In the last post of the year, I will try to provide a status update as well as key 2013 milestones for the stocks in our portfolio. I would like to use this opportunity to wish everybody happy holidays and a happy New Year.
Seattle Genetics’ (SGEN) main task is expanding Adcetris’ use outside of approved niche indications (Hodgkin’s Lymphoma and ALCL). As an anti-CD30 antibody-drug conjugate (ADC), Adcetris has potential utility wherever CD30 is expressed by tumors. Continue reading →
Synta (SNTA) reported updated results for its Hsp90 inhibitor, ganetespib, in non-small cell lung cancer (NSCLC). Synta is evaluating ganetespib in a randomized phase II trial (the GALAXY trial) where ganetespib is given in combination with standard chemotherapy. This update comes 3 months after the previous read-out, which I discussed here.
Roche recently disclosed a decision to start phase III with GDC-0973 (formerly XL518), a MEK inhibitor licensed from Exelixis (EXEL) to Genentech 6 years ago. The trial is expected to start next month and will evaluate GDC-0973 in combination with Roche’s Zelboraf in patients with BRAF-mutated melanoma. This is an extremely positive catalyst for Exelixis, who now has a second drug in pivotal studies with a high likelihood of success and a substantial market opportunity.Continue reading →
Exelixis (EXEL) and Immunogen (IMGN) will have important phase III readouts in 2014. For Exelixis, the readout is from 2 phase III trials in prostate cancer and for Immunogen, a phase III trial in 1st line breast cancer. This raises the question – why should investors hold the stocks throughout 2012-2013?
It is important to identify near term catalysts for biotech companies, but biotech stocks tend to be volatile and their movement is not always catalyzed by fundamental events. A good example for that is the recent surge in Pharmacyclics (PCYC) despite limited news flow. Unfortunately, we sold Pharmacyclics 6 months ago for a 413% profit, under the assumption that the company had no meaningful catalysts until 2014. Since then the stock is up more than 150%…
The biggest news at this year’s ASCO came from BMS’ (BMY) PD-1 antibody, BMS-936558. This antibody belongs to a new class of antibodies that stimulate patients’ immune system to attack cancer. This approach has been recently validated with another BMS antibody, Yervoy, which was approved last year for melanoma.
Based on results presented at the meeting, BMS-936558 is superior to Yervoy by any measure. In fact, it is probably one of the most promising oncology drugs ever to be tested in humans. It induces tumor shrinkage in a substantial portion of patients, creates an immune response that keeps the disease under control for long periods and it does so with limited side effects. To make things even better, there might be a way to pre-select patients who are more likely to respond to this agent. Continue reading →
Below is a list of drugs and companies which will have meaningful data at this year’s annual meeting of American Society of Clinical Oncology (ASCO). As I will be attending this year’s conference, I will try to write updates on a regular basis. Feel free to send me questions or post them as comments to this post. Continue reading →
Gilead (GILD) is garnering a huge amount of attention from investors owing to the hepatitis C virus (HCV) pipeline it got from the Pharmasset acquisition. As the market is occupied with the company’s HCV programs, investors seem to ignore additional promising assets in Gilead’s pipeline. GS-1101, which started phase III in leukemia last week, is a good example. I have no intention to downplay Gilead’s HCV pipeline, however, the minimal attention given to GS-1101, one of the promising hematology agents in development, seems unjustified.
Exelixis (EXEL) is starting to recuperate after last year’s clash with the FDA regarding a registration trial for its lead agent, cabozantinib (cabo), in prostate cancer. The company, which still sticks to its original plan of conducting a phase III trial using pain as a primary endpoint, is expected to announce it has enrolled the first patient in the study in the coming weeks. The trial will enroll 250 patients with bone metastases who are suffering from cancer associated pain and will evaluate cabo’s effect on bone scans and pain. Continue reading →
Exelixis (EXEL) saw its share price cut in half last week, due to a regulatory setback. Based on what others have published and questions I received there appears to be some confusion with respect to the implications for the company. I decided to address this issue using a questions and answers format, based on the many inquiries I received. Hope this format sheds some light on the situation.
It is hard to be neutral on Exelixis’ lead drug – people either love it or hate it. The drug, cabozantinib, got investors and researchers scratching their heads after showing mind boggling activity against bone metastases. The drug led to partial or complete resolution of bone scans in a substantial portion of patients with cancer, including prostate, breast and lung cancer. To my knowledge, this extent of activity has never been observed with approved anti-cancer drugs, all of which rarely affect bone mets. Continue reading →