- OncoGenex presented at Stifel Nicolaus Healthcare conference on 9/7/2011 - click here for full presenter schedule and links to my notes.
- Complete details on custersen (OGX-011) and pipeline programs can be found on OGXI research page.
- See below for my notes from the webcast:
- Only 4-5 slides of overview
- Upcoming key catalysts in early 2012 thru 2014 (we haven't had too many lately as we worked to execute on starting phase 3 trials)
- Cash to mid-2014, enough to complete the two prostate cancer phase 3 trials and the randomized OGX-427 trial
- Slide 5: ASCO GU hope to have interim data accepted for presentation at this February 2012 conference
- no mention on NSCLC trial on this slide [because direction and timing are still uncertain, see below]
- Most of the presentation was Q&A, but the sound quality was terrible for most of it. I have recorded my notes below as best I can and have indicated an approximation of the question asked where possible...
Question and answer section:
Impacts of new agents approved for prostate cancer? These provide patient benefit, but don't cure, we don't see docetaxel landscape changing dramatically
Amendment to SATURN custirsen OGX-011 trial? This pain palliation trial was originally planned for docetaxel retreatment. What was typical was a patient would have a good 1st line response to Taxotere, then take a treatment holiday, then retreat with docetaxel. We modified protocol to align to current standard of care with Jevtana (cabazitaxel). No change to endpoints/modeling, as expected pain palliation outocme <10% with both of these chemo agents
SPA amendment response timeline and communication to investors? We can't give a timeline - there is not a set timeline for SPA revision with FDA. Whenever we hear, we would communicate this to investors.
NSCLC trial that has been delayed - we are considering a shift to a different chemotherapy agent. See more discussion of this below.
We hear anecdotes that doctors are giving patients one or two doses of docetaxel, just to declare them intolerant and move them on to abiraterone? We've heard some of the rumors...not sure how much weight to put on that, doesn't really make sense. Now w/ other agents available, we tend to treat until progression
Is retreatment possible w/ abiraterone? We don't know much about the mechanism of resistance.
Some resistance mechanism data was presented at ASCO though? We continually evaluate custersen in combo w/ other agents. That presentation was with MDVN-3100 combo, OGX-011 reduced a known resistance mechanism to this drug.
Provenge story over last 2-3 months...broader implications? Or product execution specific? The latter. This is not a read at all on market. We know Jevtana launch in 2nd line prostate cancer has been remarkably successful. Interesting how eager and willing numerous other companies are to take shots at DNDN recently
If there is no progression benefit w/ either provenge or custirsen...how can you communciate to patient how treatment is going? We did see a difference in docetaxel combo PFS curve...5-6 week median difference at the front end of curve (treated at 10 cycles only, 30 weeks)... perhaps one would see a more durable difference if kept treating. Only one treated patient had progression as "best response" vs about 1/4 of control patients. We also observed "months" difference in PSA response. Also, it is very hard to assess progression in prostate, because will often metastasize to bone (can't do 3D imaging like soft tissue)
NSCLC trial - what is responible for delay and what is needed to move back toward registrational path? We are meeting with Teva in a couple weeks to go over all that. We went in with carboplatin/docetaxel phase 3 strategy (embraced in EU market). Phase 2 trial was carboplatin/gemcitabine (different chemotherapy doublet). 4 different doublets are used worldwide depending on geographic region, all with roughly same OS. Preclinical data showed it didn't matter which doublet custirsen was added to- we chose based on market data. We tried to do a quick evaluation of interaction with the enzyme that breaks down taxotere. Results of preclincial study showed inhibition of these enzymes, causing more profound drug circulation. But then in humans, we got the reverse effect. "left scratching your head...is it real or an artifact?" There are different ways to evaluate that and we are looking at those mechanisms now. And we are taking a step back and looking at the changing landscape in lung cancer, and ask is the original strategy the best one? is doublet chemo still best? lifecycle mgmt issues too.
Does Teva generic business influence that decision of which chemo? Great question. Back when we were evaluating partnering ...many people assumed we would go w/ SNY who had Taxotere (docetaxel)...but it was about to go generic... and Teva was about to launch. Many of the chemos are now generic, so that doesn't drive decision as much as market penetration. Consider 1) does biology justify combo? 2) Niche markets, penetration, forward look as to where is market going
OGX-427 - is hsp27 a better target in PC than clusterin? Not necessarily better, but we are exceedingly excited about the target. We don't think the 2 are competitive. Preclinical discovery: looked at what is expressed in response to stress in cancer cells? If we KD clusterin, hsp27 goes up. So potentially could use in combo or sequence.
OGX-427 - proof of concept data in 2 indications over the next 12 months, How do you think about partnering this asset? We'll hope for prostate data at ASCO GU 2/2012 and final data around year end 2012. Metastatic bladder trial have a longer timeline. Custirsen starts to finish off development by the time that randomized phase 2 suite of 427 trials will be completing. If custirsen succeeds, milestones etc would provide cash for OGX-427 phase 3 program. With custirsen, we had to partner because needed $200m development plan. Here we don't have to partner. But we may want to though.
Options to expand efforts if you had more cash? Obviously anything related to OGX-011, decisions have to be made jointly with Teva. Could consider custirsen combo with hormone ablation in prostate cancer, or combo with chemo across solid tumors. OGX-427 consider ovarian, breast, lung, pancreatic cancer. A lot of excitement on that. If cash were unlimited, preclinical assets are really good too, with a lot of potential, and they should go forward