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ABL Bio Announces Grabody-B Brain Delivery Platform License Agreement with GSK to Develop No...
- ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases- Programs will leverage ABL Bio’s Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier- ABL Bio to receive up to £77 million in upfront and near-term payments April 7, 2025, SEONGNAM, South Korea - ABL Bio Inc. (KOSDAQ: 298380), a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The agreement aims to develop multiple programs for novel targets across therapeutic modalities including antibody, polynucleotide or oligonucleotides, such as siRNA and ASOs, to address significant unmet medical needs of patients suffering from neurodegenerative conditions. The blood-brain barrier (BBB) serves as a protective barrier that restricts the entry of harmful substances and agents into the brain and is considered a significant obstacle in the development of treatments for neurological diseases. ABL Bio's Grabody-B was developed to overcome the limitations of existing drugs that have difficulty crossing the BBB by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R), facilitating drug penetration across the BBB and enabling efficient delivery into the brain. Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization. Christopher Austin, SVP of Research Technologies, GSK, said “There is a critical need for new therapeutics to treat neurodegenerative brain diseases, which are rapidly increasing in prevalence due to the aging of the population. Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB. This agreement reflects our commitment to innovative platform technologies to overcome the BBB and thus open entirely new opportunities for treating these devastating diseases, an important component of our emerging pipeline." Sang Hoon Lee, CEO of ABL Bio said “This agreement underscores ABL Bio's leadership in BBB technology and its commitment to advancing transformative therapeutics in neurodegenerative diseases through strategic partnership with global pharmaceutical leaders like GSK. Additionally, this agreement will serve as a great opportunity to strengthen ABL Bio's position in the neurodegenerative disease treatment market through the potential commercialization of Grabody-B and to expand the modality areas where Grabody-B can be utilized. Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide.” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-07ablbio
ABL Bio’s Partner, Compass Therapeutics, Announces Top-line Results from Phase 2/3 Clinica...
- 17.1% ORR, the primary endpoint, confirmed by independent central radiology review- Full clinical results, including OS, PFS, and full safety data are expected to be announced later this year Pangyo (South Korea) – April 1, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics presented the top-line data from the Phase 2/3 clinical trial of ABL001/tovecimig (CTX-009/HDB001A), COMPANION-002, in patients with advanced biliary tract cancer. Tovecimig (ABL001), originally developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4). It inhibits angiogenesis within tumor tissues, thereby inducing cancer cell death. Compass Therapeutics, which holds global rights, took over the Phase 2 clinical trial conducted in South Korea by Handok, which holds the Korean rights, and is currently conducting the Phase 2/3 clinical trial (COMPANION-002) in the United States. COMPANION-002 is a clinical trial designed to evaluate the potential of tovecimig (ABL001) as a second-line treatment for patients with biliary tract cancer. The study aims to compare the safety and efficacy of the combination therapy of tovecimig (ABL001) and paclitaxel with paclitaxel monotherapy. The primary endpoint of COMPANION-002 is the objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response (DoR). According to the top-line data from the Phase 2/3 clinical trial announced by Compass Therapeutics, the ORR of the combination therapy of tovecimig (ABL001) and paclitaxel was 17.1%, compared to a 5.3% ORR for the paclitaxel monotherapy arm, and this difference was statistically significant (p=0.031). Notably, the ORR for the combination therapy of tovecimig (ABL001) and paclitaxel was also higher than the ORR of 4.9% observed in a separate study for FOLFOX, another treatment regimen that is used in the second line setting for biliary tract cancer. The study also showed differences between treatment arms for other efficacy measures, including progressive disease (PD) rates of 16.2% in patients on tovecimig (ABL001) in combination with paclitaxel versus 42.1% in patients on paclitaxel alone. Compass Therapeutics plans to announce the full clinical results of COMPANION-002, including secondary endpoints such as PFS, OS and DoR, by the end of this year. Sang Hoon Lee, CEO of ABL Bio said, “We are very pleased that ABL001 has shown promising results in the Phase 2/3 clinical trial for patients with biliary tract cancer. The true incidence of biliary tract cancer is underappreciated; most patients suffer from advanced or metastatic forms that are not amenable to surgical treatment, leaving them with limited therapeutic options. Considering the high unmet medical need, ABL001 received Fast Track designation from the U.S. Food and Drug Administration (FDA) last year. We hope that the positive clinical data will enable a path to approval and commercialization." As background, biliary tract cancer is a malignant tumor that occurs in the cells of the bile ducts, gallbladder, or the ampulla of Vater, where the bile duct and pancreas connect to the small intestine. Compass Therapeutics estimates that approximately 23,000 patients are diagnosed with biliary tract cancer annually in the United States, with the second-line treatment market size expected to exceed $1 billion. In addition to COMPANION-002, Compass Therapeutics is also supporting an Investigator Sponsored Trial (IST) to evaluate ABL001 as a first-line treatment for biliary tract cancer. This trial is being led by MD Anderson Cancer Center at the University of Texas and is investigating the addition of tovecimig (ABL001) to the standard treatment regimen of gemcitabine, cisplatin, and durvalumab. About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111/givastomig, co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
