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ABL Bio, bispecific antibody immuno-oncology ABL 503’s Korea phase 1 IND was approved
- Phase I clinical trial in the U.S. is on the right track.- With superior safety, advantageous in verifying optimal dose over competitors ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced on the xth that it has got approval from the Ministry of Food and Drug Safety (MFDS) for the phase 1 IND of the bispecific antibody immuno-oncology ABL503. ABL503 will expand the phase 1 clinical trial to Korea which is ongoing at 6 clinical institutions in the United States. Hereafter, ABL Bio will get the additional safety data in monotherapy and determine the recommended dose (RP2D) and optimal target cancer for phase 2 clinical trials through the dose expansion part clinical trial. Both ABL503 and ABL111, which are being jointly developed with NASDAQ-listed I-Mab, are on the right track for their phase 1 clinical trial in the US and are showing good clinical results. Bispecific antibody ABL503, which targets PD-L1 and 4-1BB at the same time, selectively activates T cells only in tumor microenvironments. Since 4-1BB can be activated only in immune cells around cancer cells expressing PD-L1. Therefore, it is possible to minimize the side effects of 4-1BB that shows high hepatotoxicity when used as a monoclonal antibody. This is why ABL503 is drawing attention as a new alternative to the existing treatment, which had therapeutic effects for only 20-30% of patients on licensed immune checkpoint inhibitory anticancer drugs, and did not have a treatment with new mechanism in case of recurrence. In particular, considering the interim results of the ongoing clinical trial, ABL503 has a wide range for drug effect verification compared to competitors of the same target based on excellent safety, which is regarded as advantage compared to competitors. Sanghoon Lee, ABL Bio CEO, said "In 2023, we will announce good interim clinical result of existing pipelines as well as news of new pipeline clinical trial initiations” and added “Since ABL Bio’s pipelines are designed to have differentiation with existing competitors, I’m confident that their value will be fairly evaluated if good clinical results continue to be supported." Meanwhile, along with ABL503(PD-L1x4-1BB), ABL Bio's 7 pipelines such as ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R) etc. are on global clinical trial in the US, China and Korea. 3 pipelines, ABL103(B7-H4x4-1BB), ABL104(EGFRx4-1BB), and ABL101(BCMAx4-1BB), are also preparing for clinical entry. In addition to the 10 pipelines, R&D of a number of non-clinical pipelines, including ABL603(Claudin18.2xCD3) and ABL602(CLL1xCD3), are also actively underway.
2023-03-30ablbio
ABL Bio enters the phase 1 expansion part of global clinical trials by applying for phase 1 ...
- US phase I clinical trials dose expansion part started in earnest.- Expect excellent anti-cancer effects and minimized toxic side effects with bispecific antibody of new mechanism. ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced on the 7th that it has applied to the Ministry of Food and Drug Safety (MFDS) for the phase 1 clinical trial IND of the bispecific antibody immuno-oncology ABL503. This is to proceed with the dose expansion part, the next step after the dose escalation part of the phase 1 clinical trial currently ongoing in the United States, about two years after applying for phase 1 clinical trial in the US at the end of 2020. ABL Bio plans to secure additional safety data in solitary therapy and determine recommended phase 2 does (RP2D) and optimal target cancer through dose expansion part clinical trials conducted at Korea clinical institutions with 6 US clinical institutions. ABL503, which is applied with Grabbody-T platform technology, is a bispecific antibody immuno-oncology that targets PD-L1 and 4-1BB at the same time, and is currently under joint development with NASDAQ-listed company I-Mab. Although it cannot be disclosed in detail yet, it is said to be raising expectations as it is showing good results in both efficacy and toxicity in phase 1 clinical trials in the US, which is currently in the part of a dose escalation. 4-1BB, which helps activate T cells, is known to have excellent anticancer effects, but high toxic side effects when administered as a single antibody are pointed out as limitation. However, in the case of ABL503 bispecific antibody, 4-1BB can be activated in immune cells around cancer cells expressing PD-L1, so it is possible to minimize the toxic side effects of 4-1BB through selective T-cell activation only in the tumor microenvironment. ABL Bio Sanghoon Lee CEO said, "The US phase 1 clinical trial of ABL111 with 4-1BB-based Grabbody-T platform technology is also showing good progress," adding, "Starting with ABL503 and ABL111, many of the company's Grabbody-T-based pipelines, including ABL103, will be the center of attention." Through this, we will be able to become a leading company in the field of bisepecific antibody for T-cell engagement," he said. Meanwhile, ABL Bio is developing BBB shuttle platform Grabody-B, which is also applied to ABL301, and various pipelines using it as a new drug for degenerative brain diseases, and is developing many pipelines based on 4-1BB-based Grabbody-T in the field of immuno-oncology. Among them, ABL111 is conducting phase 1 clinical trials in the US and China, and ABL103 is expected to enter phase 1 clinical trials this year.
