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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
2021-04-07전체관리자
I-Mab and ABL Bio Receive US FDA Approval to Initiate Phase 1 Trial of Bispecific Antibody T...
March 30, 2021 - I-Mab (the “Company”) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the development of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter “ABL”), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for initiating phase 1 trial for bispecific antibody TJ-CD4B/ABL111. The phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ-CD4B/ABL111 in advanced or metastatic solid tumors. TJ-CD4B/ABL111 is a novel bispecific antibody that works through binding to a tumor antigen Claudin 18.2 (CLDN18.2) which is selectively expressed in several cancers and to 4-1BB, a co-stimulatory molecule expressed on T cells, to activate immune response within tumor for better anti-tumor activity. Preclinical studies demonstrate that TJ-CD4B/ABL111 has superior anti-tumor property as compared to the two monoclonal antibodies when acting alone or in combination. This superior anti-tumor activity is achieved locally on tumor site, thus minimizing the risk of liver and systemic side effects commonly associated with 4-1BB antibody when used alone. "With its high specificity and novel properties, TJ-CD4B/ABL111 could have significant advantages over other 4-1BB monoclonal antibodies in terms of the efficacy and toxicities. It could become a key player against various advanced cancers. We are very excited about the initiation of the clinical study and hope to bring this highly valuable compound to the cancer patients with the critical unmet needs," said Dr. Taylor Guo, chief scientific officer of I-Mab. "With the FDA approval of the IND application to initiate a phase 1 clinical trial of TJ-CD4B/ABL111, we expect to progress rapidly with the clinical development of TJ-CD4B/ABL111," said Dr. Sang Hoon Lee, Founder and CEO of ABL. "In partnership with I-Mab, we look forward to providing a superior therapeutic option for patients with advanced and metastatic solid cancers." The phase 1 clinical study will be a multi-center, dose escalation study in the U.S. I-Mab also plans to conduct dose expansion studies for TJ-CD4B/ABL111 in patients with gastric cancers, gastro-esophageal junction adenocarcinoma, esophageal adenocarcinoma and pancreatic ductal adenocarcinoma in China later this year. About TJ-CD4B/ABL111TJ-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 whilst silent elsewhere. TJ-CD4B 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. TJ-CD4B is being developed under collaboration between I-Mab and ABL. About I-MabI-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-CD4B 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-CD4B. 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-CD4B; 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 ABL111; 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.For more information, please contact: I-MabJielun Zhu, Chief Financial OfficerE-mail: jielun.zhu@i-mabbiopharma.comOffice line: +86 21 6057 8000 Gigi Feng, Chief Communications OfficerE-mail: gigi.feng@i-mabbiopharma.comOffice line: +86 21 6057 5785Investor Inquiries: The Piacente Group, Inc.Emilie WuE-mail: emilie@thepiacentegroup.comOffice line: +86 21 6039 8363 ABL ContactsJaecheon Jerry LeeChief Financial Officerbusiness.development@ablbio.com+82 31 8018 9802 Investor Inquiries: Hyunjun Kiminvestor.relations@ablbio.com+82 31 8018 9845
2021-03-30전체관리자
ABL Bio to Present Two Abstracts at the AACR Annual Meeting 2021
- Preclinical data suggest that ‘Grabody-T’ enhances anti-cancer activity without severe liver toxicity- Preclinical studies indicate ABL501 (PD-L1xLAG-3 BsAb) has potential to enhance antitumor efficacy and overcome the resistance to current immunotherapies March 11, 2021 – ABL Bio, Inc., a South Korean biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced it will make two poster presentations at the virtual American Association for Cancer Research(AACR) 2021 Annual Meeting. The presentations will focus on the preclinical data of ‘Grabody-T,’ a 4-1BB engaging bispecific antibody platform that has demonstrated anti-tumor efficacy, while successfully eliminating 4-1BB related liver toxicity issues. ABL will also present new data regarding ABL501, a bispecific antibody targeting PD-L1 and LAG-3 checkpoint pathways. The details of the presentation are as follows: Title: A novel anti-CD137 antibody recognizing the membrane-proximal CD137 domain elicits potent anti-tumor T cell activity in a bispecific antibody format Abstract Control Number: 1250 Session Type: E-Poster Session Session Title: Therapeutic Antibodies, Including Engineered Antibodies Permanent Abstract Number: 1850 Title: ABL501, PD-L1 X LAG-3, a bispecific antibody promotes enhanced human T cell activation through targeting simultaneously two immune checkpoint inhibitors, LAG-3 and PD-L1 Abstract Control Number: 2255 Session Type: E-Poster Session Session Title: Immune Checkpoints Permanent Abstract Number: 1633 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
