I-Mab Announces Encouraging Phase 1 Clinical Data of PD-L1x4-1BB Bispecific Antibody Ragistomig at ASCO 2024
May 23 2024 - 4:05PM
I-Mab (the “Company”) (NASDAQ: IMAB) a U.S.-based, global biotech
company, exclusively focused on the development and potential
commercialization of highly differentiated immunotherapies for the
treatment of cancer, today announced that Gerald Falchook, MD, and
the team at I-Mab’s partner for ragistomig (or “ABL503”), ABL Bio
(KOSDAQ: 298380), will present a poster related to Phase 1 data for
ragistomig at the 2024 American Society for Clinical Oncology
Annual Meeting (“ASCO 2024”), taking place from May 31st to June
4th at the McCormick Place Convention Center in Chicago, IL.
Ragistomig was designed as a bispecific antibody
to provide anti-PD-L1 activity and 4-1BB-driven T-cell activation
in one molecule. The combination of an Fc-silent and conditional
4-1BB engagement was intended to optimize the compound for safety,
including the potential for lower hepatotoxicity compared to
traditional 4-1BB agonists.
The first-in-human Phase 1 study was designed to
define the dose-limiting toxicity and safety profile of ragistomig
monotherapy (primary endpoints) as well as to observe the objective
response rate (ORR), pharmacokinetic (PK) and immunogenicity
profiles (secondary endpoints). The study is being conducted in
patients with advanced or relapsed/refractory solid tumors and the
majority of patients (56.6%) received prior anti-PD(L)-1
immunotherapy. The main observations from the study include:
- A manageable safety profile;
- Definition of an optimal dose of 5
mg/kg, with dose proportional pharmacokinetics (PK);
- Overall response rate of 25% at 5
mg/kg, based on 3 partial responses (PR) out of 12 patients with
median progression free survival (PFS) of 15.6 weeks;
- Clinical benefit rate of 75% at 5
mg/kg, based on 3 PRs and 6 stable disease (SD);
- 71.4% of responders had received
prior anti-PD-(L1) inhibitors and were all relapsed or refractory
to anti-PD-(L1) inhibitors; and
- A complete response (CR) was seen
in one heavily pretreated patient (7 prior lines of therapy,
ovarian cancer) at 3 mg/kg.
“We are pleased to present the Phase 1 data to
date for ragistomig at ASCO 2024. While immune checkpoint
inhibitors have made a significant contribution to the treatment of
solid tumor cancers, many tumors do not respond or become
refractory to these agents. Ragistomig was designed to provide a
new treatment option for patients who are resistant to immune
checkpoint inhibitors,” said Raj Kannan, Chief Executive Officer at
I-Mab. “Topline data indicate that the study met its objectives,
enabling the definition of an optimal dose, and provided several
early efficacy observations in patients relapsed or refractory to
prior checkpoint inhibitor treatment. These data support further
development of ragistomig as both a monotherapy and in combination
with other compounds. We look forward to advancing the clinical
program in collaboration with our partner, ABL Bio.”
Louie Naumovski, MD, PhD, Interim Chief Medical
Officer for I-Mab commented, “We are pleased by ragistomig’s
manageable safety, T-cell activation profile and dose proportional
pharmacokinetics. Observation of responses is also encouraging,
including a 25% ORR and a 75% clinical benefit rate (CBR), at the
optimal dose of 5 mg/kg. Notably, the majority of patients were
heavily pretreated, with three or more lines of therapy, including
a prior PD-(L)1 inhibitor, and the majority of responders (71.4%)
had received prior anti-PD-(L)1 therapy. Together, these data
provide sound support to continue the development of ragistomig,
with ongoing follow-up of this initial Phase 1 study.”
