A Primer On The Pink Vaccine

 

The world’s first preventive breast cancer vaccine was developed by Professor Vincent Tuohy, an immunologist at the Cleveland Clinic, in 2010.  Tuohy tested his vaccine over a period of ten years, finding that it was safe and 100%effective in preventing breast cancer in three animal models.  After vetting Tuohy’s data for more than two years, a panel of experts on the editorial review board of Nature Medicine verified and validated his results and then published his paper in May 2010.  While it’s true that not everything that works in mice works in humans, it can be said with equal conviction that everything that now works in humans first worked in mice.

Tuohy’s vaccine targets a protein called alpha lactalbumin (ALA) that is made by the majority of breast cancer cells, especially those that are triple-negative (i.e., lack estrogen, progesterone, and Her2 receptors).  Of note, triple-negative breast cancers are the most common tumors found in women who carry a BRCA mutation.  Because ALA is normally made only in women who are breastfeeding, and since the majority of breast cancer patients are diagnosed with their disease after menopause, Tuohy’s vaccine holds great promise as primary prevention of breast cancer, the most common malignancy in every country around the world.

The next step in furtherance of Tuohy’s vaccine is to conduct a clinical trial in a small group of healthy volunteers to see if the vaccine is safe.  Such a study would likely involve 40-100 women and would take a very short time to complete.  This is called a Phase I study and requires both funding and permission from the FDA before it can begin.  If Tuohy’s vaccine proves safe at the conclusion of a Phase I study, it can then be tested in a Phase II study to assess its effectiveness in preventing breast cancer.  Again, women who carry a BRCA mutation would be ideal candidates for a Phase II study, as they have the highest risk and rates of breast cancer and, thus, an effective preventive breast cancer vaccine would quickly prove its worth in such a cohort of high-risk women.

It is also worth noting that Tuohy’s vaccine, because it targets cells that produce ALA – the majority of breast cancers, especially those that are triple-negative – also holds some therapeutic potential for use in preventing breast cancer recurrence.  But before the vaccine can be moved from the bench to the bedside, the first and most important step must be completed:  we must answer the question, Is Tuohy’s vaccine safe?  That question can only be answered in the course of a Phase I study.  And since so much depends on getting this question answered – millions of lives, millions of breasts, billions of dollars – it’s worth getting the answer as soon as possible.