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ABL Bio and HiFiBiO Therapeutics Partner in Treatment for COVID-19…
- ABL Bio and HiFiBiO Therapeutics to co-develop neutralizing antibody against COVID-19- Antibody shown to have broad neutralizing capabilities and long half-life- IND submitted to U.S. FDA in August and clinical trials expected to begin this month September 14, 2020 - ABL Bio has announced its partnership with multinational company HiFiBiO Therapeutics on the development of a novel neutralizing antibody treatment for COVID-19. The two companies are soon to finalize the terms of their agreement to produce a COVID-19 treatment by mid-2021. An Investigational New Drug Application with the U.S. Food and Drug Administration was submitted on August 25. ABL901(HFB30132A) is an anti-SARS-CoV-2 antibody engineered with specific sequences identified from the B cells of COVID-19 convalescent patients. Due to its extended half-life, the antibody is anticipated to effectively treat patients who have contracted the disease, while also being used as a preventative measure for people who have a high risk of exposure to the virus, such as healthcare workers. It is expected to offer months-long protection after a single injection. In vivo and in vitro data also demonstrate that ABL901 is capable of effectively neutralizing a broad spectrum of SARS-CoV-2 variants at a low dosage. The antibody was also highly potent in neutralizing the highly infectious D614G, indicating therapeutic efficacy against mutations. Furthermore, ABL901 revealed that it provides protection against respiratory infection, while showing good tolerability in monkey tox studies even at high dosage. ABL Bio and HiFiBiO expect to initiate early clinical trials in the U.S. this month, estimated to take up to one month. Late-stage studies following the successful completion of Phase 1 trial will also be conducted in various countries, expected to be concluded in April 2021. The companies plan to accelerate the development process under the FDA Coronavirus Treatment Acceleration Program. A global CDMO is also contracted for the manufacturing of the antibody so that a global supply can be ready for distribution at the same time the clinical trials are completed. “The strategic partnership with ABL Bio is another showcase of our conviction of open innovation to fast-track life-saving therapies for patients in need,” said Jeff He, COO at HiFiBiO Therapeutics. “Bringing the program from discovery into the clinic in such a short period of time was only made possible through our collaborations with clinicians, CROs, CDMO and other research institutes along the way. With this ABL partnership in place, we are well positioned to rapidly advance the antibody through clinical development.” Sang Hoon Lee, PhD, CEO of ABL Bio says “It takes a global effort to end the worldwide coronavirus pandemic. As a leading company in antibodies, we have the responsibility to share our knowledge and know-how and contribute to world-wide efforts. We hope to bring a safe and effective treatment to the world as soon as possible, to provide a better life amid this unprecedented situation.” About ABL Bio ABL 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. About HiFiBiO Therapeutics HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The company’s strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong. To learn more, please visit www.hifibio.com.
ABL Bio’s ‘Grabody-B’ and ABL301 Emerge as Next-Generation Treatment for Brain Disorde...
- ‘Grabody-B’ and ABL301 gather attention as alternative for tranferrin target platforms at 2nd Blood-Brain Barrier Summit - ABL Bio is the only company in Asia invited to speak at the summit alongside experts in the field from both industry and academia. - Studies demonstrate strong BBB penetration of ‘Grabody-B’, whilst maintaining good safety profiles September 3, 2020 - ABL Bio Inc. today unveiled new preclinical data on its ‘Grabody-B’ platform, engineered to penetrate the blood-brain barrier for neurodegenerative diseases, at the Digital Blood-Brain Barrier Summit. ABL Bio is a leading biotech company specializing in bispecific antibody programs. The annual BBB summit brings together top pharmaceutical companies and renowned scientists looking to enhance drug delivery to the brain. ABL Bio was the only company in the Asian region to present at the event alongside global pharma companies, including Roche, Merck & Co., AbbVie, and Sanofi. ABL Bio explained that the ‘Grabody-B’ shuttling platform adopts IGF1R to transmigrate the barrier, enhancing the permeability of BBB and stability compared to other platforms. ‘Grabody-B’ and its lead molecule for Parkinson’s disease ABL301 were especially in the spotlight as an