IMAB I-MAB

37.11
-2.03  -5%
Previous Close 39.14
Open 38.3
52 Week Low 9.3
52 Week High 47.46
Market Cap $2,616,095,984
Shares 70,495,715
Float 14,815,090
Enterprise Value $630,837,889
Volume 243,049
Av. Daily Volume 256,081
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
TJD5
Advanced solid tumors
Phase 1
Phase 1
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
TJ301 (olamkicept)
Ulcerative colitis
Phase 2
Phase 2
Phase 2 trial ongoing.
MOR210/TJ210
Solid tumors
Phase 1
Phase 1
Phase 1 to commence 4Q 2020.
TJC4
Advanced cancers
Phase 1
Phase 1
Phase 1 data presented at SITC meeting November, 2020.
Enoblituzumab
Head and neck cancer
Phase 2
Phase 2
Phase 2 trial to be initiated 1Q 2021.
TJM2
COVID-19
Phase 1/2
Phase 1/2
Phase 1 interim data released May 27, 2020.
Eftansomatropin (TJ101)
Growth hormone deficiency
Phase 3
Phase 3
Phase 3 trial planned.
TJM2
Rheumatoid arthritis
Phase 1b
Phase 1b
Phase 1b trial to commence 2Q 2020.
TJ202/MOR202
Multiple Myeloma (MM) - second line
Phase 3
Phase 3
Phase 3 ongoing.
TJ202/MOR202
Systemic lupus erythematosus
Phase 1b
Phase 1b
Phase 1b trial planned.
TJ202/MOR202
Third-line multiple myeloma
Phase 3
Phase 3
Phase 3 ongoing (China).

Latest News

  1. SHANGHAI and GAITHERSBURG, Md., Dec. 1, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today filed a registration statement on Form F-1 with the Securities and Exchange Commission (the "SEC") by using a "shelf" registration process with respect to 25,123,751 ordinary shares of the Company (represented by 10,923,370 American depositary shares ("ADSs") beneficially owned by certain shareholders, which are parties to the privately negotiated subscription agreements with the Company dated September 3, 2020 (the "PIPE Agreements" and such parties, the "PIPE Investors").  

    A preliminary prospectus, which is part of…

    SHANGHAI and GAITHERSBURG, Md., Dec. 1, 2020 /PRNewswire/ -- I-Mab (the "Company") (NASDAQ:IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today filed a registration statement on Form F-1 with the Securities and Exchange Commission (the "SEC") by using a "shelf" registration process with respect to 25,123,751 ordinary shares of the Company (represented by 10,923,370 American depositary shares ("ADSs") beneficially owned by certain shareholders, which are parties to the privately negotiated subscription agreements with the Company dated September 3, 2020 (the "PIPE Agreements" and such parties, the "PIPE Investors").  

    A preliminary prospectus, which is part of the registration statement on Form F-1, is available on the SEC's website at www.sec.gov. The ordinary shares represented by ADSs may not be sold nor may offers to buy be accepted prior to the time the registration statement on Form F-1 containing the preliminary prospectus becomes effective under the Securities Act of 1933, as amended.

    This announcement shall not constitute an offer to sell, or a solicitation of an offer to buy, the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    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 LinkedInTwitter and WeChat.

    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. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in I-Mab's filings with the SEC. All information provided in this press release is as of the date of this press release, and I-Mab does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:   

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:   

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content:http://www.prnewswire.com/news-releases/i-mab-files-shelf-registration-statement-for-pipe-investors-301183076.html

    SOURCE I-Mab

    View Full Article Hide Full Article
  2. SHANGHAI and GAITHERSBURG, Md., Dec. 1, 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 the strengthening of its Scientific Advisory Board ("SAB") with the appointment of leading international experts Dr. Chen Dong and Dr. Jun Ma. Both will contribute their esteemed depth of expertise in immunology and hematology to provide scientific review and advise the Company on research and development programs.   

    "We are honored and delighted to welcome Dr. Dong and Dr. Ma to our scientific advisory board," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "Dr. Dong is a globally…

    SHANGHAI and GAITHERSBURG, Md., Dec. 1, 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 the strengthening of its Scientific Advisory Board ("SAB") with the appointment of leading international experts Dr. Chen Dong and Dr. Jun Ma. Both will contribute their esteemed depth of expertise in immunology and hematology to provide scientific review and advise the Company on research and development programs.   

