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ABL Bio and KAIST Publish ABL503 Paper in a Globally Recognized Oncology Journal
- Non-clinical studies confirmed ABL503’s ability to restore the immune function of exhausted tumor infiltrating CD8+ T cells - Studies also demonstrated that the combination of ABL503 and PD-1 blockade significantly inhibited tumor growth and enhanced the activation of TIL CD8+ T cells- The study supports the exploration of the combination of ABL503 and anti-PD-1 inhibitors in improving anticancer effects in clinical trials ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibody development, and Professor Soo Hyung Park’s research team at the Korean Advanced Institute of Science & Technology (KAIST) (President Gwang Hyeong Lee) Graduate School of Medical Sciences today announced the publication of non-clinical studies of ABL503 (ragistomig) in ‘Clinical Cancer Research (CCR)’, an internationally recognized journal of the American Association for Cancer Research (AACR). ABL503 is a bispecific antibody that is being jointly developed by ABL Bio and its global partner I-Mab Biopharma using ABL Bio’s 4-1BB-based bispecific antibody platform ‘Grabody-T’. ABL503 simultaneously targets PD-L1, an immune checkpoint protein and 4-1BB, which is involved in immune T cell activation. It was developed to overcome the limited response rate and resistance to PD-(L)1 inhibitors as well as to improve off-target effects compared to other 4-1BB monoclonal antibodies. Promising data from Phase 1 clinical trials are underway in the United States and South Korea to evaluate ABL503 for patients with advanced solid tumors and were recently reported at the Annual Meeting of the American Society for Clinical Oncology (ASCO 2024). The title of the paper, published by ABL Bio in CCR, is ‘Anti-4-1BB×PD-L1 Bispecific Antibody Reinvigorates Tumor-Specific Exhausted CD8+ T Cells and Enhances the Efficacy of Anti-PD-1 Blockade.’ The paper includes the encouraging results of non-clinical research on ABL503 combination therapy confirmed through in vitro and in vivo experiments. The study was jointly conducted by ABL Bio researchers, Professor Soo Hyung Park's research team at KAIST, Professor Seung Hyuk Jeon of Seoul National University Bundang Hospital, Professor Dae Hoon Han of Severance Hospital, and Professor Jun Sik Park of Soonchunhyang University Bucheon Hospital. According to the paper, ABL503 restored the function of exhausted CD8+ T cells that did not respond to PD-1 inhibitors. The combination of ABL503 and a PD-1 inhibitor was confirmed to enhance the functional restoration of CD8+ T cells compared to PD-1 inhibitor monotherapy. Based on these results, the researchers explained that ABL503 may improve the anticancer effect of PD-1 inhibitor by enhancing the function of exhausted CD8+ T cells and inducing tumor growth inhibition. Sang Hoon Lee, ABL Bio’s CEO said, “The non-clinical data reported in the CCR paper suggests that ABL503 has the potential to improve the anti-cancer efficacy of existing anti-PD1 agents. The combination of ABL503 and anti-PD1 treatments may show improved therapeutic effects in future clinical trials” and stated, “Encouraging Phase 1 results of ABL503 monotherapy were presented at ASCO 2024. Study results showed that treatment with ABL503 produced one complete response and six partial responses in patients previously treated with various types of anticancer drugs, including anti-PD-(L)1 therapy. Together, these data support further evaluation of ABL503 and its potential to become a globally recognized bispecific antibody.” 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).
