Ebdarokimab

HONG KONG, Jan. 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced that Michelle Xia, Ph.D, the founder, chairwoman, president, and CEO of Akeso, will deliver a keynote speech focusing on the Company's achievements in the development of new bispecific antibody drug therapeutics and the Company's 2024 key milestones at the 42nd Annual J.P. Morgan Healthcare Conference, to be held January 8-11, 2024 in San Francisco, California. The presentation will take place on Tuesday, January 9, at 4:30 PM PST. Thanks to clear strategic vision and efficient execution by our leadership and team,we delivered yet another exceptional performance, surpassing expectations and successfully achieving all of our stated goals in 2023. We are seeking to achieve the followings potential milestones that may take place in 2024 and into early 2025: Approval of four NDAs/sNDAs across five indications NDAs/sNDAs filing across four indications for three drugs Topline data readout from up to five registrational trials Completing enrollment for up to four registrational trials Initiating up to five new Phase III trials In addition, Akeso continues to plan for first-in-human clinical trials for a range of products currently in preclinical evaluation, including, for the first time, an antibody-drug conjugate (ADC). Updated Clinical Data and Milestone Outlook for Ivonescimab (PD-1/VEGF Bispecific) We currently have three Phase III clinical trials for ivonescimab at varying stages of progress: AK112-301, for which the NDA has been submitted for approval to the CDE, AK112-303, for which enrollment has completed AK112-306, for which we are currently enrolling. We are presenting updated data from our Phase II clinical trials, supporting our rapid development of ivonescimab across multiple indications. Updated Data for AK112-201 (NCT04736823) AK112-201 is an open-label, Phase II study evaluating ivonescimab plus chemotherapy across three cohorts. The patients with tumors of squamous histology in Cohort 1 help support our decision to initiate the AK112-306 Phase III clinical trial comparing ivonescimab against tislelizumab plus chemotherapy; the patients in Cohort 2 supported our earlier decision to enter into AK112-301 comparing ivonescimab plus chemotherapy against chemotherapy alone. * Confirmed responses for patients with at least one post-baseline scan; SQ-NSCLC n=60; EGFR-TKI n=19 ** NE – Not Established For Cohort 1, the frequency of treatment-emergent adverse events (TEAEs) leading to discontinuation of ivonescimab was 11%; there were no treatment-related adverse events (TRAEs) leading to the death of a patient. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and decreased white-blood cell counts. In Cohort 2, ivonescimab had an acceptable safety profile. There were no TRAEs leading to permanent discontinuation of therapy or patient death. Key Near-Term Milestones of Ivonescimab: For the NDA for ivonescimab based on AK112-301, a decision from the Chinese Center for Drug Evaluation (CDE) is expected in Q2 2024, along with a read-out of topline data from the study. Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis. Phase III data readout of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression is expected in Q2 2024. Based on this data, the Company will submit an NDA for this indication as appropriate. Phase III enrollment completion of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy for first-line treatment of advanced or metastatic squamous NSCLC is expected in the second half of 2024. Phase III completion by Summit of the global enrollment of ivonescimab (AK112/SMT112) combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic nsq-NSCLC who have progressed after treatment with a third-generation EGFR -TKI is expected in the second half of 2024. Potential initiation of Phase III clinical trials for ivonescimab in additional tumor types in 2024. Milestone Outlook for Cadonilimab (PD-1/CTLA-4 Bispecific) Following the Company's benchmark sales of cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, in 2023, the Company is poised to achieve additional important breakthroughs in 2024 that will significantly enhance clinical and commercial value. In January 2024, the NMPA accepted the sNDA for cadonilimab in combination with chemotherapy as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. NDA submission of cadonilimab + chemotherapy ± bevacizumab for first-line treatment for advanced cervical cancer is expected in Q1 2024. Phase III enrollment completion of cadonilimab for adjuvant treatment of hepatocellular carcinoma (HCC) is expected in Q4 2024. Phase III data readouts for first-line GC/GEJ cancer and first-line cervical cancer in 2024. Potential initiation of Phase III clinical trials for cadonilimab in additional tumor types in 2024. Other Potential Milestones for Oncology Products In terms of other significant oncology drug milestones, the Company is expected to reach several important milestones in 2024 to early 2025. Two bispecific antibodies, AK129 (PD-1/LAG3) and AK130 (TIGIT/TGFβ), are anticipated to enter Phase II, while ADC and neurodegenerative diseases candidates will undergo human clinical trials for the first time. Additionally, the CDE will also make a decision on the NDA for penpulimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Finally, additional combination therapy data is anticipated to be announced. Key Near-Term Milestones of Non-Oncology Products NDA decision expected in 2024 on ebronucimab (PCSK9) for the treatment of hypercholesterolemia and heterozygous familial hypercholesterolemia. NDA decision expected in 2024 on ebdarokimab (IL-12/IL-23) for the treatment of moderate-to-severe psoriasis. Phase III enrollment completion of gumokimab (IL-17) for ankylosing spondylitis. Phase III data readout of gumokimab (IL-17) for Moderate-to-severe psoriasis. Based on this data, an NDA submission for gumokimab (IL-17) for the treatment of moderate-to-severe psoriasis. Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis. Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization. Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates. About Akeso, Inc. Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode. Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA with priority review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited. For more information, please visit and follow us on X (formerly Twitter) @AkesoInc Company Codes: HongKong:9926