alternative for transferrin receptors, which have continuously raised concerns for their high toxicity. Professor Danica Stanimirovic of the National Research Council of Canada, co-developer of the technology, also emphasized in a separate presentation that IGF1R has far greater brain delivery efficacy than competitors’ BBB shuttle platforms. In vitro study of ABL301 showed 15 times higher BBB penetration as compared to a monoclonal antibody that lacks a BBB shuttle. In vivo data also verified 8 times higher penetration. These findings are promising in solving the common dilemma of brain disease treatments where medicinal substances are unable to reach the brain. Furthermore, while bispecific antibodies generally display a shorter half-life than that of monocloncal antibodies, ABL301 was found to possess an exceptionally long half-life. ABL301 has also demonstrated strong safety profiles in non-human primates, wherein no apparent clinical abnormalities were observed throughout the four-week period of repeated dosing ascending up to 100 mg/kg. Data from the PD mouse model further demonstrated a clear reduction of pathological alpha-synuclein following a 6-month treatment of ABL301, enabling the protection of dopaminergic neurons from degeneration and preventing the loss of motor functions. According to ABL Bio, “Participants of the summit expressed great enthusiasm toward our data. They were impressed by the high saturation dose and the prolonged, consistent penetration of the bispecific antibody carried by ‘Grabody-B’.” The company added that “The outstanding data verified ‘Grabody-B’ and ABL301’s potential as a treatment for currently incurable neurodegenerative diseases. The summit was an opportunity to escalate our company’s global status, opening doors for diverse global partnerships.” About ABL Bio ABL 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.
ABL Bio, Announces BCMAx4-1BB Bispecific Antibody Superb Efficacy Compared to Bispecific An...
- Celgene’s BCMAxCD3 Clinical Trial Data Attracts Attention from American Society of Hematology - ABL Bio’s BCMAx4-1BB Bispecific Antibody Expected to Show Better Efficacy and Stability Compared to Previous BCMAxCD3 December 10, 2019 - After BCMAxCD3 by Celgene Corporation (“Celgene”) garnered attention from the American Society of Hematology, ABL Bio, Inc. (“ABL Bio”) has been the topic of conversation with its announcement of BCMAx4-1BB Bisepcific Antibody (BsAb) that combines CD3 with another immune modulation target 4-1BB. It is known that Celgene’s BCMAxCD3 BsAb CC-93269, which had entered its clinical trial this April, achieved 88.9% of overall response rate (ORR) including high stringent complete response/complete response (sCR/CR) rate of 44.4% after administering high dose (10 mg) to patients of late-stage multiple myeloma, a cancer that has no suitable drugs. Compared to Celgene’s BCMAxCD3 BsAb, ABL Bio’s BCMAx4-1BB BsAb has no cytokine release syndrome (CRS), which is prevalent in CD3. In addition, while CD3 activates only the T-cells among human immune cells, 4-1BB engages with not only T-cells but also natural killer (NK) cells, making it a platform that is expected to perform remarkably better in terms of efficacy. In the case of ABL Bio’s 4-1BB platform, it has been proven to be superior in terms of stability, as it has resolved the issue of liver toxicity. The superiority of ABL Bio’s BCMAx4-1BB BsAb is gaining attention also because its half-life is overwhelmingly longer than that of BiTE platform-based BCMAxCD3 by Amgen. For BCMA CAR-T, which was the hot topic in last year’s American Society of Hematology, there is the challenge of creating patient-specific therapeutics. In case of BsAb, however, it is in the spotlight because not only is it easy to administer but also has better market opportunity than CAR-T in terms of price. Expressing strong confidence in the company’s BCMAx4-1BB BsAb, Sang Hoon Lee, the founder and CEO of ABL Bio, said, “Our BCMAx4-1BB is currently in preclinical stage but once it enters the clinical trial, it is expected to show better efficacy than Celgene’s CC-93269, as well as superb data in terms of stability.” This BsAb is currently under joint research and development with ABL Bio’s partner company TRIGR in the US and Dt&SanoMedics in Korea. In January of next year at the JP Morgan conference, ABL Bio and global big pharmas will have serious discussions not only on ABL Bio’s multiple BsAb-based immuno-oncology but also ABL301, a BsAb for treating Parkinson’s Disease, which is combined with blood brain barrier (BBB) penetration platform. This event will be of great interest to the industry as ABL Bio is expected to release data on ABL301 in comparison with that of Roche’s BsAb-base
