IMAB I-MAB

63.6
-1.29  -2%
Previous Close 64.89
Open 64.74
52 Week Low 19.1014
52 Week High 65.94
Market Cap $4,483,527,474
Shares 70,495,715
Float 14,815,090
Enterprise Value $630,837,889
Volume 507,676
Av. Daily Volume 405,235
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Upcoming Catalysts

Drug Stage Catalyst Date
Uliledlimab (TJD5)
Advanced solid tumors
Phase 1
Phase 1
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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
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

  1. TORONTO and CAMBRIDGE, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX:PMN) (OTCQB:ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three months ended March 31, 2021.

    In the first quarter of 2021, ProMIS, like much of society, started to emerge from "pandemic lockdown". Our most important milestone was securing a US $7MM round of financing from a prestigious group of Boston based investors, whose support will allow us to advance our core programs targeting neurodegenerative diseases.

    In…

    TORONTO and CAMBRIDGE, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX:PMN) (OTCQB:ARFXF) ("ProMIS or the Company"), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three months ended March 31, 2021.

    In the first quarter of 2021, ProMIS, like much of society, started to emerge from "pandemic lockdown". Our most important milestone was securing a US $7MM round of financing from a prestigious group of Boston based investors, whose support will allow us to advance our core programs targeting neurodegenerative diseases.

    In addition, in collaboration with Dr. David Wishart of the University of Alberta, we have enhanced and extended our unique technology platform. ProMIS Neurosciences has a unique antibody design capability, which not even the largest pharmaceutical companies have to the best of our knowledge based on ongoing discussions with them. We are able rapidly and cost effectively to design and create antibodies or therapeutic vaccines that only target toxic, mis-folded versions of proteins that otherwise play a normal healthy role. This capability has given ProMIS a growing portfolio of potential "best in class" monoclonal antibodies (or corresponding therapeutic vaccines), including our lead program PMN310, targeting toxic oligomers of amyloid in Alzheimer's. In the Alzheimer's field, positive results or regulatory steps were announced by Lilly, Cassava, and Biogen, all of which support the science suggesting PMN310 may be "best in class".

    Corporate Highlights

    • In January 2021, we announced an outline of our strategic priorities and action plan for 2021. The priorities for 2021 fall into four key areas: near term focus on rare neurodegenerative diseases, especially ALS; use of our proprietary platform to support portfolio expansion; advancement of our PMN310 antibody lead program for Alzheimer's disease (AD); COVID-19, further progress on serological assays.



    • In February 2021, we announced our perspectives on recent progress in the AD field.



    • Two important events occurred in January 2021, both of which we consider very positive for the AD field, for the updated amyloid hypothesis and for the Company. The Food & Drug Administration extended the Prescription Drug User Fee Act date for review of Biogen's aducanumab from March 7 to June 7, 2021.  Eli Lilly & Co. announced positive clinical results for their antibody, donanemab, on January 11, 2021, making it the third antibody with positive clinical results in AD, likely due to its targeting of aggregated amyloid-beta (not amyloid monomer). Both these events have positive implications for PMN310.



    • In March 2021, we completed a US$7.0 million (CDN$8.75 million) private placement of unsecured convertible debentures (Debentures). The Debentures are convertible into common shares at the option of the holder at a conversion price of US$0.10 per share and accrue interest at 1% per annum.

    People

    • Johannes Minho Roth resigned from the ProMIS Board of Directors in February, taking on a senior executive position at UBS Group AG, a Swiss multinational investment bank and financial services company. We thank Johannes for his excellent contributions to the Board and in support of the Company's progress.