IL-23, or Interleukin-23, is a crucial cytokine that plays a significant role in the human body's immune response. It is primarily produced by activated antigen-presenting cells, such as dendritic cells and macrophages. IL-23 acts as a mediator between innate and adaptive immunity by stimulating the production of pro-inflammatory cytokines and promoting the differentiation and expansion of T-helper 17 (Th17) cells. Th17 cells, in turn, produce various cytokines that contribute to inflammation and immune responses against pathogens. However, dysregulation of IL-23 signaling has been associated with several autoimmune diseases, making it an important target for therapeutic interventions in the pharmaceutical industry. IL-23 Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 20 Sep 2023, there are a total of 39 IL-23 drugs worldwide, from 68 organizations, covering 31 indications, and conducting 279 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. The analysis of target IL-23 reveals a competitive landscape with multiple companies actively involved in research and development. Johnson & Johnson, Alvotech Swiss AG, and AstraZeneca PLC are among the companies showing significant progress. Approved indications for IL-23 drugs include psoriasis, Crohn Disease, plaque psoriasis, colitis, ulcerative, and arthritis, psoriatic. Monoclonal antibodies and biosimilars are the most rapidly progressing drug types, indicating intense competition. The United States, European Union, and China are the leading countries in IL-23 drug development, with China showing notable progress. Overall, the target IL-23 presents a promising opportunity for the pharmaceutical industry, with a wide range of indications and potential applications. IL-23 inhibitors approved for marketing: UstekinumabUstekinumabis a monoclonal antibody drug that targets IL-12 and IL-23. It has been approved for use in various therapeutic areas, including infectious diseases, nervous system diseases, cardiovascular diseases, digestive system disorders, skin and musculoskeletal diseases, and immune system diseases. The drug is indicated for the treatment of colitis, ulcerative, Crohn disease, arthritis, psoriatic, psoriasis, plaque psoriasis, Takayasu arteritis, dermatomyositis, inflammatory bowel diseases, and spondylarthritis. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The originator organization of Ustekinumab is Janssen Biotech, Inc. It received its first approval in Canada in December 2008. The drug has also been approved in other countries globally. In China, it has received approval as well. Ustekinumab falls under the category of overseas new drugs urgently needed in clinical settings and is also classified as an orphan drug. This indicates that the drug addresses a significant unmet medical need and is intended for the treatment of rare diseases or conditions. As a monoclonal antibody, Ustekinumab works by targeting specific proteins in the immune system, namely IL-12 and IL-23. By inhibiting these proteins, the drug helps to regulate the immune response and reduce inflammation associated with various diseases. The approval of Ustekinumab in multiple therapeutic areas highlights its versatility and potential to address a wide range of medical conditions. Its efficacy and safety profile have been evaluated through clinical trials and regulatory processes, leading to its approval for use in patients. In summary, Ustekinumab is a monoclonal antibody drug that targets IL-12 and IL-23. It has been approved for the treatment of various diseases in different therapeutic areas. The drug was first approved in Canada in 2008 and has since received approval in other countries globally, including China. Its classification as an overseas new drug urgently needed in clinical settings and an orphan drug underscores its importance in addressing unmet medical needs. EbdarokimabEbdarokimab is a monoclonal antibody drug that targets IL-12p40 and IL-23. It is being developed by Akeso Biopharma Co., Ltd., a pharmaceutical company specializing in biomedicine. The drug is primarily intended for the treatment of various disorders related to the digestive system, immune system, skin, and musculoskeletal system. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The therapeutic areas that Ebdarokimab focuses on include digestive system disorders, immune system diseases, and skin and musculoskeletal diseases. This suggests that the drug may have potential applications in treating conditions such as plaque psoriasis, colitis, and ulcerative colitis. These diseases are characterized by inflammation and immune system dysregulation, and targeting IL-12p40 and IL-23 may help to alleviate symptoms and improve patient outcomes. Ebdarokimab has reached the NDA/BLA stage, both globally and in China. NDA stands for New Drug Application, while BLA stands for Biologics License Application. These phases indicate that the drug has undergone extensive preclinical and clinical testing and is now being submitted for regulatory approval. This suggests that Ebdarokimab has shown promising results in early studies and may have the potential to become a commercially available treatment option in the near future. Based on the available information, it can be concluded that Ebdarokimab is a monoclonal antibody drug targeting IL-12p40 and IL-23, with potential applications in the treatment of various disorders related to the digestive system, immune system, skin, and musculoskeletal system. The drug has reached the NDA/BLA stage, indicating its potential for regulatory approval and commercialization. However, further research and clinical trials are likely needed to fully evaluate the safety and efficacy of Ebdarokimab in treating specific indications such as plaque psoriasis, colitis, and ulcerative colitis.