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Poster Presentations Highlight Strong Preclinical Data and Differentiated Profile of ABL206 ...
- Strong anti-tumor efficacy and favorable safety profile demonstrated in preclinical studies- Currently in Phase 1 clinical trials in the U.S.; initial clinical data expected in 2027 Seoul (South Korea) – April 23, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced successful poster presentations of ABL206 (NEOK001) and ABL209 (NEOK002) at the American Association for Cancer Research (AACR) Annual Meeting held on April 20. ABL206 and ABL209 are bispecific antibody antibody-drug conjugate (ADC) pipeline candidates developed by ABL Bio. Both programs are currently undergoing Phase 1 clinical trials in the United States. Global development and commercialization of these assets are being led by NEOK Bio, a subsidiary established by ABL Bio. NEOK Bio aims to accelerate clinical development and present initial clinical data in 2027. Bispecific ADCs are designed to simultaneously target two antigens expressed on cancer cells, enabling more precise delivery of highly potent cytotoxic payloads, thereby enhancing both efficacy and safety. ABL206 targets B7-H3 and ROR1, while ABL209 targets EGFR and MUC1. According to the posters presented at AACR, ABL206 demonstrated strong anti-tumor activity in preclinical studies by binding to B7-H3 and ROR1 and rapidly internalizing into cancer cells. A bystander effect—impacting neighboring tumor cells lacking the target antigens—was also observed. In addition, ABL206 induced tumor regression across multiple patient-derived xenograft (PDX) models and showed activity against tumors that had relapsed following prior treatments. ABL209 was designed to minimize binding to normal tissues while enhancing binding affinity to cancer cells expressing both target antigens. It demonstrated potent anti-tumor efficacy in PDX models and showed the potential to improve the therapeutic window, supported by favorable pharmacokinetics (PK) and safety profiles. Sang Hoon Lee, CEO of ABL Bio, stated, “Bispecific ADCs are gaining attention as next-generation therapeutics capable of overcoming the limitations of conventional monoclonal ADCs. These preclinical results clearly demonstrate the strong potential of bispecific ADCs. Internally, we are actively advancing next-generation ADC programs, including dual-payload ADCs, to follow ABL206 and ABL209. The development of ABL Bio’s next-generation ADCs has now fully begun, and we look forward to your continued interest and support.” About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (tovecimig), currently in Phase 2/3 trial for biliary tract cancer patients, has received both Fast Track and Orphan Drug Designations from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year. In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-04-23ablbio
ABL209 (NEOK002) Preclinical Data Published in an International Oncology Journal
- Dual-targeting approach expected to mitigate target-related toxicity seen in conventional monoclonal ADCs- Currently in Phase 1 clinical trials in the U.S.; initial data expected in 2027 Seoul (South Korea) – April 21, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that a paper on the preclinical data of ABL209 (NEOK002) has been published in Molecular Cancer Therapeutics, an international oncology journal published by the American Association for Cancer Research (AACR). ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that targets EGFR and MUC1 and is conjugated with a topoisomerase I inhibitor (TOP1i) payload. It is currently undergoing a Phase 1 clinical trial in the United States, led by NEOK Bio, a U.S.-based biotech company established by ABL Bio. The paper, titled “Designing an EGFRxMUC1 bispecific TOP1i ADC with promising anti-tumor activity and enhanced therapeutic window,” was published online on April 20 and presents the design and preclinical efficacy of ABL209. EGFR is a well-established oncology target expressed across various cancer types; however, therapies targeting EGFR are often associated with skin-related toxicities. MUC1 is also a key oncology target, but its expression levels vary across tumor types, and its tendency to shed from tumor cells can limit therapeutic efficacy. Compared to monoclonal ADCs targeting either EGFR or MUC1 alone, ABL209 demonstrated enhanced binding affinity to cancer cells and improved intracellular drug delivery. Notably, no skin-related toxicity was observed in vitro studies. In addition, in vivo studies using patient-derived xenograft (PDX) models showed strong anti-tumor activity across multiple cancer types, including lung, esophageal, pancreatic, colorectal, bladder, and head and neck cancers. In non-human primate studies, ABL209 exhibited favorable pharmacokinetics (PK), with a half-life of 5.2 days at a dose of 10 mg/kg and demonstrated good tolerability at doses of up to 40 mg/kg. Sang Hoon Lee, CEO of ABL Bio, stated, “We are pleased to see ABL209 study publication in a prestigious AACR journal in the field of oncology. ABL Bio actively encourages scientific publications to enhance the credibility of our technology and increase corporate visibility. NEOK Bio is currently conducting the Phase 1 clinical trial of ABL209 in the U.S., with initial clinical data expected in 2027. We hope ABL209 will establish itself as an innovation in the ADC field.” About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (tovecimig), currently in Phase 2/3 trial for biliary tract cancer patients, has received both Fast Track and Orphan Drug Designations from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year. In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-04-21ablbio
ABL Bio’s Partner Compass Therapeutics Receives FDA Orphan Drug Designation for Biliary Tr...
