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ABL Bio’s Partner Compass Announces First Patient Dosed in IST Evaluating Tovecimig as a F...
- Tovecimig will be evaluated in combination with the standard first-line treatment for patients with biliary tract cancer… Six-month PFS, safety, and tolerability to be assessed Pangyo (South Korea) – April 23, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that the first patient has been dosed in an Investigator Sponsored Trial (IST) of tovecimig (ABL001/CTX-009/HDB001A), currently being conducted at The University of Texas MD Anderson Cancer Center. The news was announced on the 21st by ABL Bio’s global partner, Compass Therapeutics. In the MD Anderson-led, open-label trial, tovecimig is being added to a standard first-line regimen of gemcitabine, cisplatin, and durvalumab in an estimated 50 patients with unresectable or metastatic biliary tract cancer (BTC). The study will have a standard safety run-in phase in 12 patients followed by an expansion phase in which 38 additional patients will be treated. The primary objectives in the study are to assess 6-month progression-free survival, to assess the tolerability and safety of this combination, and to determine the maximum tolerated dose of tovecimig in this combination. Secondary objectives include overall response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS). “This first-line study of tovecimig in patients with BTC represents a significant step forward and we are deeply grateful to the dedicated team at MD Anderson for their leadership in conducting this trial,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “The IST complements our ongoing second-line Phase 2/3 study of tovecimig in patients with biliary tract cancer; importantly, we recently announced that tovecimig met the primary endpoint in our Phase 2/3 Study. We expect to report results of the secondary endpoints in the Phase 2/3 Study, including progression-free survival (PFS) and overall survival (OS), in the fourth quarter of this year.” Sang Hoon Lee, CEO of ABL Bio, stated, “The IST to evaluate tovecimig as a first-line treatment has officially begun. In a previously announced Phase 2/3 top-line result, tovecimig demonstrated a higher overall response rate (ORR) compared to FOLFOX, another treatment regimen that is used in the second-line setting for biliary tract cancer, successfully meeting its primary endpoint. The clinical benefit rate (CBR) also showed a promising result at 61.2 %, highlighting the strong potential of tovecimig. We look forward to sharing the upcoming PFS and OS data in the second half of this year.” Tovecimig, developed by ABL Bio, is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. The mechanism of action of tovecimig, which simultaneously inhibits DLL4 and VEGF-A, contributes to the suppression of tumor growth and demonstrates strong anti-tumor efficacy. Compass Therapeutics, which holds the global rights to tovecimig except South Korea, is currently conducting COMPANION-002, a Phase 2/3 clinical trial comparing the combination of tovecimig and paclitaxel to paclitaxel monotherapy. The trial targets patients with previously treated, unresectable metastatic or recurrent biliary tract cancer. Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301, ABL001/tovecimig, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL104, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001/tovecimig, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-23ablbio
ABL Bio Announces Grabody-B Brain Delivery Platform License Agreement with GSK to Develop No...
- ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases- Programs will leverage ABL Bio’s Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier- ABL Bio to receive up to £77 million in upfront and near-term payments April 7, 2025, SEONGNAM, South Korea - ABL Bio Inc. (KOSDAQ: 298380), a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The agreement aims to develop multiple programs for novel targets across therapeutic modalities including antibody, polynucleotide or oligonucleotides, such as siRNA and ASOs, to address significant unmet medical needs of patients suffering from neurodegenerative conditions. The blood-brain barrier (BBB) serves as a protective barrier that restricts the entry of harmful substances and agents into the brain and is considered a significant obstacle in the development of treatments for neurological diseases. ABL Bio's Grabody-B was developed to overcome the limitations of existing drugs that have difficulty crossing the BBB by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R), facilitating drug penetration across the BBB and enabling efficient delivery into the brain. Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization. Christopher Austin, SVP of Research Technologies, GSK, said “There is a critical need for new therapeutics to treat neurodegenerative brain diseases, which are rapidly increasing in prevalence due to the aging of the population. Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB. This agreement reflects our commitment to innovative platform technologies to overcome the BBB and thus open entirely new opportunities for treating these devastating diseases, an important component of our emerging pipeline." Sang Hoon Lee, CEO of ABL Bio said “This agreement underscores ABL Bio's leadership in BBB technology and its commitment to advancing transformative therapeutics in neurodegenerative diseases through strategic partnership with global pharmaceutical leaders like GSK. Additionally, this agreement will serve as a great opportunity to strengthen ABL Bio's position in the neurodegenerative disease treatment market through the potential commercialization of Grabody-B and to expand the modality areas where Grabody-B can be utilized. Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide.” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-07ablbio
ABL Bio’s Partner, Compass Therapeutics, Announces Top-line Results from Phase 2/3 Clinica...