2025-04-02ablbio
ABL Bio Attends J.P. Morgan Healthcare Conference
- Focused discussions on BBB shuttle platform and clinical-stage immuno-oncology pipeline expected to take place January 6, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, announced on the 6th that it will participate in the 43rd Annual J.P. Morgan Healthcare Conference, taking place from January 13th to 16th in San Francisco, USA, to continue discussions on various partnership opportunities. J.P. Morgan Healthcare Conference is one of the world’s largest healthcare investment events, bringing together pharmaceutical and biotech companies, medical professionals, investment banks, and venture capitalists to share the latest therapeutic technologies and explore a wide range of investment and partnership opportunities. ABL Bio has been invited to attend the conference every year since its founding, and this marks its ninth participation. During the event, ABL Bio plans to hold follow-up meetings with global pharmaceutical and biotech companies it has been in partnership talks with, while also keeping up with global trends in next-generation drug development. In particular, active discussions are anticipated around Grabody-B, the company’s Blood-Brain Barrier (BBB) shuttle platform for the treatment of neurodegenerative diseases. This focus comes in the wake of positive early results from Trontinemab, a BBB shuttle-conjugated version of Roche’s anti-amyloid beta monoclonal antibody Gantenerumab, in a Phase 1/2 clinical trial for Alzheimer’s disease- despite Gantenerumab’s prior standalone failure- making BBB shuttles a key to success in treating neurodegenerative diseases. In the field of oncology, ABL Bio will share the latest clinical data on its immuno-oncology therapeutics utilizing its Grabody-T platform, a 4-1BB-based bispecific antibody. Givastomig, currently in development for gastric cancer, is undergoing a Phase 1b trial to evaluate the safety of a triple combination therapy with chemotherapy and PD-1 inhibitor Nivolumab. Top-line data from this trial is expected in the second half of 2025. Meanwhile, Ragistomig and ABL103 are progressing smoothly in monotherapy Phase 1 clinical trials, with ABL103 set to begin early trials for combination therapy later this year. Sang Hoon Lee, CEO of ABL Bio, stated, “Since Roche’s Trontinemab opened a new era for BBB shuttles in the neurodegenerative disease treatment market, global interest in this technology has surged. As clinical data from our immuno-oncology pipeline continues to emerge, our discussions with global partners are also making remarkable progress. ABL Bio will continue to seek various growth opportunities at this conference and do our best to deliver good news soon.”
2025-01-06ablbio
ABL Bio Receives Milestone from Sanofi for Completion of Manufacturing Technology Transfer
- Milestone of 5 million dollars - ABL301 Phase 1 clinical trial is underway in the U.S…. From Phase 2 studies Sanofi will conduct the trials ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has completed the manufacturing technology transfer for ABL301, a bispecific antibody candidate for the treatment of neurodegenerative diseases including Parkinson’s disease, to Sanofi, and will receive a milestone of $5 million. ABL301 is a bispecific antibody pipeline that enhances potential therapeutic efficacy against Parkinson’s Disease by effectively carrying the anti-alpha-synuclein antibody into the brain utilizing Grabody-B platform technology of ABL Bio. Grabody-B platform targets the insulin-like growth factor 1 receptor (IGF1R) to maximize Blood-Brain Barrier (BBB) penetration of potential therapies for various CNS-related diseases. In January 2022, ABL Bio signed an exclusive collaboration and exclusive worldwide license agreement for ABL301 with Sanofi. Both companies formed a Joint Research and Development Committee and have collaborated to develop ABL301. This manufacturing technology transfer of ABL301 is also conducted as part of the agreement. ABL301 is currently undergoing Phase 1 clinical trial in the Unted States under the leadership of ABL Bio, and Sanofi will conduct the trials from Phase 2 studies. Sang Hoon Lee, CEO of ABL Bio said, “We have completed the manufacturing technology transfer for ABL301 and will receive additional milestone from Sanofi. The Phase 1 clinical trial for ABL301 in the U.S. is also undergoing smoothly,” and “Based on our collaboration with Sanofi, we will do our best to accelerate the clinical development of ABL301 and contribute to a better life for Parkinson’s disease patients.” Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer and the top-line data will be disclosed in 2025. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.
