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I-Mab, published manuscript of ABL111(TJ-CD4B) under co-development with ABL Bio on the inte...
- Demonstrated anti-tumor effect on CLDN18.2-expressing tumor through 4-1BB mediated T cell activation- Expected to be innovative treatment for gastric cancer patients that show a poor prognosis and have limited treatment options Nasdaq listed company I-Mab announced on date that it published manuscript of ABL111(TJ-CD4B, Givastomig) under co-development with ABL Bio on JITC(The journal for ImmunoTherapy of Cancer) which is official journal of SITC(Society for Immunotherapy of Cancer). Manuscript explains about anti-tumor effect of CLDN18.2x4-1BB BsAb Givastomig(hereafter ABL111) that is induced by activating T cell specifically at tumor expressing CLDN18.2, and original title is “Claudin18.2 and 4-1BB bispecific antibody Givastomig exerts anti-tumor activity through CLDN18.2-expressing tumor-directed T cell activation”. ABL111 which targets and binds to CLDN18.2 and 4-1BB at the same time induces potent tumor-killing effect by activating T cell specifically within CLDN18.2-expressing tumor. It is assessed as innovative approach to improve treatment effect in immunotherapy of gastric cancer which shows a poor prognosis and has limitation for treatment options. According to the results of the study, ABL111 binds to CLDN18.2 from low to high expression level and indicated the targeted effect by inducing 4-1BB activation only when it binds to CLDN18.2. Also, in in vivo model, ABL111 showed superior anti-tumor activity and long-lasting inhibition against tumor rechallenge by increasing CD8/Treg cell rate within tumors through immune activation. “The findings from our research demonstrate the significant potential of givastomig in treating gastric cancer patients with varying levels of CLDN18.2 expression,” said Dr. Lin Shen, Professor of Clinical Oncology at the Beijing Cancer Hospital of Peking University, Director of SIP LifeLink Oncology Research Institute, and principal investigator of the first-in-human study of givastomig (NCT04900818). “By activating 4-1BB signaling in a CLDN18.2 engagement-dependent manner, givastomig can avoid the risk of liver toxicity and systemic immune response commonly observed with other 4-1BB stimulating agents in previous clinical trials.” “We are excited to see this manuscript published in JITC, as it showcases the innovative design and remarkable anti-tumor activity in preclinical models of givastomig,” said Dr. Andrew Zhu, President of I-Mab. “This bispecific antibody has demonstrated promising results in preclinical models and ongoing clinical study by effectively activating T cells and triggering a localized immune response within the tumor microenvironment. With ongoing clinical studies, we aim to build upon these findings and ultimately make this innovative therapy accessible to patients with gastric cancer.” “It is glad that immuno-oncology pipeline ABL111’s great efficacy got recognized and introduced through international journal” said Sanghoon Lee, CEO of ABL Bio. “We will keep our active academic activity with ongoing clinical trials including ABL503’s Korea phase 1 expansion and ABL103’s Korea phase 1 that both were began in 2023” he added. ABL111’s clinical trial phase 1 is in progress smoothly in US and China, and it is encouraging that it has shown favorable safety profile and promising efficacy so far in phase 1. Clinical data will be disclosed at major medical conferences by I-Mab within the second half. Meanwhile, ABL Bio's more than 6 pipelines such as ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R) etc. are under global clinical trial by ABL Bio or by its partners in the US, China, Australia and Korea. Pipelines such as ABL103(B7-H4x4-1BB) and ABL104(EGFRx4-1BB) etc. are also under preparation to enter clinical trials by ABL Bio or by its partners. In addition, a number of non-clinical pipelines including ABL602(CLL1xCD3) are also actively underway.