ABL Bio Announces Strategic Partnership with I-Mab Biopharma of China
- Joint Development of Three Bispecific Antibodies… Acquired Global License outside China - ABL Bio, a Korean Biotech with Industry’s Top-rated Core Technology in Bispecific Antibody and Antibody Drug Conjugate (ADC) July 26, 2018 - ABL Bio formed a strategic partnership with a Chinese biotech firm I-Mab Biopharma (“I-Mab”). With this partnership, ABL Bio will conduct joint research with I-Mab on three Bispecific Antibodies (BsAbs) that combine PD-L1 and an undisclosed material. Including the development costs, licenses in China, Korea, and other countries are expected to be shared under different configurations. In addition, ABL Bio acquired the exclusive global rights to another BsAb in regions excluding Greater China. BsAb shows superior efficacy to monoclonal antibody and due to its low side effects, it reduces pain and stress for the patient. For this reason, BsAb is expected to be the new leading immuno-oncology therapy. Sang Hoon Lee, the founder and CEO of ABL Bio, said, “We are able to develop the first-in-class and the best-in-class BsAb through the partnership with I-Mab, and also to speed up the process of the development of innovative immunotherapy.” He added, “With the strong synergy between the two firms, I expect this partnership to be an exemplary case in the global biotech industry.” CEO Jingwu Zang of I-Mab said, “I am excited to have joined with ABL Bio which has the world’s best technology in BsAb. We will do our best to develop the antibody that will lead the next-generation immuno-oncology therapy.” ABL Bio currently holds core technologies in BsAb and Antibody Drug Conjugate (ADC), the next-generation antibody therapeutics platforms in the area of targeted anti-cancer therapy, immuno-oncology, and Parkinson’s Disease. For the first time in Korea, it is currently in Phase 1 clinical trial of ‘ABL-001’, the first new candidate for BsAb. I-Mab is a leading biotech firm in developing new therapeutics and runs a highly efficient team of world-class research ability. The company is developing the industry’s best biological products in immuno-oncology and immuno-inflammation. It is also preparing to submit multiple IND (Investigational New Drug) applications in order to pursue additional clinical trials and further research in the US and China.
ABL Bio Adopts Novel Bispecific Antibody Platform and Two Types of Immuno-Oncology Targete...
- US$220.5 million License-in Agreement on WuXiBody TM Bispecific Antibody Platform and Two Types of Novel Immuno-Oncology Antibody Sequences- Strategic Partnership with WuXi Biologics, Increasing Novel Immuno-Oncology Bispecific Antibody PipelinesSpecific to Patients Unresponsive to Anti-Pd1 and PD-L1 Therapeutics February 25, 2018 - ABL Bio Corporation (“ABL Bio”) announced its license-in agreement with WuXi Biologics(“WuXi Bio”) for WuXiBody TM BsAb platform and two types of novel immuno-oncology antibody sequences forUS$220.5 million. ABL Bio will pay the upfront fee and milestone payments for the development of clinical trials,as well as regulatory and commercial milestone payments. With this agreement, ABL Bio will acquire exclusive rights to the research & development and commercializationof novel Bispecific Antibody (BsAb) that utilizes WuXi Bio’s BsAb platform. As the partner for WuXi Bio, ABL Biowill adopt candidates for novel immune checkpoint inhibitors that are overexpressed among non-responsivegroups to immuno-oncology therapeutics, previously represented by PD-1 and PD-L1. With such adoption, ABLBio will be able to expand its pipeline, a move that is expected to help the company step up as the leader in theglobal BsAb industry. ABL Bio has confirmed in vivo the synergy effect of the combination treatment with PD-1 and PD-L1 immuno-oncology therapy. With this result, the company will develop novel immune checkpoint inhibitor BsAb that willovercome the limits of previous PD-1 therapeutics. WuXiBody TM BsAb platform can assemble all the sequences of monoclonal antibodies into a dual specificstructure, while having low immunogenicity, long half-life in vitro, and superb stability. In addition, it is possible toefficiently and expediently resolve in about 18 months the process of Chemistry, Manufacturing, and Controls(CMC), which is a great challenge in the development of BsAb, thereby significantly lowering the production cost.This platform yields 16g/L with not less than 95% purity, making it the only few ‘best-in-class’ BsAb platform inthe world. Sang Hoon Lee, the founder and CEO of ABL Bio, said, “The reason for recent adoption of BsAb platforms bythe global big pharmas is that one BsAb platform cannot encompass all the targets.” Lee also said, “We decidedto make the adoption with the confidence that th