Georgia Regents Trials

Hello, I’m Greg Mayes, Chief Operating Officer of Advaxis. I’m excited to take this opportunity as a ‘guest blogger’ to provide my thoughts about the clinical research agreement that we entered into with Dr. Samir Khleif and his team at the Georgia Regents University (GRU) Cancer Center this week.

My first introduction to GRU and Dr. Khleif was during my first weeks at Advaxis. At the Society for Immunotherapy of Cancer (SITC) meeting in November 2013, I had the opportunity to sit down with many of the heads of cancer immunotherapy at several big pharmaceutical (“BP”) companies. One question I consistently asked them was: “with whom should Advaxis be working as we advance our groundbreaking cancer immunotherapy platform through the clinic?” The BPers uniformly responded that the key institution and, in particular, the key player in this space were GRU and Dr. Khleif.

I thought wow- Dr. Khleif is already one of our key collaborators with a recent preclinical study showing that our HPV immunotherapy construct is synergistic with PD-1 checkpoint inhibitors. To date, his publication, explaining that an anti-PD-1 antibody significantly increases therapeutic efficacy of our Listeria monocytogenes (Lm-LLO) immunotherapy (August 2013), has been downloaded over 2,700 times.

Following the SITC meeting, we put our heads together back at our labs in Princeton and said: “What more can we do with Dr. Khleif?” With the power and strength of the cancer immunotherapy research at GRU behind him, we wanted Dr. Khleif to look at dose escalation of our drug candidate to see if an elevated dose of ADXS-HPV could be even more efficacious; we wanted him to evaluate whether our positive ADXS-cHER2 data in canine osteosarcoma would translate to Her2/neu over-expressing malignancies in humans; we wanted to understand if the preclinical publication which assessed the efficacy of an anti-PD-1 combination with our therapy would translate in the clinic; and we wanted to know whether there was an opportunity for a front-line use of our HPV construct in cervical cancer. There would likely be more questions and trials to come too.

At the end of the day, we said we have a number of Phase 1 and Phase 2 clinical questions that are key and human clinical trials that could investigate them would rapidly accelerate the potential of the Advaxis platform. If we have one of the strongest players in the field who is ready, willing, and eager to work with us, then an expansion of this collaboration is a no-brainer. The development of an umbrella clinical research agreement that would help us quickly and easily work with Dr. Khleif on not only one study, but many, means a great deal to our strategy. We met with Dr. Khleif at the JP Morgan Healthcare Conference in January where we put the final details together and prioritized the order of the trials we will pursue.

We couldn’t be more enthusiastic that additional clinical trials with our two lead immunotherapies, ADXS-HPV and ADXS-cHER2 for cervical and breast cancer, respectively, are going to be conducted at a premier cancer center by a world-renowned oncologist. The GRU team clearly has the expertise, ambition, and resources to bring our immunotherapies to the next level and we are very glad they are on the Advaxis team.

 

Warmest Regards,

Greg Mayes

 

Gregory T. Mayes joined Advaxis in October 2013 as Executive Vice President and Chief Operating Officer.

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