Phanes Therapeutics' First-in-Class Claudin 18.2/CD47 Bispecific Antibody PT886 Granted IND Approval in China for Advanced Solid Tumors

Feb 19, 2024 15:16 CST Updated 15:16

Phanes Therapeutics

Developer of Oncology and Ophthalmology Drugs

▎Edited by the WuXi AppTec content team

On February 18, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Phanes Therapeutics' Class 1 new drug PT886 has been approved for clinical trials, intended for development to treatAdvanced Solid Tumors (Including Gastric Cancer, Gastroesophageal Junction Cancer, and Pancreatic Cancer). Public information shows that PT886 is a self-developed product by Phanes Therapeutics.Bispecific Antibody Targeting Claudin18.2 and CD47。

Source of the image: CDE official website

Gastric cancer, gastroesophageal junction cancer, and pancreatic cancer are widely recognized as difficult-to-treat cancer types. Public data shows that the median overall survival for patients with advanced or metastatic gastric cancer/gastroesophageal junction cancer does not exceed 10 months, while the median overall survival for pancreatic cancer is only 6 to 11 months.

PT886 isPhanes Therapeutics has developed a bispecific antibody with a natural IgG structure, targetingClaudin18.2 and CD47.Studies have found that under normal physiological conditions, Claudin18.2 is only expressed in the differentiated epithelial cells of the gastric mucosa, and there is no expression in other healthy tissues. HoweverClaudin18.2 is highly expressed in various tumors such as gastric cancer, esophageal cancer, pancreatic cancer, lung cancer, ovarian cancer, and colon cancer.. Therefore, Claudin18.2 has the potential to becomeGastric Cancer, Pancreatic CancerEffective targets for the immunotherapy of solid tumors such as...CD47 is also a target that has gained significant attention in the industry., which can transmit the "don't eat me" signal to its receptor signal regulatory protein α (SIRPα) on phagocytes. AndBlocking the CD47-SIRPα interaction promotes macrophage phagocytosis of tumor cells.

According to the press release from Phanes Therapeutics, PT886 can directly kill tumor cells through the ADCP activity of macrophages and the ADCC activity of NK cells. It also expands the scope of tumor killing by simultaneously targeting Claudin18.2 and CD47, which are highly expressed on the surface of tumor cells. Additionally, PT886 is expected to induce the presentation of tumor neoantigens by guiding tumor cells into phagocytic antigen-presenting cells (APCs) and indirectly activate T cells to kill tumor cells with low or no expression of Claudin18.2 by recognizing these neoantigens, thereby stimulating the acquired immune system. Furthermore, the anti-CD47 arm of PT886 is highly differentiated and has demonstrated in preclinical models that it maintains strong binding activity to CD47 on tumor cells while showing minimal binding to human red blood cells.

Public information shows that PT886 has previously been granted Orphan Drug Designation by the U.S. FDA for the treatment ofPancreatic Cancer. The product was also approved to conduct Phase 1 clinical trials in the United States in 2022,Preliminary data demonstrated its good safety, tolerability, and PK profile.。

References：

[1] Center for Drug Evaluation, National Medical Products Administration of China (CDE) Official Website. Retrieved Feb 18 , 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Phanes Therapeuticsclaudin 18.2/CD47Bispecific antibodyPT886Clinical Trial Application ApprovedCDEAcceptance. Retrieved Dec 11, 2023, from https://mp.weixin.qq.com/s/WVQe3sRqWtICBvyGt62cOA

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