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.
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Greg Mayes, Executive Vice President and COO
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Forward Looking Statements
This blog may contain forward-looking statements, including, but not limited to: statements as to the anticipated timing of clinical studies and other business developments, statements as to the development of new constructs, expectations as to the adequacy of our cash balances to support our operations for specified periods of time and as to the nature and level of cash expenditures, expectations as to market opportunities, our ability to take advantage of those opportunities, and the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov. The Company undertakes no obligation to revise these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.