HomeInvestors & MediaNews
ABL Bio, completed patent registration for ABL503 in Eurasia…smoothly securing global righ...
- Confirmed several CRㆍPR in global phase 1 clinical trial... value of oncology pipelines got highlighted- Guarantee of right in Eurasia for ‘ABL503 and its use’ by 2039 ABL Bio (CEO Sanghoon Lee), company specializing in BsAb (Bispecific Antibody), announced that it has completed patent (name of patent: anti-PD-L1/anti-4-1BB bispecific antibody and its use) registration for the immuno-oncology ABL503 in Eurasia that is consist of 8 countries including the Russian Federation on date. The patent right will be guaranteed until 2039. This patent has been registered in Chile, South Africa, Japan and Eurasia, and patent examination is in progress in more than 20 countries, including the United States, China and Europe. ABL503, which targets PD-L1 and 4-1BB at the same time, is drawing attention from industry by the news it confirmed 1 Complete Response(CR) case and 3 Partial Response(PR) cases for solid cancer patients even though it is still in phase 1 that is regarded as early stage. Especially, since CR, which means absence of all detectable cancer, rarely can be found in solid cancer, it is in limelight in that it can be used not only for monotherapy with strong anti-cancer effect but also has high potential as combination therapy with existing immunotherapies. Verifying superiority of its technology, ABL Bio is ensuring patent rights smoothly to enter global market. Led by Genmab that already has 7 approved antibody drugs so far, many global bio companies are developing PD-L1x4-1BB BsAb. However, ABL503 secured competitiveness by applying ABL Bio’s Grabody-T technology which makes it possible to have optimal epitope binding for 4-1BB activation. In particular, as ABL503 shows a favorable safety profile even at several times higher dose than 100 mg (flat dose) which is the effective dose in phase 1/2 of Genmab, it is regarded not only to be advantageous in defining RP2D(recommended phase 2 dose) but also to have superior efficacy from phase 2. ABL503 was developed to have superior efficacy and safety by targeting PD-L1 and 4-1BB at the same time to overcome the limitation of existing PD-(L)1 mechanism based immuno-therapy that shows effect only for 20% of total patients such as blockbuster immunotherapy Keytruda. In addition, while maintaining the advantage of treating various cancers, it minimizes toxicity and has anti-cancer effects to prevent long-term recurrence. Meanwhile, phase 1 of ABL503, which is being jointly developed with NASDAQ listed company I-Mab, is in dose escalation and dose expansion parts in the United States and Korea, and plans to secure safety data in monotherapy and determine RP2D & optimal tumor target. "It is encouraging that the amazing results of ABL503 have been confirmed from the phase 1 clinical trial. Prompt patent registration will make it easier to enter global market.” said Sanghoon Lee, CEO of ABL Bio. "Starting with the announcement of interim clinical phase 1 data of ABL111, 4-1BB-based BsAb immunotherapy, at the ESMO(European Society for Medical Oncology) in October this year, the value of immunotherapy pipelines will be recognized and highlighted," he said. Meanwhile, 7 pipeline including ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R), ABL103(H7-H4x4-1BB) that ABL Bio originally developed, are conducting over 14 clinical trials globally in the U.S., China, Australia, and South Korea. Furthermore, ABL104(EGFRx4-1BB) is planning to enter the phase 1 clinical trial. In addition, research and development of a number of non-clinical pipeline such as ABL102(ROR1x4-1BB), ABL602(CLL1xCD3) are also actively underway.
2023-10-10ablbio
ABL Bio, Confirms multiple complete and partial responses in phase 1 clinical trial of ABL50...