2023-02-07ablbio
ABL Bio receives near-term milestone for ABL301
- $20 million in near-term milestone inflows upon completion of ABL301 GLP tox study- IND application for the phase 1 clinical trial in U.S. is scheduled in the 4Q of this year September 15, 2022 - ABL Bio Inc (CEO, Sang Hoon Lee), a company specializing in bispecific antibody (BsAb), today announced that $20 million out of $45 million in near-term milestones will be received from SANOFI for ABL301, a bispecific antibody under investigation for Parkinson’s Disease and other potential neurodegenerative diseases. The amount will be paid by SANOFI within 45 days. In January, ABL Bio signed an exclusive collaboration and license out agreement worth a total of $1.06 billion with SANOFI, including $75 million of upfront payments and $45 million of near-term milestones. With this contract, SANOFI had exclusive development and commercialization rights worldwide to ABL301. ABL Bio plans to submit IND for a phase 1 clinical trial to the U.S. FDA in the fourth quarter of this year. In addition to the $20 million inflow this time, the near-term milestone of $25 million will be additionally received according to the development progress of ABL301. Meanwhile, ABL Bio will lead the phase 1 clinical trial of ABL301 and Sanofi will be responsible for further clinical development including the phase 2 clinical trial. “As the preclinical development of ABL301 proceeds well, ABL Bio will receive the near-term milestone. IND application for the phase 1 clinical trial is also being smoothly prepared” said Sang Hoon Lee, CEO of ABL Bio. “Thanks to the strong partnership between the two companies, we will do our best to help patients with neurodegenerative diseases, including Parkinson’s disease, enjoy a better life.” Grabody-B is a blood-brain-barrier (BBB)-shuttle BsAb 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 potential therapeutic efficacy against Parkinson’s Disease. Meanwhile, ABL Bio develops BBB shuttle platform, Grabody-B and other pipeline programs as potential neurodegenerative diseases treatments. In the immuno-oncology area, pipelines based on Grabody-T and Grabody-I platforms 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.
2022-09-15ablbio
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 New Preclinical Data on 'Grabody-B' at BBB Summit
- Oral presentation on the mechanism and application of Grabody-B, an IGF1R-mediated BBB shuttle- ABL expects IND submission of ABL301, a Grabody-B-applied bispecific antibody targeting alpha-synuclein, in 2022 June 28, 2021 - ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biopharmaceutical company developing bispecific antibody platforms for immuno-oncology and neurodegenerative diseases, today announced it will share new preclinical data on its ‘Grabody-B’ platform at the 3rd Annual Blood-Brain Barrier Summit, held online June 28-30, 2021. Grabody-B is a bispecific antibody platform that targets the human insulin like-growth factor receptor (IGF1R), primarily expressed in brain endothelial cells, to maximize BBB penetration of antibodies. Its lead molecule, ABL301, a bispecific antibody targeting alpha synuclein to treat Parkinson’s disease, showed 13-fold higher brain penetration compared to an anti α-syn monoclonal antibody in non-human primates. Its PK analysis also showed sustained penetration over time with good safety profiles. “Grabody-B is gaining recognition as a next-generation BBB shuttle platform that is distinguished from other platforms that target the transferrin receptor,” said Sang Hoon Lee, PhD, CEO of ABL Bio. “With growing interest in BBB-penetrating technology following the FDA’s approval of Biogen’s aducanumab, we expect to exchange productive interactions on current trends regarding the global CNS drug market and research and development.” Highlights of the presentation include: - Various therapeutic antibodies fused with Grabody-B showed higher CNS exposure than monoclonal antibodies in both rodents and non-human primates, proving Grabody-B’s versatile applicability- The relation between the improved CNS exposure and pharmacodynamic effect was well-established in both rodents and non-human primates- ABL301 showed better efficacy than anti-a-syn monoclonal Ab in both Parkinson’s Disease and MSA models About ABL Bio ABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage 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, 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
2021-06-28ablbio
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
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’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.
2020-09-03ablbio
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
2019-12-10ablbio