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ABL Bio completes paid-in capital increase allocated to a third party for development of nex...
- The newly issued shares will be protected through the Korea Securities Depository for one year- Investment of paid-in capital increase in development of next-generation ADCs…existing BsAb will be developed based on upcoming milestones and new license-out upfront ABL Bio (CEO Sang Hoon Lee), a company specializing in BsAbs, announced on the 11th that it has completed payment for a paid-in capital increase allocated to a third party worth 140 billion won. Accordingly, ABL Bio will issue 5,778,196 shares of convertible preferred stock (CPS) with no obligation to repay to KDB Bank, Atinum Investment, Intervest, Hana FInancial Group, and Company K Partners. This will be protected by the Korea Securities Depository for one year. Convertible preferred stock will not be listed until the conversion right is exercised after the end of the protection period. On the 2nd, ABL Bio announced a paid-in capital increase through third-party allocation and officially began developing next-generation ADCs (Antibody Drug Conjugates), including bispecific ADCs (BsADCs). BsADCs are a next-generation modality that is expected to show improved safety and superior efficacy compared to the existing monoclonal ADCs by rapidly penetrating two different antigens into the target cancer cells. No drugs in this modality have yet been approved by regulatory agencies, and most candidates are being developed in early clinical stages. On the other hand, the economic value is so great that the Chinese bio company received a upfront of $800 million from global big pharma for a relocation of the global rights of the BsADC going through phase 1 clinical trials in the U.S. ABL Bio plans to proactively invest the funds secured through capital increase in accelerating the development of next-generation ADCs to dominate the global BsADCs market. Meanwhile, the existing 4-1BB-based bispecific immunotherapy drugs and blood brain barrier (BBB) shuttle platform ‘Grabody-B’ will be developed based on upcoming milestone, and upfront for additional license-out. Representative 4-1BB-based bispecific antibodies ABL503 and ABL111 are undergoing phase 1 clinical trials to evaluate the tumor expansion part and triple combination therapy, respectively. As the domestic phase 1 clinical trial of ABL103, another 4-1BB bispecific antibodies, and the Korean and Australian phase 1 clinical trial of ABL105 being developed by Yuhan Corporation, are also progressing smoothly. ABL Bio is confident that this paid-in capital increase will be an important source of momentum towards their maturation into a global bio company. Sang Hoon Lee,the CEO of ABL Bio, said, “the first paid-in capital increase since listing in 2018 has been completed with payment. The remaining task for ABL Bio is to accelerate the development and dominate the BsADC market. Using our BsAb expertise and ADC development experience, we will apply for clinical trials (INDs) for at least three BsADCs by 2025, and focus on developing monoclonal ADCs that use new targets. 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.
2024-07-11ablbio
ABL Bio proceeds with paid-in capital increase allocated to a third party to develop next-ge...
- Issuance of convertible preferred share with no obligation to repay at a price of 140 billion KRW… ABL Bio will develop next-generation ADCs in-house- The existing pipelines will be developed based on future milestones and upfront of new license-out ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies (BsAb), announced that it has decided to allocate a paid-in capital increase to a third party for the development of next-generation Antibody Drug Conjugates (ADCs) including bispecific ADCs (BsADCs). The subjects to third-party allocation are KDB Bank, Atinum Investment, Intervest, Hana Financial Group, and Company K Partners. ABL Bio will issue 5,778,196 shares of convertible preferred stock (CPS) with no obligation of repayment to these institutions. The issuance price of new shares is 24,229 KRW per share, a 2.45% premium to the base stock price of 23,650 KRW calculated in accordance with the regulations on issuance and disclosure of securities. ABL Bio plans to invest the funds secured through this paid-in capital increase in developing next-generation ADCs. Most ADCs currently being globally developed utilize only a few target antibodies, such as HER2 and TROP2, and thus have to face intense competition. On the other hand, the development of BsADCs is still in its early stages, and there are no approved drugs. Accordingly, ABL Bio plans to lead the global ADC market by developing BsADCs applied topoisomerase I inhibitor as a payload, and monoclonal ADCs with new targets. In particular, the BsADCs that ABL Bio is focusing on not only accurately binds to cancer cells by targeting two antigens, but also quickly penetrates cancer cells. Accordingly, the BsADCs show improved safety compared to the existing monoclonal ADCs, with a wide therapeutic window and excellent efficacy. ABL Bio plans to continue developing of the 4-1BB-based BsAb immunotherapy and BBB shuttle platform ‘Grabody-B’ based on upcoming milestones and upfront of additional license-out. ABL Bio has already signed license-out agreements for their BsAb pipelines with Compass Therapeutics, Yuhan Corporation, and CStone Pharmaceuticals, as well as Sanofi. CEO of ABL Bio, Sang Hoon Lee said “based on ABL Bio’s expertise in BsAbs and experience in joint development of ROR1 ADC, we have designed a next-generation ADC development strategy that will drive us forward as a global bio company. Even though BsADCs are still in the early stages of development, it is essential to quickly dominate the market through active investment in order to secure our place among the competition. Despite the difficult environment, Korea’s leading institutional investors believed in the vision presented by ABL Bio and decided to invest. Thus, we hope to establish ourselves as a leading global company by accelerating research and development, as well as submitting INDs for at least three BsADCs by 2025. 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.