2024-10-28ablbio
ABL Bio and I-Mab Presented Encouraging Phase 1 ABL111 Data at ESMO 2024
- Expanded Phase 1 study showed promising single-agent, ABL111 monotherapy activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels- Confirming 7 partial responses and 14 stable diseases in phase 1 clinical trial for ABL111 monotherapy- A Phase 1b study, evaluating ABL111 in combination with standard-of-care treatment (nivolumab + chemotherapy (FOLFOX)) in front-line gastric cancers, is ongoing ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner I-Mab presented a poster presentation highlighting encouraging top-line results from the ongoing Phase 1 clinical trial of ABL111 (Givastomig / TJ033721) in patients with advanced solid tumors, especially gastric cancers (including gastroesophageal carcinoma) at the European Society for Medical Oncology 2024 (ESMO 2024) held in Barcelona, Spain from September 13 to 17. ABL111 is a bispecific antibody developed using the Company’s Grabody-T platform. This antibody targets Claudin18.2-positive tumor cells that conditionally activates T cells via 4-1BB in the tumor microenvironment, where Clauin18.2 is expressed. It is being jointly developed by ABL Bio and I-Mab. The interim results of the Phase 1 trial for ABL111were first disclosed at ESMO 2023, and a Phase 1b clinical trial a combining ABL111 plus nivolumab plus chemotherapy (FOLFOX) is currently underway in the U.S. and China. The poster focused on 43 patients enrolled in the dose expansion study (doses ranging from 5 mg/kg to 18 mg/kg) with gastric cancers, including advanced gastroesophageal carcinoma (GEC). Study data indicates that ABL111 has a strong overall safety profile. No dose-limiting toxicity was reported up to 15 mg/kg Q2W and 18 mg/kg Q3W, and a maximum tolerated dose (MTD) was not identified. The most common treatment-related adverse events were nausea (25.6%), anemia (23.3%), and were mainly Grade 1 or Grade 2. In terms of efficacy, among 43 patients with Claudin18.2-positive gastric and esophageal cancer, seven patients reported partial responses (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg), and 14 patients confirmed as stable diseases. Five of the seven patients who had achieved a partial response (71%) had previously received a checkpoint inhibitor. Sang Hoon Lee, CEO of ABL Bio said “We are pleased by the promising monotherapy efficacy results of the Phase 1 clinical trial for ABL111 presented at ESMO 2024. These data build on positive results from last year’s ESMO congress and provide encouraging data, with a strong overall safety profile. Based on the encouraging initial efficacy signals and overall safety profile for ABL 111, we believe ABL111 has the potential to be a front-line treatment option for patients with gastric cancers. We are enthusiastic about the ongoing combination clinical trial of ABL111 plus nivolumab plus chemotherapy and will do our best to accelerate clinical development through close cooperation with I-Mab.” About ABL BioABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. ABL’s lead program, ABL001, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. The program recently completed patient enrollment in a Phase 2/3 clinical trial for biliary tract cancer and the top-line data will be disclosed in 2025. In addition, encouraging Phase 1b data were just presented at ESMO2024 for ABL111, in development with I-Mab for gastric cancers (including gastroesophageal junction, GEJ). Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.