2024-06-20ablbio
ABL Bio’s Partner Compass Therapeutics Published ABL001 Trial in Progress Paper
- Introduction to the clinical design and research methodology of COMPANION-002, a phase 2/3 clinical trial of ABL001 (CTX-009) for certain patients with advanced biliary tract cancer- A previous phase 2 clinical trial of ABL001 (CTX-009) reported an ORR of 37.5%. Due to the high unmet need for patients with biliary tract cancer, it received Fast Track Designation by the FDA ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibody today announced that its global partner Compass Therapeutics published a trial in progress paper on ABL001 (CTX-009) in the international journal ‘Future Oncology’. This paper contains information on the research methodology, including study goals, clinical design and primary endpoints of COMPANION-002, a Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen. ABL001 (CTX-009) is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4) developed by ABL Bio, which induces the death of cancer cells by inhibiting the creation of new blood vessels in cancer tissues. Compass Therapeutics, which holds global rights, is conducting a phase 2/3 clinical trial for patients with biliary tract cancer in the U.S. and Handok, which holds the domestic rights, is participating in the trial in South Korea. In addition to biliary tract cancer, clinical research targeting advanced colorectal cancer is being conducted. According to the paper, COMPANION-002 is designed to evaluate the efficacy and safety of ABL001 (CTX-009) and paclitaxel combination as a second-line treatment option by comparing this combination regimen to paclitaxel monotherapy. The number of participants is approximately 150, and the primary endpoint is overall response rate (ORR). Secondary endpoints include progression free survival, duration of response, overall survival, disease control rate, safety and quality of life. ABL001 (CTX-009) and paclitaxel combination therapy showed an ORR of 37.5% (9/24) in patients with advanced biliary tract cancer who had received one or two prior systemic therapies. Among 11 patients treated in the second-line setting, the ORR was 63.6% (n = 7/11) versus 15% (n = 2/13) among patients treated in the third-line setting. The median duration of response was 6.9 months, the median progression free survival was 9.4 months, and the 1-year survival rate was 53 %. Note that FOLFOX, a chemotherapy drug used as a second line treatment option, showed an ORR of 5% and 4 months of median progression free survival . Biliary tract cancer is a malignant tumor that occurs in the cells of the bile duct, gallbladder, or the ampulla of Vater, where the bile duct and pancreas connect to the small intestine. In the U.S. alone, approximately 23,000 cases of biliary tract cancer are reported every year, and only 10% of these patients can be diagnosed early and receive surgical treatment. The majority of patients have locally advanced or metastatic biliary tract cancer, and there are few treatment options for them, so their unmet needs are high. ABL001 (CTX-009) and paclitaxel combination therapy received Fast Track Designation by the U.S. Food and Drug Administration (FDA) in April this year for the treatment of patients with metastatic or locally advanced BTC that have been previously treated. Sang Hoon Lee, CEO of ABL Bio said “our partner Compass Therapeutics is conducting active research and development to obtain approval for ABL001 and paclitaxel combination therapy as a treatment for biliary tract cancer, including the publication in an international academic journal and receiving Fast Track Designation.” And he also said “ABL001 combination therapy is reporting encouraging clinical data, and safety is at a manageable level. We hope that our partners will accelerate the clinical development of ABL001 and help improve the treatment options for patients with biliary tract cancer.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on the 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 new drugs. Assets such as ABL104 are also preparing to enter clinical trials. In addition, ABL Bio is continuously researching and developing several other non-clinical drugs, including bispecific ADCs.
2024-06-17ablbio
ABL Bio Presented Phase 1 Interim Results of ABL503 and Reported 1 CR and 6 PR at ASCO 2024
- At effective doses of 3mg/kg and 5mg/kg, CR and PR cases were reported- Safety findings were manageable with steroid treatment, etc. ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibody development, today announced that it successfully completed its poster presentation on the interim Phase 1 clinical data of ABL503 (TJ-L14B, ragistomig) at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024). The ABL503 poster was presented at ASCO’s Developmental Therapeutics Immunotherapy session on June 1st. ABL503 is a bispecific antibody being jointly developed by ABL Bio and its global partner I-Mab Biopharma, using ABL Bio’s 4-1BB-based bispecific antibody platform ‘Grabody-T’. It simultaneously targets PD-L1, an immune checkpoint protein and 4-1BB, which is involved in immune T cell activation. Currently, a Phase 1 clinical trial for patients with solid tumors is underway in the United States and Korea. The dose escalation portion of the study is underway in the United States. Two segments of the study are ongoing in the United States and Korea: the dose expansion portion of the study, focused on the preliminary antitumor activity of a specific dose for which safety has been confirmed, and the tumor expansion portion, which is being carried out for selected specific cancer types. As of the data cut-off date, a total of 53 patients were enrolled in the study, including 34 participants from the dose escalation portion and 19 participants from the dose expansion part. Among the patients enrolled, 56.6% did not respond to existing PD-(L)1 inhibitor treatment or had a recurrence of cancer after PD-(L)1 treatment. The