UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO
RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Month of May, 2024
Commission File Number: 001-39173
I-MAB
(Translation of registrant’s name into English)
2440 Research Blvd, Suite 400
Rockville, MD 20850
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F
x Form 40-F ¨
EXHIBIT INDEX
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 23, 2024
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I-MAB |
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By: |
/s/ Joseph Skelton |
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Name: |
Joseph Skelton |
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Title: |
Chief Financial Officer |
Exhibit 99.1
I-Mab
Announces Encouraging Phase 1 Clinical Data of PD-L1x4-1BB Bispecific Antibody Ragistomig at ASCO 2024
| - | Encouraging objective responses were observed in heavily pre-treated
patients, including 1 complete response (CR) and 6 partial responses (PR), mainly in patients previously treated with checkpoint
inhibitors |
| - | Phase
1 dose-escalation data demonstrated that ragistomig monotherapy can be safely administered
through the highest planned doses |
| - | Data
will be presented at the 2024 Annual Meeting of the American Society of Clinical Oncology
(ASCO2024) in a poster session scheduled for June 1, 2024 at 9:00 am CDT |
ROCKVILLE, MD,
May 23, 2024 – 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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