Overland ADCT BioPharma, a joint venture of Overland
Pharmaceuticals (CY) Inc. and ADC Therapeutics SA (NYSE: ADCT),
today announced that the China National Medical Products
Administration (NMPA) has accepted the Biologics License
Application (BLA) for ZYNLONTA® (loncastuximab tesirine-lpyl),
which is seeking an indication for the treatment of adult patients
with relapsed or refractory (r/r) diffuse large B-cell lymphoma
(DLBCL) after two or more lines of systemic therapy in China. The
BLA has been granted priority review by the NMPA.
The application was made based on the positive
results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for
ZYNLONTA. The study was designed to evaluate the efficacy and
safety of ZYNLONTA as a single-agent treatment for Chinese patients
with r/r DLBCL.
Professor Zhu Jun, principal
investigator of the OL-ADCT-402-001 study and Party Secretary of
Beijing Cancer Hospital and Director of Internal Medicine,
said: “Safer and more effective treatments are still urgently
needed to address significant unmet medical needs among r/r DLBCL
patients after two or more lines of systemic therapy in China. I
hope ZYNLONTA will be accessible to Chinese r/r DLBCL patients
soon.”
“We are pleased with the swift progress of the
development program for ZYNLONTA in China as evidenced by the
NMPA’s recent acceptance of the BLA and priority review
designation,” said Ameet Mallik, Chief Executive Officer of
ADC Therapeutics. “This is a significant step forward in
our commitment to making ZYNLONTA available to benefit patients
worldwide.”
Ed Zhang, Co-founder and CEO of Overland
Pharmaceuticals, said: "This is a meaningful milestone.
Our partnership with ADC Therapeutics began in December 2020, and
it took us only two and a half years to complete the clinical study
and submit the first BLA. We would like to extend our sincere
gratitude to participating patients, clinical investigators, the
health authority and our partner ADC Therapeutics for their strong
support in making this achievement possible. We look forward to our
continued collaboration with all stakeholders to maximize the
potential benefits of ZYNLONTA for patients in China."
Overland ADCT BioPharma holds the exclusive
rights to develop and commercialize ZYNLONTA in Greater China and
Singapore. The BLAs for ZYNLONTA have already been submitted in
Singapore, Hong Kong and Taiwan. It is expected to address the
unmet needs of patients with r/r DLBCL across these regions.
About
ZYNLONTA® (loncastuximab
tesirine-lpyl)
The U.S. Food and Drug Administration (FDA) and
the European Medicines Agency have 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 and in the European Union under conditional
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. Please see full
prescribing information including important safety information
about ZYNLONTA at www.ZYNLONTA.com.
About ADC Therapeutics
ADC Therapeutics (NYSE: ADCT) is a
commercial-stage global leader and pioneer in the field of antibody
drug conjugates (ADCs). The Company is advancing its proprietary
ADC technology to transform the treatment paradigm for patients
with hematologic malignancies and solid tumors.
ADC Therapeutics’ CD19-directed ADC ZYNLONTA
(loncastuximab tesirine-lpyl) received accelerated approval by the
FDA and conditional approval from the European Commission 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 and in earlier lines
of therapy. In addition to ZYNLONTA, 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.
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 our 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
ADC Therapeutics Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are subject to certain risks and uncertainties that can
cause actual results to differ materially from those described.
Factors that may cause such differences include, but are not
limited to: Overland ADCT BioPharma’s ability to obtain marketing
authorization approval for ZYNLONTA in China, actions by the NMPA
related to the pending BLA in China for ZYNLONTA, the timing of any
BLA approval in China and any revenue from the same, the Company’s
ability to achieve the 2023 net product sales guidance for
ZYNLONTA® and the decrease in total operating expenses for 2023 and
2024, the expected cash runway into the middle of 2025, the
Company’s ability to continue to commercialize ZYNLONTA® in the
United States and future revenue from the same; Swedish Orphan
Biovitrum AB (Sobi®) ability to successfully commercialize
ZYNLONTA® in the European Economic Area and market acceptance,
adequate reimbursement coverage, and future revenue from the same;
our strategic partners’, including Mitsubishi Tanabe Pharma
Corporation and Overland Pharmaceuticals, ability to obtain
regulatory approval for ZYNLONTA® in foreign jurisdictions, and the
timing and amount of future revenue and payments to us from such
partnerships; the Company’s ability to market its products in
compliance with applicable laws and regulations; the Company’s
expectations regarding the impact of the Infrastructure Investment
and Jobs Act; the timing and results of the Company’s or its
partners’ research projects or clinical trials including LOTIS 2, 5
and 9, ADCT 901, 601 and 212, the timing and outcome of regulatory
submissions and actions by the FDA or other regulatory agencies
with respect to the Company’s products or product candidates;
projected revenue and expenses; the Company’s indebtedness,
including Healthcare Royalty Management and Blue Owl and Oaktree
facilities, and the restrictions imposed on the Company’s
activities by such indebtedness, the ability to repay such
indebtedness and the significant cash required to service such
indebtedness; the Company’s ability to obtain financial and other
resources for its research, development, clinical, and commercial
activities and other statements regarding matters that are not
historical facts, and involve predictions. These statements involve
known and unknown risks, uncertainties and other factors that may
cause actual results, performance, achievements or prospects to be
materially different from any future results, performance,
achievements or prospects expressed in or implied by such
forward-looking statements. In some cases you can identify
forward-looking statements by terminology such as “may,” “will,”
“should,” “would,” “expect,” “intend,” “plan,” “anticipate,”
“believe,” “estimate,” “predict,” “potential,” “seem,” “seek,”
“future,” “continue,” or “appear” or the negative of these terms or
similar expressions, although not all forward-looking statements
contain these identifying words. Additional information concerning
these and other factors that may cause actual results to differ
materially from those anticipated in the forward-looking statements
is contained in the “Risk Factors” section of the Company's Annual
Report on Form 20-F and in the Company's other periodic reports and
filings with the Securities and Exchange Commission. The Company
cautions investors not to place undue reliance on the
forward-looking statements contained in this document. The Company
undertakes no obligation to revise or update these forward-looking
statements to reflect events or circumstances after the date of
this press release, except as required by law.
Overland Pharmaceuticals
Investors and MediaMichael ChenOverland
Pharmaceuticalsylchen@overlandpharma.com +86 152-2175-2295
ADC
TherapeuticsInvestorsEugenia LitzADC
TherapeuticsEugenia.Litz@adctherapeutics.com +44 7879 627205+1
908-723-2350
MediaNicole RileyADC
TherapeuticsNicole.Riley@adctherapeutics.com +1 862-926-9040
ADC Therapeutics (NYSE:ADCT)
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