    • Michael Grundman, MD, MPH, joins the ProMIS team as senior consultant medical advisor. Dr. Grundman is President and CEO of Global R&D Partners, LLC, a consulting firm that works closely with pharmaceutical and biotechnology companies to develop novel agents for the diagnosis and treatment of serious and life-threatening diseases. Dr. Grundman is Professor of Neurosciences at the University of California San Diego (UCSD). Prior to joining industry, Dr. Grundman was Associate Director of the Alzheimer's Disease Cooperative Study (ADCS) at the University of California, San Diego (UCSD). He received his BA from New York University magna cum laude with Honors in Biochemistry. He obtained his MD and Neurology training at the Albert Einstein College of Medicine and a Master of Public Health degree from Columbia University.



    • Neil K. Warma, MBA, was appointed to the Board of Directors in May 2021. Neil Warma has been a successful healthcare entrepreneur for over 25 years having founded, managed and advised numerous biotech and pharmaceutical companies across the globe. Currently, Mr. Warma is the CEO/General Manager of I-Mab Biopharma U.S., (NASDAQ:IMAB) a publicly traded global biopharmaceutical company with offices and research labs in China (Shanghai, Beijing) and the U.S. (San Diego, Gaithersburg) that focuses on developing and commercializing novel immuno oncology drugs. Previously, as President and CEO of Opexa Therapeutics, a publicly traded biopharmaceutical company, Mr. Warma led the turnaround and rebuilding of the company's cell therapy platform and oversaw its advance through clinical development in autoimmune and orphan diseases, expansion into China and its eventual merger with Acer Therapeutics. Prior to Opexa, he was CEO of Viron Therapeutics, a private biotechnology company developing novel protein-based therapeutics for cardiovascular disease and transplantation.

    Financial Results

    Results of Operations – Three months ended March 31, 2021 and 2020

    Net loss for the three months ended March 31, 2021 was $7,599,417, compared to a net loss of $1,761,919 in the three months ended March 31, 2020. Included in the net loss for the three months ended March 31, 2021 were non-cash expenses of 7,054,543, representing the change in the fair value of an embedded derivative associated with the Debenture financing, reversal of share-based compensation due to the forfeiture of unvested share options, foreign exchange loss, amortization of property and equipment and amortization of an intangible asset, compared to $213,737 for the three months ended March 31, 2020.

    Operating loss before non-cash expenses for the three months ended March 31, 2021 was $582,331, as compared to $1,761,919 in the three months ended March 31, 2020. The decrease in the operating loss for the three months ended March 31, 2021 reflects decreased costs associated with external contract research organizations for internal programs, patent costs, share-based compensation due to the forfeiture of unvested share options, contracted salaries and associated costs and general corporate expenditures offset by an increase in professional fees.

    Research and development expenses for the three months ended March 31, 2021 were $193,923, as compared to $973,586 in the three months ended March 31, 2020. The decrease in research and development expense for the three months ended March 31, 2021, compared to the same period ended March 31, 2020 reflects the conservation of cash resources and decreased costs associated with external contract research organizations for internal programs, reduced patent expense, share-based compensation due to the forfeiture of unvested share options, contracted research salaries and associated costs and external consulting expense.

    General and administrative expenses for the three months ended March 31, 2021 were $388,408, as compared to $788,346 in the three months ended March 31, 2019. The decrease for the three months ended March 31, 2021, compared to the same period in 2020, is primarily attributable to a reduction in contracted corporate salaries and associated costs, share-based compensation and a decrease in foreign exchange losses expense offset by consulting and professional fees.

    Outlook

    Going forward ProMIS will focus on accelerating or re-initiating programs in our core business area, best in class therapeutics for neurodegenerative diseases. In addition, we will continue to expand the application of our unique discovery platform, with which we can "rationally design" antibodies or vaccines to be selective for only mis-folded, pathogenic proteins involved in disease.

