SHANGHAI, China and GAITHERSBURG, MD. October 5, 2021 – I-Mab (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel or highly differentiated biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter “ABL”), a clinical-stage biotech developing bispecific antibody technology for immune-oncology and neurodegenerative diseases, jointly announced that data from the preclinical studies of TJ-CD4B/ABL111 and TJ-L14B/ABL503, will be presented at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021), taking place November 12 – 14, 2021.
TJ-CD4B/ABL111 and TJ-L14B/ABL503 are part of I-Mab's highly differentiated bispecific antibody pipeline that target the 4-1BB co-stimulatory molecule on T-cells and mount an anti-tumor response. Using ABL’s ‘Grabody-T’ bispecific antibody platform technology, both target a highly specific epitope on 4-1BB, which results in localized action and reduced systemic toxicity.
TJ-CD4B/ABL111 engages the Claudin18.2 (CLDB18.2) tumor antigen mainly on gastric and pancreatic cancers to produce localized T-cell activation at the cancer site. It has demonstrated a strong affinity to CLDN18.2-positive cancer cells even at low levels of CLDN18.2 and has potential application in a wide range of cancers. TJ-CD4B/ABL111 is currently undergoing phase 1 trials in the U.S. (NCT04900818) and soon will be in China, in patients with advanced solid tumors, including gastric cancers.
TJ-L14B/ABL503 is a novel bi-specific antibody targeting both PD-L1 and 4-1BB. It engages the PD-L1 molecule on cancer cells and exerts a strong anti-tumor activity through localized activation of T-cells and it is designed to overcome the limited efficacy of anti-PD-L1 therapies and anti-4-1BB-related toxicity. TJ-L14B/ABL503 is currently undergoing a phase 1 clinical trial in the U.S. (NCT04762641) in patients with locally advanced or metastatic solid tumors.
Details of the poster discussion session are as follows:
Abstract Number: 702
Title: TJ-CD4B (ABL111), a Claudin18.2-targeted 4-1BB tumor engager induces potent tumor-dependent immune response without dose-limiting toxicity in preclinical studies
Poster Session: Poster hall, 12-14th November 2021, 7.00 am-5.00 pm
Presenter: Dr. Wenqing Jiang, I-Mab
Abstract Number: 892
Title: ABL503 (TJ-L14B), PD-L1x4-1BB bispecific antibody induces superior anti-tumor activity by PD-L1-dependent 4-1BB activation with the increase of 4-1BB+CD8+ T cells in tumor microenvironment
Poster Session: Poster Hall, 12-14th November 2021, 7.00am-5.00pm
Presenter: Dr. Jaeho Jung, ABL Bio
TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement while silent elsewhere. TJ-CD4B/ABL111 effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Being developed under collaboration between I-Mab and ABL, TJ-CD4B/ABL111 is currently being investigated in a Phase 1 clinical study in the U.S.
Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL's “Grabody-T” bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination. Phase 1 study in currently being conducted in the U.S.
I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and preclinical-stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical-stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility, and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou, Guangzhou, Lishui, 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.
About ABL Bio
ABL Bio, Inc. (Kosdaq: 298380) is a clinical-stage South Korean biotechnology company developing antibody therapeutics for immuno-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, ABL has developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, ABL has developed Grabody-B platform, 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
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 TJ-CD4B and TJ-L14B preclinical studies, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones, and commercialization of TJ-CD4B and TJ-L14B. 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 US 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.
ABL Forward Looking Statements
Statements in this press release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform act of 1995. Words such as “will,” “could,” “hope,” “expect,” “plan” and similar expressions that are based on ABL’s current expectations and assumptions are subject to risks and uncertainties that are difficult to predict. The risks and uncertainties include but are not limited to, potential delays in clinical trial recruitment and participation; ABL and I-Mab’s ability to demonstrate the safety and efficacy of ABL-111 and ABL-503; adverse results in the clinical development process; changes in expected or existing competition; changes in the biopharmaceutical landscape; ABL’s ability to obtain and maintain protection of intellectual property for its technology and drugs; ABL’s reliance on third parties to conduct drug development; the company’s financial position; future decisions by the FDA or other regulatory authorities; volatile global economic conditions; and the impact of the global COVID-19 pandemic. The reader is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to ABL and the company assumes no obligation to provide public updates to these forward-looking statements that are only as of the date of this press release, even if new information is available in the future.