2021-03-11ablbio
ABL Bio to Present New Preclinical Data from its Parkinson’s Program at Virtual AD/PD 2021
- ABL to announce preclinical results for ABL301, the leading BsAb targeting α-synuclein with BBB shuttle (Grabody-B)- ABL’s novel IGF-1 Receptor-based shuttle (Grabody-B) mediates efficient delivery of biologics across the blood-brain barrier with outstanding PK profiles in primate study March 9, 2021 - ABL Bio, Inc., a South Korean biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced that it will present results from the preclinical study for ABL301 at the 15th International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD 2021). The presentation will highlight preclinical results demonstrating the efficacy, tolerability and pharmacokinetics of ABL301. ABL demonstrated insulin-like growth factor 1(IGF1R)’s unexpected role as a target for BBB shuttle of biologics into brains and Grabody-B as a novel BBB shuttle with high efficiency and safety. The major challenge of BBB shuttles is faster clearance of the shuttle-fused bispecific antibody. As a result, shorter PK profile than a therapeutic antibody itself may result in only transient CNS exposure without a sustained BBB penetration. A study with primates suggested Grabody-B’s superior and sustained delivery of ABL301 into the brain with more than 13 times higher BBB penetration levels than a monoclonal antibody. Grabody-B-based ABL301 also achieved significantly higher therapeutic outcomes compared to the therapeutic antibody alone in an animal model of PD due to its elevated CNS exposure. “We look forward to sharing this new data with worldwide experts in the field,” said ABL Bio. “The presentation highlights the great amount of interest in our ‘Grabody-B’ platform and ABL301 as innovative treatments that overcome the limitations of neurodegenerative disease therapies.”About ABL BioABL 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
2021-03-08ablbio
TRIGR Therapeutics and Elpiscience Biopharmaceuticals Announce $117 Million Exclusive China ...
https://www.prnewswire.com/news-releases/trigr-therapeutics-and-elpiscience-biopharmaceuticals-announce-117-million-exclusive-china-licensing-transaction-for-tr009-a-phase-1b-dual-angiogenic-bispecific-antibody-targeting-dll4vegf-301211811.html
2021-01-25ablbio
ABL Bio Announces Publication of Research Demonstrating Mechanism of Action and Antitumor Ef...
- Preclinical data of ABL’s 4-1BB bispecific antibody published in Science Advances - Paper highlights antitumor efficacy and safety of ABL’s 4-1BB bispecific antibody as monotherapy and combination with PD-1 blockade January 18, 2021 - ABL Bio, Inc., a South Korean biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, announced today the publication of its paper in peer-reviewed scientific journal Science Advances. Co-authored with Professor Seung-Woo Lee of the Department of Life Sciences at POSTECH and his team, the paper examines the mechanism of action and therapeutic antitumor efficacy of ABL’s 4-1BB bispecific antibody. The bispecific was developed with the company’s ‘Grabody-T’ bispecific antibody platform, allowing it to activate T cells only in the tumor microenvironment. According to the paper, in vivo studies indicated high tumor localization of the 4-1BB bispecific compared to 4-1BB monoclonal antibodies. The 4-1BB bispecific accumulated in tumor tissues were found to activate terminally differentiated CD8 T cells, which lead to a significantly improved antitumor immune response. The treatment also did not induce 4-1BB mediated liver toxicity, a common limitation among standard 4-1BB antibody therapeutics. In addition, ABL’s 4-1BB bispecific was shown to be increasingly effective and safe as monotherapy and combination therapy with PD-1 blockade.“The published data verifies the synergetic efficacy in immuno cancer therapy under the combination of PD-1 blockade, which increases stem-like CD8 T cells, and the 4-1BB bispecific antibody, which activates terminally differentiated CD8 T cells,” said Professor Seung-Woo Lee. “The work was supported by the Ministry of Science and ICT. I believe this is a great example of ideal collaboration between industry, academy and the government for the advancement of the domestic bio industry. Sang Hoon Lee, PhD, CEO of ABL Bio said: “These impressive findings reported in the paper raise expectations for combination therapy with our 4-1BB bispecific antibody. With ABL’s advanced 4-1BB technology that overcomes the limitations of traditional cancer immunotherapy, we will continue our commitment to developing a series of effective pipelines.” About ABL BioABL 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
2021-01-18ablbio
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