    In Alzheimer's we will restart IND enabling work for PMN310, our antibody highly selective for toxic oligomers of amyloid. That selectivity may prove to give PMN310 significant competitive advantages in safety and efficacy over products from Biogen, Lilly, and Eisai that appear to provide benefit slowing the progression of Alzheimer's disease. In addition, starting with the same proprietary technology that creates selective antibodies ("passive" immunotherapy), we are moving forward our program to create therapeutic vaccines ("active" immunotherapy) targeting toxic oligomers of amyloid. Therapeutic vaccines may be a preferred therapy for Alzheimer's prevention; the ultimate goal in Alzheimer's treatment is to detect disease in the ~20 year window before symptoms arise and treat to prevent symptoms of cognitive decline.

    In ALS we will advance our program targeting toxic TDP-43 with further in vitro and in vivo validation, and we will build on the significant scientific advances we have made targeting RACK1 (Receptor for A Activated C Kinase 1). We will also further advance our alpha-synuclein program with further in vivo and in vitro validation, targeting diseases like Parkinson's disease and Multiple System Atrophy.

    About ProMIS Neurosciences, Inc.

    ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). The Company's proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform -ProMIS™ and Collective Coordinates - to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

    Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

    For Investor Relations please contact:

    Alpine Equity Advisors

    Nicholas Rigopulos, President



    Tel. 617 901-0785

    The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



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  2. SHANGHAI and GAITHERSBURG, Md., May 13, 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 I-Mab has been selected for inclusion in the MSCI China All Shares Index, following MSCI's most recent semi-annual review. The inclusion will be implemented as of market close on Thursday, May 27, 2021.

    The MSCI China All Shares Index is constructed based on the integrated China equity universe included in the MSCI Emerging Markets Index, providing a standardized definition of the China equity opportunity set. The index aims to represent the performance of large- and mid-cap segments with H-shares, A-shares, B-shares, red-chips, P-chips and foreign listings (e.g., ADRs) of Chinese stocks. This flagship index is calculated using transparent and innovative methodologies, with a strong emphasis on investability and replicability using stringent size and liquidity eligibility criteria. It is widely followed and closely tracked by global investors as a major benchmark for China equity exposure. For more information, please refer to the Index Review page on MSCI's website at https://www.msci.com/index-review.

    "Becoming a constituent in the MSCI China Index is another significant capital markets milestone for I-Mab, following the inclusion in the NASDAQ Biotechnology Index in December 2020. We are honored to be one of the few China biotech stocks added to this bellwether index, further demonstrating I-Mab's growing profile and recognition among the global investor communities," said Mr. Jielun Zhu, Director and Chief Financial Officer of I-Mab. "As we continue on our journey to become a fully integrated global biopharmaceutical company and execute key value-driving catalysts across our pipeline, from the near-term NDA filing of felzartamab (CD38 antibody) to important data readouts of lemzoparlimab (CD47 antibody) and uliledlimab (CD73 antibody), we are strongly positioned to deliver even greater value to our shareholders."

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the 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 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's 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 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:

    The Piacente Group, Inc.

    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-added-to-msci-china-index-301290822.html

    SOURCE I-Mab

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  3. SHANGHAI and GAITHERSBURG, Md., April 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 its participation in the following conferences in May. Details of the conferences and management presentation are as follows:

    HSBC 8th Annual China Conference (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior Director Investor Relations

    One-on-one and small group meetings: May 11-21, 2021

    For more information, please contact your HSBC representative.

    CICC 2021 Healthcare Investment Forum

    Presentation: Tuesday, May 18, 2021 at 4:30 p.m. China Time

    Presenter: Dr. Joan Huaqiong Shen, Director and Chief Executive Officer

    Location: Pudong Shangri-La Hotel, Shanghai

    One-on-one and small group meetings: May 18-20, 2021

    Management participants: Dr. Joan Huaqiong Shen, Director and Chief Executive Officer and Ms. Leah Liu, Senior Director Investor Relations

    For more information, please contact your CICC representative.

    Macquarie D.E.L.T.A.H. China Conference (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior Director Investor Relations

    One-on-one and small group meetings: May 21, 2021

    For more information, please contact your Macquarie representative.