    "We are honored and delighted to welcome Dr. Dong and Dr. Ma to our scientific advisory board," said Dr. Jingwu Zang, Founder, Honorary Chairman and Director of I-Mab. "Dr. Dong is a globally recognized leader in the field of immunology and Dr. Ma is a distinguished pioneer in hematology and oncology. I-Mab will greatly benefit from their experience and expertise in their respective fields as we advance our mission to bring transformational medicines to patients around the world through innovation."

    "I-Mab has built a leading position in immuno-oncology and I have been impressed with what this company has been able to accomplish in research and clinical development. I look forward to bringing my expertise to the advisory board and contributing to I-Mab's rapid growth, in China and globally," said Dr. Chen Dong.

    Dr. Dong is currently Professor and Director of the Institute for Immunology at Tsinghua University, and a principal investigator at Shanghai Renji Hospital. He is a fellow of the American Association for the Advancement of Science and a member of the Chinese Academy of Sciences. Dr. Dong specializes in immunology, and his transformative research has led to ground-breaking discoveries in the field of T cell biology and interleukin (IL)-17 family cytokines. His research focuses on understanding the molecular mechanisms whereby immune and inflammatory responses are normally regulated, and to apply this knowledge to the understanding and treatment of autoimmunity and allergy disorders as well as cancer. With over 200 publications, Dr. Dong has been rated a highly cited researcher for seven consecutive years from 2014 to 2020. He is the recipient of several distinguished awards, including the 2009 American Association of Immunologists-BD Bioscience Investigator Award and the 2019 International Cytokine and Interferon Society Biolegend-William E. Paul Award.

    "I-Mab is developing advanced and innovative programs in novel anti-cancer therapies. The company is well-positioned to bring to patients target therapies in areas of significant unmet need, and I am pleased to be joining at such an exciting stage in its growth," said Dr. Jun Ma.

    Dr. Ma is currently Director of the Harbin Institute of Hematology & Oncology, and Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology. He started his studies in the University of Tokyo Hospital and, over the decades, his research focused on treatments for leukemia and lymphoma. He was the first to establish a culture system for multiple hematopoietic progenitor cells in vitro in China. Since 1983, he has used sequential therapy of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) to treat acute promyelocytic leukemia (APL) for about 1200 cases. Dr. Ma has published about 200 articles and conducted 8 China's National R&D Programs and 25 provincial or municipal-level projects. He is highly recognized as the leader in hematology in China.

    Dr. Dong and Dr. Ma join existing SAB members Patricia LoRusso, Eric K. Rowinsky, Howard L. Weiner, Yilong Wu, Timothy A. Yap and Roy S. Herbst.

    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, Twitter and WeChat.

    For more information, please contact:

    I-Mab

    Jielun Zhu, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-appoints-leading-immunology-and-hematology-experts-to-its-scientific-advisory-board-301182310.html

    SOURCE I-Mab

    View Full Article Hide Full Article
  3. SHANGHAI and GAITHERSBURG, Md., Nov. 13, 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 it will hold a call with investors on Friday, November 13 at 8:20 a.m. ET to provide deep dive analysis of preliminary clinical efficacy results of its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors. The results are being presented this week at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The purpose of the call is to provide an expanded analysis of the clinical efficacy signal from…

    SHANGHAI and GAITHERSBURG, Md., Nov. 13, 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 it will hold a call with investors on Friday, November 13 at 8:20 a.m. ET to provide deep dive analysis of preliminary clinical efficacy results of its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors. The results are being presented this week at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The purpose of the call is to provide an expanded analysis of the clinical efficacy signal from the U.S. phase 1 clinical trial, which is not previously discussed.  

    Please click here to access the meeting presentation.

    I-Mab Conference Call and Webcast Information

    Investors and analysts are invited to join the conference call on November 13 at 8:20 a.m. ET using the following dial-in information:

    United States:

    +1-866-519-4004

    International:         

    +65-6713-5090

    Mainland China:

    400-620-8038

    Hong Kong:

    800-906-601

    Conference ID:

    4556519

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1 855-452-5696 (U.S.), +61 2 8199-0299 (International), 400-632-2162 (Mainland China), or 800-963-117 (Hong Kong). The conference ID number for the replay is 4556519. The replay will be available through November 20, 2020.

