ADXS-HPV Designated Orphan Drug for HPV-Associated Anal Cancer

Advaxis announced that its lead drug candidate ADXS-HPV has been granted Orphan Drug Designation by the FDA for the treatment of human papillomavirus (HPV)-associated anal cancer.

ADXS-HPV is an immunotherapy that is 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. Eliminating these cells can eliminate the dysplasia or malignancy.

ADXS-HPV is currently being evaluated in four clinical trials for human papillomavirus (HPV)-associated cancers: recurrent/refractory cervical cancer, locally advanced cervical cancer, head and neck cancer, and anal cancer.

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