I-Mab to Present Phase 1 Data of Lemzoparlimab at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

Rhea-AI Summary

I-Mab (Nasdaq: IMAB) announced it will present findings from its U.S. phase 1 trial of lemzoparlimab (TJC4), a novel anti-CD47 monoclonal antibody, at the SITC 2020 annual meeting from November 9-14. The data will cover safety, pharmacokinetics, pharmacodynamics, receptor occupancy, and preliminary efficacy of the drug in treating relapsed or refractory malignancies. Lemzoparlimab aims to minimize the side effects commonly associated with similar therapies, marking a significant advancement in cancer treatments. The partnership with AbbVie is expected to enhance its development and commercialization efforts.

Positive

• Presentation of promising phase 1 trial data for lemzoparlimab could enhance investor confidence.
• Lemzoparlimab shows a distinct safety profile compared to other CD47 antibodies.
• Partnership with AbbVie to develop and commercialize lemzoparlimab, expanding its market potential.

Negative

• None.

SHANGHAI and GAITHERSBURG, Md., Oct. 15, 2020 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that the Company's abstract highlighting its U.S. phase 1 dose escalation trial data from its CD47 program, lemzoparlimab (also known as TJC4) in relapsed or refractory malignancy, will be presented at the Society for Immunotherapy of Cancer's 35^th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 - 14, 2020. The data to be presented will include clinical safety, pharmacokinetics (PK) & pharmacodynamics (PD), receptor occupancy (RO), and preliminary evidence of efficacy of lemzoparlimab as a monotherapy.

Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab that has been designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in differentiating lemzoparlimab from other antibodies of the same class currently in clinical development. Initial results from I-Mab's phase 1 study in U.S. described above have demonstrated the unique differentiation in drug safety and pharmacokinetics profile in cancer patients.

Details of the poster are as follows:

Title	A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results
Abstract #	385
Presenting Author	Jordan Berlin, MD, Vanderbilt University

The abstract is available at https://sitc.sitcancer.org/2020/abstracts/titles/

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia. 

Lemzoparlimab's hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda® for solid tumor and with Rituxan® for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML/MDS in China.

In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions. 

About I-Mab

I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to transitioning from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Hong Kong and Maryland, United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn and WeChat.

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 the lemzoparlimab (TJC4) phase 1 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of lemzoparlimab (TJC4). 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 U.S. 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.

For more information, please contact:

I-Mab
Jielun Zhu, CFO
E-mail: jielun.zhu@i-mabbiopharma.com
Office line: +86 21 6057 8000

Gigi Feng, Vice President and Global Head of Corporate Communications
E-mail: gigi.feng@i-mabbiopharma.com
Office line: +86 21 6057 8000

Investor Inquiries:

Burns McClellan, Inc. (Americas and Europe)
Steve Klass
E-mail: sklass@burnsmc.com
Office line: +1 212 213 0006

The Piacente Group, Inc. (Asia)
Emilie Wu
E-mail: emilie@thepiacentegroup.com
Office line: +86 21 6039 8363

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SOURCE I-Mab

FAQ

What are the key findings from I-Mab's phase 1 trial of lemzoparlimab?

The phase 1 trial data includes safety, pharmacokinetics, pharmacodynamics, receptor occupancy, and preliminary evidence of efficacy.

When will I-Mab present its findings from the lemzoparlimab trial?

I-Mab will present its findings at the Society for Immunotherapy of Cancer's annual meeting from November 9-14, 2020.

What is lemzoparlimab's advantage over other CD47 antibodies?

Lemzoparlimab is designed to minimize binding to normal red blood cells, reducing anemia risks while maintaining strong anti-tumor activity.

What is the significance of the partnership between I-Mab and AbbVie?

The partnership aims to enhance the development and commercialization of lemzoparlimab, allowing for broader clinical trials.

What is the focus of I-Mab as a company?

I-Mab focuses on discovering, developing, and commercializing novel biologics, particularly in immuno-oncology and autoimmune diseases.