2023-07-06ablbio
ABL Bio to receive 6 million milestone payment for ABL001
- Receive milestone payment from Compass Therapeutics as clinical development progresses- Results of the Phase 1b clinical trial was announced in March 29th… U.S. Phase 2 clinical trial begin in Q3 2022 ABL Bio Inc (CEO, Sang Hoon Lee), a company specializing in bispecific antibody (BsAb), today announced that it will receive $6 million milestone payment from Compass Therapeutics as the clinical development of bispecific antibody ABL001(CTX-009/ES104/NOV1501) has progressed. ABL Bio has issued an invoice to Compass Therapeutics, and is expected to receive the milestone payment within 45 days. Compass Therapeutics (Nasdaq: CMPX) is an American biotech company listed on Nasdaq stock exchange. Compass Therapeutics acquired TRIGR Therapeutics last year and gained global rights to ABL001 (renamed CTX-009) with the exception of South Korean rights. Greater China’s rights were out-licensed to Elpiscience. According to the agreement, ABL Bio is responsible for conducting the Phase 1 clinical trial of ABL001, and Compass Therapeutics will continue further clinical development of the program, including the Phase 2 clinical trial. ABL Bio finished the Phase 1b clinical trial of ABL001 and announced the results of the study in March 29th. The U.S. Phase 2 clinical trial of ABL001 has already received IND approval from the FDA, and dosing of the first patient is expected to take place in Q3 2022. “With the completion of Phase 1b study of ABL001 and the ongoing Phase 2 clinical trials in South Korea and the U.S., ABL Bio secures an additional 6 million dollars. If ABL001 succeeds in commercialization, royalties based on sales can also be expected. In the future, we will improve financial stability through continuous technology transfer and lay the foundation to leap forward as a global biotech company” said Sang Hoon Lee, CEO of ABL Bio. ABL001 is a bispecific antibody that simultaneously blocks Vascular Endothelial Growth Factor A (VEGF-A) and Delta-Like Ligand 4 (DLL4) signaling pathways, which are critical to angiogenesis and tumor vascularization. Compass Therapeutics and Handok are conducting multinational Phase 2 clinical trials for patients with biliary tract cancer in South Korea and the U.S.in China, Elpiscience is conducting Phase 1/2 study in patients with advanced colorectal cancer. Meanwhile, ABL Bio develops BBB shuttling platform, Grabody-B and other pipeline programs including ABL30 1 as potential neurodegenerative diseases treatments. In the immuno-oncology area, pipelines based on Grabody-T and Grabody-I are being developed. ABL503 and ABL111 based on Grabody-T are undergoing phase 1 clinical trials in the U.S. ABL101 and ABL103 are expected to initiate phase 1 clinical trials in 2023. ABL501 utilizing Grabody-I is conducting phase 1 clinical trial in South Korea.
2022-06-27ablbio
ABL Bio Enters Global Collaboration and License Agreement with SANOFI to Advance ABL301 for ...
- ABL and SANOFI to collaborate on the development of ABL301, a potential first-in-class bispecific antibody targeting alpha-synuclein and containing a proprietary brain shuttle, for alpha-synucleinopathies, including Parkinson’s disease- ABL301 uses ABL’s Grabody-B platform technology to effectively cross the blood-brain barrier- ABL to receive $75M upfront and up to $985M in potential milestone payments for exclusive global license to ABL301 January 11, 2022, SEONGNAM, South Korea - ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced an exclusive collaboration and worldwide license agreement with SANOFI to develop and commercialize ABL301, a pre-clinical stage bispecific antibody targeting alpha-synuclein and IGF1R to treat Parkinson’s disease and other potential indications with enhanced blood-brain barrier (BBB) penetration. Under the terms of the agreement, ABL will receive $75 million in upfront payments. In addition, ABL is eligible to receive up to $985 million based on the achievement of predefined development, regulatory and commercialization milestones, including $45 million in near-term milestones. ABL is also eligible to receive royalties on net sales if the product from the collaboration is commercialized. The transaction will become effective after customary closing conditions are met, such as the HSR clearance. SANOFI will receive worldwide exclusive development and commercialization rights to ABL301. Meanwhile, ABL will lead the preclinical development