As Vudalimab moves closer to clinical approval, what is the likelihood that the drug will be approved?

Vudalimab is under clinical development by Xencor and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Vudalimab’s likelihood of approval (LoA) and phase transition for Adenocarcinoma Of The Gastroesophageal Junction took place on 05 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 05 Dec 2022 decreased Vudalimab’s Phase Transition Success Rate (PTSR) for Anal Cancer, decreased PTSR for Basal Cell Carcinoma (Basal Cell Epithelioma), increased PTSR for Bile Duct Cancer (Cholangiocarcinoma), decreased LoA and PTSR for Colorectal Cancer, increased PTSR for Thymic Carcinoma, increased PTSR for Thymoma (Thymic Epithelial Tumor), increased PTSR for Transitional Cell Carcinoma (Urothelial Cell Carcinoma), decreased PTSR for Triple-Negative Breast Cancer (TNBC), increased LoA and PTSR for Vulvar Cancer, increased PTSR for Neuroendocrine Carcinoma, decreased LoA and PTSR for Non-Small Cell Lung Cancer, decreased LoA and PTSR for Non-Small Cell Lung Carcinoma, increased PTSR for Penile Cancer, decreased PTSR for Renal Cell Carcinoma, increased LoA and PTSR for Salivary Gland Cancer, decreased PTSR for Gastric Cancer, decreased PTSR for Head And Neck Cancer Squamous Cell Carcinoma, decreased LoA and PTSR for Hepatocellular Carcinoma, decreased LoA and PTSR for Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer, decreased LoA and PTSR for Melanoma, and decreased PTSR for Nasopharyngeal Cancer.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Vudalimab LoA and PTSR Report.

Vudalimab overview

XmAb-717 is under development for the treatment of cervical cancer, squamous cell carcinoma of the anus, melanoma, triple-negative breast cancer, high-grade neuroendocrine carcinoma, squamous cell carcinoma of the penus, hepatocellular carcinoma, urothelial cell carcinoma, renal cell carcinoma, colorectal cancer, endometrial cancer, non-small cell lung carcinoma, prostate cancer, mesothelioma, gastroesophageal junction carcinomas, gastric cancer, small cell carcinoma of the lung, head and neck cancer squamous cell carcinoma, nasopharyngeal cancer, cholangiocarcinoma, gall bladder cancer, basal cell carcinoma, ovarian cancer, fallopian tube cancer, peritoneal cancer, thymic carcinoma, vulvar cancer, salivary gland cancer, thymoma, Hodgkin Lymphoma, anaplastic thyroid cancer, spindle cell squamous cell carcinoma, HER2 negative breast cancer and non-small cell lung cancer . It is administered through intravenous route. The drug candidate is a bi-specific monoclonal antibody that acts by targeting programmed cell death protein 1(PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). It is developed based on XmAb bi-specific/ Xtend Fc domains antibody engineering technology. It was under development for the treatment of anal cancer.

Xencor overview

Xencor is a clinical stage biopharmaceutical company that focused on discovering and developing engineered monoclonal antibody and cytokine therapeutics to treat patients with cancer and autoimmune diseases. The company product pipeline includes Vudalimab (PD1 x CTLA4), Plamotamab (CD20 x CD3), XmAb819 (ENPP3 x CD3), XmAb564 (IL-2-Fc) and XmAb104 (PD1 x ICOS). Xencor‘s Vudalimab is a bispecific antibody that simultaneously targets immune checkpoint receptors PD-1 and CTLA-4 and is designed to promote tumor-selective T-cell activation. Its Plamotamab is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). The company utilizes its proprietary XmAb technology platform to develop next generation antibody product candidates. . Xencor is headquartered in Monrovia, California, the US.

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