- Confirmed case of ‘complete response’ in solid tumor- The value of multiple Immuno-oncology pipeline will be highlighted ABL Bio(CEO Sanghoon Lee), a company specializing in bispecific antibodies, announced one case of complete response(CR) and three cases of partial response(PR) of ABL503(PD-L1 x 4-1BB) that is currently conducting a phase 1 clinical trial for solid tumor patients with NASDAQ-listed biotech, I-Mab. The CR case was confirmed in ovarian cancer, and the PR cases were confirmed in melanoma, gastric cancer and head and neck cancer. The phase 1 clinical trial of ABL503 is currently undergoing dose escalation and dose expansion at 6 sites and 3 sites in the U.S. and in South Korea respectively. ABL Bio plan to determine the RP2D(recommended phase 2 dose) and optimal target cancer. These cases, which are being confirmed at a clinical stage that is still only in the early stages, are attracting attention as they not only have a strong anti-cancer effect as a monotherapy, but also open up the possibility of use as a combination therapy with existing immunotherapy. Although the oncology market is one where numerous companies, including global pharmaceutical companies, are fiercely competing, it is expected that its commercial value, including the possibility of licensing-out and late-stage clinical trials of combination therapy, will be recognized as ABL Bio obtained such the clinical results. ABL503 is a bispecific antibody that combines the capabilities of PD-L1 checkpoint pathway inhibitor with 4-1BB agonistic activity to have advantage of being able to treat various tumor indications as the blockbuster immunotherapy, ‘Keytruda’. In addition, the Grabody-T platform is applied to activate 4-1BB only in immune cells surrounding tumor cells that express PD-L1, minimizing the toxic side effects of 4-1BB and preventing long-term recurrence. Furthermore, it is expected that ABL503 will be able to overcome the limited short-term efficacy and toxic side effects, which are pointed out as limitation in CD3 based bispecific antibodies and ADCs that have recently been highlighted. It is expected that ABL503 will hold a dominant position in global competition with 'GEN1046 (Genmab, Phase 2 clinical trial)' and 'INBRX-105 (Inibrix, Phase 1 clinical trial) in the development of PD-L1x4-1BB bispecific antibodies. In the case of GEN1046, the administered dose was already limited to 100mg (flat dose) in the phase 1/2 clinical dose expansion part, but in the case of ABL503, toxicity was not shown even when administered several times more than 100mg (flat dose). In other words, not only has superior safety already been secured compared to GEN1046, but it is also expected to be advantageous in determining the optimal administration dose (RP2D) for higher efficacy. Through this, it is expected that even more excellent efficacy will be shown from phase 2 clinical trials when the optimal dose is determined. In addition, ABL Bio will present clinical results of pipelines applying the 4-1BB-based Grabody-T platform one by one starting this year, positioning it the best-in-class among the global 4-1BB-based bispecific antibodies. It is expected that the immune-oncology pipeline being developed by ABL Bio will be re-evaluated through those the results of clinical trials. Meanwhile, the interim results of the phase 1 clinical trial of ABL111 will be announced at the European Society of Medical Oncology (ESMO 2023), which will be held from October 20 (Spanish local time) this year, and the interim results of the phase 1 clinical trial of ABL503 will be announced early next year. The plan is to maximize not only the value of pipeline, but also corporate value by continuing to accumulate these clinical results and reviewing various methods and measures, including licensing-out to global pharmaceutical companies. Dr. Sanghoon Lee, CEO of ABL Bio, said, “Many people tend to only focus on ABL Bio’s Neurodegenerative diseases treatment pipeline such as ABL301 and Grabody-B, but we are also committed to developing a variety of oncology pipeline. “As competition is fierce in the oncology market, more time was needed to obtain clinical results, and the interim clinical results of the 4-1BB-based pipeline have now begun to be disclosed. “ABL Bio’s pipeline have clear differences from existing treatments, so their value will also be highlighted,” he said, drawing attention to ABL Bio’s next moves to stand out in the oncology market, including the newly introduced bispecific antibody ADC. Meanwhile, 7 pipeline including ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R), ABL103(H7-H4x4-1BB) that ABL Bio originally developed, are conducting over 14 clinical trials globally in the U.S., China, Australia, and South Korea. Furthermore, ABL104(EGFRx4-1BB) is planning to enter the phase 1 clinical trial. In addition, research and development of a number of non-clinical pipeline such as ABL102(ROR1x4-1BB), ABL602(CLL1xCD3) are also actively underway.
2023-09-04ablbio
ABL Bio, Completed patent registration for ABL503 in Japan following Chile and South Africa
- Guarantee of right in Japan for ‘ABL503 and its use’ by 2039- Japan is regarded as major market in that cancer is the number one cause of death for Japanese. ABL Bio (CEO Sanghoon Lee) specializing in BsAb (Bispecific Antibody) company announced that it has completed patent (name of patent: anti-PD-L1/anti-4-1BB bispecific antibody and its use) registration in Japan for the immuno-oncology ABL503 on date. The patent in Japan was third registration after Chile and South Africa, and It is guaranteed its right until 2039. In addition, patent examination is in progress in more than 20 countries, including the United States, China and Europe. ABL503, which is under joint development with Nasdaq-listed company I-Mab, was developed to target PD-L1 and 4-1BB at the same time to overcome the limitation of prior PD-(L)1 mechanism based immuno-oncology that shows effect only for 20% of total patients. PD-L1x4-1BB is the one of BsAb models that is raising expectations because many global bio companies are conducting clinical trials for it including Genmab that already has 7 approved antibody drugs. In this competitive situation, ABL503 secured competitiveness by applying ABL Bio’s Grabody-T technology which makes it possible to have optimal epitope binding for 4-1BB activation. It has been verifying its superiority by showing great safety profile at higher dose than valid dose of other PD-L1x4-1BB BsAb pipelines in its ongoing clinical trial in US and South Korea. "Entering an super-aged society where the elderly population aged 65 or older accounts for nearly 30% of the total population, Japan’s national level of interest and support for national health are active, and especially cancer is the number one major cause of death for Japanese" said Sanghoon Lee CEO of ABL Bio. “As a PD-(L)1 mechanism based immuno-oncology that is effective in more than 20 indications, ABL503 is expect to have high competitiveness in the Japanese anticancer market in the future” he added. 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.