    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 minimal untoward effect on red blood cells, thus avoiding 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 the 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 the treatment of solid tumors and with Rituxan® for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with 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, Twitter 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, Chief Financial Officer

    E-mail:   

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:   

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-to-hold-investor-call-and-expand-clinical-data-analysis-on-efficacy-signal-of-lemzoparlimab-from-phase-1-clinical-trial-301172669.html

    SOURCE I-Mab

    View Full Article Hide Full Article
  4. SHANGHAI and GAITHERSBURG, Md., Nov. 11, 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 new preclinical data from in vivo and in vitro studies of its C5aR antibody project, TJ210/MOR210, at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data will be shared in an oral presentation entitled "TJ210 (MOR210), A Differentiated Anti-C5aR Antibody for Anti-Cancer Therapy", on November 12, 2020 at 11:30 am EST (Abstract #607).

    Complement component fragment 5a receptor (C5aR1, CD88) is a G-protein coupled receptor (GPCR) that is being investigated as a potential new drug target in the field of immuno-oncology. Produced in the tumoral microenvironment, C5a acts as a chemoattractant to recruit, through its C5aR1 receptor, tumor-promoting cells such as myeloid derived suppressive cells (MDSCs), neutrophils and M2 macrophages to the tumor site, resulting in the inhibition of tumor-attacking immune cells and promotion of tumor progression.

    TJ210/MOR210 is an anti-C5aR monoclonal antibody in-licensed from MorphoSys. It is designed to interact with the N-terminus of C5aR1 and induces anti-tumor properties by blocking the activation and migration of C5aR1-expressing myeloid cells. Key results from preclinical studies show that: 

    • TJ210/MOR210 selectively binds to the N-terminus of C5aR1 with high affinity and is not cross-reactive to other related GPCRs.
    • Blockade of C5a/C5aR pathway inhibits the recruitment of tumor promoting cells, leading to the significant inhibition of tumor growth when combining with another immuno-oncology therapy, e.g. anti-PD-1 antibody.
    • TJ210/MOR210 demonstrated a good safety profile of a 4-week repeat dose GLP toxicity study in cynomolgus monkeys, with no observed adverse effects up to the highest dose tested at 200 mg/kg and no impact on neutrophils.

    "TJ210/MOR210 is one of the innovative monoclonal antibodies in our differentiated pipeline that brings together the best of science in immuno-oncology," said Dr. Joan Shen, CEO of I-Mab. "We are eager to advance this innovative program in clinical development, which has the potential to address the unmet need in cancer for patients around the world."

    The preclinical data provide new understanding of the underlying mechanism of TJ210/MOR210 and a strong scientific rationale for TJ210/MOR210 to be further evaluated as a potential treatment for cancers. I-Mab and MorphoSys recently announced that the U.S. Food & Drug Administration approved the Investigational New Drug (IND) application to initiate a phase 1 trial of TJ210/MOR210 for the treatment of relapsed or refractory advanced solid tumors.

    About TJ210/MOR210

    TJ210/MOR210 is a novel human antibody directed against C5aR derived from MorphoSys's HuCAL Platinum® technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a, which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), M2 macrophages and neutrophils, is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. TJ210/MOR210 is intended to block the interaction between C5a and its receptor, thereby potentially neutralizing the immune suppressive function of C5a and enabling immune cells to attack the tumor.

    HuCAL Platinum® is a registered trademark of MorphoSys AG.

    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, Twitter 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 TJ210 preclinical and clinical studies, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of TJ210. 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, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-announces-preclinical-data-on-differentiated-anti-c5ar-antibody-tj210mor210-at-sitc-2020-301170813.html

    SOURCE I-Mab

    View Full Article Hide Full Article
  5. SHANGHAI and GAITHERSBURG, Md., Nov. 9, 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 initial results from its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors and lymphoma. The results were released in a poster entitled "A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results" at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, on November 9, 2020 (Abstract #385).  

    SHANGHAI and GAITHERSBURG, Md., Nov. 9, 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 initial results from its U.S. phase 1 clinical trial (NCT03934814) evaluating lemzoparlimab (also known as TJC4) for the treatment of relapsed or refractory solid tumors and lymphoma. The results were released in a poster entitled "A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results" at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting, on November 9, 2020 (Abstract #385).  

