Erfonrilimab Clinical Trials Mechanism Of Action Insight
25 Apr 2023
Orphan DrugPhase 3Clinical ResultImmunotherapyPhase 2
Delhi, April 24, 2023 (GLOBE NEWSWIRE) -- Immune checkpoints play an important role in the regulation of the immune response against antigens under normal conditions. However, in cases when the response is really needed, as in the case of cancer, activities of these immune checkpoints can be detrimental. Therefore, companies have been developing antibodies and using other approaches to block signaling from immune checkpoints. The PD-1, PD-L1 and CTLA-4 checkpoints proteins have emerged as the most popular checkpoint proteins for achieving this. Recently, a China-based biopharmaceutical company Alphamab Biopharmaceuticals announced the development of a novel bispecific antibody named Erfonrilimab and its evaluation in different solid cancers, which has provided hope for patients suffering from these cancers and those refractory to existing therapies.
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By developing Erfonrilimab, Alphamab independently achieved a feat that no other pharmaceutical company had done before; Erfonrilimab is the first recombinant humanized bispecific antibody targeting the PD-L1 and CTLA-4 proteins. Some of its novel features include the inclusion of a proprietary CTLA-4 domain antibodyCTLA-4 domain antibody, a bispecific antibody fused with PD-L1 antibody, intended to target the tumor microenvironment that has elevated PD-L1 expression, and Treg clearing activity. This also shines light on the capabilities of Alphamab in the research and development of novel therapeutics, especially antibodies.
Erfonrilimab is being evaluated in several clinical trials across different cancer indications. Early-stage clinical trials using the drug for the treatment of several cancers, such as non-small cell lung cancer, urothelial carcinoma, and gastric cancer, have yielded positive results. Additional clinical trials were being carried out by Alphamab Oncology to assess the safety and effectiveness of Erfonrilimab. The companies is reportedly conducting a total of about 20 clinical trials of Erfonrilimab in Australia, the US, and China, which are in stages, addressing more than 10 different tumor types, including thymic cancer, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), pancreatic cancer, triple negative breast cancer (TNBC) and esophageal carcinoma (ESCC). These clinical trials' findings indicated that patients had a better chance of surviving upon treatment with Erfonrilimab.
Based on the clinical outcomes in China and Australia, the US FDA has given Alphamab Oncology permission to begin the phase II trial of Erfonrilimab. Additionally, Erfonrilimab was granted the orphan drug designation by the FDA in September 2020 for thymic epithelial tumor. The intermediate assessment of the phase III clinical study of Erfonrilimab coupled with chemotherapy as the first-line treatment of non-small cell lung cancer, one of four critical clinical trials presently underway, successfully achieved the intended progression-free survival endpoint.
Erfonrilimab and chemotherapy first-line combination studies for patients with squamous NSCLC and pancreatic cancer are anticipated to begin in 2023, according to the company's announcement, and a biological license application (BLA) will be submitted to China's Center for Drug Evaluation (CDE). Additionally, Alphamab also intends to begin combination trials using Erfonrilimab in conjunction with Axitinib, a small molecule inhibitor of VEGFR, for the first-line treatment of NSCLC patients who have both received and have not received prior treatment with PD-L1 targeted therapy. Last but not least, trials will be conducted to compare the use of PD-1 targeted therapy and chemotherapy to the use of Erfonrilimab and Axitinib as a first-line therapy for the treatment of NSCLC.
A considerable fraction of the drugs being developed and evaluated in modern times are antibodies, as seen by the vast number of clinical studies being undertaken internationally, and scientists are experimenting with antibodies having varying targets. One of these experiments led to the development of the drug Erfonrilimab, which has since demonstrated promise in numerous clinical trials. The judgment to stop cancer growth at its source has received enough attention because cancer keeps mutating. Erfonrilimab is a promising medicine that targets two such proteins that are crucial in the growth of cancer, and based on successful clinical trial outcomes, is projected to receive market authorization in the coming years.
Contact:
Neeraj Chawla
Kuick Research
Research Head
neeraj@kuickresearch.com
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