IMAB I-MAB

76.85
-1.29  -2%
Previous Close 78.14
Open 78.36
52 Week Low 28.29
52 Week High 85.4
Market Cap $5,782,341,859
Shares 75,241,924
Float 19,561,299
Enterprise Value $5,270,545,707
Volume 411,980
Av. Daily Volume 735,247
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Upcoming Catalysts

Drug Stage Catalyst Date
Plonmarlimab (TJM2)
COVID-19
Phase 2
Phase 2
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Plonmarlimab (TJM2)
Rheumatoid arthritis
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
Protollin
Alzheimer's Disease
Phase 1
Phase 1
Phase 1 IND filing acceptance announced July 30, 2021.
TJ-CD4B/ABL111
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced July 1, 2021.
Uliledlimab (TJ004309)
Solid tumors
Phase 1
Phase 1
Phase 1 data to be presented at ASCO June 4, 2021. 3/30 (15%) response rate.
Lemzoparlimab with Vidaza (Azacitidine)
Acute Myeloid Leukemia / Myelodysplastic Syndrome
Phase 2
Phase 2
Phase 2 trial initiation announced May 18, 2021.
TJ301 (olamkicept)
Ulcerative colitis
Phase 2
Phase 2
Phase 2 trial met primary endpoint.
TJ-CD4B/ABL111
Solid tumors
Phase 1
Phase 1
Phase 1 trial to be initiated.
TJ202/MOR202
Multiple Myeloma (MM) - second line
Phase 3
Phase 3
Phase 3 completion of enrollment due 3Q 2021.
Eftansomatropin (TJ101) - TALLER
Growth hormone deficiency
Phase 3
Phase 3
Phase 3 initiation of dosing announced February 25, 2021. Data due 2Q 2023.
Efineptakin alfa (TJ107)
Glioblastoma multiforme (GBM)
Phase 2
Phase 2
Phase 2 clinical trial initiation in China announced February 4, 2021.
Lemzoparlimab (TJC4)
Advanced cancers
Phase 1
Phase 1
Phase 1 data presented at SITC meeting November, 2020.
MOR210/TJ210
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced January 25, 2021.
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

    • Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer's Disease

    SHANGHAI and GAITHERSBURG, Md., July 30, 2021 /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 U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer's disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer's disease or other dementias, with no cure available…

    • Planning underway for a Phase 1 Trial to assess new immunotherapy aimed at stimulating the innate immune system to clear beta amyloid protein plaques in Alzheimer's Disease

    SHANGHAI and GAITHERSBURG, Md., July 30, 2021 /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 U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) submission for Protollin, an investigational drug to treat Alzheimer's disease, enabling a Phase 1 clinical trial to be initiated. Worldwide, around 50 million people are living with Alzheimer's disease or other dementias, with no cure available. 

    (PRNewsfoto/I-Mab)

    "Advancing Protollin into clinic is a critical milestone in the search to develop novel therapies for this devastating disease, and we are honored to be engaging in a planning process with partners around the globe and contributing our expertise," said Dr. Jingwu Zang, Founder, Chairman and Director of I-Mab.

    Protollin is a new type of immunotherapy aimed at stimulating the innate immune system to activate a response against the build-up of beta amyloid protein plaques and subsequent tau tangles that cause memory loss.

    Brigham and Women's Hospital and Inspirevax (formerly Biodextris) granted I-Mab and Nhwa global exclusive licenses to develop, manufacture, and commercialize Protollin, and Biodextris will manufacture and supply Protollin for preclinical and clinical studies until the recruitment of the first patient in the Phase 1b MAD study[1]. I-Mab will develop and commercialize Protollin outside of the Greater China territory, while Nhwa will develop and commercialize the drug in mainland China, Hong Kong, Macau, and Taiwan.