2023-08-09ablbio
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, Completed patent registration for ABL503 in Chile & South Africa
- Guarantee of rights in each country for ABL503 and its use by 2039- Multinational patent acquisition adds flexibility to clinical and commercialization strategies ABL Bio (CEO Sanghoon Lee) specializing in BsAb (Bispecific Antibody) company announced that it has completed patent (name of patent: anti-PD-L1/anti-4-1BB bispecific antibody and its use) registration in Chile and South Africa for the immuno-oncology ABL503 on date. These patents are guaranteed their rights until 2039. In addition, patent examination is in progress in more than 20 countries, including the United States, China, Europe, and Japan. ABL503, which is under joint development with Nasdaq-listed company I-Mab, is a BsAb pipeline that targets PD-L1 and 4-1BB at the same time. In the case of PD-(L)1 mechanism-based blockbuster drug Keytruda, it is widely applicable to more than 20 kinds of cancer, but there is still a limitation that it is effective for only 20% of total patients. ABL503, developed to overcome the limitation of these PD-(L)1 mechanism-based immuno-oncology, is a BsAb that combines PD-L1 target antibody with 4-1BB target antibody, and is designed to show improved efficacy by enhancing immune cell activity and adding memory T-cell activation. ABL503’s phase 1 clinical trial is progressing smoothly in the United States and South Korea, also it is expected to have differentiated strength in searching optimal dose with great safety profile at higher dose than valid dose of other companies’ PD-L1x4-1BB BsAb phase 2. "In the case of pure R&D-based biotech company like ABL Bio, the protection of intellectual property rights including patents, is as important as R&D of new drugs," said Sanghoon Lee CEO of ABL Bio. “Patent registration in various countries will also create more opportunities and flexibility in establishing clinical and commercialization strategies for new drug pipelines in the future” he explained the meaning of patent registration. 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.
2023-07-05ablbio
ABL Bio, collaborate with global No.1 CDMO Lonza… to spur development and manufacturing
- Increased efficiency and stability of bispecific antibody manufacturing with diversification of CDMO- Acceleration of clinical preparation is expected with End to End Solution ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced that it has signed a collaboration contract with Lonza (Switzerland), the global No. 1 biopharmaceutical CDMO company, for the development and manufacturing of bispecific antibodies. With Lonza supporting the End-to-End Solution, the two companies will work closely together from the initial DNA stage to IND for ABL Bio pipelines. If GS Xceed®, a unique gene expression technology of Lonza, is applied to ABL Bio's bispecific antibody manufacturing, which has already been proven to have advanced technology with its clinical data and license-out experiences, effective and stable manufacturing of high-quality antibodies can be expected. Jennifer Cannon, Global Head of Mammalian Biologics, Lonza commented “With the biologics pipeline evolving towards more complex protein formats, bi- and multi-specific molecules are a growing part of Lonza’s portfolio. For more than 35 years, our teams have built extensive experience and capabilities in this area, and we are committed to supporting our customers in their unique journey to IND. This collaboration will provide ABL Bio with greater flexibility and speed on the path to commercialization. We look forward to working together to bring this innovative therapeutic antibody candidate one step closer to patients.” Sanghoon Lee, ABL Bio CEO, said "This collaboration with Lonza, the world's No. 1 CDMO company, is another leap forward of ABL Bio to become a global top-tier bio company” and added, “As Lonza’s CDMO service is not limited to bispecific antibodies, ABL Bio will diversify its next-generation pipelines such as ADCs to increase growth potential and lead the antibody field.” Meanwhile, ABL Bio's more than 6 pipelines such as ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1xADC), ABL301(a-synxIGF1R) etc. are under global clinical trial in the US, China, and Korea. Pipelines such as ABL103 (B7-H4x4-1BB) and ABL104 (EGFRx4-1BB) etc. are also under preparation to enter clinical trials. In addition to the number of non-clinical pipelines, including ABL603(Claudin18.2xCD3) and ABL602(CLL1xCD3), are also actively underway.
2023-04-04ablbio
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