and Phase 1 clinical trial of ABL301. Thereafter, SANOFI will be responsible for further clinical development, regulatory approval and commercialization of ABL301 worldwide. Grabody-B is a BBB shuttling platform that targets the insulin-like growth factor 1 receptor (IGF1R) to maximize BBB penetration of potential therapies for various CNS-related diseases. Utilizing Grabody-B technology, ABL301 effectively carries the anti-alpha-synuclein antibody across the BBB to enhance therapeutic efficacy against Parkinson’s disease. “This groundbreaking partnership with SANOFI proves the immense possibilities of ABL’s innovative bispecific antibody technology” said Sang Hoon Lee, PhD, CEO of ABL Bio. “We will continue to develop our Grabody-B platform and expand its applicability in other neurodegenerative diseases, such as Alzheimer’s, to contribute to improving the lives of patients worldwide.” About ABL301ABL301 is a bispecific antibody composed of an anti-alpha-synuclein antibody and Grabody-B, a BBB-penetrating shuttle targeting insulin-like growth factor 1 receptor (IGF1R). It is being developed as a potential first-in-class bispecific antibody therapeutics for the treatment of synucleinopathies, including Parkinson’s disease. In preclinical studies, ABL301’s anti-alpha-synuclein domain showed robust recognition of pathological aggregates with high affinity and with minimal affinity to monomeric alpha-synuclein. By utilizing the Grabody-B platform, ABL301 is proven to enter the brains and cerebrospinal fluid (CSF) of rodents and non-human primates more efficiently than an alpha-synuclein monoclonal antibody. Due to its superior BBB-penetrating capability, ABL301 showed better efficacy to reduce brain aggregated alpha-synuclein in a Parkinson’s disease mouse model than the monoclonal alpha- synuclein binding antibody. About Grabody-BLow brain exposure has been one of the major obstacles to the development of central nervous system (CNS) drugs. Grabody-B is a molecular shuttle to facilitate the CNS-penetration of therapeutics through straightforward generation of a bispecific antibody or antibody-drug conjugate. Grabody-B is a non-neutralizing anti-IGF1R antibody and therefore does not interfere with IGF1R signaling nor seriously affect the body’s innate IGF1R axis. Grabody-B has proven to induce significantly higher BBB-penetration of various therapeutic antibodies in rodents and non-human primates with superior efficacy or pharmacodynamic effects compared to monoclonal antibodies. Given IGF1R’s relatively specific expression in the CNS and its non-neutralizing property, Grabody-B is believed to be a safe and efficient shuttle to enhance the efficacy of therapeutics for various CNS-related diseases in clinics. About ABL BioABL 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
2022-01-12ablbio
ABL Bio to Present ABL602 Data at the 63rd ASH Annual Meeting
- ABL602 is a CLL-1/CD3 bispecific antibody for acute myeloid leukemia- Preclinical data highlight potential of ABL602 as a new treatment for AML November 5, 2021, SEONGNAM - ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced that new preclinical data for its ABL602, a T-cell engager bispecific antibody targeting CLL-1 and CD3 to treat acute myeloid leukemia (AML), will be presented at the 63rd American Society of Hematology (ASH) Annual Meeting, taking place both online and offline from December 11-14, 2021. “As part of our aim to apply our innovative bispecific antibody technology to a wide range of indications, we are striving to expand our portfolio of blood cancer therapeutics,” said Sang Hoon Lee, PhD, CEO of ABL Bio. “We look forward to participating in the 2021 ASH annual meeting, which will be the first time we showcase ABL602 to a global audience.” Details of the accepted abstract are as follows: Title: A Novel Asymmetrical Anti-CLL-1 x CD3 Bispecific Antibody, ABL602, Induces Potent CLL1-Specific Antitumor Activity with Minimized Sensitization of Pro-Inflammatory CytokinesAbstract Number: 145274Session Title: Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster IIDate & Time: 6:00 PM – 8:00 PM, Sunday, December 12, 2021 About ABL BioABL 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 ABL ContactsInvestor InquiriesHyunjun Kiminvestor.relations@ablbio.com+82 31 8018 9845Media InquiriesHee Jun Parkmedia.relations@ablbio.com+82 31 8014 7032
2021-11-05ablbio
ABL Bio Announces Publication of Preclinical Data Demonstrating Safety and Efficacy of ABL50...
