Akeso Launches Crucial Phase III Trial for Cancer Treatment
Groundbreaking Trial for Pancreatic Cancer Treatment Initiated
Akeso, Inc. (9926.HK) is thrilled to announce a major milestone in its clinical research journey. The company has successfully enrolled its first patient in the pivotal Phase III trial of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody designed for the challenging field of pancreatic cancer treatment. This study, named AK112-310/HARMONi-GI2, aims to explore ivonescimab in combination with chemotherapy and ligufalimab, a CD47 monoclonal antibody, primarily for patients requiring first-line treatment for metastatic pancreatic cancer.
Understanding the Challenges of Pancreatic Cancer
Pancreatic cancer poses one of the most formidable challenges in oncology due to its notoriously strong resistance to existing therapeutic modalities. Despite the success of immunotherapies in treating various solid tumors, this type of cancer has unique mechanisms that allow it to evade the immune system. Previous Phase III clinical trials focusing on immunotherapies for first-line treatment of metastatic pancreatic cancer have largely failed, underscoring the pressing need for innovative therapeutic strategies.
The Promise of Ivonescimab
Ivonescimab presents a tantalizing possibility in the armory against pancreatic cancer. By combining this drug with standard chemotherapy and ligufalimab, Akeso is potentially addressing the stark lack of effective options in immunotherapy for metastatic cases. This trial is part of a broader, multi-faceted approach by Akeso to fulfill the substantial unmet clinical needs within the global oncology landscape.
The Reality of Pancreatic Cancer Statistics
As an extremely aggressive malignancy, pancreatic cancer contributes to dismal patient prognoses and an alarming increase in global incidence rates. In recent years, hundreds of thousands of new cases have emerged annually. Tragically, the mortality rate closely aligns with incidence, resulting in persistently low overall survival statistics. Approximately 511,000 new pancreatic cancer cases and 467,000 related deaths occurred in a recent year alone. The challenge of early diagnosis leads to 80% of patients being diagnosed at advanced stages, complicating treatment efforts. Even among those with early-stage or locally advanced disease, prognosis remains poor, with a median overall survival of less than one year following first-line treatments.
Mechanisms of Action
Crucially, both PD-1 and VEGF are prevalent in the tumor microenvironment of pancreatic cancer. As a bispecific antibody, ivonescimab can simultaneously target both pathways, enhancing immune cell functionality against tumor cells. Moreover, ligufalimab disrupts the interaction between tumor cells and phagocytic cells, promoting phagocytosis and obstructing tumor growth. This synergistic action is anticipated to significantly bolster anti-tumor activity, representing a potential foundational shift in first-line treatment options for this difficult-to-treat cancer.
Expertise Behind the Research
The HARMONi-GI2 study features esteemed investigators, including Professor Yu Xianjun from Fudan University Shanghai Cancer Center, Professor Ying Jie’er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital. Their expertise underscores the trial's credibility and potential impact.
About Akeso
Akeso (HKEX: 9926.HK) stands out in the biopharmaceutical industry for its commitment to innovative research and drug development. Established in 2012, this company has fostered a comprehensive integrated R&D system, focusing on the development of groundbreaking biological medicines. Akeso employs the ACE Platform for its end-to-end drug development and harnesses cutting-edge technologies in bispecific antibody production, transforming it into a globally competitive entity in the biopharmaceutical arena. Currently, Akeso is advancing over 50 innovative assets targeting major health issues, with 24 candidates active in clinical trials. The company's vision prioritizes creating accessible therapeutic solutions for patients worldwide, thereby sustaining its commitment to transforming the landscape of healthcare.
Frequently Asked Questions
What is the significance of the Phase III trial for ivonescimab?
The trial marks a critical step in developing a new treatment option for metastatic pancreatic cancer, addressing a significant unmet need in oncology.
How does ivonescimab differ from existing cancer treatments?
Ivonescimab is a bispecific antibody that targets both PD-1 and VEGF pathways, potentially offering enhanced anti-tumor activity compared to traditional therapies.
What challenges does pancreatic cancer present?
Pancreatic cancer is known for its resistance to current therapies, high rates of late diagnosis, and poor overall survival rates, making innovative treatments essential.
Who are the investigators involved in the trial?
The trial features prominent experts including Professor Yu Xianjun and Professor Ying Jie’er, who bring significant experience in oncology research.
What is Akeso's broader vision?
Akeso aims to develop first-in-class biopharmaceuticals, focusing on innovative solutions that can provide effective and affordable treatments for serious health conditions worldwide.
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