- 17.1% ORR, the primary endpoint, confirmed by independent central radiology review- Full clinical results, including OS, PFS, and full safety data are expected to be announced later this year Pangyo (South Korea) – April 1, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics presented the top-line data from the Phase 2/3 clinical trial of ABL001/tovecimig (CTX-009/HDB001A), COMPANION-002, in patients with advanced biliary tract cancer. Tovecimig (ABL001), originally developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4). It inhibits angiogenesis within tumor tissues, thereby inducing cancer cell death. Compass Therapeutics, which holds global rights, took over the Phase 2 clinical trial conducted in South Korea by Handok, which holds the Korean rights, and is currently conducting the Phase 2/3 clinical trial (COMPANION-002) in the United States. COMPANION-002 is a clinical trial designed to evaluate the potential of tovecimig (ABL001) as a second-line treatment for patients with biliary tract cancer. The study aims to compare the safety and efficacy of the combination therapy of tovecimig (ABL001) and paclitaxel with paclitaxel monotherapy. The primary endpoint of COMPANION-002 is the objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response (DoR). According to the top-line data from the Phase 2/3 clinical trial announced by Compass Therapeutics, the ORR of the combination therapy of tovecimig (ABL001) and paclitaxel was 17.1%, compared to a 5.3% ORR for the paclitaxel monotherapy arm, and this difference was statistically significant (p=0.031). Notably, the ORR for the combination therapy of tovecimig (ABL001) and paclitaxel was also higher than the ORR of 4.9% observed in a separate study for FOLFOX, another treatment regimen that is used in the second line setting for biliary tract cancer. The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig (ABL001) in combination with paclitaxel versus 42.1% in patients on paclitaxel alone. Compass Therapeutics plans to announce the full clinical results of COMPANION-002, including secondary endpoints such as PFS, OS and DoR, by the end of this year. Sang Hoon Lee, CEO of ABL Bio said, “We are very pleased that ABL001 has shown promising results in the Phase 2/3 clinical trial for patients with biliary tract cancer. The true incidence of biliary tract cancer is underappreciated; most patients suffer from advanced or metastatic forms that are not amenable to surgical treatment, leaving them with limited therapeutic options. Considering the high unmet medical need, ABL001 received Fast Track designation from the U.S. Food and Drug Administration (FDA) last year. We hope that the positive clinical data will enable a path to approval and commercialization." As background, biliary tract cancer is a malignant tumor that occurs in the cells of the bile ducts, gallbladder, or the ampulla of Vater, where the bile duct and pancreas connect to the small intestine. Compass Therapeutics estimates that approximately 23,000 patients are diagnosed with biliary tract cancer annually in the United States, with the second-line treatment market size expected to exceed $1 billion. In addition to COMPANION-002, Compass Therapeutics is also supporting an Investigator Sponsored Trial (IST) to evaluate ABL001 as a first-line treatment for biliary tract cancer. This trial is being led by MD Anderson Cancer Center at the University of Texas and is investigating the addition of tovecimig (ABL001) to the standard treatment regimen of gemcitabine, cisplatin, and durvalumab. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-02ablbio
ABL Bio Submits an Additional Clinical Trial Amendment to Evaluate ABL103 in a Phase 1b/2 St...
