivotal Phase 2
clinical trial of ZYNLONTA in relapsed or refractory DLBCL in
China, which is intended to support the anticipated registration of
ZYNLONTA in China.
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 DLBCL not
otherwise specified, 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 ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a commercial-stage
biotechnology company improving the lives of those affected by
cancer 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’ CD19-directed ADC ZYNLONTA® (loncastuximab
tesirine-lpyl) is approved by the FDA for the treatment of relapsed
or refractory diffuse large B-cell lymphoma after two or more lines
of systemic therapy. ZYNLONTA is also in development in combination
with other agents. Cami (camidanlumab tesirine) is being evaluated
in a late-stage clinical trial for relapsed or refractory Hodgkin
lymphoma and in a Phase 1b clinical trial for various advanced
solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics
has multiple ADCs in ongoing clinical and preclinical
development.
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.
ADC Therapeutics Forward-Looking Statements
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statements regarding our future results of operations and financial
position, business and commercialization strategy, products and
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approvals, planned commercialization activities, research and
development costs, timing and likelihood of success, as well as
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forward-looking statements. Forward-looking statements are based on
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currently available to our management. Such statements are subject
to risks and uncertainties, and actual results may differ
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statements due to various factors, including those described in our
filings with the U.S. Securities and Exchange Commission. No
assurance can be given that such future results will be achieved.
Such forward-looking statements contained in this document speak
only as of the date of this press release. We expressly disclaim
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(expressed or implied) are made about the accuracy of any such
forward-looking statements.
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Investors
Eugenia Litz ADC Therapeutics Eugenia.Litz@adctherapeutics.com
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