majority of patients were heavily pretreated before participating in the clinical trial. Among the 44 efficacy-evaluable patients, one complete response (CR) and six partial responses (PRs) were observed at the cut-off date of April 19, 2024. Five of these patients did not respond to prior PD-(L)1 inhibitor treatment or experienced cancer recurrence after PD-(L)1 treatment. Notably, the one patient who experienced a CR had been diagnosed with ovarian cancer and had received more than seven prior treatments, including recurrence after prior PD-(L)1 inhibitor treatment. The seven patients who experienced a response (a CR or a PR) received ABL503 at the effective dose levels of 3mg/kg and 5mg/kg. The Overall Response Rate (ORR) of ABL503 observed at the effective dose was 26.9% (7/26), and the Clinical Benefit Rate (CBR) was 69.2% (18/26). Safety was found to be manageable. At least one Treatment-related Adverse Event (TRAE) was reported in 40 patients. The most common TRAE was increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, and those patients with grade 3 or higher ALT and AST levels were managed with steroid treatment. In addition, all five patients who experienced dose-limiting toxicity have recovered or are recovering, and the maximum tolerated dose identified was 7mg/kg, dosed every two weeks. Sang Hoon Lee, CEO of ABL Bio said, “PD-(L)1 inhibitors, including pembrolizumab, a global blockbuster with 2023 sales of $25 billion, are widely used in the treatment of various cancer types, but many patients do not respond to this treatment, which creates an unmet medical need. ABL503 has shown promising results to date, with one CR and multiple PRs, in patients who have not responded to prior PD-(L)1 inhibitor treatment or who have relapsed.” and stated, “the treatment-related increase in AST and ALT caused by ABL503 occurs not only with ABL503 but also with treatments targeting PD-(L)1, and the Phase 1 data suggest that recovery is possible. ABL Bio plans to consider future clinical strategies by comprehensively understanding these interim data and additional results confirmed in the ongoing Phase 1 clinical trial.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on the bispecific antibody platform ‘Grabody.’ More than 15 clinical projects for more than seven 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 new drugs. Assets such as ABL104 are also being prepared to enter clinical trials. In addition, ABL Bio is continuously researching and developing several other non-clinical pipeline drug candidates, including bispecific ADCs.
2024-06-04ablbio
ABL Bio To Present Phase 1 Data for ABL503 at ASCO 2024
- Poster to outline interim Phase 1 results for ABL503 (ragistomig) monotherapy in patients with advanced solid tumors- ABL503 is a bispecific antibody that combines two immune-oncology targets, PD-L1 and 4-1BB, based on ABL Bio’s proprietary Grabody-T platform technology- Data will be presented at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024) in poster session scheduled for June 1, 2024 at 9:00 am CDT ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it will present a poster at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO 2024) regarding the interim results of the phase 1 clinical trial of ABL503 (TJ-L14B, ragistomig), an immunotherapy drug candidate which is being jointly developed with our global partner, I-Mab Biopharma. This is the first disclosure of ABL503 clinical data at a global scientific conference and this data will be presented at ASCO’s Developmental Therapeutics Immunotherapy poster session. ASCO is one of the world's top three cancer societies, and every year, many medical specialists, scientists, multinational pharmaceutical companies, and biotech companies attend and share the latest research results and anticancer drug’s clinical data. It will be held in Chicago from May 31st to June 4th. At this event, ABL Bio will present key data on the Dose Escalation and Dose Expansion portions of the ABL503 study in a poster. The title of the poster is ‘Phase 1 trial safety and efficacy of ragistomig, a bispecific antibody targeting PD-L1 and 4-1BB, in advanced solid tumors’ and will be released for three hours from 9 a.m. to noon on June 1. ABL503 is a bispecific antibody that simultaneously targets PD-L1 and 4-1BB, which is involved in immune T cell activation. It was developed to overcome the limited response rate and resistance of existing PD-(L)1 treatments, and limit potential 4-1BB off target toxicity. Currently, the phase 1 clinical trial for patients with solid tumors is underway in the United States and Korea. The dose escalation part of the study, which sequentially increases the administered dose, is ongoing in the United States, and the dose expansion part of the study, to assess preliminary antitumor activity of a specific dose for which safety has been confirmed, as well as the tumor expansion part, which is carried out for selected specific cancer types, is ongoing in the United States and Korea. Sang Hoon Lee, CEO of ABL Bio, said, “ABL Bio is excited to share new, promising interim monotherapy results from new data from patients in the Phase 1 program for ragistomig at ASCO 2024, one of the world’s pre-eminent medical meetings. Ragistomig incorporates two powerful targets, PD-L1 and 4-1BB, into our proprietary Grabody-T bispecific antibody technology, ASCO is the second time that data from a product candidate using the 4-1BB bispecific antibody platform, Grabody-T will be presented.” and also stated, “We look forward to sharing the positive results achieved by ABL503 in the phase 1 clinical trial at ASCO.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on the 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 new drugs. Assets such as ABL104 are also preparing to enter clinical trials. In addition, ABL Bio is continuously researching and developing several other non-clinical pipeline drugs, including bispecific ADCs.