    Morgan Stanley China Summit (Virtual)

    Management participants: Dr. Jingwu Zang, Founder, Chairman and Director, Dr. Joan Huaqiong Shen, Director and Chief Executive Officer, Mr. Jielun Zhu, Director and Chief Financial Officer, and Ms. Leah Liu, Senior Director Investor Relations

    One-on-one and small group meetings: May 26-28, 2021

    For more information, please contact your Morgan Stanley representative.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter 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:

    The Piacente Group, Inc.

    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-upcoming-participation-at-may-conferences-301279916.html

    SOURCE I-Mab

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  4. SHANGHAI and GAITHERSBURG, Md., April 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 the Company has filed its annual report on Form 20-F for the full year ended December 31, 2020 with the U.S. Securities and Exchange Commission ("SEC") on April 28, 2021.

    The annual report is available on the Company's investor relations website at ir.i-mabbiopharma.com and on the SEC's website at www.sec.gov. The Company will provide hard copies of the annual report, free of charge, to its shareholders and ADS holders upon written request. Requests should be directed to Investor Relations, I-Mab, Suite 802, West Tower, OmniVision, 88 Shangke Road, Pudong District, Shanghai 201210, People's Republic of China.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter 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:

    The Piacente Group, Inc.

    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-filed-2020-annual-report-on-form-20-f-301279034.html

    SOURCE I-Mab

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  5. SHANGHAI and GAITHERSBURG, Md., April 26, 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 positive topline results from its regional multi-center, randomized, double-blind and placebo-controlled phase 2 study (NCT03235752) evaluating the efficacy and safety of olamkicept (also known as TJ301) administered intravenously biweekly in patients with active ulcerative colitis (UC).

    (PRNewsfoto/I-Mab)

    Olamkicept is the only clinical stage selective IL-6 inhibitor that works through the trans-signaling mechanism. IL-6 is an important driver cytokine in the propagation and maintenance of chronic inflammation in autoimmune…

    SHANGHAI and GAITHERSBURG, Md., April 26, 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 positive topline results from its regional multi-center, randomized, double-blind and placebo-controlled phase 2 study (NCT03235752) evaluating the efficacy and safety of olamkicept (also known as TJ301) administered intravenously biweekly in patients with active ulcerative colitis (UC).

    (PRNewsfoto/I-Mab)

    Olamkicept is the only clinical stage selective IL-6 inhibitor that works through the trans-signaling mechanism. IL-6 is an important driver cytokine in the propagation and maintenance of chronic inflammation in autoimmune diseases, such as UC.

    The phase 2 study, one of the first placebo-controlled, proof-of-concept studies of an IL-6 inhibitor in UC, has met both its primary and key secondary efficacy endpoints, demonstrating significantly higher clinical response rates after 12 weeks of treatment in patients receiving 600 mg olamkicept compared to those on placebo (p=0.032). Significantly more patients in the 600 mg olamkicept group achieved clinical remission and mucosal healing than in placebo (p<0.001), two key secondary endpoints of the study. Olamkicept was well tolerated, and with a very acceptable safety profile. Detailed data analysis will be presented at Digestive Disease Week (DDW) 2021 in the U.S. in May and at European Crohn's and Colitis Organisation (ECCO) meeting in July 2021.

    "We are very excited to see that olamkicept demonstrated significant clinical benefits for active UC patients in terms of safety and efficacy through this successful phase 2 study. This is the first demonstration that IL-6 blockade through the trans-signaling pathway plays a significant therapeutic role in UC.  The study provides confidence for further clinical development of this differentiated IL-6 blocker as a treatment option for UC and IBD," said Prof. Minhu Chen, Chair of Gastroenterology and Hepatology and Vice President at the First Affiliated Hospital of Sun Yat-sen University, principal investigator of the study.