- OS and PFS data to be announced in April- Compass plans to continue expedited discussions with the FDA using Fast Track and Orphan Drug Designations Seoul (South Korea) – April 8, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner Compass Therapeutics has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for tovecimig (ABL001), a treatment for biliary tract cancer currently under development. Orphan Drug Designation is a system designed to encourage the development of treatments for rare diseases with patient populations under 200,000, where drug development is typically limited. Drugs granted this designation receive various benefits in the U.S., including market exclusivity for a certain period (typically 7 years), tax credits, partial exemption from FDA review fees, clinical trial grants, and regulatory support. Tovecimig is a bispecific antibody originally developed by ABL Bio and licensed to Compass Therapeutics. It simultaneously inhibits the DLL4 (Delta-like ligand 4) and VEGF-A (Vascular Endothelial Growth Factor-A) signaling pathways, both of which play key roles in angiogenesis and tumor vascular formation. Preclinical and clinical findings have shown that dual inhibition of DLL4 and VEGF-A suppresses tumor growth, resulting in strong anticancer activity. Currently, Compass Therapeutics is conducting the Phase 2/3 COMPANION-002 clinical trial in second-line biliary tract cancer patients, combining tovecimig with the chemotherapy drug paclitaxel. Key efficacy data, including Overall Survival (OS) and Progression-Free Survival (PFS), which are critical for FDA approval, are expected to be released this month. CEO Sang-Hoon Lee of ABL Bio stated, “Compass Therapeutics previously received Fast Track Designation from the FDA for tovecimig in April 2024 and has been leveraging its benefits in clinical development. Based on the COMPANION-002 clinical data, Compass Therapeutics plans to engage with the FDA following the OS and PFS readout on next steps. We hope that this Orphan Drug Designation, following Fast Track Designation, will positively impact the approval process of tovecimig.” About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (tovecimig), currently in Phase 2/3 trial for biliary tract cancer patients, has received both Fast Track and Orphan Drug Designations from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year. In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-04-08ablbio
ABL Bio to Present Posters on ABL206 (NEOK001) and ABL209 (NEOK002) at AACR
- The posters will be disclosed on April 20- Both programs recently received U.S. Phase 1 IND approvals… Initial clinical data expected to be presented in 2027 Seoul (South Korea) – March 19, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will participate in the American Association for Cancer Research (AACR) Annual Meeting and present non-clinical data on ABL206 (NEOK001) and ABL209 (NEOK002) in poster sessions. The AACR Annual Meeting is a global event where pharmaceutical and biotech companies, researchers, healthcare professionals, and patients gather to share the latest research findings. This year’s meeting will be held from April 17 to 22 at the San Diego Convention Center in California, USA. ABL206 (NEOK001) and ABL209 (NEOK002), which will be introduced in poster presentations at the event, are bispecific antibody-drug conjugate (ADC) pipelines developed by ABL Bio. NEOK Bio, which holds the clinical development and global development rights rights to both pipelines, is rapidly initiating clinical development for both programs after receiving Investigational New Drug (IND) approvals for Phase 1 trials from the U.S. Food and Drug Administration (FDA). ABL206 (NEOK001) targets both B7-H3 and ROR1, while ABL209 (NEOK002) targets EGFR and MUC1. Both pipelines utilize a payload based on a topoisomerase I inhibitor. The posters for ABL206 (NEOK001) and ABL209 (NEOK002) will be presented on April 20 during the session titled “Antibody-Drug Conjugates and Linker Engineering 2.” According to the abstracts, in preclinical studies, ABL206 (NEOK001) demonstrated improved efficacy and safety compared to single-antibody ADCs targeting either ROR1 or B7-H3 in both in vitro and in vivo settings. It also