Two Ivonescimab (PD-1/VEGF) Results including Phase 3 Monotherapy versus Pembrolizumab Monotherapy in First-Line Treatment for PD-L1 Positive NSCLC to Be Presented at WCLC 2024

• First Release of Phase III Head-to-Head Clinical Study Data of Ivonescimab versus Pembrolizumab in NSCLC
  
• Ivonescimab Is the First Drug to Achieve Clinically Meaningful Benefit over Pembrolizumab in a Randomized Phase III Clinical Trial in NSCLC

HONG KONG, Aug. 11, 2024 /PRNewswire/ — Akeso, Inc. (HKEX: 9926.HK) (“Akeso,”) today announced two upcoming oral presentations of ivonescimab (PD-1/VEGF bispecific antibody) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer¯(“WCLC24”), taking place in San Diego, USA from September 7-10, 2024. Among these is a late-breaking Presidential Symposium presentation featuring results from the HARMONi-2/AK112-303 study, which evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS ‰¥1%).

The late-breaking result of HARMONi-2/AK112-303 will be presented by Professor Zhou Caicun, the principal investigator of HARMONi-2 and director in the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University.

Presentations during WCLC 2024

Akeso will also participate as an exhibitor, actively engaging with professionals from diverse fields.

Milestones of ivonescimab:

May 2024:
Ivonescimab was granted marketing approval for the treatment of epidermal growth factor receptor (“EGFR”) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (“nsq-NSCLC”), making it the world’s first approved PD-1/VEGF bi-specific antibody.

May 31:
At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

June 01:
Interim result of the Phase III study of ivonescimab combined with platinum-doublet chemotherapy in patients with   EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR-TKIs treatment (HARMONi-A ), was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, and the study was ranked as the top report on the TOP 10 list of lung cancer at ASCO by OncoAlert, an international cancer support organization. On the same day, the research findings were also published simultaneously in the JAMA journal.

July 25:
Akeso’s partner, Summit Therapeutics (NASDAQ:) Inc. (NASDAQ: SMMT) (“Summit,”) announced a strategic five-year collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for the purpose of accelerating the development in certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer.

July 29:
The supplemental New Drug Application (sNDA) for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS ‰¥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA). This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study.

August 02:
The supplemental New Drug Application (sNDA) for ivonescimab monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS ‰¥1%) locally advanced or metastatic NSCLC was accepted by China NMPA with priority review.

About Ivonescimab (AK112/SMT112)
Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’ license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique 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 core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.

With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases, with 19 drug candidates in the clinical stage, including 8 multispecific antibodies. Akeso has successfully promoted the commercialization of three innovative biological drugs, and marketing applications of multiple indications are submitted for 4 new drugs. 安尼可 ®, approved for marketing in August 2021, is currently the only differentiated PD-1 monoclonal antibody that applies the IgG1 subtype with modified Fc-null domain. å¼€å¦å°¼ ® (PD-1/CTLA-4 bi-specific antibody, Cadonilimab injection) was granted marketing approval in June 2022, making it the world’s first bi-specific antibody drug for tumor immunotherapy and the first bi-specific antibody new drug in China.In May 2024, ä¾è¾¾æ–¹ ® (PD-1/VEGF bi-specific antibody, Ivonescimab injection), the first-in-class PD-1/VEGF bi-specific antibody independently developed by Akeso, was granted marketing approval for the treatment of epidermal growth factor receptor (“EGFR”) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (“nsq-NSCLC”), making it the world’s first approved PD-1/VEGF bi-specific antibody. The drug had been granted three Breakthrough Therapy Designations for the treatment of lung cancer by the Center for Drug Evaluation (CDE). In December 2022, a license agreement with total potential deal value of USD $5 billion, plus a low double-digit royalty of product net sales in the authorized countries of the new drug, ä¾è¾¾æ–¹ ®, set a new record in overseas licensing for the transaction amount of a single innovative drug in China.

Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.