    About Protollin

    Protollin is a novel immunotherapy aimed at stimulating the innate immune system. It is composed of outer membrane proteins of bacteria complexed with lipopolysaccharides (LPS). There are preclinical data indicating that it can modulate immune cells and has the potential to treat disorders with an immune component. Delivery of Protollin through nasal spray will enable the molecule reach brain and stimulate the expected immune response. The initial data support its potential application in neurodegenerative diseases such as Alzheimer's disease.

    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 transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities 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.

    Special Note Regarding Forward-Looking Statements

    This press release includes certain disclosures which contain "forward-looking statements." You can identify forward-looking statements because they contain words such as "anticipate" and "expected." Forward-looking statements are based on I-Mab, Jiangsu Nhwa, and Inspirevax's (formerly Biodextris) current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in filings with the U.S. Securities and Exchange Commission. I-Mab, Jiangsu Nhwa, and Inspirevax (formerly Biodextris) undertake 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 5709

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:  

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/i-mab-announces-ind-approval-by-fda-to-initiate-phase-1-study-for-protollin-for-the-treatment-of-alzheimers-disease-301345030.html

    SOURCE I-Mab

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  1. SHANGHAI and GAITHERSBURG, Md., July 29, 2021 /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 its Board of Directors (the "Board") has authorized a new stock repurchase program. With the Board's authorization, the Company may repurchase up to US$40 million of its ordinary shares in the form of American depositary shares ("ADS") over the next 12 months.

    In July 2020, the Board first authorized a stock repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of ADS over a 12-month period. The renewed stock repurchase program now has an increased cap of US$40 million.

    "We are pleased that the Board has authorized this new stock repurchase program by the Company." said Dr. Jingwu Zang, Founder and Chairman of I-Mab, "The Company's fundamentals remain very strong and the authorization demonstrates the confidence we have in our globally competitive innovative pipeline and our journey to becoming a fully integrated global biopharma."

    Repurchases, if any, under the program will be made at the discretion of management, and will depend upon market pricing and conditions, business, legal, accounting and other considerations. Any such share purchases will be made by the Company from time to time in open market transactions, or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, or pursuant to a trading plan adopted in accordance with Rule 10b5–1 of the Securities Exchange Act of 1934.

    The repurchase program is effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The program does not obligate I-Mab to acquire any particular number of its ADSs, and the program may be modified or suspended at any time at the management's discretion.

    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 transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities 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.

    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" and similar statements. 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. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking 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, including but 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 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 5709

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:
     

    Office line: + 86 21 6039 8363

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/i-mab-announces-authorization-of-a-renewed-stock-repurchase-program-by-the-company-up-to-us40-million-301344228.html

    SOURCE I-Mab

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    • Efineptakin alfa in combination with pembrolizumab induced 27.8% ORR in metastatic TNBC patients in a phase 1b/2 trial in South Korea
    • Efineptakin alfa in patients with GBM showed a 83.3% survival ratio over one year in a phase 1 trial in the U.S.

    SHANGHAI and GAITHERSBURG, Md., July 28, 2021 /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 an IND application for the initiation of a phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with anti-PD-1 antibody in patients with advanced solid tumors, including triple-negative breast…

    • Efineptakin alfa in combination with pembrolizumab induced 27.8% ORR in metastatic TNBC patients in a phase 1b/2 trial in South Korea
    • Efineptakin alfa in patients with GBM showed a 83.3% survival ratio over one year in a phase 1 trial in the U.S.

    SHANGHAI and GAITHERSBURG, Md., July 28, 2021 /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 an IND application for the initiation of a phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with anti-PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) and head and neck cancers (HNC), has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).  

    Efineptakin alfa is the world's first and only long-acting recombinant human interleukin-7 ("rhIL-7") being developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show a therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Its T-cell properties comes with unique selectivity that only stimulates tumor-fighting lymphocytes and spares tumor-protecting Treg cells, differentiating it from other cytokines such as human IL-2.

