- Astex Pharma (formerly SuperGen, click for research page) presented 10/26/2011 at the BIO Investor Forum (click for complete biotech webcast calendar) - see my quick notes below:
- dacogen is now marketed in 30 countries including china
- 35% of full time employee efforts devoted to janssen (JNJ) and GSK deals.
- 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)
- 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.