Advaxis (NasdaqCM: ADXS) has formed a collaboration with Memorial Sloan Kettering called My Immunotherapy Neo-Epitopes (MINE™), which will focus on creating and validating personalized cancer treatments that target neo-epitopes. This approach is a good fit for Advaxis’s listeria platform, and the Company’s experience with existing cancer vaccine programs should allow rapid development and manufacturing of personalized cancer treatments. The collaboration will begin with preclinical mouse studies to compare the listeria platform with other technologies, and Advaxis plans to file an IND for the program in 2016.
MINE Collaboration Shines Light on Advaxis’s Efforts in Personalized Oncology.
Advaxis first mentioned the possibility of using its Listeria monocytogenes (Lm) platform for neo-epitope targeting this June. The Company has now announced the formation of a collaboration with Memorial Sloan Kettering (MSK) called My Immunotherapy NeoEpitopes (MINE™). Neo-epitopes are generated by mutations in tumor DNA that create protein fragments recognized as antigens by the immune system. They differ from other tumor antigens in the sense that they are not widely shared among patients and are often specific for each individual. Dr. Jedd Wolchok from MSK and Advaxis will initially conduct preclinical mouse experiments comparing the Lm approach with other approaches. Advaxis plans to file an IND in 2016 and conduct clinical trials at MSK. Studies are likely to include a personalized Lm agent in combination with a checkpoint inhibitor to maximize the potential efficacy.
Listeria Platform has Advantages for Neo-Epitope Targeting. Targeting neo-epitopes on a commercial scale requires rapid engineering of each personalized product candidate and cost effective manufacturing. Advaxis’s Lm platform has certain features that make this process feasible on a commercial scale. The general process for creating a personalized cancer vaccine is listed below along with potential advantages of using Advaxis’s Lm platform.
1. Tissue harvesting and sequencing analysis. A sample of the tumor is collected and compared to normal tissue in the same patient. Sequencing analysis identifies the neo-epitopes specific to that individual’s tumor to begin creating the therapy.
2. Computational prediction of neo-epitopes and introduction of neo-epitope sequences into a delivery vehicle. The current computational methods for identifying neo-epitopes are not robust. Therefore, it could be better to present multiple neo-epitopes rather than to choose only a few and be incorrect. The plasmids used to express antigens within Lm can express upwards of 50 neo-epitope sequences in tandem. The bacteria can also retain up to 100 individual plasmids, allowing many potential neo-epitope sequences to be expressed at once. Moreover, multiple bacterial constructs can be administered to a single patient, meaning Advaxis’s technology has the advantage of tremendous bandwidth.
3. Manufacturing. Advaxis has substantial experience manufacturing listeria for its completed and ongoing clinical trials, and is currently developing a method for inhouse manufacturing of personalized Lm products. The manufacturing component of personalized oncology could be a major differentiator going forward.
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