@adamfeuerstein @BioRunUp any thoughts on $NLNK— OddStockTrader (@OddStockTrader) June 22, 2013Before I address a specific question about NewLink Genetics ( NLNK), I want to lay down a bifurcated position on cancer immunotherapy in general. Position No. 1: Until I see convincing evidence of efficacy (successful phase III studies, FDA approvals) I am extremely skeptical of any company taking the "vaccine" approach to targeting cancer cells. I define a cancer vaccine as any therapy made up of tumor cells (autologous or patient specific), antigens or other immune-boosting agents designed to provoke the body's immune system to mount an attack on specific types of cancer cells. Who's in this cancer vaccine group? Dendreon ( DNDN), of course. Provenge is approved, but it's a fluke and a commercial disappointment. The list of companies with failed cancer vaccines is much longer -- Cell Genesys, Genitope, Favrille, Oncothyreon ( ONTY), Antigenics ( AGEN), CancerVax, etc. Despite a lot of convincing evidence debunking the vaccine approach to cancer immunotherapy, tiny biotech companies push ahead -- NewLink, Galena Biopharma ( GALE), Vical ( VICL), Northwest Biotherapeutics ( NWBO), ImmunoCellular Therapeutics ( IMUC). I'm not a believer. I'll be happy to admit my error if/when one of these companies produces boffo clinical data. I just don't see that happening anytime soon. Position No. 2: The anti-PD1/PDL1 approach to cancer immunotherapy works. These therapies turn off a cloaking device used by cancer cells to hide from a patient's immune system. One way cancer cells grow is by donning molecular camouflage which tricks the immune system into thinking they're normal, healthy cells. The anti-PD1/PDL1 (and anti-CTLA4) drugs turn off cancer's cloaking device. Without the protective camo, the immune system attacks cancer cells as foreign and deadly.
@adamfeuerstein $CELG still your favourite large cap pick? Any thoughts on MM020 data coming up?— Ryan Ziemer (@ZiemzFinancial) June 26, 2013Let's check out Celgene's ( CELG) stock performance so far this year. CELG data by YCharts
As of Thursday, Celgene shares are up 51% for the year, tops among the large-cap biotech stocks. Biogen Idec ( BIIB) (+45%) and Gilead Sciences ( GILD) (+40%) are second and third, respectively. One second, allow me to reach around and pat myself on the back for predicting Celgene's outperformance. Six months into the year, I'm right. Yippee! MM020 is a large and very important phase III study seeking to establish Celgene's Revlimid as the preferred front-line treatment for multiple myeloma. Celgene will use data from the MM020 study to seek an expansion of the U.S. and European labels to include front-line and maintenance use of Revlimid in multiple myeloma. Celgene is expected to announce top-line results from MM020 between now and September, with more detailed data presented in December at the American Society of Hematology annual meeting. Bernstein analyst Geoff Porges described investor expectation for MM-020 results in a recent investor note: MM020 Announcement Still a Key Catalyst. One of the most important questions for investors remains the outlook for the approaching MM-020 study. Celgene's management suggests that the expectations for the PFS outcome of the trial are now in the 30 months (active arm/maintenance Revlimid) vs. 24 months (MPT arm) range; we think the Revlimid maintenance arm PFS will not be shorter 30 months, but the MPT arm could be several months shorter than this 24 months hurdle. Celgene suggested that the initial analysis of PFS will have between 20 and 30% of OS events accumulated, and they expect at best a weak trend towards an improvement in OS at this initial analysis. They certainly do not expect any negative incremental effect of Revlimid on Second Primary Malignancy (SPM) events in this study, and they question whether such a result might significantly reduce the implied importance of the Overall Survival endpoint. Celgene's long-term guidance of $12 billion-plus in revenue in 2017 -- half of which will come from Revlimid -- is tied to positive MM020 data. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein