The strong rebuke by the FDA and its Oncologic Drugs Advisory Committee (ODAC) to ASTX's attempt to gain approval for DACOGEN (decitabine) for elderly AML patients raised significant doubts as to whether the drug will gain approval in this indication in the US or Europe. If not, increased attention will shift to the rest of the company's pipeline. The slide deck from the companies joint analyst and investor R&D day in April 2011 is a good place to start. Find these presentations below and as always get more details on the ASTX research pages. Look forward to additional analysis of these programs here at BiotechDueDiligence and for Chimera Research Group subscribers.
- See below for my notes from Astex Pharma's presentation at the Lazard conference
- Select "Supergen" and "Astex Pharma" categories to the right for history of other blog posts about this stock
- Complete stock research notes on ASTX page
- Complete webcast listings and links to my notes on Upcoming Events page
- Celgene held its 3q2011 earnings call on 10/27 - click here for transcript.
- CELG is partnered with LGND for CC-930 and sells Vidaza, the key competitor for Dacogen from ASTX.
- See the Upcoming Events page for notes and catalysts for companies I cover and see the Partnerships page for notes from larger company conference calls that is relevant to stocks I follow.
AT13387 HSP90 inhibitor
- wrapping up 2 phase 1 trials (one internal, one US NCI) - data will be presented at AACR-NCI-EORTC conference 11/12-16.
- most potent based on IC50 and preclinical data. No off-target effects (liver, CV)
- Does share in common class effect (if drug is pharmacologically active) of visual disturbances which are usually very mild and reversible, lasts 1-2 days. Most drugs share this to different levels.
- difference- saw PET and RECIST responses in phase 1, leading to combo phase 2 trial in GIST (have started enrolling patients)
- some previous drugs went after single agent hsp90 inhibition, but it is obvious this target works better in combo [this may or may not be true in specific patients populations like ALK+ NSCLC]
- focus of development will be in combo, particularly with TKI (you'll see as we roll out phase 2 program next year - run by Astex and NCI, under discussion for other solid tumors)
Rest of pipeline:
- only developing as subcutaneous formulation, expect 1-2ml injection volume
- Currently in dose escalation randomized phase with stratification between MDS and AML
- goal is to have clinical proof of concept at end of phase 1/2 trial
- dose expansion will be in treatment-naive MDS and elderly AML patients
- phase 1/2 data - targeting both ASCO and ASH 2012
- working on program for ovarian cancer, consider other solid tumors
- amuvatinib trial hope to have data by end of 2012 [this is the first time they have stated this goal and based on the lack of progress the past few years in this program I will be shocked if this amounts to any substantial data release]
- 7519: two phase 2 trials ongoing, no further expansion until see this data (MM and CLL)
- 9283: part of portiolfio that we would like to license/spinout - given to Montigen
- Montigen will be small public company with two phase 2 drugs, discovery group that could not be integrated into Cambridge, UK
- PIPE investment ($2m ASTX plus public money) into reverse takeover being led by Rodman and Renshaw
- Astex's initial 80% stake will be "crammed down" by PIPE and then stepped up by $2m investment
- PPM available a little later this year - will have additional details
- earnings coming monday 10/31/2011 (check back for link and my notes)
- On GAAP basis, will have slight loss 2011, on cash basis will be slightly positive. Guidance will be updated at earnings.
- Astex Pharma presented 9/27 at Jefferies conference. Click here for calendar of other webcasts and catalysts with links to my notes and find more detailed company and pipeline info on ASTX research page.
- pipeline slide (see below) - programs listed in order or prioritization after merger
- focus on molecularly-targeted small molecules, primarily in oncology space
- HSP90 - phase 1 just about complete. we've seen very early indications of clinical activity, including 1 SD and 1 PR among 4 GIST patients
- Montigen - in process of forming new public spinout company (more info here).
- no questions asked...
- Astex Pharma (formerly known as Supergen) presented at UBS on 9/21/11 - see my notes below. As always, new comments/updates are bolded for convenience.
- See the Upcoming Events page for links to biotech webcasts and my notes.
- See the ASTX (formerly SUPG) research page for more detailed company info.
We all know that it has been a rough month or two for the biotech sector, fueled by the overall market decline following the debt ceiling debate as well as the biotech sector weakness following $DNDN Dendreon's weak Provenge prostate cancer vaccine sales and resulting 70% drop in stock value. This has resulted in a large list of biotech companies trading at extremely low valuations. While I can't promise that prices won't continue lower, I think now is the time for careful research and evaluation on stocks you may want to own in the coming months. I feel some of the companies listed below are worth owning at today's prices (8/23/11), others may decline even further. For full disclosure, click here for a current list of which stocks I own among those I cover. As always, complete your own research and consider your circumstances before taking any action based on my thoughts.Keep reading below the jump for my stock by stock analysis: