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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 Global Partner Compass Therapeutics Completes Patient Enrollment for Phase 2/3 C...
- Completed enrollment of the planned 150 patients in COMPANION-002, a Phase 2/3 trial of CTX-009 plus paclitaxel in patients with advanced Biliary Tract Cancer- Approved an Investigator Sponsored Trial of CTX-009 in the first-line setting in patients with Biliary Tract Cancer ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its global partner, Compass Therapeutics has completed planned enrollment of 150 patients in COMPANION-002, a randomized Phase 2/3 clinical trial of CTX-009 (ABL001) in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers. In addition, along with the completion of enrollment of patients in COMPANION-002, Compass Therapeutics announced the approval of a new Investigator Sponsored Trial (IST) evaluating CTX-009 as a first-line treatment for patients with biliary tract cancer. The clinical trial will be conducted at the MD Anderson Cancer Center at the University of Texas, USA. CTX-009 will be added to gemcitabine, cisplatin, and durvalumab, which is the current standard first-line treatment for biliary tract cancer. CTX-009, initially developed by ABL Bio, is a bispecific antibody targeting VEGF-A (Vascular Endothelial Growth Factor A) and DLL4 (Delta-Like Ligand 4) which induces the death of tumor cells by inhibiting the creation of new blood vessels in cancer. Compass Therapeutics, which holds global rights, is currently conducting a phase 2/3 clinical trial for biliary tract cancer patients in the United States based on the phase 2 clinical trial (HDB001A) conducted in Korea by Handok, which holds Korean rights. CTX-009 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in April to support the rapid development of new drugs by developers, and an additional phase 2 clinical trial for patients with colorectal cancer is also underway. Sang Hoon Lee, CEO of ABL Bio said “Compass Therapeutics has completed patient enrollment in COMPANION-002. We would like to thank the patients and their families who participated in the clinical trial, and all those involved who helped make it run smoothly. In addition, we are very pleased to announce plans to expand the clinical investigation of CTX-009 to first-line treatment with MD Anderson, one of the most prestigious cancer centers in the United States. We will continue to do our best to quickly share news regarding the progress of CTX-009 clinical development.” 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.
2024-08-09ablbio
ABL Bio’s ABL503 Patent Issued in Indonesia and China
- ABL503 is a bispecific “Grabody-T” that targets both PD-L1 and 4-1BB- Positive interim Phase 1 data for ABL503 were reported at ASCO 2024… including 1 complete response (CR) and 6 partial responses (PR)- Accelerated development plan announced for bispecific antibodies, while the Company prepares new INDs for bispecific ADCs ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that ABL503 (ragistomig) patent has been issued in Indonesia and China. ABL503 is being jointly developed with ABL’s global partner I-Mab (NASDAQ: IMAB). ABL503 is a bispecific antibody that simultaneously targets PD-L1, an immune checkpoint protein, and 4-1BB, which is involved in immune T cell activation. Promising Phase 1 data were presented at the American Society for Clinical Oncology Annual Meeting (ASCO 2024). ABL Bio already has ABL503 patents in Eurasia, Japan, Chile, and South Africa. By securing additional patents in Indonesia and China, the global rights for ABL503 will be protected in numerous countries around the world until 2039. Patent examination is currently underway in Europe, the United States, and Canada. ABL503 was developed using ABL Bio’s 4-1BB-based bispecific antibody platform ‘Grabody-T’. A Phase 1 clinical trial for patients with solid tumors is currently 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. According to data disclosed at ASCO 2024, 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. In addition to ABL503, ABL Bio is developing various bispecific antibodies utilizing the Grabody-T platform. For ABL111 (givastomig), ABL’s global development partner, I-Mab, is conducting a monotherapy study and a combination therapy study. Clinical trials for other Grabody-T-based bispecific antibodies, ABL103 and ABL105, are progressing as planned. “ABL503 has shown encouraging safety and efficacy in clinical trials for PD-(L)1 relapsed and refractory patients. Securing the patents for ABL503 in various countries around the world marks an important milestone for the Company” said Sang Hoon Lee, CEO of ABL Bio. Sang also stated, “the Company will use internal resources and potential milestone payments to invest in accelerating the development of bispecific antibodies, while also working to submit clinical trial applications (INDs) for at least three bispecific ADCs next year.” 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.
2024-08-01ablbio
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