showed overall favorable tolerability in GLP toxicity studies conducted in non-human primates. ABL209 (NEOK002) likewise exhibited strong anticancer activity while reducing EGFR-related toxicity. CEO Sang Hoon Lee of ABL Bio stated, “ABL206 (NEOK001) and ABL209 (NEOK002) are promising next-generation ADC pipelines with encouraging preclinical data. Clinical development of both programs is being carried out by NEOK Bio in the United States. NEOK Bio, together with ADC development experts, has established an optimal clinical strategy and aims to present initial Phase 1 clinical data in 2027. In addition, ABL Bio is actively advancing next-generation ADC research to follow ABL206 (NEOK001) and ABL209 (NEOK002), and we will accelerate R&D efforts to disclose subsequent pipelines as soon as possible.” About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (Tovecimig), ABL111 (Givastomig), ABL503 (Ragistomig), ABL105 (Nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (Tovecimig), currently being evaluated in a Phase 2/3 clinical trial for patients with biliary tract cancer, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ABL111 (Givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year. In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-03-19ablbio
ABL Bio-NovaBridge Confirm Productive FDA Type B Meeting on Potential for FDA Accelerated Ap...
- Type B meeting with the FDA completed based on positive Phase 1b data, written meeting minutes received Seoul (South Korea) – March 17, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner NovaBridge Biosciences (NASDAQ: NBP) has confirmed the possibility of an accelerated approval pathway for givastomig (ABL111), a gastric cancer treatment under development, during a meeting with the U.S. Food and Drug Administration (FDA). The meeting was conducted based on positive data from a Phase 1b clinical trial evaluating the combination therapy of givastomig (ABL111) with the PD-1 inhibitor nivolumab and chemotherapy. NovaBridge held a Type B meeting with the FDA and subsequently received written meeting minutes outlining the potential pathways toward an accelerated approval for givastomig. In addition, the companies aim to initiate a registrational clinical trial as early as Q4 2026, with the final study design to be determined through further discussions with the FDA. “Givastomig (ABL111) has demonstrated strong efficacy and safety not only in tumors with high Claudin18.2 expression but also in those with low expression, giving it broader market potential than currently approved Claudin18.2 therapies. Givastomig is expected to generate $3 billion in sales in the first-line gastric cancer market across the United States, European 5 countries, and Japan alone, and $5 billion if its indications are expanded to other Claudin18.2-positive tumors. Through close collaboration with NovaBridge, we will accelerate development and aim to become a leader in the Claudin18.2 therapeutic market” Said Sang Hoon Lee, CEO of ABL Bio. “We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. “This important regulatory milestone builds on compelling Phase 1b givastomig results, that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and bringing givastomig to patients as quickly as possible.” Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents. Givastomig is being jointly developed through a global partnership with NovaBridge Biosciences, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio. About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for 10 pipeline assets—including ABL301 (SAR446159), ABL001 (Tovecimig), ABL111 (Givastomig), ABL503 (Ragistomig), ABL105 (Nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (Tovecimig), currently being evaluated in a Phase 2/3 clinical trial for patients with biliary tract cancer, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ABL111 (Givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global conference in the second half of this year. In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development. About NovaBridge NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, Claudin 18.2 X 4-1BB bispecific antibody, and VIS-101, purpose-designed to be a best-in-class dual VEGF-A X ANG-2 inhibitor.
