- Among 14 efficacy-evaluable
patients in the ongoing Phase 1 study, one achieved a complete
response, one had partial response and two unconfirmed partial
responses; maximum tolerated dose not yet reached
- Patent rights
secured for TJ-L14B/ABL503 in Eurasia until 2039
ROCKVILLE,
Md. and SHANGHAI, Oct. 10,
2023 /PRNewswire/ -- I-Mab (Nasdaq: IMAB) (the
"Company"), a global biotechnology company focused on bringing
highly differentiated medicines to patients around the world
through the discovery, development, and commercialization of novel
immunotherapies and biologics, today announced multiple recent
developments in TJ-L14B/ABL503, a differentiated PD-L1 x 4-1BB
bispecific antibody developed in collaboration with ABL Bio
(Kosdaq: 298380). TJ-L14B/ABL503 is designed to address tumors
resistant to PD-(L)1 antibodies through its unique ability to
conditionally activate 4-1BB upon binding to its target, PD-L1.
I-Mab owns 50% of the global rights of TJ-L14B/ABL503.
On September 7, 2023,
TJ-L14B/ABL503 successfully obtained patent registration in eight
Eurasian countries. The patent, officially named
"Anti-PD-L1/Anti-4-1BB Bispecific Antibody and Its Applications,"
secures patent rights extending through 2039. Furthermore, this
patent has already been granted in Chile, South
Africa, and Japan. Patent
examinations are currently underway in over 20 countries, including
the U.S., China, and Europe.
TJ-L14B/ABL503 is currently being investigated in a Phase 1
dose-escalation study in patients with progressive, locally
advanced or metastatic solid tumors who are relapsed or refractory
following prior lines of treatment. The dose-expansion portion of
the Phase 1 study is actively progressing in the U.S. and
South Korea. Currently, we have
observed 1 complete response (CR), 1 partial response (PR), and 2
patients who achieved an unconfirmed objective response upon recent
enrollment. While preliminary efficacy signals have emerged, the
maximum tolerated dose (MTD) has not yet been reached. The Company
anticipates presenting the top-line Phase 1 clinical data at a
major medical conference in the first half of 2024.
"We're encouraged by these early results of TJ-L14B/ABL503 as
they continue to demonstrate the potential of this highly
differentiated treatment for tumor types with significant unmet
need," said Raj Kannan, CEO of I-Mab. "With the success of patent
registrations across multiple countries, and promising preliminary
data from the Phase 1 study, we're reaffirming the possibility for
TJ-L14B/ABL503 to make a significant impact on the lives of people
with cancer. We look forward to sharing more progress on the global
development of TJ-L14B/ABL503."
"The clinical responses observed in the Phase 1 clinical study
of TJ-L14B/ABL503, though in early stages, not only provide
validation of our technology platform but also offer proof of the
mechanism behind this innovative bispecific antibody," said
Sanghoon Lee, CEO of ABL Bio. "We
express our heartfelt gratitude to the patients who participated in
the study, healthcare professionals, study investigators, and our
partners for their invaluable collaboration in achieving this
milestone. Concurrently, we are expediting patent filings for
TJ-L14B/ABL503 to safeguard its rights and facilitate its seamless
entry into the global market."
About TJ-L14B/ABL503
Being developed jointly with ABL Bio (Kosdaq: 298380, hereafter
"ABL"), TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific
antibody with the PD-L1 arm as the tumor-dependent T-cell activator
and the 4-1BB arm as the conditional T cell activator upon tumor
engagement. Using ABL's "Grabody-T" bispecific antibody platform
technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the
presence of PD-L1 expressing tumor cells to minimize the risk of
off-tumor toxicity. Preclinical studies have demonstrated that the
bispecific antibody shows better anti-tumor activity than equimolar
doses of single agents alone or in combination. A Phase 1 study is
currently being conducted in the U.S. and South Korea.
About I-Mab
I-Mab (Nasdaq: IMAB) is a global biotechnology
company focused on bringing highly differentiated medicines to
patients around the world through the discovery, development, and
commercialization of novel immunotherapies and
biologics. I-Mab's innovative pipeline is driven by
internal R&D's Fast-to-Proof-of-Concept, Fast-to-Market
development strategies, and through global partnerships. For
more information, please
visit https://www.i-mabbiopharma.com and follow us
on LinkedIn, Twitter, and WeChat.
I-Mab Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and other federal securities laws, including statements regarding
data from clinical studies of TJ-L14B/ABL503, the potential
implications of clinical data for patients, and I-Mab's advancement
of, and anticipated clinical development, regulatory milestones,
and commercialization of TJ-L14B/ABL503. Actual results may differ
materially from those indicated in the forward-looking statements
as a result of various important factors, including but not limited
to I-Mab's ability to demonstrate the safety and efficacy of its
drug candidates; the clinical results for its drug candidates,
which may not support further development or NDA/BLA approval; the
content and timing of decisions made by the relevant regulatory
authorities regarding regulatory approval of I-Mab's drug
candidates; I-Mab's ability to achieve commercial success for its
drug candidates, if approved; I-Mab's ability to obtain and
maintain protection of intellectual property for its technology and
drugs; I-Mab's reliance on third parties to conduct drug
development, manufacturing and other services; I-Mab's limited
operating history and I-Mab's ability to obtain additional funding
for operations and to complete the development and
commercialization of its drug candidates; and the impact of the
COVID-19 pandemic on the Company's clinical development, commercial
and other operations, as well as those risks more fully discussed
in the "Risk Factors" section in I-Mab's most recent annual report
on Form 20-F, as well as discussions of potential risks,
uncertainties, and other important factors in I-Mab's subsequent
filings with the US Securities and Exchange Commission. All
forward-looking statements are based on information currently
available to I-Mab, and I-Mab undertakes no obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
may be required by law.
I-Mab Contacts
Investors
|
Media
|
Tyler Ehler
|
Gigi Feng
|
Senior Director,
Investor Relations
|
Chief Communications
Officer
|
IR@i-mabbiopharma.com
|
PR@i-mabbiopharma.com
|
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