The data will be reported in a poster entitled
“Phase 1 trial Safety and Efficacy of Ragistomig, a Bispecific
Antibody Targeting PD-L1 and 4-1BB in Advanced Solid Tumors”
(Abstract #2529, Poster Board 8), at ASCO 2024 on June 1, 2024 from
9:00 a.m. – 12:00 p.m. C.D.T. in the Developmental Therapeutics –
Immunotherapy session by Dr. Gerald Falchook, MD, Director of the
Sarah Cannon Research Institute at HealthONE, a clinical trials
program in Denver, Colorado, for patients with advanced cancer.
About Ragistomig
Being developed jointly with ABL Bio, ragistomig
(also known as ABL503) is a differentiated PD-L1-based bispecific
antibody that fuses an Fc-silent anti-PD-L1 arm, as the
tumor-dependent T-cell activator, with a single chain variable
fragment of an anti-4-1BB engaging antibody, as the conditional
T-cell activator, upon tumor engagement. Using ABL Bio’s
“Grabody-T” bispecific antibody platform technology,
ragistomig/ABL503 stimulates 4-1BB activation only in the presence
of PD-L1 expressing tumor cells to minimize the risk of off-tumor
toxicity and overcome resistance to PD-(L)1 inhibition. 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 dose escalation and dose expansion study
(NCT04762641) is currently being conducted in the U.S. and South
Korea. The study was designed to define the dose-limiting toxicity
and adverse event profile of ragistomig (primary endpoints) as well
as to observe the objective response rate, pharmacokinetic and
immunogenicity profiles (secondary endpoints).
About I-Mab
I-Mab (NASDAQ: IMAB) is a U.S.-based global
biotech company, exclusively focused on the development and
potential commercialization of highly differentiated
immunotherapies for the treatment of cancer. I-Mab has established
operations in the U.S. in Rockville, Maryland, and in San Diego,
California. For more information, please visit
http://www.i-mabbiopharma.com and follow us on LinkedIn and X.
I-Mab Forward Looking Statements
This announcement contains forward-looking
statements. These statements are made under the “safe harbor”
provisions of the U.S. Private Securities Litigation Reform Act of
1995. These forward-looking statements can be identified by
terminology such as “will”, “expects”, “anticipates”, “future”,
“intends”, “plans”, “believes”, “estimates”, “confident”, “design”,
“encourage”, “forward”, “continue”, “ongoing”, and similar terms or
the negative of such terms. Statements that are not historical
facts, including statements about I-Mab’s beliefs and expectations,
are forward-looking statements. These forward-looking statements
include, but are not limited to, statements regarding the
following: the anticipated reporting of Phase 1 data for
ragistomig/ABL503 at ASCO 2024; the intended design, composition,
use, and benefits of ragistomig/ABL503 (including to optimize the
compound for safety, including the potential for lower
hepatotoxicity compared to traditional 4-1BB agonists, and to
provide a new treatment option for patients who are resistant to
immune checkpoint inhibitors); the intended design of the Phase 1
study; the potential implications of the observations of the first
in-human Phase 1 study; I-Mab’s intent to advance the clinical
program in collaboration with ABL Bio; and the intent to continue
the development of ragistomig/ABL503, with ongoing follow-up of the
initial Phase 1 study. These forward-looking statements involve
inherent risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
forward-looking statements. These risks and uncertainties include,
but are not limited to the following: I-Mab’s ability to
demonstrate the safety and efficacy of its drug candidates; the
clinical results for its drug candidates, which may or may not
support further development or New Drug Application/Biologics
License Application 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; as well as the
discussions of potential risks, uncertainties, and other important
factors in I-Mab’s most recent annual report on Form 20-F and
I-Mab’s subsequent filings with the SEC. I-Mab may also make
written or oral forward-looking statements in its periodic reports
to the U.S. Securities and Exchange Commission (the “SEC”), in its
annual report to shareholders, in press releases and other written
materials and in oral statements made by its officers, directors or
employees to third parties. All forward-looking statements are
based on information currently available to I-Mab. 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 |
Senior Director, Investor
Relations |
IR@i-mabbiopharma.com |
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