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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’s Partner, I-Mab Announces Collaboration with Bristol Myers Squibb to Evaluate Giv...
- I-Mab enters clinical collaboration with Bristol Myers Squibb to evaluate Claudin 18.2 x 4-1BB bispecific antibody givastomig in combination with nivolumab and chemotherapy for the treatment of gastric and esophageal cancer- Collaboration builds on promising safety and efficacy data from the givastomig monotherapy study reported at the European Society of Medical Oncology Congress 2023 Seongnam-si, Gyeonggi-do, June 7, 2024 – ABL Bio’s Partner, I-Mab (NASDAQ: IMAB), today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY). The collaboration will evaluate the combination of givastomig (ABL111), an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by ABL Bio and I-Mab, with Bristol Myers Squibb’s immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers. Under the terms of the agreement, the study will be a multi-national Phase 1 study conducted by I-Mab. Bristol Myers Squibb will supply nivolumab. Nivolumab is an immune checkpoint inhibitor that is designed to block the PD-L1 protein on cancer cells from binding to PD-1, enhancing T-cell function and resulting in improved anti-tumor responses. “We are pleased to enter into this clinical collaboration agreement with Bristol Myers Squibb as we embark on the next stage of givastomig’s development to explore the significant promise of this bispecific antibody in a triple-therapy regimen,” said Raj Kannan, CEO of I-Mab. “The study builds on the encouraging single-agent activity and safety we have observed with givastomig as presented at ESMO 2023. We remain optimistic that givastomig in combination with nivolumab and chemotherapy will drive potent anti-tumor activity in specific tumors, and we look forward to accelerating progress in the clinic.” ### About ABL BioABL 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. About GivastomigGivastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. Givastomig uniquely binds to tumor cells expressing various levels of CLDN18.2, including gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T-cells at the tumor site through 4-1BB. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Developed through a collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.
2024-06-07ablbio
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 Attends the BIO USA 2024
- Introducing its pipeline and BBB Shuttle platform at various business meetings ABL Bio (CEO Sang Hoon Lee), a company that specializes in bispecific antibodies, announced that it will attend the ‘BIO International Convention (BIO USA) 2024’. BIO USA is the world’s largest bio conference at which pharmaceutical and bio industry officials from around the world gather to discuss various topics. This year, it is scheduled to be held for four days in San Diego, USA from June 3rd to the 6th. At this event, ABL Bio plans to meet with various global pharmaceutical and bio companies to share clinical data from its immuno-oncology pipeline that uses the 4-1BB-based bispecific antibody platform, ‘Grabody-T’. Following the presentation of the interim phase 1 clinical data of ABL111 (givastomig) at the European Society of Oncology (ESMO 2023) last year, interim phase 1 clinical data of ABL503 (ragistomig) and ABL202 (CS5001, LCB71) are to be disclosed this year at the American Society of Clinical Oncology (ASCO 2024). Given these milestones, ABL Bio expects meaningful in-depth discussions to take place. Also, ABL Bio plans to discuss potential collaborations related to the Blood Brain Barrier (BBB) shuttle platform, ‘Grabody-B’. In addition, ABL Bio will explore various opportunities that will help develop its bispecific ADCs (Antibody Drug Conjugates) while identifying competitive new drug development technologies and the latest trends of global companies. Sang Hoon Lee, CEO of ABL Bio, said “pipelines using the Grabody-T platform are showing promising clinical data as they enter the clinical stages. Following ABL111, which previously demonstrated encouraging safety and anti-cancer effects last year, we plan to introduce interim phase 1 clinical data of ABL503 and ABL202 at ASCO this year. Also, clinical trials of ABL103 and ABL105 are progressing smoothly, our business meetings are focusing on these clinical data. We will do our best to conduct a successful meeting, and continue to search new drug development technologies that are currently attracting attention in the global market in order to establish future strategies of ABL Bio.” 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.
2024-05-29ablbio
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.
2024-05-24ablbio
CStone Announces Presentation of Latest First-in-Human Data for CS5001 (ROR1 ADC) at ASCO 20...
https://www.cstonepharma.com/en/html/news/3693.html https://www.cstonepharma.com/en/html/news/3704.html
2024-05-24ablbio
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