- ABL103 in combination with KEYTRUDA and Taxane will be evaluated for safety and efficacy in South Korea, the United States, and Australia Pangyo (South Korea) – March 20, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has submitted an additional clinical trial amendment for the Phase 1b/2 study of ABL103 in combination with MSD’s (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and Taxane as a triple combination therapy. ABL103 is a bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio’s 4-1BB based bispecific antibody platform ‘Grabody-T’ has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, potentially reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. A Phase 1 clinical trial evaluating ABL103 monotherapy is currently underway in the United States and South Korea. ABL Bio plans to amend the investigational new drug (IND) application for this Phase 1 trial to include a Phase 1b/2 study assessing combination therapy in South Korea, the United States, and Australia. The Phase 1b/2 study will consist of two safety lead-in parts to determine the appropriate dosage for the triple combination therapy, as well as one dose expansion part. Through this study, ABL Bio aims to evaluate the safety and efficacy of the ABL103 triple combination therapy. Sang Hoon Lee, CEO of ABL Bio said “with the submission of this clinical trial amendment, the journey to evaluate ABL103 combination therapy in solid tumor patients has officially begun. We hope that ABL103 will demonstrate strong efficacy in combination with KEYTRUDA and Taxane. Along with ABL103, clinical trials for 4-1BB-based bispecific antibodies, including ABL111/Givastomig, ABL503/Ragistomig, and ABL105, are progressing smoothly. Among them, ABL111/Givastomig is advancing the fastest in clinical development and is expected to announce the top-line results of its Phase 1b combination study this year. We appreciate your continued interest and support in our progress.” Meanwhile, ABL Bio entered a clinical trial collaboration and KEYTRUDA supply agreement with MSD in October last year to evaluate ABL103 combination therapy in patients with advanced or metastatic solid tumors. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2025-03-20ablbio
ABL Bio/I-Mab Present ABL111/Givastomig Data at SITC 2024
- ABL111/givastomig is a bispecific antibody targeting Claudin 18.2 (CLDN 18.2)-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, with potential CLDN 18.2 specificity even in tumors with low levels of CLDN 18.2 expression- Poster highlights Phase 1 pharmacokinetic modeling data for dose optimization of givastomig- The optimal dose of ABL111/givastomig is identified as 8-12 mg/kg dosed every two weeks (Q2W) ABL Bio (CEO Sang Hoon Lee, “ABL”), a company specializing in bispecific antibodies, today announced that its partner I-Mab presented the Phase I pharmacokinetic modeling clinical of ABL111/givastomig (TJ033721), at the 39th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2024) 2024, held in Houston, Texas from November 8th through 10th. Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB. It is being evaluated in ongoing Phase 1b dose expansion and combination studies in treatment-naive metastatic gastric cancers. The poster highlighted the dose optimization analysis for givastomig monotherapy using data from three clinical studies and non-clinical experiments. The poster entitled “Optimal dose estimation using an integrated approach from Phase I data of givastomig, a novel Claudin18.2×4-1BB bispecific antibody” was presented on November 9, 2024, in the Poster Hall of the George R. Brown Convention Center. The studies demonstrated a dose-response relationship for givastomig and identified 8-12 mg/kg Q2W as the optimal monotherapy dose range for gastric cancer patients. ABL Bio and I-Mab are currently conducting a Phase 1b study evaluating givastomig in combination with nivolumab plus chemotherapy in patients with treatment-naïve Claudin18.2-positive metastatic gastric cancers. “ABL111/givastomig is an investigational agent that was developed based on the company’s Grabody-T platform. Our Grabody-T platform has led to promising product candidates, enhanced by our efforts to advance and optimize the 4-1BB technology in our bispecific antibodies,” said Sang Hoon Lee, CEO of ABL Bio. “Givastomig appears to maintain strong tumor binding and anti-tumor activity, while minimizing liver toxicity and systemic immunotoxicity commonly seen with other emerging 4-1BB-based product candidates. Top line data are expected in H2 2025 from the Phase 1b dose escalation clinical trial evaluating the combination of givastomig plus nivolumab and chemotherapy.” About ABL111/givastomig Givastomig (TJ033721/ABL111) is a bispecific antibody targeting Claudin (CLDN) 18.2-positive tumor cells. It conditionally activates T cells in the tumor microenvironment where CLDN18.2 is expressed using 4-1BB. Activated T cells attack Claudin 18.2-positive tumor cells while preserving normal cells, potentially avoiding potential for serious liver toxicity. . In March 2022, ABL111/givastomig received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) as a treatment for gastric cancer (including gastroesophageal junction cancer). Givastomig, is being jointly developed through a global partnership with I-Mab. ABL shares worldwide rights with I-Mab equally, excluding China and South Korea, where ABL retains full rights. About ABL Bio ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 programs, including ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, ABL301, and ABL103, are directed at important cancer targets such as PD-L1, Claudin 18.2, B7-H4 and HER-2, and are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer, and the top-line data will be disclosed in 2025. In addition, encouraging Phase 1 data were just presented at the European Society of Medical Oncology (ESMO2024) for ABL111/givastomig, in development with I-Mab for gastric cancers (including gastroesophageal junction, GEJ). Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean language document prevails.