2026-03-17ablbio
ABL Bio–NEOK Bio Receive U.S. IND Clearance for Phase 1 Clinical Trial of ABL209 (NEOK002)
- Phase 1 clinical trials of ABL206 and ABL209 to be initiated by NEOK Bio in 1H2026 Seoul (South Korea) – March 3, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL209 (NEOK002). ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that targets EGFR and MUC1 and is conjugated with a Topoisomerase I inhibitor. By simultaneously targeting two complementary antigens, ABL209 is expected to overcome the limitations of competing candidates that target either EGFR or MUC1 alone. The development of ABL209, along with ABL206 (NEOK001)—another bispecific antibody-drug conjugate (ADC) that previously received U.S. IND clearance for a Phase 1 clinical trial—will be led by NEOK Bio, which holds the global development and commercialization rights to both candidates. NEOK Bio plans to initiate Phase 1 trials in 1H2026 and disclose initial clinical data for ABL206 and ABL209 in 2027. Sang Hoon Lee, CEO of ABL Bio, stated, “Following ABL206, the FDA’s clearance of the IND for ABL209 marks the full-scale initiation of our next-generation ADC development program. NEOK Bio has already completed clinical preparations, led by experts with extensive experience in ADC development. Given their strong global reputation, we have high expectations for the upcoming clinical development of ABL206 and ABL209.” Mayank Gandhi, CEO of NEOK Bio, commented, “Bispecific ADCs represent a novel solution that could expand the therapeutic window of conventional monospecific ADCs. We will advance the clinical development of ABL206 and ABL209 swiftly and efficiently to deliver innovative treatments that address the unmet medical needs of patients with solid tumors.” About ABL BioABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for ten pipeline assets—including ABL301 (SAR446159), ABL001 (Tovecimig), ABL111 (Givastomig), ABL503 (Ragistomig), ABL105 (Nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea. Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (Tovecimig) has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ABL111 (Givastomig), which is being co-developed with NovaBridge, has reported encouraging interim results from a Phase 1b study evaluating a triple combination regimen with nivolumab and chemotherapy. Additional data are expected to be presented at a global scientific conference in the second half of this year.In addition, multiple preclinical programs—including bispecific ADCs and dual-payload ADCs—are being continuously advanced through research and development.
2026-03-03ablbio
ABL Bio–NEOK Bio Submit U.S. IND for Phase 1 Clinical Trial of ABL209 (NEOK002)
- Further development of ABL209 (NEOK002) to be led by NEOK Bio and Phase 1 trial is expected to begin by mid-2026 in the U.S. ABL Bio announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on January 30 for a Phase 1 clinical trial of ABL209 (NEOK002). ABL209 is a bi-specific antibody–drug conjugate (ADC) candidate that combines an EGFR- and MUC1-targeting bispecific antibody with a topoisomerase I inhibitor. In preclinical studies, ABL209 demonstrated superior efficacy compared to monospecific antibody ADCs. By simultaneously targeting two complementary antigens, ABL209 is expected to demonstrate improved efficacy and safety compared to competing agents that target only EGFR or MUC1. NEOK Bio is a bispecific ADC clinical development company established by ABL Bio in the United States and holds global development and commercialization rights to ABL209, as well as another bi-specific ADC candidate, ABL206 (NEOK001). ABL206’s Phase 1 IND was approved by the FDA on January 16, 2026. NEOK Bio plans to initiate Phase 1 trials for both candidates by mid-2026 and to disclose initial clinical data in 2027. Sang Hoon Lee, CEO of ABL Bio, said, “NEOK Bio has already completed preparations for clinical development together with an advisory group with extensive experience in ADC development and clinical research organizations (CROs). Following IND approval, NEOK plans to promptly enter full-scale clinical trials. Global interest in bispecific ADCs is currently very high, and we held numerous related meetings together with NEOK at the recent JPM Healthcare Conference. We ask for continued interest in ABL Bio’s next-generation ADC development, which will be advanced through ABL206 and ABL209.” Mayank Gandhi, CEO of NEOK Bio, said, “Recent IND approval of NEOK001 followed quickly by NEOK002 IND submission reflects our commitment to rapidly and efficiently advance ADC innovation. We can’t wait to initiate a robust clinical development plan for both NEOK001/002 and demonstrate the value of our differentiated bispecific ADCs in patients with solid tumors.” About ABL BioABL Bio is developing a wide range of clinical and preclinical pipelines based on its proprietary bi-specific antibody platforms, including Grabody. A total of nine pipeline programs—ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), ABL206 (NEOK001)—are currently in clinical development across multiple countries, including the United States, China, Australia, and South Korea. Follow-up clinical development of ABL301 (SAR446159), which has completed Phase 1, will be conducted by Sanofi, while ABL001 (tovecimig) has received Fast Track designation from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has reported encouraging interim Phase 1b data in a triple-combination regimen with nivolumab and chemotherapy, with additional data to be presented at a global scientific conference in the second half of this year. In addition, multiple preclinical programs, including bispecific ADCs and dual-payload ADCs, are under continuous research and development.