    The IND submission leverages accumulative clinical data from multiple previous studies of efineptakin alfa as monotherapy and in combination with checkpoint inhibitors in the treatment of advanced solid tumors, conducted by I-Mab in China and Genexine and NeoImmuneTech in South Korea and the U.S., respectively. Data from the phase 1b/2 Keynote-899 study, presented at SITC 2020, have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda®) induced 27.8% ORR in patients with  metastatic TNBC. According to the data from NIT-110 dose escalation presented at ASCO 2021, the combination treatment was safe and well-tolerated in the study. In addition, interim results from the phase 1 trial (NCT03687957) in newly diagnosed patients with high-grade gliomas that have undergone chemoradiotherapy showed that absolute lymphocyte count (ALC) increased by 1.3 – 4.1 fold at week 4 in a dose-dependent manner and lasted up to 12 weeks after injection, with a one-year survival rate of 83.3% being observed so far.[1] Furthermore, a phase 1b trial (NCT04001075) in China is about to complete to facilitate the further development of efineptakin alfa.

    "Current clinical data suggest that efineptakin alfa has the great potential to revolutionize the treatment in particularly difficult-to-treat cancers," said Dr. Joan Shen, CEO of I-Mab. "We have already initiated a phase 2 trial in lymphopenic patients with newly-diagnosed glioblastoma multiforme earlier this year. With these additional studies, we hope to fast-track the clinical development of efineptakin alfa in China and bring this potentially very valuable treatment to a large population of cancer patients."

    [1] Data can be viewed in NeoImmuneTech's poster presentation at 2021 ASCO Annual Meeting at the following link: http://neoimmunetech.com/_down.html?upload=%2Fupload_rb&fname=AX_7356756659.pdf&orifname=nit_ir%20presentation_asco2021_e.pdf

    About Efineptakin alfa

    Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world's first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine's proprietary hyFc® platform for the discovering of long-acting biologics.  I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

    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 transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities 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.

    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 the efineptakin alfa phase 1/2 trial, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones and commercialization of efineptakin alfa. 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 5709

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: + 86 21 6039 8363

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/i-mab-announces-ind-acceptance-for-phase-2-clinical-trial-of-efineptakin-alfa-in-combination-with-pd-1-therapy-in-china-301343001.html

    SOURCE I-Mab

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  2. SHANGHAI and GAITHERSBURG, Md., July 27, 2021 /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 on July 27, 2021, the Board of Directors of the Company (the "Board") approved a preliminary proposal for the potential dual listing of the Company's newly issued shares on the Science and Technology Innovation Board of the Shanghai Stock Exchange (the "STAR Board"). The Board also authorized certain officers to execute the Listing Tutoring Agreement between the Company and the Sponsor China International Capital Corporation Limited (the "Tutoring Agreement").

    SHANGHAI and GAITHERSBURG, Md., July 27, 2021 /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 on July 27, 2021, the Board of Directors of the Company (the "Board") approved a preliminary proposal for the potential dual listing of the Company's newly issued shares on the Science and Technology Innovation Board of the Shanghai Stock Exchange (the "STAR Board"). The Board also authorized certain officers to execute the Listing Tutoring Agreement between the Company and the Sponsor China International Capital Corporation Limited (the "Tutoring Agreement").

    The proposed dual listing on the STAR Board is expected to be completed in 2022, conditional upon and subject to, among other things, market conditions, further approval of the Board and potentially of the Shareholders at a general meeting of the Company, and the obtaining of the necessary regulatory approvals. Shareholders and potential investors should exercise caution when dealing in the securities of the Company.

    Upon the signing of the Tutoring Agreement, the Company will proceed to make a filing with the Shanghai Branch of China Securities Regulatory Commission for entering the IPO tutoring program, as required by the relevant rules and regulations.

    "We are making concrete progress in our plan to pursue further equity listings on Greater China stock exchanges (including Shanghai Stock Exchange and Hong Kong Stock Exchange)," said Jielun Zhu, CFO of I-Mab. "The potential dual listing on the STAR Board in China will enable us to tap into a complementary shareholder base in the onshore market to support our exciting growth and transition into a fully-integrated global biopharma company."

