On July 2, 2020 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported First Patient Dosed in its VB C-02 trial; a multi-centre, open-label Phase II clinical trial testing a combination of Vaccibody’s VB10.16, a targeted DNA vaccine, and Roche’s PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced or recurrent, non-resectable HPV16 positive cervical cancer (Press release, Vaccibody, JUL 2, 2020, View Source [SID1234561646]).
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Siri Torhaug, Chief Medical Officer of Vaccibody, said: "We are excited to have the first patient dosed with VB10.16 at our Norwegian site at Oslo University Hospital, and to initiate the clinical collaboration with Roche. Today, advanced cervical cancer patients have limited treatment options. The trial addresses the high unmet medical need in this patient population, as well as the need for novel treatment options."
Agnete B. Fredriksen, President & Chief Scientific Officer of Vaccibody, added: "VB10.16 is the frontrunner in the Vaccibody cancer vaccine portfolio. The rationale for this trial is supported by the positive data from the Phase I/IIa clinical trial with VB10.16 as monotherapy in patients with precancerous cervical lesions and data supporting a scientific rationale for synergistic effect of combining VB10.16 with checkpoint inhibitors. We believe the combination of VB10.16 and atezolizumab can enhance the anti-tumor efficacy in advanced cervical cancer patients."
The planned open-label Phase II clinical trial is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16 positive cervical cancer, who failed or are not eligible for current standard of care. The VB C-02 clinical trial is a multi-centre, open-label clinical trial and will enroll up to 50 patients in six European countries. The clinical trial has the ClinicalTrials.gov Identifier: NCT04405349. 2
About VB10.16
VB10.16 is an investigational therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced malignancies and pre-malignancies. The drug candidate has demonstrated favorable 12M clinical data in a Phase I/IIa clinical trial in precancerous HPV16 induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).
About cervical cancer
Cervical cancer is the most common cancer among women in developing countries and is the second most common cancer amongst women worldwide. An estimated 45 thousand cases of cervical cancer will be diagnosed in the US and EU in 2020 and similarly an estimated 18 thousand deaths from cervical cancer will occur in 2020. Cervical cancer is caused by high risk HPV. HPV16 is the virus 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; 70% of oropharyngeal cancers, 40% of penile-, vaginal-, and vulvar cancers; and 25% of oral cavity 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.