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Biotech Stocks: Breast Cancer Drugs in Clinical Trials Offer New Hope
Several companies appear to be on the verge of making a
significant breakthrough in the treatment of breast cancer. This is
a medical area that has certainly seen improvement over the past
decade but is still searching for answers. The
American Cancer Society
estimates that there will be 232,340 new cases of breast cancer
diagnosed among women in 2013. There were also an estimated 39,620
deaths among women during the same year. The chance of a woman
having breast cancer sometime during her life is about 1 in 8.
Currently, only lung cancer accounts for more cancer deaths among
women. These statistics have been so alarming that foundations and
philanthropists have spent hundreds of millions of dollars on
breast cancer research over the past decade. Investors looking to
make an early investment in this area should strongly consider the
below companies that appear to be close to offering hope to
millions of women.
The first company that is getting close to a treatment for breast cancer is Celldex Therapeutics ( CLDX ). Celldex is a biopharmaceutical company focused on the development and commercialization of several immunotherapy technologies for the treatment of cancer and other difficult-to-treat diseases. Shareholders in Celldex have enjoyed share price appreciation of more than 300% over the past 12 months. The company has soared on expectations that its deep drug portfolio will continue to grow and eventually receive approval. The product candidate that seems to have the most potential is CDX-011, which is currently being evaluated in the EMERGE trial. CDX-011 is an antibody-drug conjugate that targets glycoprotein NMB. This is a particular type of protein that is overe-xpressed by various types of tumors, including breast cancer and melanoma. Thus far, the company has had extremely encouraging results. In December 2012, Celldex reported final data from the Phase II study. The trial results supported overall survival benefit in patients with high GPNMB expression. The next steps for Celldex include evaluating CDX-011 in patients with GPNMB over-expressing triple-negative breast cancer in an accelerated approval registration study. This study is expected to begin by the end of the year.
A second company that has shown an incredible amount of promise thus far in its trials is Galena Biopharma ( GALE ). Galena is a biopharmaceutical company focused on developing oncology treatments to address major unmet medical needs to advance cancer care. The company has developed a deep pipeline of immunotherapy product candidates based on the E75 peptide . Currently, the company is focused on evaluating Neuvax, which is used in the treatment of breast cancer and other tumors. Galena has had a series of positive press announcements since December of last year. On December 4, 2012, Galena announced an agreement with Teva Pharmaceuticals ( TEVA ) to commercialize Neuvax in Israel. This agreement will allow Galena to save a great deal of money and time as Teva will handle the development and regulatory process in Israel. Galena expects to receive a significant amount of royalty revenue from any and all eventual sales in Israel. Another positive press release was announced on December 7, 2012. Galena was presenting at the San Antonio Breast Cancer Symposium when the company revealed its data from the Neuvax Phase 1 and II trials . The data was overwhelmingly positive and demonstrated a more-than-acceptable safety and efficacy profile. Remarkably, Neuvax showed a 5.6% recurrence rate vs. a 25.9% recurrent rate in the control arm. This represents a recurrence reduction of 78.4%. In addition to their breast cancer product portfolio currently in development, Galena intends to launch Abstral in the fourth quarter of this year. Galena acquired Abstral on March 18, 2013 . Abstral is a rapidly acting tablet used in the management of breakthrough cancer pain in opioid tolerant patients. The breakthrough pain market generated sales of approximately $400 million in the United States during 2012. Given that the size is much larger across the rest of the world, Galena stands poised to capture a significant portion of this market, which will serve as a nice bonus and a way to continue funding their breast cancer trials.
The third company, and certainly the largest company, that is getting closer to a treatment is Pfizer ( PFE ). Pfizer has developed a compound called palbociclib, which is an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6. In pre-clinical studies, palbociclib was shown to be an inhibitor of cell growth and a suppressor of DNA replication by preventing cells from entering S phase. On April 30, 2013, Pfizer announced that palbociclib received Breakthrough Therapy designation by the United States Food and Drug Administration for the potential treatment of patients with breast cancer. Pfizer has already initiated a Phase III trial to gather more data for the FDA. Currently, Pfizer is working with the FDA to determine the next steps in order to stand the best chances for receiving approval.
Synta Pharmaceuticals ( SNTA ) is another potential player in the breast cancer treatment industry. The company recently announced positive results from its ENCHANT-1 clinical trial . The trial evaluated ganetesib monotherapy in patients with newly diagnosed locally advanced or metastatic HER2 positive or triple-negative breast cancer. Synta now plans to advance the drug to the next stage of the trial with hopes of enrolling a total of 33 patients per cohort.
All four of these companies appear poised to play a large role in developing breakthrough therapies for the treatment of breast cancer. Although still a ways off from facing the FDA in hopes of receiving approval, the companies do appear to making solid progress. As always, investors need to remember that these trials are experimental and nothing is guaranteed, no matter how strong the data appears. That being said, investors looking to make an early investment in this space should strongly consider these companies.
Editor's note: TM Meyer is a former equity derivatives market maker based out of Dallas. He currently manages his own personal portfolio using a combination of fundamental analysis, technical analysis, and event driven catalysts.