- 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 July 9, 2021 - 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, Ph.D., 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 ABL ContactsInvestor InquiriesHyunjun Kiminvestor.relations@ablbio.com+82 31 8018 9845 Media InquiriesHee Jun Parkmedia.relations@ablbio.com+82 31 8014 7032
2021-07-09ablbio
I-Mab and ABL Bio Announce First Patient Dosed in Phase 1 Trial of Bispecific Antibody TJ-L1...
SHANGHAI, China, GAITHERSBURG, MD, and SEONGNAM, South Korea – April 6, 2021 -- I-Mab (the “Company”) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter “ABL”), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the first patient has been dosed in a phase 1 trial for bispecific antibody TJ-L14B/ABL503. The phase 1 clinical trial is an open-label, multi-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), preliminary antitumor activity, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TJ-L14B/ABL503 in locally advanced or metastatic solid tumors (NCT04762641). 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. “Immune checkpoint inhibitors, such as PD-L1, have created a new paradigm for cancer treatment; however, they have limitations in their efficacy and response rates,” said Dr. Joan Shen, CEO of I-Mab. “Co-targeting of PD-L1 with a bispecific antibody molecule using this particular platform is postulated to enhance antitumor activity while ensuring the safety of the patients. It may provide an alternative therapeutic approach for patients who have not responded to existing treatments.” “We are very pleased to advance the clinical development of TJ-L14B/ABL503 as planned.,” said Dr. Sang Hoon Lee, CEO of ABL. “With phase 1 trial for TJ-L14B/ABL503 being the first testbed for our Grabody-T bispecific antibody platform, we look forward to validating our company’s technology in the field of cancer immunotherapy.” “We are excited to be the first center to conduct this study for TJ-L14B/ABL503,” said Dr. Anthony W. Tolcher, FRCPC, FACP, CEO and director of clinical research at NEXT Oncology. “TJ-L14B/ABL503 has demonstrated potential to overcome the adverse toxicity issues of anti-4-1BB antibodies. In collaboration with I-Mab and ABL, we hope for a thorough evaluation to deliver a highly promising treatment for the benefit of cancer patients.” NEXT Oncology is a phase 1 center in the U.S. dedicated to providing patients with advance cancer access to the newest cancer treatments available. 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. About ABL Bio ABL Bio, Inc. (Kosdaq: 298380) is a 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, 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 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-L14B clinical trials, the potential implications of clinical data for patients, and the advancement by I-Mab and ABL, and anticipated clinical development, regulatory milestones and commercialization of 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 the ability of I-Mab and ABL to demonstrate the safety and efficacy of TJ-L14B; the clinical results for the drug candidate, 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 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. 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 ABL503; 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. I-Mab ContactsJielun ZhuChief Financial Officerjielun.zhu@i-mabbiopharma.com+86 21 6057 8000 Gigi FengChief Communications Officergigi.feng@i-mabbiopharma.com+86 21 6057 8000 Investor InquiriesThe Piacente Group, Inc.Emilie WuE-mail: emilie@thepiacentegroup.comOffice line: +86 21 6039 8363ABL ContactsJaecheon Jerry LeeChief Financial Officerbusiness.development@ablbio.com+82 31 8018 9802 Investor InquiriesHyunjun Kiminvestor.relations@ablbio.com+82 31 8018 9845
2021-04-07ablbio
ABL Bio and LegoChem Biosciences Expand ADC Technology Cooperation
- Companies sign MOU for wider scope of ADC cooperation - Companies recently announced successful L/O of ABL202 November 2, 2020 – ABL Bio and LegoChem Biociences have announced the signing of a memorandum of understanding(MOU) to expand their partnership on ADC technology. The agreement draws attention as it comes shortly after ABL202(LCB71), an ADC co-developed by the two companies, was licensed out to CStone Pharmaceuticals. Under the agreement, the two companies will cooperate on two additional projects, totaling their joint projects to four. While their previous focus was on treatments that combine monoclonal antibodies with LCB’s platform technology, such as ABL202(LCB71), their new projects will center on bispecific antibody ADCs that global pharmaceutical companies are increasingly viewing as a promising sector. This new agreement by ABL Bio and LCB reflect the growing interest in ADC technology. Gilead Sciences recently announced its