Vaccibody AS, a clinical stage immuno-oncology company, announced today that it has entered into a collaboration with Roche to explore a combination of Vaccibody’s VB10.16 and the PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq®) in patients with advanced cervical cancer. Vaccibody expects to start a phase II study with up to 50 patients in the second half of 2019.
Martin Bonde, CEO of Vaccibody, said: “We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with advanced cervical cancer.” Agnete Fredriksen, President and CSO of Vaccibody added: “The combination of VB10.16 and atezolizumab is building on the positive data VB10.16 has generated as monotherapy in patients with precancerous cervical lesions. In this study, it was observed that VB10.16 creates a target for PD-1/PD-L1 checkpoint inhibitors, thereby providing a sound scientific rationale for combining VB10.16 with an immune-checkpoint inhibitor like atezolizumab in cervical cancer patients.”
The planned study will assess the safety, tolerability, immunogenicity and efficacy of the VB10.16-atezolizumab combination in patients with advanced cervical cancer.
VB10.16 is an investigational therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies. The drug candidate has demonstrated favorable 6M interim clinical data in a Phase I/IIa study in pre-cancerous HPV16 induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).
About cervical cancer
Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide. An estimated 45,800 cases of cervical cancer will be diagnosed in the US and EU in 2019 and similarly an estimated 18,400 deaths from cervical cancer will occur in 2019. Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer. It has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It is detected in up to 60% of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers). Gardasil® and Cervarix® are preventive HPV vaccines which prevent infection of HPV, but these do not have an effect in already infected patients. A high percentage of the eligible population for the preventive vaccines does not get vaccinated, thus HPV infection and HPV+ cancer still requires effective therapeutic interventions. There is currently no available therapy treating HPV specifically.
Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. The company is a leader in the rapidly developing field of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need. A phase I/IIa neoantigen clinical trial is currently enrolling patients with locally advanced or metastatic melanoma, non-small cell lung carcinoma, clear renal cell carcinoma as well as urothelial or squamous cell carcinoma of the head and neck. Vaccibody’s front runner program (VB10.16) is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study (phase I/IIa), which has reported positive 6M interim data, evaluates the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).
CEO Martin Bonde, PhD
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