Expert Briefing: New Immunotherapy Technologies Provide Hope In Breast and Ovarian Cancer Print E-mail
By M.E.Garza   
Wednesday, 23 July 2014 04:20

icon_expertbriefingLast month, TapImmune Inc. (OTCQB: TPIV) announced that Dr. Keith Knutson, PhD had been appointed to chair the company’s scientific advisory board.
TapImmune, an immunotherapy company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of oncology and infectious disease. had licensed cancer vaccine technologies originating from Dr Knutson’s former laboratory at the Mayo Clinic. Those platforms are currently completing Phase I clinical trials in breast and ovarian cancer.  The start of Phase II clinical studies is planned for Q4 of 2014.

BioMedReports: Keith, perhaps we can start with you giving a brief overview of yourself and your research at Mayo and why you believe Immunotherapy is the Next Frontier in the battle against Cancer. I know Science Magazine called it the 'Breakthrough of the year' in 2013. 

First of all, Immunotherapy of cancer, in my view, is not a new frontier but rather an existing strategy borne out by decades of research into the role of immune system in cancer.  Through our increased understanding of the immune system and how it is regulated we have become better equipped with knowledge to apply immunotherapy, particularly in humans.

I am currently Director of the Cancer Vaccine and Immune Therapies program at VGTI and an Affiliate Associate Professor in the Department of Immunology at the Mayo Clinic and in the Center for Molecular Biology and Biotechnology (CMBB) at Florida Atlantic University.  I received my Ph.D. degree in physiology and pharmacology from the University of Georgia in 1995, and completed two postdoctoral fellowships in immunology at the University of British Columbia and the University of Washington. I was a 2004 recipient of a Howard Temin Award from the National Cancer Institute. In the lab, I conduct research on cancer vaccines focusing on augmenting T cell immunity using epitope based approached. These vaccine strategies are aimed at primary prevention and also preventing the patients from relapsing after optimal conventional therapies.  For years 2012 and 2013, I was a full member of the Department of Defense's Breast Cancer Research Program Integration Panel.  I am a full member of the Tumor Microenvironment Study Section at the National Institutes of Health Center for Scientific Review.

BioMedReports: We noticed that along with your involvement with many of the leading cancer research groups like Susan G Komen, and the Breast Cancer 20/20 etc that you recently took a position as the Chair of TapImmune scientific advisory board. What is it about the approach TapImmune is taking that has lead you to become more involved in their product development? 

Two philosophies are being developed at TapImmune that have interested greatly leading me to accept a role as Chair of their scientific advisory board.  The first approach involves generating tumor-specific immunity with innovative vaccine strategies with the main thrust being the use of epitopes (fragments of proteins which are recognized by the immune system) from tumor proteins which are unique to the tumor.  This is different than other approaches which use the whole protein which contains other irrelevant epitopes that interfere with or directly suppress the immune response.  This epitope-driven approach coupled with the innovative vector systems are likely to lead to high level tumor rejecting immune responses.  The second approach that TapImmune is taking is defining ways to modify the tumor to make more susceptible to the immune response.  There are many strategies which tumors use to evade immune detection and one prominent strategy is to reduce or eliminate expression of TAP molecules.  TAP molecules are essential proteins produced by nearly all cells in the body which allows those cells to be scrutinized by the immune system and killed if they are aberrant such as is the case with tumor cells.  TapImmunes approach is to restore immune recognition to tumor by reintroducing TAP expression in tumor using PolyStart technology.  Thus, the overall the concept of stimulating the immune system as well as modifying the tumors to make them more susceptible to the immune response seems like a winning concept. 

BioMedReports: We have followed TapImmunes progress for many years now and the advances they have made in the last few years are quite remarkable. Their clinical programs appear to be right on track with some of the most comprehensive approaches out there. Stimulating the full T Cell response (helpers and Killers) as well a very exciting new platform antigen expression system they call PolyStart that looks like it augments antigen presentation of targeted peptides. Combining these assets appears to me that they would have the 'holy grail' in fully encompassing the immune response needed to successfully treat cancer and many other diseases for that matter?

Yes, as stated above, the combination of vaccine to stimulate tumor-rejecting T cells along with enhancing the ability of the tumor to be recognized is likely to be a winning approach.  Additionally, there is no question that successful development of the TapImmune technologies will foster significant discoveries that have a wide range of applications to other diseases such as infectious diseases. 

BioMedReports: Can we discuss the current clincal trials that involve the peptides discovered in your labs at Mayo. Whats the status on those. I see the Her2 trial has had a positive read out on the first batch of patients treated. Clinical shows that trial started in mid 2012, so should we expect further data in near future? 

Currently, there are 3 vaccine clinical trials being done at the Mayo Clinic involving TapImmune technologies.  Two trials are fully accrued and patients are being followed up for safety and immunologic evaluations which we will use to determine our approaches to phase II studies.  While safety can be rapidly assessed due to industry standardization of the analytical approaches, the assessment of immune responses is logistically challenging because the assays must be developed specifically for each vaccine and they must be rigorously quality checked before each run.  Furthermore, samples collected from each patient over the time course of the vaccine must be run together to ensure optimal comparison.  Pending optimal performance of the assays, we expect to release additional data within the next several weeks.  Our overall goal is to best informed about both safety and immunogenicity which will greatly reduce the risk of failure in advanced clinical trials. 

BioMedReports: The Ovarian trial which also stared in mid 2012 is a great addition to their pipeline and a very much needed therapeutic. From my knowledge of the FDA and their Orphan Drug designation, this looks like an ideal candidate and I note from a recent interview with Dr Glynn Wilson (CEO of TapImmune) that this is something they are planning for once the data is prepared for the Phase 2 application? Would you agree that this is a possibility? And what if anything can you say about the current status of the trial? 

While I am not an expert on all the regulatory restrictions for orphan drug designation, ovarian cancer is classified as a rare disease by the US Department of Health and Human Services and there are examples in which ovarian cancer therapeutics including vaccines have been granted orphan drug designation.  Orphan drug designation, if approved, could enhance market exclusivity as well as potentially providing access to federal technical and financial assistant for product development.

BioMedReports: For those who don't follow biotech, can you summarize in the most simple terms possible what makes these new advances so different that anything else out there?

Dr Knutson, we appreciate how busy you are with all of these programs at Mayo and VGTI and we dont want to intrude any further on your time. Thank you for spending this time with us and we look forward to seeing your research move through the clinic and hopefully one day soon being use in first line therapeutic treatments!

The technologies and platforms being developed are significant advances because they will be enable generation of more potent cancer-rejecting immune responses in a broader number of cancer patients as compared to existing modalities.

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