- Synta Pharma $SNTA released 2q2011 earnings and held a conference call on 8/4/2011 - click here for press release.
- Click here to access my comprehensive SNTA resource page with detailed info on the company and its pipeline drugs, especially the HSP90 inhibitor ganetespib.
- My complete notes from the webcast are below the jump:
- EDIT: crizotinib (tradename Xalkori) from Pfizer $PFE was approved by FDA on Firday 8/26/2011 - click here for press release.
- Ganetespib (aka STA-9090, a small molecule heat shock protein 90 [HSP90] inhibitor) is in lead contention to be first to market in its class.
- In late stage non small-cell lung cancer (NSCLC), typically have see a 30-55% disease control rate (DCR, consisting of complete responses CR + partial responses PR + stable disease SD) for approved/experimental drugs, and much lower for placebo
- Following ganetespib data presentation at ASCO (Click here for details/analysis these abstracts), SNTA has fielded many inquiries for multiple tumor types from investigators and cooperative groups. We think these discussions will lead to new trials in 2012. Interest driven by results in ALK/kRAS subpopulations.
- In the next several months, we expect to announce new trials that represent alternative routes to registation vs ongoing phase 2b/3 GALAXY trial in combination with docetaxel (extensive discussion of possible routes to approval on SNTA research page)
- Key highlights of ganetespib include:
2) favorable safety >400 pts to date
3) sizable opportunity in ALK pt population in lung cancer. First line combo of crizotinib plus ganetespib could become SOC, like cocktail for HIV
4) Unique leading positon. Top tier centers in US, increasingly in Europe, and soon in Asia.
- GALAXY trial is progressing very well. All 50 sites in North America and EU will be up and running by end of 3q11. Data from phase 2b portion patients early 2012. Most likely will occur in March or April depending on discussions/conference acceptance
- SNTA is in advanced discussions w/ potential partners for several programs. Focused on Asia ganetespib partnerships, as well as regional or global deals for elesclomol or CRACM program. Expect one or more by ye11
- $63m cash 6/30/11, sufficient into 2h2012 without new deals.
- In my opinion, the only important driver for SNTA between now and end of the year is the Asian partnership for ganetespib. This deal will carry a huge upfront payment (My estimate is $50m if it is a pan-Asia deal) that is critical for the GALAXY and other trials that SNTA wants to fund before partnering US/EU rights to the drug. Elesclomol and CRACM deals are important only to the degree that SNTA will invest very little of its own cash in these programs, in my opinion, any ramp up will be contingent on partnering. Note that Elesclomol was previously partnered with $GSK before its implosion in metastatic melanoma, an event that is surely hindering deal interest in the program now on its "take two"
Question and Answer session:
1) GALAXY interim analysis...what sort of data? Expect 1/3 to 1/2 pts (of 240 total patient enrollment), and the endpoint that is generally accepted is landmark analysis (DCR, CTS at cycle two)- This is typically used when the phase 3 endpoint is PFS vs OS. It is probably too early to get into specifics re which patient subgroups will be broken out...maybe on next call. The big point for this portion of the trial is to be able to look at biomarkers/groups of interest.
Phase 1 data in Septmeber at ESMO from docetaxel combo -what to expect? Focus will be on safety, may have clinical activity data (not sure how many patients or what endpoints)...this will be reported by the investigator though, depending on maturity of data, and will cover a fairly large fraction of accumulated pts.
2) Are there multiple GALAXY interim analyses? Is there an alpha spend that affects phase 3 portion's statistical plan? Phase 3 portion will be a different patient population...we are not trying to use phase 2b pts combined w/ phase 3 as one pool. Therefore there is no alpha spend because this is only an operational connection between the two parts of GALAXY. Interim analysis is an administrative look, not a futility or go vs.no go decision.
Re combo with Crizotinib (ALK inhibitor from PFE): HSP90 inhibitor targets different portion of ALK fusion (hits area that is the "glue" that connects to EML half of fusion protein) compared to crizotinib.
3) What is the biggest risk for the company? what is focus of CEO? #1 focus is partnership discussions (over half a dozen very interested parties...many variables, options such as global vs regional, 3 different clinical programs). #2 area of focus is operations...execute on time/on budget/on spec #3 new potential paths to registration for ganetespib. Prioritize interest from those wanting to run trials in other cancers: breast, colon, lung, pancreas, prostate, melanoma
4) Crizotinib is not yet approved - FDA has no path for combining two unapproved drugs in trials, but the combo seems to be what NSCLC community is screaming for- what is strategy? We are in very close contact with the lung cancer community. It is fair to say that wide expectations are that crizotinib will receive approval imminently in US, followed quickly in Europe and Asia next year. People expect wide and quick adoption. You can expect some announcements on our plans there within the next several months.