2024-07-02ablbio
ABL Bio Introduces Bispecific ADCs at World ADC Asia 2024
- Bispecific ADCs show improved safety and efficacy compared to existing monoclonal ADCs- Plans to lead the global market by accelerating development of bispecific ADCs ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies (BsAbs), announced that it attended the ‘3rd World ADC Asia 2024’ held in Incheon from June 25th to 27th, where it presented the development strategy for bispecific ADCs (Antibody Drug Conjugates, BsADCs). World ADC Asia is one of the Asia’s representative bio-related events, where various participants interested in ADC gather to discuss ADC technologies. The topic presented by ABL Bio at this event was ‘Exploring the Advantages of Using BsADCs & Their Impact on In Vitro Activities and Toxicity’, which included an overview of the BsADCs currently being developed by the company. Specific targets and indications for all BsADC pipelines are still undisclosed and will be released sequentially in the future. ABL Bio is focusing on development of BsADCs as a next-generation growth engine. BsADCs deliver a payload, a potent chemotherapeutic agent, to tumor cells more accurately than monoclonal ADCs that target only one antigen, resulting in improved safety, and their anticancer activities are also enhanced by blocking tumor cells’ evasion mechanisms. Tumor cells acquire resistance to anticancer drugs by activating other circuits that can compensate when the existing signaling system is blocked by anticancer drugs. BsADCs therefore simultaneously target two targets that are in a compensatory relationship with each other to kill cancer cells by suppressing their resistance. So far, no BsADCs have been approved. As most BsADCs are still in the early clinical development stage, ABL Bio plans to take the lead through rapid entry into the global market. They are actively conducting research and development with the goal of submitting clinical trial applications (INDs) for at least three BsADCs by 2025. Sang Hoon Lee, CEO of ABL Bio, said, “The future value of BsADCs is tremendous. We will accelerate the clinical entry of BsADCs currently in progress, submit INDs for three pipelines by 2025, and become a global leader in the BsADC market." 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.
2024-06-28ablbio
ABL Bio Holds IR events to share its development strategy for Bispecific ADCs
- It will communicate with various stakeholders such as analysts through offline IR meetings and online Youtube live broadcast on July 3rd- Next-generation ADC development strategy and interim phase 1 clinical data for ABL503 and ABL202 disclosed at this year’s ASCO will be shared ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies (BsAbs), announced that it will hold an offline IR meetings for analysts and an online meeting through Youtube on Wednesday, July 3rd. This events are organized for sharing the company's next-generation ADC development strategy, and for presenting interim phase 1 clinical data of ABL503 (TJ-L14B, Ragistomig) and ABL202 (LCB71, CS5001), which were both disclosed at the American Society of Clinical Oncology (ASCO) this year. The analyst meeting will be held privately in Yeouido, and in the online meeting everyone who have interest in the company can participate through the company’s official YouTube channel, ‘ABL Bio’. The online meeting will be broadcasted for approximately 1 hour and 30 minutes starting at 8:40 am. Currently, ABL Bio is focusing on ADC development, including strengthening internal ADC expertise, by setting the development of next-generation ADCs, including bispecific ADCs (BsADCs), as one of its key strategies for leaping forward as a global bio company. Considering the license-out cases related to BsADC, the economic value of BsADC is very large. ABL503 is a BsAb currently being jointly developed with global partner I-Mab. It uses the Grabody-T platform to simultaneously target 4-1BB, which is involved in immune T cell activation, and PD-L1, one of the immune checkpoints expressed on the surface of tumor cells and restricting the function of T cells. ABL202 is a ROR1 (Receptor tyrosine kinase-like Orphan Receptor 1) ADC. It was developed by applying LigaChem Biosciences’ tumor-specific cleavable linker and PBD prodrug to the ROR1 antibody that was developed by ABL Bio. In October 2020, ABL Bio and LigaChem Bioscience signed a license agreement with CStone Pharmaceuticals for ABL202, which guarantees CStone's development and commercialization rights for ABL202 globally, excluding Korea. Sang Hoon Lee, CEO of ABL Bio, said “as clinical data from pipelines begin to be announced, we are preparing a meeting to share the company's new development strategy. This is one of the cornerstones for becoming a global bio company. We plan to explain the phase 1 clinical data of ABL503 and ABL202 in detail at this meeting.” 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.
2024-06-26ablbio
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’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