2024-11-13ablbio
ABL Bio will Present Bispecific ADC development strategy at World ADC San Diego
- The company aims to be the leader of the bispecific ADC market ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will attend 'World ADC San Diego' held in USA from November 4th to 7th to introduce its bispecific Antibody Drug Conjugate (ADC) development strategy. World ADC is the largest ADC specialized event celebrating its 15th anniversary this year, where various participants interested in ADC gather to discuss ADC development strategies and new technologies. ABL Bio was invited to attend this event as a program speaker, and the presentation title is ‘Bispecific ADC as Next Generation of ADC may Overcome Current Clinical Limitations.’ The presentation will include non-clinical data on the bispecific ADC pipeline that ABL Bio is developing. ABL Bio is developing bispecific ADC as a new driving force for growth into a global bio company. The success of ADC is depending on safe delivering of a larger amount of payload to tumor cells. In the case of bispecific ADC, compared to monoclonal ADC, the payload is delivered to tumor cells more accurately, thereby improving safety and anticancer efficacy, and it is possible to block the tumor cell's evasion mechanism. Tumor cells acquire resistance to anticancer drugs by activating other circuits that can compensate for the blockage of the existing signal transmission systems. However, bispecific ADC can suppress tumor cell's acquisition of resistance by simultaneously targeting two antigens that have a compensatory relationship with each other. Sang Hoon Lee, CEO of ABL Bio said "as the development of bispecific ADC has become an important topic, we are receiving requests to share ABL Bio's bispecific ADC development strategy at various events. Bispecific ADC market is still in its early stages. We expect to take the leadership in this market through rapid entry. We will do our best to submit INDs for bispecific ADC pipelines by next year by focusing on ongoing non-clinical development of them." Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer and the top-line data will be disclosed in 2025. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.
2024-11-01ablbio
ABL Bio Participates in BIO Europe 2024
- Exploring various business opportunities based on its 4-1BB based bispecific antibodies and BBB shuttle platforms ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will attend BIO Europe 2024 to explore various business opportunities. Bio Europe is the largest bio conference in Europe, with over 2,800 pharmaceutical and bio companies and over 5,500 industry professionals. Bio Europe is held twice a year, in spring and fall, and the fall event that ABL Bio is participating in will be held in Stockholm, Sweden from November 4th to 6th. At this event, ABL Bio plans to meet with various global pharmaceutical and bio companies to share the latest clinical data of its immuno-oncology pipelines utilizing the 4-1BB-based bispecific antibody platform ‘Grabody-T’. The clinical-stage 4-1BB-based bispecific antibodies of ABL Bio are ABL503/ragistomig, ABL111/givastomig, and ABL103, all of which are in the Phase 1 clinical stage. ABL503/ragistomig presented the interim results of a Phase 1 clinical trial for monotherapy at the American Society of Clinical Oncology (ASCO) this year, and ABL111/givastomig additionally disclosed the results of a Phase 1 clinical trial for monotherapy at the recent European Society for Medical Oncology (ESMO). ABL103 is currently undergoing a Phase 1 dose escalation part in Korea. ABL Bio will also have a meeting to discuss on its Blood Brain Barrier (BBB) shuttle platform, 'Grabody-B'. As interest in BBB shuttle is increasing globally, ABL Bio expects that there will be many meaningful meetings at this event. Sang Hoon Lee, CEO of ABL Bio said "starting with the J.P. Morgan Healthcare Conference early this year, we have been continuing meeting with global pharmaceutical and bio companies at events including BIO USA and BIO Europe to share the latest clinical data. In addition to the development of existing pipelines, ABL Bio is also focusing on the development of bispecific ADCs (Antibody Drug Conjugate). We plan to do our best to communicate with various industry players around the world to understand the trends and not miss any business opportunities." Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer and the top-line data will be disclosed in 2025. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.