    The Company will make further announcement(s) to disclose any material updates and progress in respect of the proposed dual listing in accordance with applicable laws and regulations as and when appropriate. This announcement is for information purposes only and does not constitute, or form part of, any invitation or offer to acquire, purchase or subscribe for any securities of the Company.

    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 transition from a clinical stage biotech company toward a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, world-class GMP manufacturing facilities 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.

    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" and similar statements. 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. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking 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, including but 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 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 5709

    Investor Inquiries:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail:

    Office line: +86 21 6039 8363

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/i-mab-announces-preliminary-proposal-for-potential-dual-listing-on-the-star-market-of-the-shanghai-stock-exchange-301342106.html

    SOURCE I-Mab

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    • ABL503/TJ-L14B demonstrates stronger anti-tumor efficacy than anti-PD-L1 or anti-4-1BB monotherapy as well as a good safety profile
    • ABL503 currently in Phase 1 trial to evaluate the safety, tolerability, MTD PK and PD in patients with advanced or metastatic solid tumors

    SEONGNAM, South Korea, July 9, 2021 /PRNewswire/ -- ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC).

    Jointly developed with I-Mab (NASDAQ:IMAB), ABL503 is a bispecific antibody…

    • ABL503/TJ-L14B demonstrates stronger anti-tumor efficacy than anti-PD-L1 or anti-4-1BB monotherapy as well as a good safety profile
    • ABL503 currently in Phase 1 trial to evaluate the safety, tolerability, MTD PK and PD in patients with advanced or metastatic solid tumors

    SEONGNAM, South Korea, July 9, 2021 /PRNewswire/ -- ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC).

    Jointly developed with I-Mab (NASDAQ:IMAB), ABL503 is a bispecific antibody combining PD-L1 checkpoint pathway with 4-1BB agonistic activity to overcome the current limitation of PD-(L)1 therapy and 4-1BB related toxicity. Using ABL's Grabody-T bispecific antibody platform technology, ABL503 induces 4-1BB activation only in the presence of PD-L1 expressing tumors to minimize the risk of 4-1BB related peripheral toxicity. ABL503 is currently being evaluated in a Phase 1 study in the U.S. in patients with locally advanced or metastatic solid tumors (NCT04762641).

    The paper, "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade," was published in collaboration with Su-Hyung Park, PhD, Professor at the KAIST Graduate School of Medical Science and Engineering. The paper highlights key in vitro and in vivo research that demonstrate ABL503's potential as a promising immunotherapeutic agent against cancer.

    In the study, ABL503 induced complete tumor regression in humanized mice, which was superior to anti-PD-L1 or anti-4-1BB monotherapy. Moreover, no tumor growth was observed in these mice when they were rechallenged at 40 days after their first ABL503 treatment, demonstrating that ABL503 treatment yields a prolonged anti-tumor response despite a short-term administration schedule.

    In addition, ABL503 was well-tolerated following a repeated high dose administration of ABL503 in monkeys. Monkeys treated with ABL503 exhibited overall good tolerance with normal liver functions.

    "These published data validate our Grabody-T platform technology to achieve anti-tumor efficacy with a low risk of off-tumor liver toxicity and support the therapeutic value of ABL503 as a potential best-in-class treatment for cancer," said Sang Hoon Lee, PhD, CEO of ABL Bio. "We have great expectations for the program and look forward to further evaluating ABL503 in our Phase 1 study with I-Mab."

    About ABL Bio

    ABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as 'Grabody-T,' 'Grabody-I' and 'Grabody-B' and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier(BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com

    Cision View original content:https://www.prnewswire.com/news-releases/abl-bio-announces-publication-of-preclinical-data-demonstrating-safety-and-efficacy-of-abl503tj-l14b-a-novel-anti-pd-l1-x-4-1bb-bispecific-antibody-301327732.html

    SOURCE ABL Bio, Inc.

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