SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2020
Commission File Number: 001-39173
Suite 802, West Tower, OmniVision, 88 Shangke Road, Pudong District
Peoples Republic of China
(Address of principal executive offices)
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 ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
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, thereunto duly authorized.
|Title||:||Director and Chief Financial Officer|
Date: November 12, 2020
Exhibit 99.1Press Release
I-Mab Announces Preclinical Data on Differentiated Anti-C5aR Antibody
TJ210/MOR210 at SITC 2020
Oral presentation highlights the unique epitope, pharmacological profile and anti-tumor
properties of TJ210/MOR210
SHANGHAI, China, and GAITHERSBURG, MD. November 11, 2020 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.
TJ210/MOR210 is a novel human antibody directed against C5aR derived from MorphoSyss 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.
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 Companys mission is to bring transformational medicines to patients around the world through innovation. I-Mabs innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Companys 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-Mabs 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-Mabs 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-Mabs drug candidates; I-Mabs ability to achieve commercial success for its drug candidates, if approved; I-Mabs ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mabs reliance on third parties to conduct drug development, manufacturing and other services; I-Mabs limited operating history and I-Mabs 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 Companys clinical development, commercial and other operations, as well as those risks more fully discussed in the Risk Factors section in I-Mabs most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mabs 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.
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