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From Two Checkpoint Inhibitor Development Agreements to Two IND Filings in Four Months – A Special Thanks…

Posted on Monday, November 24th, 2014 at 8:00 am
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With Thanksgiving fast approaching (wasn’t it just summer?), I would like to take a moment to salute the extremely hard working team at Advaxis and particularly our research, clinical development and business development groups.

In the past two weeks, we have announced the filing of two separate INDs involving our ADXS-HPV and ADXS-PSA technologies. These INDs are noteworthy in that both are the result of separate development agreements that we secured just four months ago with two global pharmaceutical companies – MedImmune, the global biologics research and development arm of AstraZeneca, and Merck – involving each company’s checkpoint inhibitor technology (for MedImmune, MEDI4736, and for Merck, its recently approved KEYTRUDA® (pembrolizumab)).

Going from concept to IND in four months is a remarkable feat for a standard clinical program. But when factoring in the coordination with research teams from two global pharmaceutical companies AND the fact that each study is seeking to evaluate our immunotherapy technology in combination with a checkpoint inhibitor (still a very new and groundbreaking concept), it’s an even more remarkable accomplishment.

But there’s more. Pending FDA acceptance of the INDs, we anticipate initiating both Phase 1/2 studies in early 2015. Thus, there is the potential of advancing two licensing agreements to two clinical study initiations in just three quarters time! Worth emphasizing again, both studies will involve our immunotherapies – ADXS-HPV and ADXS-PSA – in combination with PD-L1 and PD-1 checkpoint inhibitors, respectively.

For this, I raise a drumstick and say thank you to the research, clinical development and business development teams at Advaxis. 2014 has been a tremendous year at our company, and much of our success is due to your tireless work.
- See more at: http://www.thechairmansblog.com/advaxis/daniel-oconnor/two-checkpoint-inhibitor-development-agreements-two-ind-filings-four-months-special-thanks/#adxs