Y-mAbs Therapeutics Announces U.S. FDA Clearance of Investigational New Drug Application for CD38-SADA
17 Outubro 2023 - 5:05PM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a commercial-stage biopharmaceutical company focused on the
development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer, today announced
that the U.S. Food and Drug Administration (“FDA”) has cleared the
Company’s Investigational New Drug (“IND”) application for
CD38-SADA, the Company’s second program within its Self-Assembly
DisAssembly Pre-targeted Radioimmunotherapy (“SADA Y-PRIT”)
Theranostic Platform. The Phase 1 trial is a first-in-human,
dose-escalation, open-label, single-arm, multi-center trial (Study
1201) investigating the safety and tolerability of the CD38-SADA:
177Lu-DOTA Drug Complex in patients with Relapsed or Refractory
non-Hodgkin Lymphoma.
This trial will have two parts: Part A,
CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to
explore optimal CD38-SADA protein dose and interval between the
SADA protein administration and the payload; and Part B, 177Lu-DOTA
therapeutic dose escalation with the CD38-SADA dose determined in
Part A. Patients will receive up to three cycles of therapy. The
primary study outcome will evaluate safety and initial signals of
efficacy using repeated dosing. Y-mAbs expects a total of
approximately 30 patients and up to 12 U.S. sites to be included in
the trial.
The CD38-SADA construct was created using SADA
technology, which was licensed by the Company from Memorial Sloan
Kettering Cancer Center (“MSK”) and Massachusetts Institute of
Technology (“MIT”) in April 2020. The SADA technology platform
utilizes a pre-targeted payload delivery method where antibody
constructs assemble in tetramers and bind to the tumor target.
Unbound constructs predictably disassemble into smaller antibody
fragments and are predominantly excreted through the kidneys within
hours after administration. In a second infusion, a radioactive
payload binds to the antibody constructs attached to the tumor
target in order to radiate the tumor. This provides the possibility
of targeting tumors with precision while minimizing radiation of
normal tissues. We believe that the SADA technology platform can
deliver a variety of payloads and could potentially be developed
against multiple tumor targets, as well as for theragnostic
purposes.
“We are pleased by the FDA clearance of our IND
for CD38-SADA, marking the second program utilizing our novel SADA
technology platform to enter clinic development within just 15
months,” said Thomas Gad, Founder, President and Interim Chief
Executive Officer. “With our team’s proven CD38-targeted drug
development track record and our unique two-step SADA mechanism, we
believe our CD38-SADA program has the potential to address a clear
unmet medical need. We are incredibly excited about the potential
of SADA to transform the treatment paradigm across a variety of
targets.”
“The FDA clearance of our IND paves the way for
a new way of addressing CD38-positive tumors, with the potential
for CD38-SADA to be a key addition to the physician toolbox in
treating Relapsed or Refractory non-Hodgkin Lymphoma patients of
both of B-cell and T-cell origin,” said Steen Lisby, M.D., DMSc,
SVP and Chief Scientific Officer, Global Head of Translational
Medicine. “Despite the growing range of available treatment options
for patients with lymphoma, many patients will develop disease that
no longer responds to treatment and risk succumbing to the disease.
Hence, there is still significant unmet medical need in Relapsed or
Refractory non-Hodgkin Lymphoma. CD38-SADA marks our first
hematology radiotherapy program. We look forward to initiating this
Phase 1 trial and expect to dose the first patient in 2024.”
Researchers at MSK, including Dr. Cheung,
developed the SADA technology for radioimmunotherapy, which is
exclusively licensed by MSK to Y-mAbs. Dr. Cheung has
intellectual property rights and interests in the technology, and
as a result of this licensing arrangement, MSK has institutional
financial interests in the technology and in Y-mAbs.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel,
antibody-based therapeutic cancer products. In addition to
conventional antibodies, the Company’s technologies include
bispecific antibodies generated using the Y-BiClone platform and
the SADA platform. The Company’s broad and advanced product
pipeline includes one FDA-approved product, DANYELZA®
(naxitamab-gqgk), which targets tumors that express GD2, and one
product candidate, OMBLASTYS® (omburtamab), which targets tumors
that express B7-H3.
Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements include, but are not limited
to, statements about our business model and development,
commercialization and product distribution plans, including without
limitation statements about expectations with respect to CD38-SADA
and the SADA technology platform; statements about current and
future clinical and pre-clinical studies and our research and
development programs, including without limitation statements about
expectations with respect to the anticipated Phase 1 trial
investigating the safety and tolerability of CD38-SADA: 177Lu-DOTA
Drug Complex in patients with Relapsed or Refractory non-Hodgkin
Lymphoma; statements about the expected benefits of CD38-SADA and
the SADA technology platform; and other statements that are not
historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’
“contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’
“hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’
‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’ “will”,
‘‘would’’, “guidance,” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Our
product candidates and related technologies are novel approaches to
cancer treatment that present significant challenges. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various factors,
including but not limited to: risks associated with our financial
condition and need for additional capital; the risks that actual
results of our restructuring plan and revised business plan will
not be as expected; risks associated with our development work;
cost and success of our product development activities and clinical
trials; the risks of delay in the timing of our regulatory
submissions or failure to receive approval of our drug candidates;
the risks related to commercializing any approved pharmaceutical
product including the rate and degree of market acceptance of our
product candidates; development of our sales and marketing
capabilities and risks associated with failure to obtain sufficient
reimbursement for our products; the risks related to our dependence
on third parties including for conduct of clinical testing and
product manufacture; our inability to enter into partnerships; the
risks related to government regulation; risks related to market
approval, risks associated with protection of our intellectual
property rights; risks related to employee matters and managing
growth; risks related to our common stock, risks associated with
macroeconomic conditions, including the conflict between Russia and
Ukraine and sanctions related thereto, inflation, increased
interest rates, uncertain global credit and capital markets and
disruptions in banking systems; and other risks and uncertainties
affecting the Company including those described in the "Risk
Factors" section included in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2022, the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2023,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2023 and future filings and reports by the Company. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and the Company undertakes no
obligation to update any forward-looking statement, whether as a
result of new information, future events or otherwise.
DANYELZA®, OMBLASTYS® and Y-mAbs® are registered trademarks of
Y-mAbs Therapeutics, Inc.
Investor Contact:
Courtney DuganVP, Head of Investor Relationscdu@ymabs.com
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