    I-Mab entered into a license agreement with Ferring Pharmaceuticals to develop and commercialize olamkicept for Greater China and South Korea in 2016. On April 23rd, 2021, the Company and Ferring signed a memorandum of understanding (MoU) to explore a possible collaboration to advance the development and commercialization of olamkicept in US and Canada, the European Union and Japan, if so agreed.

    "There is an unmet need in the management of inflammatory bowel disease, such as UC, as current pharmacological therapies have significant side effects and develop resistance over time," said Dr. Joan Shen, CEO of I-Mab. "The positive phase 2 clinical data support our belief that olamkicept has the potential to become standard of care in UC, and we are excited by the prospect of exploring a broader reach to patients globally and offer a new treatment option."

    About Olamkicept 

    Olamkicept is a homodimer of a fusion protein consisting of the extracellular domains of human glycoprotein130 ("gp130") and the fragment crystallizable (Fc) domain of human IgG1. It is the only clinical stage selective interleukin-6 ("IL-6") inhibitor that works through the trans-signaling mechanism which is considered an important mediator of the proinflammatory effects of IL-6. The existing IL-6 or IL-6R blockers cause total inhibition of IL-6 signaling, including inhibition of homeostatic effects, and are associated with significant adverse events such as infection, gastrointestinal perforation and metabolic disturbances. Olamkicept, on the other hand, is expected to have more selective effect on the IL-6 driven inflammation and provide a better safety profile based on its mechanism of action and the data from preclinical and clinical studies. Olamkicept has the potential to be a best-in-class to treat UC and other autoimmune diseases where IL-6 is a critical inflammatory mediator. I-Mab acquired an exclusive license from Ferring Pharmaceuticals to develop and commercialize olamkicept in Greater China and South Korea with an option, on terms as further described in the licensing agreement, to expand I-Mab' rights to any of the mutually agreed upon countries from U.S, Canada, the European Union and Japan.

    About the olamkicept Phase 2 clinical study

    The study is a global multicenter, randomized, double-blind, placebo-controlled phase 2 trial (NCT03235752). The primary efficacy endpoint is the percentage of subjects achieving a clinical response per Full Mayo Score at Week 12. The study was conducted at 27 sites in Mainland China, Taiwan and South Korea and enrolled 91 patients who had active ulcerative colitis with a full Mayo score ≥5, a rectal bleeding subscore ≥1, an endoscopy subscore ≥2, and had an inadequate response with conventional UC therapy. Patients were randomized 1:1:1 to receive either olamkicept 300 mg biweekly, or olamkicept 600 mg biweekly or matching placebo, stratified by use of corticosteroids and prior biologics treatment. All endoscopic tests have been read and confirmed by an independent central review committee.

    About ulcerative colitis 

    Ulcerative colitis ("UC") is an inflammatory bowel disease ("IBD") that causes chronic and often relapsing inflammation and ulceration of the colon and rectum, resulting in gastrointestinal symptoms that greatly affect the quality of life of patients. Disease complications may include megacolon, inflammation of the eye, joints, or liver, and colon cancer. Currently, there is no curative treatment for UC especially for those with a moderate-to-severe disease. There is a substantial unmet medical need in UC for a treatment agent(s) that is efficacious and safe through pathways beyond the traditional drug targets.

    About I-Mab

    I-Mab (NASDAQ:IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedInTwitter 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 clinical trials for TJ301, potential implications of clinical data for patients, further development of TJ301 by I-Mab in additional countries, and anticipated clinical development, regulatory milestones and commercialization of TJ301. 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 the ability and timing of I-Mab and Ferring should they agree upon any additional countries to develop TJ301; the ability of I-Mab to demonstrate the safety and efficacy of TJ301; the clinical results for the drug candidate, which may not support further development or BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the drug candidate; the ability to achieve commercial success for the drug candidate, 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:

    The Piacente Group, Inc.

    Emilie Wu

    E-mail: 

    Office line: +86 21 6039 8363

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    SOURCE I-Mab

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