    Lemzoparlimab is a unique CD47 antibody that exerts strong anti-tumor activity while exhibiting a minimal binding to red blood cells. It is designed to avoid severe anemia -- a common toxicity of CD47 antibodies of the same class.

    "Lemzoparlimab was originally discovered and developed by I-Mab as a globally competitive CD47 antibody and has been uniquely designed to overcome the toxicity associated with this drug target," said Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of I-Mab. "The initial clinical results are consistent with the key differentiation of lemzoparlimab in terms of drug safety and the PK profile. These clinical advantages put lemzoparlimab in a highly competitive position among CD47 antibodies of the same class."

    The phase 1 study is an open-label, multi-center, multiple dose study conducted in two parts. The first part is comprised of a single agent dose escalation followed by two separate combination regimens in an escalating dose range (Part 1b with pembrolizumab; Part 1c with rituximab). The second part is a dose expansion study in the combination therapies.

    The data to be presented at SITC include the initial results from the single agent therapy (N=20), which is designed to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of lemzoparlimab. The key findings include:

    • Lemzoparlimab was well tolerated up to 30 mg/kg on a weekly basis without priming dosing strategy. No dose-limiting toxicity and no clinical or laboratory evidence of hemolytic anemia were observed throughout.
    • Lemzoparlimab PK appears to be linear at mid to high dose levels following a single dose with no significant "sink effect".
    • One confirmed Partial Response (PR) was observed in the 30 mg/kg monotherapy cohort (N=3). The patient had failed prior treatments with checkpoint inhibitors.

    "We are very encouraged by the safety and tolerability data that have emerged from the phase 1 trial," said Jordan Berlin, M.D. from Vanderbilt University, the principal investigator of the trial. "It shows the promise of lemzoparlimab as a differentiated CD47 antibody for multiple cancers, and we look forward to advancing the development of lemzoparlimab for patients with advanced solid tumors and hematologic malignancies."  Dr. Berlin will present the data during the virtual poster sessions on November 11, 2020 5:15-5:45 p.m. EST and November 13, 2020 4:40-5:10 p.m. EST.

    Recruitment of patients for the dose escalation study of lemzoparlimab in combination with pembrolizumab or rituximab is ongoing. Additional information on the clinical trial (NCT03934814) is available on www.clinicaltrials.gov.

    In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab. Subject to pre-closing conditions, both companies will be collaborating to further advance the clinical development of lemzoparlimab for the treatment of multiple cancers globally and in China.  

    I-Mab Conference Call and Webcast Information

    Investors and analysts are invited to join the conference call today at 8:30 a.m. ET using the following dial-in information:

    United States:

    +1-888-346-8982

    International:         

    +1-412-902-4272

    Mainland China:

    400-120-1203

    Hong Kong:

    800-905-945

    Conference ID:

    10149942

    A live webcast and an archived replay of the conference call can be accessed on the Company's investor relations website at http://ir.i-mabbiopharma.com.

    A telephone replay will be available approximately two hours after the conclusion of the call by dialing +1-877-344-7529 (U.S.), 1-412-317-0088 (International). The conference ID number for the replay is 10149942. The replay will be available through November 16, 2020.

    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 minimal untoward effect on red blood cells, thus avoiding 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 the 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 the treatment of solid tumors and with Rituxan® for the treatment of patients with lymphoma in the U.S., in addition to an ongoing clinical trial with 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, Twitter 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, Chief Financial Officer

    E-mail:

    Office line: +86 21 6057 8000

    Gigi Feng, Chief Communications Officer

    E-mail:

    Office line: +86 21 6057 5785

    Investor Inquiries:

    Burns McClellan, Inc. (Americas and Europe)

    Steve Klass

    E-mail:

    Office line: +1 212 213 0006

    The Piacente Group, Inc. (Asia)

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/i-mab-reports-phase-1-clinical-trial-data-of-highly-differentiated-anti-cd47-monoclonal-antibody-lemzoparlimab-at-the-2020-sitc-annual-meeting-301168649.html

    SOURCE I-Mab

    View Full Article Hide Full Article
View All I-MAB News