2024-05-23ablbio
SITC 2023 successfully ended with ABL Bio and I-Mab introducing ABL503/TJ-L14B and ABL111/TJ...
- ABL503 and ABL111, more powerful anti-cancer effect confirmed when administered in combination- ABL111 will be entered in clinical trial for triple combination therapy as a first-line treatment for gastroesophageal adenocarcinoma ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced that both the Company and its partner I-Mab (NASDAQ: IMAB) have successfully completed its poster presentation at the 2023 Society for Immunotherapy of Cancer (SITC) held from November 1 to 5 amid great interest in ABL503 (TJ-L14B) and ABL111 (TJ-CD4B, Givastomig). ABL503 and ABL111 are bispecific antibodies being jointly developed by ABL Bio and Nasdaq-listed company, I-Mab. ABL503 is undergoing phase 1 clinical trials in the United States and Korea, and ABL111 is undergoing phase 1 clinical trials in the United States and China. ABL503 is a bispecific antibody targeting PD-L1 and 4-1BB, and is developed to improve resistance and low response rates, which are considered as limitations of existing PD-(L)1 treatments. According to the ABL503 poster presented by ABL Bio at SITC, the combination therapy of ABL503 and PD-1 treatment appears to have a stronger anticancer effect by enhancing the activation of CD8+ T cells, which are immune cells in the tumor microenvironment. ABL Bio will flesh out its clinical plans for ABL503 combination therapy based on these non-clinical data. ABL111, another bispecific antibody introduced at SITC, simultaneously targets 4-1BB and Claudin18.2 which are overexpressed in gastric cancer, gastroesophageal junction cancer, and esophageal cancer. According to the ABL111 poster presented by I-Mab, T cells activated by ABL111 caused the death of not only Claudin18.2 positive tumor cells but also Claudin18.2 negative tumor cells. In addition, when ABL111 was administrated in combination with chemotherapy and PD-1 treatment, an increase in tumor-infiltrating lymphocytes and enhanced tumor killing effects were confirmed. Based on this, in order to obtain approval for ABL111 as a first-line treatment for gastroesophageal adenocarcinoma, follow-up clinical trials will be conducted on triple combination therapy that simultaneously administers ABL111, chemotherapy, and PD-1 treatment. Sang Hoon Lee, CEO of ABL Bio said “as presented at the SITC, the anticancer effects were found to be stronger when ABL503 administered in combination with immunotherapy, and when ABL111 administered in combination with chemotherapy and immunotherapy. ABL Bio and I-Mab plan to expand clinical trials of ABL503 and ABL111 based on these encouraging results.” And he also said “we will do our best to deliver good news from clinical trials.” Meanwhile, ABL Bio is developing more than 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, and is conducting more than 14 clinical projects with different indications in various countries, including the United States, China, Australia, and Korea. Pipelines such as ABL104 are also preparing to enter clinical trials, and in addition, we are continuing to research and develop several non-clinical pipelines, including ABL102.
