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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
ABL Bio and I-Mab Presented Encouraging Phase 1 ABL111 Data at ESMO 2024
- Expanded Phase 1 study showed promising single-agent, ABL111 monotherapy activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels- Confirming 7 partial responses and 14 stable diseases in phase 1 clinical trial for ABL111 monotherapy- A Phase 1b study, evaluating ABL111 in combination with standard-of-care treatment (nivolumab + chemotherapy (FOLFOX)) in front-line gastric cancers, is ongoing ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner I-Mab presented a poster presentation highlighting encouraging top-line results from the ongoing Phase 1 clinical trial of ABL111 (Givastomig / TJ033721) in patients with advanced solid tumors, especially gastric cancers (including gastroesophageal carcinoma) at the European Society for Medical Oncology 2024 (ESMO 2024) held in Barcelona, Spain from September 13 to 17. ABL111 is a bispecific antibody developed using the Company’s Grabody-T platform. This antibody targets Claudin18.2-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, where Clauin18.2 is expressed. It is being jointly developed by ABL Bio and I-Mab. The interim results of the Phase 1 trial for ABL111were first disclosed at ESMO 2023, and a Phase 1b clinical trial a combining ABL111 plus nivolumab plus chemotherapy (FOLFOX) is currently underway in the U.S. and China. The poster focused on 43 patients enrolled in the dose expansion study (doses ranging from 5 mg/kg to 18 mg/kg) with gastric cancers, including advanced gastroesophageal carcinoma (GEC). Study data indicates that ABL111 has a strong overall safety profile. No dose-limiting toxicity was reported up to 15 mg/kg Q2W and 18 mg/kg Q3W, and a maximum tolerated dose (MTD) was not identified. The most common treatment-related adverse events were nausea (25.6%), anemia (23.3%), and were mainly Grade 1 or Grade 2. In terms of efficacy, among 43 patients with Claudin18.2-positive gastric and esophageal cancer, seven patients reported partial responses (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg), and 14 patients confirmed as stable diseases. Five of the seven patients who had achieved a partial response (71%) had previously received a checkpoint inhibitor. Sang Hoon Lee, CEO of ABL Bio said “We are pleased by the promising monotherapy efficacy results of the Phase 1 clinical trial for ABL111 presented at ESMO 2024. These data build on positive results from last year’s ESMO congress and provide encouraging data, with a strong overall safety profile. Based on the encouraging initial efficacy signals and overall safety profile for ABL 111, we believe ABL111 has the potential to be a front-line treatment option for patients with gastric cancers. We are enthusiastic about the ongoing combination clinical trial of ABL111 plus nivolumab plus chemotherapy and will do our best to accelerate clinical development through close cooperation with I-Mab.” About ABL BioABL 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. In addition, encouraging Phase 1b data were just presented at ESMO2024 for ABL111, 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 document prevails.
2024-09-20ablbio
ABL Bio receives the Most Promising Biologics Drug Pipeline award at IMAPAC-hosted ceremony
- The company will keep developing Innovative BsAb-based biopharmaceuticals ABL Bio (CEO Sang Hoon Lee), a company that specializes in bispecific antibodies, announced that it received an award in the ‘Most Promising Biologics Drug Pipeline’ category at the Korea Biopharma Excellence Awards 2024 hosted by IMAPAC specialized in bio industry-related events. The awards ceremony was carried out on the 13th as one of the programs within the Biologics Manufacturing Korea 2024 & Vaccine World East Asia 2024 conference that was held in Songdo, Incheon, which hosted over 300 industry insiders. ABL Bio is a bio company that develops immunotherapy using the 4-1BB-based BsAb platform ‘Grabody-T’, as well as neurodegenerative disease treatment that applies the Blood-Brain Barrier (BBB) shuttle platform, ‘Grabody-B’. Currently, the development of immunotherapy drugs ABL503 (ragistomig), ABL111 (givastomig), ABL103, and ABL105 in phase 1 clinical trials is underway, and in January 2022, an exclusive collaboration and worldwide license agreement with Sanofi worth $1.06B for ABL301, a treatment for Parkinson’s disease, was signed. Recently, it has focused on developing next-generation modality bispecific ADCs that can improve the safety and efficacy of existing monospecific ADCs, with the goal of submitting Investigational New Drug applications (INDs) for at least three pipelines by 2025. Sang Hoon Lee, CEO of ABL Bio, states, “We are very pleased to have won the Most Promising Biopharmaceutical Pipeline category. This award ceremony was a good opportunity to once again promote the technologies of the bispecific antibodies and ADC pipelines that ABL Bio is developing. In addition to the development of existing BsAb immunotherapy drugs and degenerative brain disease treatments, ABL Bio is developing new Bispecific ADC treatments to take this further into the future. We plan to accelerate our development of bispecific ADCs to dominate the global bispecific ADC market, which is still in its early stages. Please look forward to ABL Bio’s continued efforts to develop innovative biopharmaceuticals.” 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 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. 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). 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.
2024-08-16ablbio
ABL Bio’s Global Partner Compass Therapeutics Completes Patient Enrollment for Phase 2/3 C...
- Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel in patients with advanced Biliary Tract Cancer- Approved an Investigator Sponsored Trial of CTX-009 in the first-line setting in patients with Biliary Tract Cancer ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics has completed planned enrollment of 150 patients in COMPANION-002, a randomized Phase 2/3 clinical trial of CTX-009 (ABL001) in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers. In addition, along with the completion of enrollment of patients in COMPANION-002, Compass Therapeutics announced the approval of a new Investigator Sponsored Trial (IST) evaluating CTX-009 as a first-line treatment for patients with biliary tract cancer. The clinical trial will be conducted at the MD Anderson Cancer Center at the University of Texas, USA. CTX-009 will be added to gemcitabine, cisplatin, and durvalumab, which is the current standard first-line treatment for biliary tract cancer. CTX-009, initially developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4) which induces the death of tumor cells by inhibiting the creation of new blood vessels in cancer. Compass Therapeutics, which holds global rights, is currently conducting a phase 2/3 clinical trial for biliary tract cancer patients in the United States based on the phase 2 clinical trial (HDB001A) conducted in Korea by Handok, which holds Korean rights. CTX-009 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in April to support the rapid development of new drugs by developers, and an additional phase 2 clinical trial for patients with colorectal cancer is also underway. Sang Hoon Lee, CEO of ABL Bio said “Compass Therapeutics has completed patient enrollment in COMPANION-002. We would like to thank the patients and their families who participated in the clinical trial, and all those involved who helped make it run smoothly. In addition, we are very pleased to announce plans to expand the clinical investigation of CTX-009 to first-line treatment with MD Anderson, one of the most prestigious cancer centers in the United States. We will continue to do our best to quickly share news regarding the progress of CTX-009 clinical development.” 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 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. 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). 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.
2024-08-09ablbio