decision to acquire Immunomedics for approximately $21 billion, at $88 per share in cash. MSD signed a $1.6 billion deal with Seattle Genetics on two new oncology projects. AstraZeneca and Daiichi Sankyo also entered collaboration for the global development and commercialization of another ADC. ABL Bio has the knowledge and proven experience of bispecific antibodies, having acquired a set of bispecific antibody platforms. Combining the company’s BsAb specialty with LCB’s linker and ConjuAllTM Site-specific conjugation technology is anticipated to create a synergy effect in developing next-generation ADCs. Yong-Zu Kim, CEO of LCB said ““Four years of joint research have allowed ABL Bio and LegoChem Biosciences to understand each other’s strengths and build trust. Our long-standing relationship will lead to a much more accelerated and efficient research collaboration.” Sang Hoon Lee, CEO of ABL Bio said “We are happy to announce our two companies’ expanded cooperation in ADC technology. On the backdrop of the recent success of achieving a licensing deal for ABL202, ABL Bio and LCB will work closely together to continue this momentum.” About ABL BioABL Bio, Inc., is a South Korean biotechnology company dedicated to developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. Our company was founded in 2016 and listed on the Korean stock exchange (KOSDAQ) in 2018. With our deep expertise in bispecific antibodies and distinguished R&D personnel, ABL Bio has developed its own set of productive BsAb platforms – ‘Grabody-T,’ ‘Grabody-I,’ and ‘Grabody-B.’ Our company discovered ABL001, the first bispecific antibody to undergo clinical trials in South Korea. Currently in Phase 1b/2a clinical studies in oncology, ABL001 targets VEGF and DLL4 and is anticipated to be the cornerstone for anti-angiogenic, cancer therapy. In the neurodegenerative disorder space, we have developed 'Grabody-B' platform, which is designed to maximize blood-brain barrier(BBB) penetrance. '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, such as Parkinson's disease. For more information, please visit www.ablbio.com.
2020-11-02ablbio
ABL Bio Participates in BIO-Europe Digital
- ABL Bio took part in largest bio conference in Europe- Global pharmaceuticals expressed great interest in ‘Grabody-B’ platform October 30, 2020 – ABL Bio, Inc. announced that it participated in this year’s BIO-Europe Digital, the largest bio conference in Europe. The 26th annual BIO-Europe was held October 26-29, 2020, bringing together over 1,700 companies from 60 countries. The event is considered an opportunity to expand global connections and discover the latest biopharmaceutical trends. ABL Bio said it held one-on-one partnering meetings with global pharmaceutical companies that expressed great interest in the company’s BBB shuttle platform ‘Grabody-B.’ The company also provided an update on the development of ABL301, developed with ‘Grabody-B’ technology as a potential treatment for Parkinson’s disease. ‘Grabody-B’ adopts IGF1R to cross the blood-brain barrier, enhancing the permeability of BBB and stability compared to other platforms. It is considered an alternative for transferrin receptors, which are known to have potential risks of toxicity. Meanwhile, ABL301 demonstrated 15 times higher BBB penetration as compared to a monoclonal antibody without a BBB shuttle in in vitro experiments. In vivo data showed 8 times higher penetration, validating its potential as a next-generation treatment for neuro-degenerative diseases. ABL Bio said “Our participation in BIO-Europe allowed us to understand the global demand for a treatment for neuro disorders, while verifying multinational companies’ interest in our ‘Grabody-B’ platform. We plan to extend our discussions after the conference and anticipate negotiations at a deeper-level at the J.P. Morgan Healthcare Conference next January.” About ABL BioABL Bio, Inc., is a South Korean biotechnology company dedicated to developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. Our company was founded in 2016 and listed on the Korean stock exchange (KOSDAQ) in 2018. With our deep expertise in bispecific antibodies and distinguished R&D personnel, ABL Bio has developed its own set of productive BsAb platforms – ‘Grabody-T,’ ‘Grabody-I,’ and ‘Grabody-B.’ Our company discovered ABL001, the first bispecific antibody to undergo clinical trials in South Korea. Currently in Phase 1b/2a clinical studies in oncology, ABL001 targets VEGF and DLL4 and is anticipated to be the cornerstone for anti-angiogenic, cancer therapy. In the neurodegenerative disorder space, we have developed 'Grabody-B' platform, which is designed to maximize blood-brain barrier(BBB) penetrance. '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, such as Parkinson's disease. For more information, please visit www.ablbio.com.
