Expert Financial Analysis and Reporting

Can Cancer Vaccines Work?

The issue of whether cancer vaccines are viable therapeutic candidates has been hotly debated by investors. A long string of previous cancer vaccine trial failures has led to widespread pessimism on Wall Street. There are some widely followed bloggers who are extremely negative on cancer vaccines and maintain (wrongly) that no credible researchers or institutions believe that these drugs may work. See the summary of an article by Adam Feuerstein.

His article was directed against the dendritic cell vaccines of Northwest Biotherapeutics (NWBO) and ImmunoCellular (IMUC) rather than specifically at the heat shock vaccine approach of Agenus' (AGEN) Prophage. The aim of all three products is to load autologous dendritic cells with antigens specific to a patient's tumor. Feuerstein has also been extremely negative on Agenus' Prophage which is being studied in recurrent and newly diagnosed glioblastoma.

There Has Been Strong Support from the Scientific Community for Prophage

Feuerstein's assertion that no credible person or institution believes in the promise of dendritic cell cancer vaccines is demonstrably wrong. The strongest supporter of Prophage is Dr. Andrew Parsa. He is an MD surgeon with a PhD in immunology who is currently Chair of the Department of Neurological Surgery at the Northwestern University Feinberg School of Medicine. He sponsored a phase II trial of Prophage whose results were published in the December 16, 2013 edition of the peer reviewed Journal of Neural Oncology.

The phase II trial results published in the journal were from an investigator sponsored study conducted by Dr. Parsa. Dr. Parsa did not receive any financial support or travel expense reimbursement for this work or for consulting activities on behalf of Agenus. The trial was funded by the American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society and National Cancer Institute Special Programs of Research Excellence. Agenus' only role in the trial was to manufacture the product.

Based on the results of this trial, a new phase II trial called ALLIANCE is now underway. This study is being sponsored and totally funded by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI. The NCI is funding the costs of the trial which based on an estimated cost per patient of $100,000 could cost $22 million. Agenus is not providing any of the funding, but will manufacture the product.

This shows that there is impressive key opinion leader support for Prophage in contrast to what the naysayers contend. Dr. Parsa is the unquestioned champion for this product and I don't think anyone can question his credentials or integrity. Also, the involvement of American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society, and National Cancer Institute Special Programs of Research Excellence provides strong credibility. And finally the decision of the NCI to fund the recently started ALLIANCE trial further enhances the belief of scientific community in the promise of Prophage and by extension dendritic cell vaccines.

Another Key Opinion Leader Weighs In

Today, there was another very positive sign of support from an editorial in the January 21, 2014 edition of the Journal of Neural Oncology. John Sampson, MD, PhD, The Dr. Robert H. Wilkins and Gloria Wilkins Professor of Neurosurgery and Professor of Immunology and Pathology at Duke University Medical Center, called the results 'impressive' and said they represent a potentially 'very promising therapy' in patients in desperate need of new treatments.

Conclusion

It is not my contention that this support guarantees success for Prophage in its current phase II trial (ALLIANCE) in recurrent glioblastoma or in a potential upcoming phase III trial in newly diagnosed glioblastoma. We all recognize that this is a yet unproven, paradigm changing therapy in what has so far been an intractable cancer and there are considerable risks that the trial may fail. My position is not that I guarantee success in upcoming trials. Rather it is that that there is legitimate evidence and strong support from credible key opinion leaders to believe that the trials may be successful. I would think that this should silence Feurstein and his ilk as we await the results of the ALLIANCE trial.