2023-11-07ablbio
ABL Bio presents posters about non-clinical data for ABL503 and ABL111 at SITC
- Non-clinical data on the anti-cancer effect of ABL503 and PD-1 treatment combination therapy will be presented- Partner company I-Mab introduces non-clinical data related to triple combination therapy of ABL111, chemotherapy, and PD-1 treatment ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced that it will present the posters of ABL503 (TJ-L14B) and ABL111 (TJ-CD4B, Givastomig) at the 2023 Society for Immunotherapy of Cancer (SITC), which will be held from November 1 to 5. The poster of ABL503 is presented by ABL Bio, and the poster of ABL111 is introduced by its global partner I-Mab. I-Mab is a bio company listed on Nasdaq, USA. ABL Bio and I-Mab are jointly developing immuno-anticancer bispecific antibodies ABL503 and ABL111. ABL503 simultaneously targets PD-L1 and 4-1BB. It is developed to improve resistance and low response rates, which are limitations of existing PD-(L)1 treatments, and phase 1 clinical trials of ABL503 are currently underway in the United States and Korea. Although ABL503 is still in the early stages of clinical trials, one case of complete response (CR) and three cases of partial response (PR) have been confirmed in solid cancer patients. At this SITC, ABL Bio will present the results of non-clinical trials on the anticancer effect of ABL503 and PD-1 treatment combination therapy. ABL111 is a bispecific antibody that simultaneously targets 4-1BB and Claudin18.2 which is expressed in gastric cancer and gastroesophageal junction cancer, and attracted attention in October this year when I-Mab presented the interim results of phase 1 clinical trial that demonstrated excellent efficacy and safety at ESMO. At SITC, the strong anti-cancer effect of the triple combination therapy of ABL111, chemotherapy, and PD-1 treatment confirmed in non-clinical experiments will be introduced. Sang Hoon Lee, CEO of ABL Bio, said, “we are happy to present two posters at SITC, which has the highest authority in the field of immuno-oncology.” and he also said “recently, a combination of chemotherapy and PD-(L)1 treatment has been proposed as a standard treatment for cancer. We plan to develop ABL503 and ABL111 in line with this trend.” Meanwhile, ABL Bio is conducting global clinical trials for more than seven pipelines developed by the company, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, in more than 14 countries, including the United States, China, Australia, and Korea. Pipelines such as ABL104 are also preparing to enter clinical trials, and in addition, ABL Bio is continuing to research and develop several non-clinical pipelines, including ABL102.
2023-10-31ablbio
ABL Bio, completed patent registration for ABL503 in Eurasia…smoothly securing global righ...
- Confirmed several CRㆍPR in global phase 1 clinical trial... value of oncology pipelines got highlighted- Guarantee of right in Eurasia for ‘ABL503 and its use’ by 2039 ABL Bio (CEO Sanghoon Lee), company specializing in BsAb (Bispecific Antibody), announced that it has completed patent (name of patent: anti-PD-L1/anti-4-1BB bispecific antibody and its use) registration for the immuno-oncology ABL503 in Eurasia that is consist of 8 countries including the Russian Federation on date. The patent right will be guaranteed until 2039. This patent has been registered in Chile, South Africa, Japan and Eurasia, and patent examination is in progress in more than 20 countries, including the United States, China and Europe. ABL503, which targets PD-L1 and 4-1BB at the same time, is drawing attention from industry by the news it confirmed 1 Complete Response(CR) case and 3 Partial Response(PR) cases for solid cancer patients even though it is still in phase 1 that is regarded as early stage. Especially, since CR, which means absence of all detectable cancer, rarely can be found in solid cancer, it is in limelight in that it can be used not only for monotherapy with strong anti-cancer effect but also has high potential as combination therapy with existing immunotherapies. Verifying superiority of its technology, ABL Bio is ensuring patent rights smoothly to enter global market. Led by Genmab that already has 7 approved antibody drugs so far, many global bio companies are developing PD-L1x4-1BB BsAb. However, ABL503 secured competitiveness by applying ABL Bio’s Grabody-T technology which makes it possible to have optimal epitope binding for 4-1BB activation. In particular, as ABL503 shows a favorable safety profile even at several times higher dose than 100 mg (flat dose) which is the effective dose in phase 1/2 of Genmab, it is regarded not only to be advantageous in defining RP2D(recommended phase 