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news.Advaxis, a clinical-stage biotechnology company, has received Orphan Drug Designation from the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV for the treatment of Stage II-IV invasive cervical cancer.
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ADXS-HPV is Advaxis’ lead immunotherapy drug candidate designed to target cells expressing the HPV gene E7.
Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. Dismissal of the infected cells can eliminate the dysplasia or malignancy.
Advaxis has designed ADXS-HPV to infect antigen-presenting cells and direct them to generate a cellular immune response to HPV E7. The resulting cytotoxic T cells infiltrate and attack the tumors while specifically inhibiting tumor Tregs and MDSCs in the tumors that are protecting it.
Advaxis CEO Daniel J. O’Connor noted that the company is very pleased that the FDA has granted Orphan Drug Designation for ADXS-HPV in Stage II-IV invasive cervical cancer.
"ADXS-HPV is our most advanced product candidate with encouraging Phase 2 data, the potential to proceed along a registrational pathway, and now the benefits of orphan drug status," O’Connor added.