2020-10-30ablbio
ABL Bio Announces U.S. FDA Approval for COVID-19 Treatment
- FDA greenlights IND Application for Phase 1 clinical trial OFABL901 - Healthy volunteers to be dosed in the coming weeks - ABL901 to enter global Phase 2/3 trials planned for late 2020 September 18, 2020 – ABL Bio and HiFiBiO Therapeutics announced today that the U.S. FDA cleared an investigational new drug application for Phase 1 clinical trial of ABL901(HFB30132A) within three weeks of the IND submission. Following the FDA acceptance, the first healthy volunteer is expected to be dosed early next week. The Phase 1 clinical trial, a single IV administration ascending dose study on 24 healthy subjects, is focused on verifying the safety tolerability, and pharmacokinetics of the antibody drug in healthy participants. The two companies are planning to collaborate on additional trials globally. The Phase I study will be followed immediately by Phase 2/3 studies with study outcome expected in the first half of 2021. ABL901 is a SARS-CoV-2 neutralizing antibody identified from the B cells of a COVID-19 convalescent patient with a high anti-SARS-CoV-2 antibody titer. In vitro and in vivo studies revealed ABL901’s high potency in neutralizing wild-type SARS-CoV-2 and a wide spectrum of mutants, including the highly infectious D614G. ABL901 was engineered to possess a long half-life for long-term protection of individuals against the virus. ABL Bio anticipates the remarkable qualities of ABL901 to help the treatment surpass the global competition. Conducting clinical studies in the U.S. also allows the two companies to expand the market to a global level, so that the antibody treatment can hit markets in all corners of the world. “The fast IND acceptance by the FDA reflects the strong preclinical efficacy and excellent neutralizing potency of ABL901,” said Sang Hoon Lee, PhD, CEO of ABL Bio. “ABL Bio and HiFiBiO plan to cooperate closely to ensure prompt and high-quality clinical development, that can lead to the distribution of an effective COVID-19 treatment to the global population as soon as possible.” About ABL BioABL Bio, Inc., is a South Korean biotechnology company dedicated to developing antibody therapeutics for immuno-oncology and neurodegenerative diseases. Our company was founded in 2016 and listed on the Korean stock exchange (KOSDAQ) in 2018. With our deep expertise in bispecific antibodies and distinguished R&D personnel, ABL Bio has developed its own set of productive BsAb platforms – ‘Grabody-T,’ ‘Grabody-I,’ and ‘Grabody-B.’ Our company discovered ABL001, the first bispecific antibody to undergo clinical trials in South Korea. Currently in Phase 1b/2a clinical studies in oncology, ABL001 targets VEGF and DLL4 and is anticipated to be the cornerstone for anti-angiogenic, cancer therapy. In the neurodegenerative disorder space, we have developed 'Grabody-B' platform, which is designed to maximize blood-brain barrier(BBB) penetrance. '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, such as Parkinson's disease. For more information, please visit www.ablbio.com.
2020-09-18ablbio