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news.Advaxis, a biotechnology company developing the next generation of cancer immunotherapies, has expanded its relationship by entering into a master clinical trial agreement with GRU Cancer Center at Georgia Regents University to conduct four Phase I/II clinical trials.
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The trials will be conducted under the supervision of GRU Cancer Center director and former chief of the Vaccines Section at the National Cancer Institute Dr Samir Khleif.
The planned trials will further develop Advaxis’ two lead immunotherapies: ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer. The four clinical trials will be designed to assess:
– High dose, repeating cycles of ADXS-HPV in recurrent or refractory cervical cancer.
– ADXS-cHER2 in women with Her2/neu over-expressing breast cancer with measurable disease who have progressed after prior standard therapy.
– The optimal combination dose of ADXS-HPV and PD-1 antibody in patients with recurrent or refractory cervical cancer.
– ADXS-HPV prior to surgery in patients with surgically treatable cervical cancer.
Advaxis CEO Daniel J O’Connor noted the company is excited that Dr Khleif, a visionary in oncology, and his elite team at the most prominent center for cancer immunology research will conduct these additional trials with two of our immunotherapies.
"Through our prior collaboration, Dr. Khleif has already generated positive preclinical data using ADXS-HPV in combination with anti-PD-1 therapy," O’Connor added.