2026-02-02ablbio
ABL Bio–NEOK Bio, FDA Approves IND for Phase 1 Clinical Trial of ABL206 (NEOK001) in the U...
- Phase 1 clinical development to be initiated by NEOK Bio in the U.S. by the first half of this year - Initial clinical data will be disclosed in 2027 ABL Bio today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL206 (NEOK001). ABL206 is a first-in-class bispecific antibody–drug conjugate (ADC) targeting B7-H3 and ROR1 , conjugated with a topoisomerase I inhibitor payload via a linker. Leveraging its proprietary bispecific antibody technology and extensive experience in monoclonal antibody ADC development, ABL Bio is advancing next-generation ADC programs, including bispecific ADCs. Among these, ABL206 is the first candidate from ABL Bio’s next-generation ADC pipeline to enter the clinical stage. The clinical development of ABL206 will be conducted by NEOK Bio, a bispecific ADC-focused biotechnology company established by ABL Bio in the United States. NEOK Bio holds global development and commercialization rights to ABL206 as well as another bispecific ADC candidate, ABL209 (NEOK002). NEOK Bio plans to initiate the Phase 1 clinical trial for both programs in the first half of this year and aims to disclose initial clinical data in 2027. Sang Hoon Lee, CEO of ABL Bio, stated, “With ABL206, our first bispecific ADC candidate, entering Phase 1 clinical trials, we have taken the first step in our journey toward developing next-generation ADCs. We are very pleased to have successfully obtained IND approval without any issues, thanks to the close collaboration and dedicated R&D efforts of ABL Bio and NEOK Bio. We will continue to accelerate our research and development to introduce a diverse range of next-generation ADC candidates following ABL206.” Mayank Gandhi, CEO of NEOK Bio, said, “The timely IND submission and approval represents a significant milestone in NEOK Bio’s evolution into a clinical-stage company and reflects the strong collaboration between ABL Bio and NEOK Bio. We are excited to advance a rigorous clinical development program and look forward to demonstrating the differentiated potential of this novel bispecific ADC for patients with solid tumors of high unmet need” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 9 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), ABL206(NEOK001) are underway for different indications in various countries, including the United States, China, Australia, and Korea. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial 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).
2026-01-19ablbio
ABL Bio’s Partner Compass to Deliver IR Presentation at JPM Healthcare Conference
- On-site presentation scheduled for 7:30 a.m. on the 14th; recorded version to be released online Seoul (South Korea) – January 9, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its licensing partner for tovecimig, Compass Therapeutics, will deliver a presentation at the JPM Healthcare Conference 2026, taking place from January 12 to 15. Compass Therapeutics is a Boston-based, clinical-stage biotechnology company in the United States. The company has licensed tovecimig, a bispecific antibody developed by ABL Bio, and is developing it as a treatment for biliary tract cancer. Compass Therapeutics’ presentation will be held on January 14 at 7:30 a.m. and will discuss the development status and business strategies of tovecimig, along with updates on its other pipeline assets. A recorded version of the presentation will also be made available on the Compass Therapeutics website. ABL Bio CEO Sanghoon Lee stated, “Our partner Compass Therapeutics will be presenting to global pharmaceutical and biotechnology stakeholders, and tovecimig, originally developed by ABL Bio, will be highlighted on the global stage. tovecimig has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and Compass Therapeutics plans to submit a Biologics License Application (BLA) based on Phase 2/3 clinical data. Starting with this presentation, we ask for continued interest in tovecimig throughout the year.” Tovecimig, originally developed by ABL Bio, is a bispecific antibody that simultaneously blocks the signaling pathways of DLL4 (Delta-like ligand 4) and VEGF-A (Vascular Endothelial Growth Factor-A), both of which play key roles in angiogenesis and tumor vascular formation. Preclinical and clinical evidence supports the hypothesis that concurrent inhibition of DLL4 and VEGF-A yields anticancer efficacy by suppressing tumor growth. Compass Therapeutics is currently conducting the Phase 2/3 COMPANION-002 clinical trial, which compares a combination therapy of tovecimig and paclitaxel with paclitaxel monotherapy. The company plans to release clinical results from COMPANION-002, including overall survival (OS) and progression-free survival (PFS), in the first half of this year. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), are underway for different indications in various countries, including the United States, China, Australia, and Korea. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial 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).
2026-01-09ablbio