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HONG KONG, Nov. 14, 2022 /PRNewswire/ -- Akeso, Biopharma (9926. HK) ("Akeso") announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody, AK112) combined with docetaxel for the treatment of locally advanced or metastatic Non-Small-Cell Lung Carcinoma (NSCLC) patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy. This is the third BTD for AK112 for use with NSCLC patients, and AK112 is the only drug candidate granted BTD for PD-(L)1 resistant lung cancer treatment in China.
The three BTDs of AK112 comprise:
Breakthrough Therapy Designations aim to accelerate development and regulatory review of new drugs to treat severe diseases which show encouraging preliminary clinical results. These drugs need to demonstrate a significant improvement in clinical endpoints over existing therapies, or fulfill unmet medical needs. Akeso believes that these three designations of AK112 for NSCLC will accelerate the R&D and marketing progress of AK112 in China.
PD-1/L1 monoclonal antibody combined with platinum-based chemotherapy is the standard of care for first-line therapy for patients with advanced NSCLC. However, the majority of patients do not benefit from the treatment or may relapse after a period of response, highlighting the need for more effective treatment. However, there are currently no immunotherapy regimens approved for NSCLC patients who failed to respond to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.
Immunotherapy plus anti-angiogenesis therapy has proven its combined advantages in previous studies worldwide. Lung cancer is one of the mainstream exploration areas of this therapy. AK112 can potentially simultaneously block PD-1 and VEGF targets, and has demonstrated a favorable safety profile and promising anti-tumor efficacy in recent studies conducted by the Company. AK112 is expected to provide a valuable option for NSCLC patients to overcome immunotherapy resistance antibody therapy.
ABOUT IVONESCIMAB (PD-1/VEGF BI-SPECIFIC ANTIBODY, AK112)
Ivonescimab is a first-in-class and the first to enter phase III clinical trial PD-1/VEGF bi-specific antibody independently developed by Akeso Biopharma. Engineered with our unique Tetrabody technology, Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody combined with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In view of the co-expression of VEGF and PD-1 in the tumor microenvironment, Ivonescimab, as a single agent to block these two targets, may block these two pathways more effectively and enhance the antitumor activity, as compared to combination therapy.
Currently, Akeso is conducting a phase III clinical trial of AK112 monotherapy versus Pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, a phase III clinical trial of AK112 plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy is ongoing. AK112 has started multiple clinical trials for various stages treatment of indications including non-small cell lung cancer and small cell lung cancer.
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