On June 1, more than 25,000 cancer specialists will come together at the 2012 American Society of Clinical Oncology Annual Meeting in Chicago. Thousands of scientific abstracts will be released, and just as many investors will gather in hopes of finding the next big thing. With ASCO hours away, we look at some small biotech companies making headway in cancer treatment.
Celsion [NAS: CLSN] is a small medical device-turned-oncology drug development company focusing on delivering high concentrations of known chemotherapeutics to the lesion site. The company’s lead candidate, ThermoDox®, is a heat-activated liposomal formulation of the chemotherapeutic drug doxorubicin. The treatment delivers doxorubicin to the cancer cells that have survived radio frequency ablation of the tumor. In addition to a more efficient delivery, the company believes ThermoDox has the potential to reduce drug exposure distant to the tumor site and thus limit associated side effects. In 2009, the US FDA granted Orphan Drug designation to ThermoDox, and in 2010 granted Fast Track Designation.
Celsion is conducting a Phase III trial for primary liver cancer, a Phase II trial for liver metastases, and a Phase II trial for breast cancer. If ThermoDox is approved for liver cancer by 2013, projected annual revenues (based on a fraction of the radiofrequency ablation market share alone) are expected to reach $230M in 2014, According to Seeking Alpha. A successful demonstration in primary liver cancer could lead to great success in other cancers.
CLSN declined to a low of $1.63 in December 2011 and stayed below $2 until this month. Seeking Alpha notes that 6 insiders have been constantly buying back shares since December 2011, which the financial blog believes is a strong indicator of the stock’s undervaluation.
Celsion has a market cap of $61.47M. After a mid-March low at $1.65, the stock is currently hovering at $1.90.
Del Mar Pharmaceuticals is a private company developing new drug candidates targeting orphan cancer indications representing market opportunities in the potentially billions of dollars worldwide. The company aims to develop products that will have a high impact in patient care and a high return for investors.
The United States FDA Office of Orphan Products Development has granted orphan drug designation for VAL-083 for the treatment of glioma, including glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The company’s lead product, VAL-083, is a well-studied chemotherapeutic for patients with Glioblastoma. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action. Glioblastoma (GBM) remains one of the most difficult tumors to treat first because many new agents fail to cross the blood brain barrier (BBB), and second due to intrinsic drug resistance. VAL-083 readily crosses the BBB and is currently undergoing human clinical trials in the USA in refractory GBM patients.
Northwest Biotherapeutics [OTC: NWBO] is another small biotech company focused on developing immunotherapy products to treat cancers. One month ago, NW Bio made a joint announcement with the Fraunhofer IZI Institute that their 13-month collaborative efforts have resulted in the completion of “significant milestones” in NW Bio’s DCVax®-L program for brain cancer in Germany, leaving the company positioned to move forward with the manufacturing process for DCVax®-L. The company has completed and filed all necessary documentation and applications as part of the regulatory process. The parties are now awaiting the final inspection required before the manufacturing authorization can be granted and manufacturing can proceed for clinical trials and hospital exemption cases. The inspection is scheduled for June 2012.
NW Bio has a market cap of $40.24M. After sitting at a per-share price of next to nothing for most of April, stocks rose to almost $.35 per share by the end of the month, and now sit around $.25.
Galena [NAS: GALE] is a company conducting the PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study, which is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The PRESENT study was initiated January 20, 2012, and the study’s primary endpoint is 36 month Disease Free Survival. On March 20, 2012, Galena was granted a patent that covers the use of NeuVax for treating certain breast cancer patients who have achieved remission with their current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status. The patent provides exclusivity for this indication until 2028. If the vaccine works in that lower level of HER2-Negative group, then Galena can go look at other cancers that come from an epithelial cell, which are the big cancers like lung cancer, prostate cancer, colon cancer, some blood cancers, ovarian cancer, and gastric cancer. The vaccine has already been tested in prostate cancer. Galena is also currently testing its Folate Binding Protein (E39) in ovarian and endometrial cancer. The company’s candidates have the potential to treat several other cancer types, including both lung and colon. Galena also has approximately $25 million in cash as of April 30, thanks to additional funding from company’s April financing and the recent exercises of a majority of outstanding warrants.
Galena has a market cap of $65.05M. Stocks peaked with the March announcement at $2.75 per share, and now sit around $1.50.