2 dose) but also to have superior efficacy from phase 2. ABL503 was developed to have superior efficacy and safety by targeting PD-L1 and 4-1BB at the same time to overcome the limitation of existing PD-(L)1 mechanism based immuno-therapy that shows effect only for 20% of total patients such as blockbuster immunotherapy Keytruda. In addition, while maintaining the advantage of treating various cancers, it minimizes toxicity and has anti-cancer effects to prevent long-term recurrence. Meanwhile, phase 1 of ABL503, which is being jointly developed with NASDAQ listed company I-Mab, is in dose escalation and dose expansion parts in the United States and Korea, and plans to secure safety data in monotherapy and determine RP2D & optimal tumor target. "It is encouraging that the amazing results of ABL503 have been confirmed from the phase 1 clinical trial. Prompt patent registration will make it easier to enter global market.” said Sanghoon Lee, CEO of ABL Bio. "Starting with the announcement of interim clinical phase 1 data of ABL111, 4-1BB-based BsAb immunotherapy, at the ESMO(European Society for Medical Oncology) in October this year, the value of immunotherapy pipelines will be recognized and highlighted," he said. Meanwhile, 7 pipeline including ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R), ABL103(H7-H4x4-1BB) that ABL Bio originally developed, are conducting over 14 clinical trials globally in the U.S., China, Australia, and South Korea. Furthermore, ABL104(EGFRx4-1BB) is planning to enter the phase 1 clinical trial. In addition, research and development of a number of non-clinical pipeline such as ABL102(ROR1x4-1BB), ABL602(CLL1xCD3) are also actively underway.
2023-10-10ablbio
ABL Bio, Confirms multiple complete and partial responses in phase 1 clinical trial of ABL50...
- Confirmed case of ‘complete response’ in solid tumor- The value of multiple Immuno-oncology pipeline will be highlighted ABL Bio(CEO Sanghoon Lee), a company specializing in bispecific antibodies, announced one case of complete response(CR) and three cases of partial response(PR) of ABL503(PD-L1 x 4-1BB) that is currently conducting a phase 1 clinical trial for solid tumor patients with NASDAQ-listed biotech, I-Mab. The CR case was confirmed in ovarian cancer, and the PR cases were confirmed in melanoma, gastric cancer and head and neck cancer. The phase 1 clinical trial of ABL503 is currently undergoing dose escalation and dose expansion at 6 sites and 3 sites in the U.S. and in South Korea respectively. ABL Bio plan to determine the RP2D(recommended phase 2 dose) and optimal target cancer. These cases, which are being confirmed at a clinical stage that is still only in the early stages, are attracting attention as they not only have a strong anti-cancer effect as a monotherapy, but also open up the possibility of use as a combination therapy with existing immunotherapy. Although the oncology market is one where numerous companies, including global pharmaceutical companies, are fiercely competing, it is expected that its commercial value, including the possibility of licensing-out and late-stage clinical trials of combination therapy, will be recognized as ABL Bio obtained such the clinical results. ABL503 is a bispecific antibody that combines the capabilities of PD-L1 checkpoint pathway inhibitor with 4-1BB agonistic activity to have advantage of being able to treat various tumor indications as the blockbuster immunotherapy, ‘Keytruda’. In addition, the Grabody-T platform is applied to activate 4-1BB only in immune cells surrounding tumor cells that express PD-L1, minimizing the toxic side effects of 4-1BB and preventing long-term recurrence. Furthermore, it is expected that ABL503 will be able to overcome the limited short-term efficacy and toxic side effects, which are pointed out as limitation in CD3 based bispecific antibodies and ADCs that have recently been highlighted. It is expected that ABL503 will hold a dominant position in global competition with 'GEN1046 (Genmab, Phase 2 clinical trial)' and 'INBRX-105 (Inibrix, Phase 1 clinical trial) in the development of PD-L1x4-1BB bispecific antibodies. In the case of GEN1046, the administered dose was already limited to 100mg (flat dose) in the phase 1/2 clinical dose expansion part, but in the case of ABL503, toxicity was not shown even when administered several times more than 100mg (flat dose). In other words, not only has superior safety already been secured compared to GEN1046, but it is also expected to be advantageous in determining the optimal administration dose (RP2D) for higher efficacy. Through this, it is expected that even more excellent efficacy will be shown from phase 2 clinical trials when the optimal