2024-10-30ablbio
ABL Bio Receives Milestone from Sanofi for Completion of Manufacturing Technology Transfer
- Milestone of 5 million dollars - ABL301 Phase 1 clinical trial is underway in the U.S…. From Phase 2 studies Sanofi will conduct the trials ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has completed the manufacturing technology transfer for ABL301, a bispecific antibody candidate for the treatment of neurodegenerative diseases including Parkinson’s disease, to Sanofi, and will receive a milestone of $5 million. ABL301 is a bispecific antibody pipeline that enhances potential therapeutic efficacy against Parkinson’s Disease by effectively carrying the anti-alpha-synuclein antibody into the brain utilizing Grabody-B platform technology of ABL Bio. Grabody-B platform targets the insulin-like growth factor 1 receptor (IGF1R) to maximize Blood-Brain Barrier (BBB) penetration of potential therapies for various CNS-related diseases. In January 2022, ABL Bio signed an exclusive collaboration and exclusive worldwide license agreement for ABL301 with Sanofi. Both companies formed a Joint Research and Development Committee and have collaborated to develop ABL301. This manufacturing technology transfer of ABL301 is also conducted as part of the agreement. ABL301 is currently undergoing Phase 1 clinical trial in the Unted States under the leadership of ABL Bio, and Sanofi will conduct the trials from Phase 2 studies. Sang Hoon Lee, CEO of ABL Bio said, “We have completed the manufacturing technology transfer for ABL301 and will receive additional milestone from Sanofi. The Phase 1 clinical trial for ABL301 in the U.S. is also undergoing smoothly,” and “Based on our collaboration with Sanofi, we will do our best to accelerate the clinical development of ABL301 and contribute to a better life for Parkinson’s disease patients.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer and the top-line data will be disclosed in 2025. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.
2024-10-28ablbio
ABL Bio Announces Clinical Collaboration to Evaluate ABL103 in Combination with KEYTRUDA® (...
- MSD will supply KEYTRUDA to be evaluated in combination with ABL Bio's ABL103 in a Phase 1b/2 clinical trial Pangyo (South Korea) – October 2, 2024, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), to evaluate ABL103 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced or metastatic solid tumors. Under the terms of the agreement, ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA. In this combination study, MSD will supply KEYTRUDA. ABL103 is bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio’s 4-1BB based bispecific antibody platform ‘Grabody-T’ has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. ABL103 also has mechanism to activate the 4-1BB signaling pathways in the tumor microenvironments where the B7-H4 antigens exist, allowing T cells to selectively attack tumor cells while sparing normal cells. Currently, the dose escalation part of the phase 1 clinical trial for ABL103 is ongoing in South Korea. Sang Hoon Lee, CEO of ABL Bio said “we are pleased to enter into this clinical collaboration agreement with MSD. With this agreement, we are ready to move on to the next stage of ABL103 clinical development. We hope that the combination of ABL103 and KEYTRUDA contributes to a better life for patients with advanced or metastatic solid tumors. To date, the phase 1 study for ABL103 monotherapy is progressing smoothly, and we will do our best in clinical development to achieve meaningful results from ABL103.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for more than 7 assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
2024-10-02ablbio