On August 29, 2023 Akeso (9926. HK) reported its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization (Press release, Akeso Biopharma, AUG 29, 2023, View Source [SID1234634760]).
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Currently, Akeso has a total of 13 registrational Phase III clinical trials underway for 4 products, 3 drugs are approved.
Cadonilimab (PD-1/CTLA-4)
Patient enrollment was completed on the registrational Phase III clinical trials of PD-1/CTLA-4 bispecific antibody cadonilimab for the first-line treatment of advanced cervical cancer and gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.
The Phase III clinical trial of cadonilimab for the adjuvant treatment of hepatocellular carcinoma is undergoing efficiently.
The clinical development for lung cancer, pancreatic cancer, esophageal squamous cancer and other major tumor diseases is also in orderly progress.
In addition, 40+ Investigator initiated trials (IITs) for cadonilimab are underway.
Ivonescimab(PD-1/VEGF)
Ivonescimab(PD-1/VEGF) is Akeso’s another bispecific antibody. 1 NDA of ivonescimab has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).
There are 4 Phase III clinical trials been initiated/are underway globally, of which 3 are Phase III clinical trials with PD-1 monoclonal antibody as the positive control drug, 2 are international multicenter Phase III clinical trials; 9 Phase II clinical trials for Ivonescimab have been conducted.
4 Phase III trials of ivonescimab:
Patient enrollment was complete in the registrational Phase III clinical trial of ivonescimab versus pembrolizumab for the first-line treatment of PD-L1 positive NSCLC;
Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi / AK112-301) is enrolling patients;
An international Phase III clinical trial of ivonescimab in combination with chemotherapy versus pembrolizumab in combination with chemotherapy as first-line treatment for metastatic squamous NSCLC has also been initiated；
In China, a registrational Phase III clinical trial of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy as first-line treatment for advanced squamous NSCLC is underway.
In December 2022, Akeso out-licensed Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan in. Akeso is to receive a US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive a low double-digit percentage of royalties on net product sales of ivonescimab .
Ivonescimab is engaged in many clinical trials for multiple types of lung cancer, gastric cancer, biliary tract cancer, pancreatic cancer, triple-negative breast cancer, head and neck squamous cell carcinomas, ovarian cancer and other gynecologic cancer, colorectal cancer, hepatocellular carcinoma, as well as other solid tumors.
It is noteworthy that Akeso announced clinical progress and new products and therapies. In addition to the two bispecific antibodies mentioned above, AK129 (PD-1/LAG-3 bispecific antibody) and AK130 (TIGIT/TGF-β bispecific antibody) have already entered into the clinical trial, and AK131 (PD-1/CD73 bispecific antibody) and AK132 (Claudin18.2/CD47 bispecific antibody) are about to be approved for the clinical trial. Akeso also announced that a number of ADC drugs will soon enter clinical trials, including bispecific antibody ADC drugs.
The clinical development of CD47, IL-4R, IL-17, CD73, TIGIT and other phase II and III target products is also in orderly progress.
"We are very encouraged to see that our team has continued to achieve excellent results.In the first half of 2023 we had our best results since the company’s inception in terms of financial performance, commercialization of new drugs, clinical development, and operation." Said Dr. Michelle Xia, founder, Chairwoman, CEO, and President of Akeso.
"Such achievements do not come easily in a complex and difficult external situation. We would like to thank Akeso’s team for their ten years of continual pursuit of excellence and improvement. We have put into practice the concept of new drug development driven by clinical value, maintain a forward-looking strategic layout and exceptional managerial efficiency, calmly respond to market changes, seize development opportunities, and grow on an ongoing basis. In the future, with successive approval of our innovative core products and their broad indications, and the further increase in our operational and managerial capabilities, Akeso will enter another period of rapid growth. We will continue to work diligently, professionally, and effectively to promote the more rapid, thorough, and wide-ranging translation of new drug innovations into global value, and we look forward to seeing the company enter a new stage of commercialization and sustained profitability in the coming years, to better deliver innovative clinical value to patients, and reward society and investors."Dr. Michelle Xia said.