The American Society of Clinical Oncology (ASCO) will hold its 46th annual meeting on June 4th-8th, 2010, in Chicago. Over 30,000 oncologists, researchers and specialists are expected to attend this year’s event to discuss the latest advances and breakthroughs in the ongoing fight against cancer. The theme of this year’s meeting is “Advancing Quality Through Innovation.” As such, the clinical data, new studies and technological developments presented over this five day affair are of keen interest to both the medical and investment community alike. To be sure, some of the findings that emerge from this year’s ASCO have the potential to become next year’s new blockbuster drugs. With this in mind, here are a few of the companies whose abstracts have caught our eye.
ArQule, Inc. (ARQL)
ArQule, Inc. is a biotech company that engages in the research and development of cancer therapeutics. Its lead product, ARQ 197-209, is an orally available non-adenosine triphosphate competitive inhibitor of the c-Met receptor tyrosine kinase. ARQ 197 is currently undergoing Phase 2 clinical trials as both a mono-therapy and combination therapy for the treatment of non-small cell lung cancer, c-Met sarcomas, pancreatic cancer, hepatocellular carcinoma, germ cell tumors and colorectal cancer.
While impressive top-line Phase 2 data was announced on March 31st, causing a huge jump in the stock price, we believe ArQule’s full presentation at ASCO, on June 5th, could be another meaningful catalyst. As of Friday, May 21st, the company’s abstract was a late-breaking submission, implying the data for the presentation is the most recent data-set to be collected during these trials and, thus, the most meaningful.
Analysts see ARQ 197-209 as one of the most interesting emerging novel-mechanism anti-cancer agents in the small-cap biotech arena. They believe its advancement into global Phase 3 clinical trials and readouts in additional indications should boost the share price relative to its modest enterprise value of around $150M. Analysts have an $8 per share price target for now.
Of note, institutional insider, BVP Partners, sold 4,356,000 shares at an average price of $6.12 in the week following the successful Phase 2 announcement at the end of March. The proceeds from this sale amounted to $26.6M.
Curis, Inc. (CRIS)
Curis, Inc. is a drug discovery and development company focusing on targeted cancer therapies through the use of signaling pathway drug technologies. Currently in collaboration with Genentech/Roche (OTCQX:RHHBY), at its last conference call Curis announced Roche will be presenting the safety data at ASCO from its Phase 2 trial of GDC-0449, for the treatment of colorectal cancer. Investors can expect the efficacy data for this trial in the days soon following the conclusion of ASCO.
Curis will also have an update at ASCO for the GDC-0449 Phase 1 trial, for the treatment of pancreatic cancer. Beyond these, Curis has additional trials on the horizon for 2010 and 2011. The company plans to initiate a GDC-0449 Phase 2 trial for ovarian cancer in 2010 as well as a Phase 2 trial for operable basal cell carcinoma (BCC). Curis has noted that there is currently no standard of care to date for the types of BCC being treated in its Phase 2 trial. If the data proves to be positive, it could serve as the basis for new drug application (NDA) with the FDA as soon as 2011. If this was to occur, analysts have predicted a significant market expansion for GDC-0449 beyond its initial indication.
Delcath Systems, Inc. (DCTH)
Delcath Systems, Inc. develops and manufactures devices to administer high dose chemotherapy and other therapeutic agents directly to diseased organs or specific regions of the body. The company is currently developing the Delcath Percutaneous Hepatic Perfusion (PHP) System, a Phase 3 clinical trial product, which isolates the liver from the patient’s general circulatory system and delivers a high dose of melphalan hydrochloride or other therapeutic agents directly to the organ.
On April 21st, Delcath provided an update to its PHP System Phase 3 trial stating “it resulted in a more than 50% reduction in the time-to-tumor progression or death compared to treatment with the best alternative care.” It went on to say the findings from the study would form the basis of a new drug application (NDA) with the FDA later on this year.
The full data set on the PHP system is to be presented at ASCO on June 5th. Delcath expects to begin its rolling NDA submission within 30 days and file its final module by September, 2010. Research analyst, Jason White at Cannacord Adams, recently estimated that PHP System sales could reach $700M for melanoma treatment alone, upon approval by the FDA. He currently has a $21 price target on the stock. We expect any forthcoming US approval to be a major catalyst for increased price appreciation.
Ziopharm Oncology, Inc. (ZIOP)
Ziopharm Oncology, Inc. is a biopharmaceutical company focusing on the development and commercialization of a portfolio of cancer drugs in North America. On June 7th at ASCO, Ziopharm will present its full Picasso Phase 2 trial results for the treatment of sarcoma, lymphoma, testicular and other cancers.
On May 21st, Ziopharm announced that patient enrollment in the soft-tissue sarcoma segment of the trial was halted early as a result of positive efficacy. Of the 62 patients enrolled in the study, 28 progression-free survival events were documented. On average, patients who received a combination therapy of the Ziopharm drug, palifosfamide, and chemotherapy drug, doxorubicin, experienced a median 7.8 months of progression-free survival versus the 4.4 months of the group receiving a sole application of doxorubicin.
Seemingly Ziopharm’s next step is to begin a Phase 3 clinical trial and secure a Special Protocol Application (SPA) with the FDA. The company expects the Phase 3 trial to begin by mid-year 2010 and conclude sometime in early 2012. As the only FDA-approved treatment for soft-tissue sarcoma is already decades old, palifosfamide would fill an unmet need for sarcoma sufferers, meaning SPA approval would be highly likely should Phase 3 trials prove encouraging.
Ziopharm is slated to be on the “Best of ASCO” road-show this year, which will travel to San Francisco, Boston and Europe. Ziopharm is also the top ASCO pick this year from JMP Securities. JMP has a $10 price target for the stock, with estimates for $375M in 2018, in North America, and $250M outside of the US. 2015 estimates are modeled for $225M in the US and $16M internationally. If palifosfamide can obtain “orphan drug” status, wherein drugs that fight rare diseases enjoy longer exclusivity, sales could reach blockbuster status.
Disclosure: Long call position in DCTH. No position in other 3 names.