Breast Cancer Vaccine - Holds Promise For Several Players
By Rob Wright, Chief Editor, Life Science Leader magazine
I came across a headline in one of my news feeds announcing the FDA clearing the way for RXi Pharmaceuticals to move forward with plans for final-stage testing of a cancer vaccine. This might not seem like big news. The headline was not very attention getting in my opinion — "RXi gets go-ahead for cancer vaccine testing." So what? I see announcements about cancer drugs being developed on daily basis. Thanks in large part to biomarkers, oncology drug development is where the action is in pharma and biotech. But, for some reason, I decided to read the story, which was on a site I had never heard of — telegram.com. As I read, I realized this is big news for several reasons and holds promise for a variety of players.
The Victim
The most important player who may benefit if the drug makes it to final approval will be women with breast cancer. NeuVax, the drug RXi Pharmaceuticals is working on, is a peptide vaccine aimed at patients who suffer who suffer from breast cancer. Seeing as October is breast cancer awareness month, this announcement could not have come at a better time. According to the American Cancer Society, breast cancer claims the lives of nearly 40,000 women each year and is the number one cancer in women. Personally, I have three relatives who developed breast cancer and only one is still surviving. The keys to surviving have always been knowing your risk factors, early detection, and perhaps a little luck. But now there is the possibility of a new treatment on the horizon.
Shareholders Rejoice
If RXi is successful in bringing NeuVax to market, shareholders of this stock (NASDAQ: RXII) will be the next group to rejoice. As of this writing, the stock is trading around a dollar a share, down from its historical high of just under $10. How big a business could this be? Let's put it in perspective. As I mentioned, NeuVax is aimed at breast cancer patients. More specifically, it is aimed at patients who do not qualify for the cancer treatment Herceptin — Roche's billion dollar blockbuster cancer treatment. So, how many patients don't qualify for Herceptin — nearly 75%. For 2010, Herceptin had over $5 billion in revenues on just 25% of the potential market. NeuVax is targeted at 50% of the market which does not qualify for being treated by Herceptin. If approved this drug could be well above $5 billion in annual sales. Not bad considering that RXi gained control of NeuVax by acquiring Apthera for the bargain price of $7.2 million in April 2011. The results of its Phase 2 clinical trial were statistically significant. At 36 months, the NeuVax treated group had 0% recurrence of cancer versus the control group which had a 22% recurrence. Seems like a win-win. Patients benefit and perhaps investors,but that's not all.
UT Gets No Respect
Ever heard of Dr. Beth Mittendorf? She is an assistant professor at the University of Texas (UT) M.D. Anderson Cancer Center. Mittendorf has been named as the principal investigator for the study. She has been involved in cancer vaccine research for more than 10 years, lead numerous investigator-sponsored studies,and has been published extensively in the areas of breast cancer immunotherapy. Many might not realize the significance, so here it is. RXi Pharmaceuticals is partnering with Texas Medical Center (TMC), considered by one source to be the most prestigious medical center in the world. TMC, located in Houston, has one of the highest volumes of clinical facilities for patient care, basic science, and research. In addition, it has two medical schools, four nursing schools, and other specialized institutions. The internationally renowned UT M.D. Anderson Cancer Center consistently ranks as the number one cancer care hospital in the United States. This places UT ahead of, or at least on par with – depending which ranking you use – the Mayo Clinic, The London Clinic, as well other well-known institutions. However, UT does not even get entered into the discussion when it comes to the most prestigious medical schools for research or primary care. Successful execution of this trial leading to an eventual product launch, just might move UT up to the same level as Harvard and Yale, ranked 1st and 10th respectively for research by one source. Considering the statistical significance of early research and the prominence and awareness breast cancer holds in the United States, Mittendorf's efforts might do for UT what the Jarvik heart did for the University of Pittsburgh Medical Center (UPMC) back in 1985.
A CRO To Watch
The other player I see getting a big bump from this news is APTIV Solutions, a contract research organization (CRO). APTIV has been named as the company which will be managing the trial. Mark Ahn, Ph.D., president, and CEO of RXi Pharmaceuticals has been pulling all the right levers. Having a highly promising drug in the highly publicized area of breast cancer research and partnering with one of the most prestigious medical centers in the world may have just pushed APTIV Solutions into the spotlight of up-and-coming CROs — truly, a win-win-win-win proposition.