2024-09-20ablbio
ABL Bio receives the Most Promising Biologics Drug Pipeline award at IMAPAC-hosted ceremony
- The company will keep developing Innovative BsAb-based biopharmaceuticals ABL Bio (CEO Sang Hoon Lee), a company that specializes in bispecific antibodies, announced that it received an award in the ‘Most Promising Biologics Drug Pipeline’ category at the Korea Biopharma Excellence Awards 2024 hosted by IMAPAC specialized in bio industry-related events. The awards ceremony was carried out on the 13th as one of the programs within the Biologics Manufacturing Korea 2024 & Vaccine World East Asia 2024 conference that was held in Songdo, Incheon, which hosted over 300 industry insiders. ABL Bio is a bio company that develops immunotherapy using the 4-1BB-based BsAb platform ‘Grabody-T’, as well as neurodegenerative disease treatment that applies the Blood-Brain Barrier (BBB) shuttle platform, ‘Grabody-B’. Currently, the development of immunotherapy drugs ABL503 (ragistomig), ABL111 (givastomig), ABL103, and ABL105 in phase 1 clinical trials is underway, and in January 2022, an exclusive collaboration and worldwide license agreement with Sanofi worth $1.06B for ABL301, a treatment for Parkinson’s disease, was signed. Recently, it has focused on developing next-generation modality bispecific ADCs that can improve the safety and efficacy of existing monospecific ADCs, with the goal of submitting Investigational New Drug applications (INDs) for at least three pipelines by 2025. Sang Hoon Lee, CEO of ABL Bio, states, “We are very pleased to have won the Most Promising Biopharmaceutical Pipeline category. This award ceremony was a good opportunity to once again promote the technologies of the bispecific antibodies and ADC pipelines that ABL Bio is developing. In addition to the development of existing BsAb immunotherapy drugs and degenerative brain disease treatments, ABL Bio is developing new Bispecific ADC treatments to take this further into the future. We plan to accelerate our development of bispecific ADCs to dominate the global bispecific ADC market, which is still in its early stages. Please look forward to ABL Bio’s continued efforts to develop innovative biopharmaceuticals.” About ABL Bio ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.
2024-08-16ablbio
ABL Bio’s 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, 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 enters the phase 1 expansion part of global clinical trials by applying for phase 1 ...
- US phase I clinical trials dose expansion part started in earnest.- Expect excellent anti-cancer effects and minimized toxic side effects with bispecific antibody of new mechanism. ABL Bio (CEO Sanghoon Lee), a company specializing in bispecific antibody, announced on the 7th that it has applied to the Ministry of Food and Drug Safety (MFDS) for the phase 1 clinical trial IND of the bispecific antibody immuno-oncology ABL503. This is to proceed with the dose expansion part, the next step after the dose escalation part of the phase 1 clinical trial currently ongoing in the United States, about two years after applying for phase 1 clinical trial in the US at the end of 2020. ABL Bio plans to secure additional safety data in solitary therapy and determine recommended phase 2 does (RP2D) and optimal target cancer through dose expansion part clinical trials conducted at Korea clinical institutions with 6 US clinical institutions. ABL503, which is applied with Grabbody-T platform technology, is a bispecific antibody immuno-oncology that targets PD-L1 and 4-1BB at the same time, and is currently under joint development with NASDAQ-listed company I-Mab. Although it cannot be disclosed in detail yet, it is said to be raising expectations as it is showing good results in both efficacy and toxicity in phase 1 clinical trials in the US, which is currently in the part of a dose escalation. 4-1BB, which helps activate T cells, is known to have excellent anticancer effects, but high toxic side effects when administered as a single antibody are pointed out as limitation. However, in the case of ABL503 bispecific antibody, 4-1BB can be activated in immune cells around cancer cells expressing PD-L1, so it is possible to minimize the toxic side effects of 4-1BB through selective T-cell activation only in the tumor microenvironment. ABL Bio Sanghoon Lee CEO said, "The US phase 1 clinical trial of ABL111 with 4-1BB-based Grabbody-T platform technology is also showing good progress," adding, "Starting with ABL503 and ABL111, many of the company's Grabbody-T-based pipelines, including ABL103, will be the center of attention." Through this, we will be able to become a leading company in the field of bisepecific antibody for T-cell engagement," he said. Meanwhile, ABL Bio is developing BBB shuttle platform Grabody-B, which is also applied to ABL301, and various pipelines using it as a new drug for degenerative brain diseases, and is developing many pipelines based on 4-1BB-based Grabbody-T in the field of immuno-oncology. Among them, ABL111 is conducting phase 1 clinical trials in the US and China, and ABL103 is expected to enter phase 1 clinical trials this year.
2023-02-07ablbio