AstraZeneca Submits Clinical Trial Application in China for PD-1/TIGIT Bispecific Antibody AZD2936

On March 14, the NMPA official website announced that AstraZeneca has submitted a clinical trial application in China for its Class 1 new drug AZD2936, which has been accepted. Public information shows that AZD2936 is a bispecific antibody that simultaneously targets PD-1 and TIGIT, and is currently undergoing Phase 1/2 clinical trials overseas for non-small cell lung cancer.

Screenshot source: CDE official website

Immune checkpoint inhibitors represented by anti-PD-1/PD-L1 antibodies are a significant advancement in the field of cancer treatment. Globally, many PD-1/PD-L1 inhibitors have been approved for the market to treat various types of cancers. However, the low response rate of monotherapy is one of the challenges faced by PD-1/PD-L1 inhibitors, including in non-small cell lung cancer. Therefore, researchers are exploring new therapies such as combination therapies or bispecific antibodies, hoping to bring new treatment options to cancer patients.

TIGIT is an immune checkpoint protein primarily expressed on the surface of T cells and natural killer cells (NK cells), and its role in tumor immune suppression is similar to that of PD-1/PD-L1. Studies have found that blocking the immunosuppression caused by the binding of TIGIT to its ligand can relieve the inhibition and exhaustion of T cells and NK cells, thereby promoting the anti-tumor effects mediated by T cells and NK cells. Blocking both PD-1 and TIGIT is expected to exert a synergistic anti-tumor effect.

Public information shows that AZD2936 is a PD-1/TIGIT bispecific antibody developed by AstraZeneca based on Compugen's investigational anti-TIGIT antibody COM902. Compugen is a clinical-stage drug discovery and development company aiming to leverage its broadly applicable predictive computational discovery platform in the field of cancer immunotherapy to identify new drug targets and novel biological pathways, as well as develop new therapeutic approaches. COM902 is a high-affinity anti-TIGIT antibody developed by Compugen, currently in Phase 1 clinical trials.

In 2018, Compugen entered into an agreement with AstraZeneca, granting AstraZeneca an exclusive license to use its anti-TIGIT monoclonal antibody (including COM902) for the development of bispecific and multispecific antibody products. Under the agreement, AstraZeneca will be responsible for the research, development, and commercialization of the corresponding products.

ClinicalTrials.gov shows that AstraZeneca is conducting a Phase 1/2 clinical trial of AZD2936, which is also the first-in-human (FIH) trial for this drug. The data indicates that this is an open-label, multi-center study aimed at evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of AZD2936 in adult patients with unresectable Stage III or Stage IV non-small cell lung cancer (NSCLC).

The acceptance of the clinical trial application for AZD2936 in China means that the drug is also expected to initiate clinical trials in China soon. It is hoped that the subsequent research of this drug will proceed smoothly and achieve positive results, bringing new treatment options to patients as early as possible.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Mar 14, 2022, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2]Compugen Announces Milestone Payment from AstraZeneca Triggered by First Patient Dosed with TIGIT Bispecific Derived from COM902. Retrieved Oct 04, 2021, from https://www.prnewswire.com/il/news-releases/compugen-announces-milestone-payment-from-astrazeneca-triggered-by-first-patient-dosed-with-tigit-bispecific-derived-from-com902-301391604.html

[3] ClinicalTrials.gov. From https://clinicaltrials.gov/ct2/show/NCT04995523?term=AZD2936&draw=2&rank=1

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