Ivonescimab (PD-1/VEGF BsAbs,AK112), developed independently by Akeso, Inc, is the world’s first PD-1/VEGF bispecific antibody for clinical trail. Based on Tetrabody technology, it can block the binding of PD-1 to PD-L1 and PD-L2, and simultaneously block the binding of VEGF to VEGF receptors. The anti-PD-1 end of ivonescimab adopts the structure of pembrolizumab, and the anti-VEGF end adopts the structure of bevacizumab.
As a first-in-class PD-1/VEGF bispecific antibody, ivonescimab combined with VEGF inhibitors have shown strong efficacy in a variety of tumor types, including renal cell carcinoma, NSCLC, and hepatocellular carcinoma.
According to the previous ivonescimab clinical trial data that Akeso, Inc. published at 2022 ASCO Annual Meeting, ivonescimab monotherapy was safe and well tolerated in patients with advanced NSCLC regardless of histology from a multicenter, open-label, phase 1b/2 trial (NCT04900363).
Akeso is conducting a phase III study of Ivonescimab monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III study of Ivonescimab plus chemotherapy versus chemotherapy in EGFR+ advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy (NCT05184712) is ongoing. Ivonescimab has been investigated for different stages of treatment for both NSCLC and small cell lung cancer. https://www.akesobio.com/en/media/akeso-news/20220606-2/
For NSCLC, Ivonescimab injection(AK112) has received 3 breakthrough therapy designation(BTD) in China.
- In August 2022, Ivonescimab won the first breakthrough therapy designation for lung cancer. The indications are: first-line treatment of locally advanced or metastatic NSCLC with positive PD-L1 expression (TPS ≥ 1%);
- In October 2022, Ivonescimab received the second breakthrough therapy designation in the field of lung cancer. The indication is: Treatment in combination with chemotherapy for locally advanced or metastatic non-squamous NSCLC with EGFR mutation which have failed bytreatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). (No:CXSL2101154).
- In November 2022, Ivonescimab won the third breakthrough therapy designation. The indication is:Combined with docetaxel for the treatment of locally advanced or metastatic non-small cell disease that failed by previous PD-1/L1 inhibitors and platinum-based chemotherapy NSCLC(No: CXSL2101154).
About AKESO INC
Akeso, Inc. (9926.HK), established in 2012, is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide.