- NCI Benchmarks - http://benchmarks.cancer.gov -

Private-Public Partnerships in Cancer Vaccine Research

Posted By admin On July 28, 2008 @ 12:00 am In Drug development,Partnerships | Comments Disabled

Taxol Molecule

Taxol Molecule

Even though the National Cancer Institute is the leading Federal government agency for cancer research, it is hardly the sole contributor in the fight against cancer. Other government agencies, non-profit organizations, academia and private industry all play critical roles in helping find a cure for the disease. The combined efforts of many groups can result in productive partnerships where different organizations can, collectively and individually, play significant roles in achieving progress.

Benchmarks sat down with Philip Arlen, M.D., director of the Clinical Research Group in the Laboratory of Tumor Immunology and Biology, part of NCI’s Center for Cancer Research, to discuss his views on partnerships related to vaccine development.

Benchmarks -What are some examples of major successes in public/private partnerships when it comes to vaccine development?

Dr. Philip Arlen: There are therapeutic vaccines and preventative vaccines– a good example for preventative vaccines is the work of Drs. Douglas Lowy and John Schiller here at NCI which has led to the development of the HPV vaccine that is being utilized not only in the U.S., but all over the world commercially. Currently, no therapeutic [treatment] vaccine has been approved by the FDA. However, a couple of examples of partnerships resulting with private industry and NCI/academia include:

- The PSA-TRICOM vaccine was developed at NCI, and initially involved a partnership with Therion Biologics. [This partnership] resulted in a number of promising Phase II studies with the vaccine in prostate cancer. A CRADA [Cooperative Research and Development Agreement] to work with the NCI and Bavarian Nordic (BN) ImmunoTherapeutics Inc., to further develop this vaccine is now ongoing.

- A partnership with Globeimmune Inc. and the NCI through a CRADA has resulted in a Saccharomyces-CEA based vaccine that is leading to an IND [Investigational New Drug] and Phase I study at the NCI.

- Johns Hopkins University (an NCI-funded institution) has worked extensively with CellGenesys in developing whole-cell tumor vaccines secreting GM-CSF (a protein that stimulates immune cell growth).

Benchmarks: What are the major barriers when working with private industry?

Dr. Philip Arlen: With the cutting edge science developments that occur at NCI, things like combination therapies are coming into play. A significant barrier is that when one company owns a particular drug which works better with an experimental drug from another company (or when trying to test the effects of a combination of two drugs, when both drugs are owned by different companies)–issues may arise when having the two groups come together to make an agreement to be able to use them collectively. Other barriers – even though NCI has platforms to try to mend these issues – include intellectual property rights [which define] who has the rights to what type of discovery. These issues depend upon whether a drug has been given to NCI from an outside [organization] to work with or [if we are testing] something that is being licensed from within. These issues can raise legal concerns and can slow things down, hindering forward development.

Benchmarks: How does NCI benefit from these partnerships?

Dr. Philip Arlen: In the long run working with the private sector has quite a few benefits. One being we can do studies quicker and move the field faster scientifically, allowing the process to move to the next step. This [progress] occurs by allowing larger studies and the use of multi-centers. Through commercialization we can ensure that end-stage products developed at NCI are accessible to the public. Private industry can produce and sell the drugs developed at NCI, making the product commercially available to the people. In that sense, having a partner on the outside is beneficial. Beyond vaccine research, the private sector can be a valuable contributor in all other stages of the research and development process.

Benchmarks: Do these partnerships accelerate the process of vaccine development?

Dr. Philip Arlen: Yes – there is less conflict of interest so things can move quicker. (Can you explain further?) Secondly, even if NCI does not work directly on a product, private industry can use the information gained from our cutting edge research and translate that information to their studies. For example, we did work with combining the chemotherapy drug docetaxel with vaccines, so essentially we were going against the dogma that one cannot pair the two since chemotherapy is immunosuppressive. A company called Cell Genesys is now developing a vaccine platform called GVAX and even though we are not working directly with GVAX, they have been able to use the research done in our labs and go into phase III clinical trials with their vaccine. We spoke with them about pitfalls and strategies and were able to give them ideas on clinical trial design that helped them move forward. This is a great example of how sharing the scientific wealth here at NIH with private industry can assist in speeding up the process.

Benchmarks: Do these partnerships help in clinical trial recruitment?

Dr. Philip Arlen: Yes, absolutely. There are number of advantages to partnering with NCI when it comes to clinical trials. The NCI name carries with it a level of excellence that patients trust. Additionally, working with NCI allows for smaller clinical trials to be done on the NIH campus. This has a variety of benefits: patients treatment costs are covered by NIH, transportation can be provided and, if the patient does not have proper insurance to participle in trials outside of NIH, we can provide assistance. So if the patients meet the eligible criteria to participate in the study, they can do so with little cost.

Animation/Video

Public-private partnerships are critical to NCI’s mission of fostering the best cancer research and promoting translation of that research from the bench to the bedside. NCI is the primary means of support for cancer research in America, with 3.8 billion dollars spent in 2007 alone on cancer research being conducted at institutions across the country, and another one billion spent hear at the NCI.

This animation requires the Flash plug-in. If you do not have the plug-in, please click here [1] to install. Get Flash button [1]



Photos/Stills

Taxol molecule [2]

Taxol molecule

Taxol extraction from bark of Yew tree [3]

Taxol extraction from bark of Yew tree

Laser Capture Microdissection device [4]

Laser Capture Microdissection device


Article printed from NCI Benchmarks: http://benchmarks.cancer.gov

URL to article: http://benchmarks.cancer.gov/2008/07/private-public-partnerships-in-cancer-vaccine-research/

URLs in this post:

[1] click here: http://www.macromedia.com/shockwave/download/index.cgi?P1_Prod_Version=ShockwaveFlash

[2] Image: http://visualsonline.cancer.gov/details.cfm?imageid=2540

[3] Image: http://visualsonline.cancer.gov/details.cfm?imageid=2555

[4] Image: http://visualsonline.cancer.gov/details.cfm?imageid=3297