Draft:Penpulimab
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Penpulimab** is a humanized IgG1 monoclonal antibody that targets the programmed cell death protein 1 (PD-1) receptor. It is primarily developed for the treatment of cancers and is approved in China for specific indications.
Medical Uses
[edit]Penpulimab is indicated for the treatment of adult patients with relapsed or refractory classic Hodgkin's lymphoma who have undergone at least two prior lines of chemotherapy.[1] It is also under regulatory review for the treatment of nasopharyngeal carcinoma and non-small cell lung cancer (NSCLC) in China.[2]
Adverse Effects
[edit]The most common adverse effects associated with penpulimab include:
- Hypothyroidism - Fever - Elevated alanine aminotransferase levels - Decreased white blood cell count - Rash[1]
- Grade 3 or higher immune-related adverse events (irAEs) reported in clinical trials include skin rash, hyperlipidemia, and lung infections.[1]
Mechanism of Action
[edit]Penpulimab binds to the PD-1 receptor on T cells, preventing interaction with its ligands, PD-L1 and PD-L2.[1] This blockade restores T-cell-mediated immune responses against tumor cells. The antibody has been engineered with modifications to its Fc region to eliminate Fcγ receptor binding and Fc-mediated effector functions, reducing the risk of immune-related adverse effects such as antibody-dependent cellular cytotoxicity (ADCC) or phagocytosis.[3]
Pharmacology
[edit]Penpulimab demonstrates a slower dissociation rate from the PD-1 receptor compared to other PD-1 inhibitors, resulting in higher receptor occupancy and enhanced T-cell activity.[1] This property is attributed to its unique binding interactions with the glycosylated N58 residue on the BC loop of the PD-1 receptor.[1]
Chemistry and Manufacturing
[edit]Penpulimab is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It has been specifically designed with an IgG1 backbone and modified Fc regions to minimize immune-related side effects, ensuring optimized therapeutic activity.[3]
Regulatory Status
[edit]Penpulimab was developed by Akeso Biopharma in collaboration with Chia Tai Tianqing, a subsidiary of Sino Biopharm. The drug received its first regulatory approval in China in August 2021 for the treatment of relapsed or refractory classic Hodgkin's lymphoma.[2] It is currently being evaluated in clinical trials for other cancer indications, including nasopharyngeal carcinoma and NSCLC.[2]
Penpulimab is marketed under the brand name “安尼可®” (Anike) in China. [2]
Research
[edit]Penpulimab is being studied in various clinical trials to evaluate its efficacy and safety for additional cancer indications, including nasopharyngeal carcinoma, NSCLC, and other solid tumors. Preliminary results have demonstrated anti-tumor activity with a favorable safety profile.[4]
References
[edit]- ^ a b c d e f Wang, J., Fei, K., Jing, H., Wu, Z., Wu, W., Zhou, S., ... & Zhang, Y. (2021). "Penpulimab, a novel anti–PD-1 monoclonal antibody with unique binding characteristics, in patients with advanced solid tumors: Preliminary results from a phase 1 trial." *Journal of Clinical Oncology*, 39(15_suppl), e15091.
- ^ a b c d Zhang, L., Wu, Z., & Zhou, S. (2021). "Development of Penpulimab in China for Relapsed/Refractory Classic Hodgkin Lymphoma." *Springer’s Drugs & Therapy Perspectives*, https://link.springer.com/article/10.1007/s40265-021-01640-9
- ^ a b Akeso Biopharma. (2021). "Product Overview of Penpulimab." Akeso Official Website, https://www.akesobio.com
- ^ Wu, W., Zhou, S., & Wang, J. (2022). "Penpulimab in clinical trials for nasopharyngeal carcinoma and NSCLC." *Frontiers in Immunology*, https://www.frontiersin.org/articles/10.3389/fimmu.2022.924542/full