- OncoGeneX announced 3q2011 earnings and held a conference call on 11/3/2011.
- Check out more OGXI company info and complete guide to upcoming biotech catalysts and webcasts, along with links to my notes.
- New feature – checked out the embedded link to listen to the conference call if interested – courtesy of EarningsCast.com
- As usual, see below for the notes from the webcast and Q&A session.
- OGXI webcast presentation notes:Custirsen (OGX-011)
- SYNERGY – primary registrational trial. encouraged by physician and pateint enthusiasm. on track to complete enrollment by ye2012, as previously forecast…expect results before ye2013
- SATURN – 2nd line chemo combo for pain paliation – augment registration strategy. got protocol change, “will carefully monitor” its effect on previous pt accrual problems (this is very different from saying we already see an uptick)
new emphasis on the fact that OS is main trial and pain is supportive in the wake of EXEL disaster this week
- NSCLC – we and teva continue to revise development plan for this indication. we will provide guidance on timing on initiation when available [so no progress since 2q11 cc]
- randomized IST in chemo naive CRPC, started 9/2011, PSA progression is primary endpoint (“imperfect” metric, but useful PD tool for certain drug candidates, such as 427 based on its MOA
- preliminary data has been submitted to 2012 ASCO-GU symposium february 2-4, 2012
- this drug’s action on AR signaling is still relvant despite other advances (abiraterone and mdv-3100) being avail to pts, because reactivation of AR represents possible contribution to disease progression – ratioanle for combo with these AR inhibitors
- bladder cancer: phase 1 IST in superficial - infused prior to surgery – preliminary data submitted to ASCO-GU also
- company-sponsored randomized p2 in metastatic bladder cancer – recently initiated enrollment (aim for 180 pts in NA and select EU countries) add to 1st line chemo (gem/cis plus placebo or one of 2 doses OGX-427)
- assume 14m median survial in control arm – compare each dose separately to contorl and both 427 arms combined to control
- event driven – final analysis has 80% power to detect HR of 0.66-0.71 for overall survival (OS) endpoint. results will allow better predicteion of size needed for phase 3 trial with OS endpoint (but makes p2 slower)
- 5th most diagnosed (69k diagnoses and 15k deaths this year), few recent survial extensions.
- Teva deal performance period estimated to end 4q2013 (recognized $19 of $30m so far)
- $69.3m cash on hand 9/30/11, year-end cash balance higher because of SATURN trial lag -
- $23-27m cash burn ($8m lower than initial guidance), year-end balance $58-62m ($8m higher), cash sufficient into 2014
OGXI Question and Answer session notes:
- no specificity for NSCLC trial issues- continuing discussions, will come back when we have details on trial design.
- SATURN trial SPA agreement – will r&d ramp back up?we’d expect it to increase because of 1) saturn and 2) metastatic bladder trial
- MDVN news – if they get approval, how would that impact 2nd line strategy? clearly that data was very positive for prostate cancer patients, congratulations to them. We see direct impact and benefits for OGXI programs:
**Custisen – preclincal data presented this year showed synergy w/ MDV-3100, presents opportunity “should ogxi and teva decide to go down that path”
**OGX-427 – shares biologic impact on androgen receptor (AR) itself, but interacts with AR differently HSP27 chaperone escorts AR into nucleus.
- plans for other combos? zytiga? It would take time to get 3100 thru regulatory process. hard for us to discuss re custirsen without teva, so we can’t speak to that with talking to them. OGX-427 randomized data in prechemo space will be presented soon, hope we see intro of AR-targeting agents like abiraterone and MDV-3100 so we can target that pathway too. These are now being used later in disease progression, makes it easier to do those studies. But it will be awhile before MDV-3100 is available for other clinical studies.
- recent EXEL experience in pain…i know you have SPA…how is FDA looking at your compound differently? We certainly had many questions after that incident, and it is important to draw differences. We have two tirals we presented to FDA, one for OS, second for durable pain palliation. Consistent with our comments, if you’re going to demonstrate pain paliation as primary effect, you have to also show anticancer activity (and for prostate cancer this tpyically requires surivial endpoints). It is not a big surpirse that FDA would want to combine pain with another endpoint. We happen to be doing it thru 2 separate trials. FDA response is consitent with and reflected in our development program with an SPA granted from FDA for both trials.
- None Found