dose is determined. In addition, ABL Bio will present clinical results of pipelines applying the 4-1BB-based Grabody-T platform one by one starting this year, positioning it the best-in-class among the global 4-1BB-based bispecific antibodies. It is expected that the immune-oncology pipeline being developed by ABL Bio will be re-evaluated through those the results of clinical trials. Meanwhile, the interim results of the phase 1 clinical trial of ABL111 will be announced at the European Society of Medical Oncology (ESMO 2023), which will be held from October 20 (Spanish local time) this year, and the interim results of the phase 1 clinical trial of ABL503 will be announced early next year. The plan is to maximize not only the value of pipeline, but also corporate value by continuing to accumulate these clinical results and reviewing various methods and measures, including licensing-out to global pharmaceutical companies. Dr. Sanghoon Lee, CEO of ABL Bio, said, “Many people tend to only focus on ABL Bio’s Neurodegenerative diseases treatment pipeline such as ABL301 and Grabody-B, but we are also committed to developing a variety of oncology pipeline. “As competition is fierce in the oncology market, more time was needed to obtain clinical results, and the interim clinical results of the 4-1BB-based pipeline have now begun to be disclosed. “ABL Bio’s pipeline have clear differences from existing treatments, so their value will also be highlighted,” he said, drawing attention to ABL Bio’s next moves to stand out in the oncology market, including the newly introduced bispecific antibody ADC. Meanwhile, 7 pipeline including ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R), ABL103(H7-H4x4-1BB) that ABL Bio originally developed, are conducting over 14 clinical trials globally in the U.S., China, Australia, and South Korea. Furthermore, ABL104(EGFRx4-1BB) is planning to enter the phase 1 clinical trial. In addition, research and development of a number of non-clinical pipeline such as ABL102(ROR1x4-1BB), ABL602(CLL1xCD3) are also actively underway.
2023-09-04ablbio
ABL Bio, Completed patent registration for ABL503 in Japan following Chile and South Africa
- Guarantee of right in Japan for ‘ABL503 and its use’ by 2039- Japan is regarded as major market in that cancer is the number one cause of death for Japanese. ABL Bio (CEO Sanghoon Lee) specializing in BsAb (Bispecific Antibody) company announced that it has completed patent (name of patent: anti-PD-L1/anti-4-1BB bispecific antibody and its use) registration in Japan for the immuno-oncology ABL503 on date. The patent in Japan was third registration after Chile and South Africa, and It is guaranteed its right until 2039. In addition, patent examination is in progress in more than 20 countries, including the United States, China and Europe. ABL503, which is under joint development with Nasdaq-listed company I-Mab, was developed to target PD-L1 and 4-1BB at the same time to overcome the limitation of prior PD-(L)1 mechanism based immuno-oncology that shows effect only for 20% of total patients. PD-L1x4-1BB is the one of BsAb models that is raising expectations because many global bio companies are conducting clinical trials for it including Genmab that already has 7 approved antibody drugs. In this competitive situation, ABL503 secured competitiveness by applying ABL Bio’s Grabody-T technology which makes it possible to have optimal epitope binding for 4-1BB activation. It has been verifying its superiority by showing great safety profile at higher dose than valid dose of other PD-L1x4-1BB BsAb pipelines in its ongoing clinical trial in US and South Korea. "Entering an super-aged society where the elderly population aged 65 or older accounts for nearly 30% of the total population, Japan’s national level of interest and support for national health are active, and especially cancer is the number one major cause of death for Japanese" said Sanghoon Lee CEO of ABL Bio. “As a PD-(L)1 mechanism based immuno-oncology that is effective in more than 20 indications, ABL503 is expect to have high competitiveness in the Japanese anticancer market in the future” he added. Meanwhile, ABL Bio's more than 6 pipelines such as ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), ABL503(PD-L1x4-1BB), ABL105(HER2x4-1BB), ABL202(ROR1 ADC), ABL301(a-synxIGF1R) etc. are under global clinical trial by ABL Bio or by its partners in the US, China, Australia and Korea. Pipelines such as ABL103(B7-H4x4-1BB) and ABL104(EGFRx4-1BB) etc. are also under preparation to enter clinical trials by ABL Bio or by its partners. In addition, a number of non-clinical pipelines including ABL602(CLL1xCD3) are also actively underway.
2023-08-09ablbio