Vaccibody AS announced today vaccination of the first patient in its phase IIa study – an exploratory, open-label, multicenter study with VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).
The phase I part of this trial enrolled patients in two cohorts of eight patients each receiving three doses of 3 mg of VB10.16 either at week 0, 3 and 6 (Cohort 1) or week 0, 4 and 12 (Cohort 2). Cohort 1 showed stronger effect of treatment and has been selected for the clinical phase IIa. Vaccibody will enroll 15-20 additional patients with CIN 2/3 in this phase. The vaccine will be delivered with a needle-free pain-less PharmaJet® Stratis Needle-free Injection System. The primary objectives of the phase IIa study are to assess T cell mediated immune responses in the peripheral blood as well as in the pre-malignant tissue of the CIN 2/3 lesions and to evaluate early signs of efficacy by means of HPV clearance and CIN regression.
Martin Bonde, CEO of Vaccibody, commented: We are pleased to announce the vaccination of the first patient in the clinical phase IIa with Vaccibody’s lead product VB10.16. Surgery is currently the only available therapy to remove abnormal cervical lesions caused by human papillomavirus and thereby stop the progression to cervical cancer. We are hopeful that VB10.16 immunotherapy can help change this treatment paradigm by offering a safe and efficacious alternative in the form of a therapeutic HPV vaccine.
Principal investigator, Prof. Dr. med. Karl Ulrich Petry, Department of Obstetrics & Gynaecology Klinikum Wolfsburg commented: We have been encouraged to see the outcome of the phase I trial with VB10.16 and are excited to initiate this phase IIa clinical study that offers a chance to get more valuable understanding on how patients respond to VB10.16 immunotherapy. On the basis of results from the phase I part of the trial, we believe that patients with CIN 2/3 will be very motivated to participate in the study to test this therapeutic vaccination as it might offer a non-invasive treatment option avoiding the side effects associated with surgical excision of the affected tissue. Moreover, the treatment can potentially also cure the underlying HPV infection and thereby prevent recurrence and may protect from other HPV16 induced cancers at other sites.
The company’s lead product, VB10.16, is a therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies.
About Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer
Per year approximately 530,000 women are diagnosed with cervical cancer worldwide and over 275,000 women die of the disease annually. Invasive cervical cancer is preceded by a long phase of pre-invasive disease called Cervical Intraepithelial Neoplasia (CIN). Globally the number of high grade lesions (CIN 2/3) the immediate precursors to malignancy, is estimated to be in the range of 10 million.
Virtually all cervical cancers are caused by high risk HPV types. Among the different high risk HPV types known, HPV16 has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It can be 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).
Current standard therapy for CIN 2/3 varies between countries and regions and often involves surgical removal of the affected tissue. These invasive procedures are associated with bleeding, infection, cervical stenosis, scarring and most importantly pre-term deliveries in subsequent pregnancies. As a result, there is a significant need for an effective therapeutic vaccine to treat existing HPV infection and associated pre-malignancies and malignancies of the cervix and thereby prevent the development of cervical cancer caused by human papillomavirus.
About Vaccibody AS
Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. Vaccibody also has a strong focus on so-called cancer neoantigen vaccines and is in late preclinical development with this program.