- ASTX (click for stock research page) presented 10/21 at the BioCentury Newsmakers Conference (find webcast link and complete biotech webcast calendar on Upcoming Events page)
- Continue reading below for my complete notes from presentation:
- 8 drugs in clinic
- take drugs at minimum to phase 2 POC then consider partnering...work to manage risk
- Dacogen EU filing expect to hear decision early 2q2012. Approval would mean 10 yr orphan exclusivity. US exclusivity term runs out end of 2013
- AT13387- first combo trial of hsp90 inhibitor and gleevec in GIST
- SGI-110 trial progressing "very satisfactorily"
- Phase 2 has been initiated
- neuroendocrine tumors are very amorphous group of tumors, so decided to go with SCLC [phase 1 data they alway present is SCLC plus NE patients...this is the first time I recall explanation of why only SCLC was chosen for phase 2]
- rolling out phase 2 and accruing patients as we speak [still has never been any comment on enrollment timeline]
- Monetize early and as appropriate, "can't take everything up the line", so doing montigen spinout (click here for details). Initially will be 80% astex, 20% ascalon ownership [seems pretty skewed as each contributed one phase 2 asset and the Ascalon drug is much closer to registration...not sure how they pulled that off]
- ASTX will invest $2m alongside new money coming in. "intended to be a PIPE into a reverse merger to be a public company very rapidly" [the details of mechanism of funding this Montigen company have been different every time it has been discussed...so we'll see what happens]
- Dacogen sDNA accepted. "We don't know whether it will come under discussion at the agency in any form at this point" [meaning FDA advisory committee I guess...]
- AT13387 phase 1 complete 4q2011
- Astex analyst and investor day will be held 3/27/2012
- SGI-110 dose expansion phase start 1q2012, complete enrollment 3q2012 and preliminary data 4q2012
- SGI-110 solid tumor phase 2 start 2q2012
- 7519 finish phase 2 enrollment 2q2012, preliminary multiple myeloma data 4q2012
- q&a in breakout session