Do you agree that such a combo is the most rapid path to market? Waffle answer. GALAXY is straightforward, well-designed, represents a large patient population. There is increasing use of docetaxel as 2nd line, so trial should enroll rapidly.
Crizotinib response rate (RR) is 50-60% not 80+% like analyst incorrectly stated. Median time to progression (TTP) is 10 months, so we absolutely want to improve this. There is a huge opportunity there. 10% of lung cancer population is bigger than all of melanoma or all of gleevec's population.
You have missed partnership deadlines before. Is this because SNTA is a moving target as programs advance? I'm not sure i'd agree with that [analyst is right here, SNTA did previously predict a deal in 2010 and then in first half of 2011. My notes/slides definitely confirm this]
5) Will there be ganetespib trials in both ALK and kRAS patient populations? A number of people are excited about both of this indications and have come to us about this.
Crizotinib-failure and combo, could this be done together in one trial? No, this couldn't be in the same trial. Both have been proposed, we are evaluating and following up re combo trial. There is interest after progression on crizotinib - both using ganetespib as single agent therapy or combo trials there. We are in active discussions on both.
Looks like the elesclomol phase 2 lung cancer trial is delayed? We have interesting biomarker findings that we want to flesh out first to incorporate into trial design. There is also a bandwith/resource issue [I think the money is the overriding factor at the moment...waiting for partner or for gantespib Asia deal].
So as you can see, this story is focused on ganetespib, which is right in the middle of a resurgence of excitement in the lung cancer field. In addition to the numerous investigator sponsored exploratory clinical trials already underway, it is clear that there will be additional trials started in the next 6-12 months that are larger and more late-stage. SNTA cannot currently pay for these, so the question is a matter of how this will sort out. Does a large oncology cooperative group sponsor a trial with Crizotinib? Does SNTA use Asian proceeds to fund the ALK combo trial? Does PFE simply buy SNTA?
1) GALAXY interim analysis...what sort of data? Expect 1/3 to 1/2 pts (of 240 total patient enrollment), and the endpoint that is generally accepted is landmark analysis (DCR, CTS at cycle two)- This is typically used when the phase 3 endpoint is PFS vs OS. It is probably too early to get into specifics re which patient subgroups will be broken out...maybe on next call. The big point for this portion of the trial is to be able to look at biomarkers/groups of interest.
Phase 1 data in Septmeber at ESMO from docetaxel combo -what to expect? Focus will be on safety, may have clinical activity data (not sure how many patients or what endpoints)...this will be reported by the investigator though, depending on maturity of data, and will cover a fairly large fraction of accumulated pts.
2) Are there multiple GALAXY interim analyses? Is there an alpha spend that affects phase 3 portion's statistical plan? Phase 3 portion will be a different patient population...we are not trying to use phase 2b pts combined w/ phase 3 as one pool. Therefore there is no alpha spend because this is only an operational connection between the two parts of GALAXY. Interim analysis is an administrative look, not a futility or go vs.no go decision.
Re combo with Crizotinib (ALK inhibitor from PFE): HSP90 inhibitor targets different portion of ALK fusion (hits area that is the "glue" that connects to EML half of fusion protein) compared to crizotinib.
3) What is the biggest risk for the company? what is focus of CEO? #1 focus is partnership discussions (over half a dozen very interested parties...many variables, options such as global vs regional, 3 different clinical programs). #2 area of focus is operations...execute on time/on budget/on spec #3 new potential paths to registration for ganetespib. Prioritize interest from those wanting to run trials in other cancers: breast, colon, lung, pancreas, prostate, melanoma
4) Crizotinib is not yet approved - FDA has no path for combining two unapproved drugs in trials, but the combo seems to be what NSCLC community is screaming for- what is strategy? We are in very close contact with the lung cancer community. It is fair to say that wide expectations are that crizotinib will receive approval imminently in US, followed quickly in Europe and Asia next year. People expect wide and quick adoption. You can expect some announcements on our plans there within the next several months.
Do you agree that such a combo is the most rapid path to market? Waffle answer. GALAXY is straightforward, well-designed, represents a large patient population. There is increasing use of docetaxel as 2nd line, so trial should enroll rapidly.
Crizotinib response rate (RR) is 50-60% not 80+% like analyst incorrectly stated. Median time to progression (TTP) is 10 months, so we absolutely want to improve this. There is a huge opportunity there. 10% of lung cancer population is bigger than all of melanoma or all of gleevec's population.
You have missed partnership deadlines before. Is this because SNTA is a moving target as programs advance? I'm not sure i'd agree with that [analyst is right here, SNTA did previously predict a deal in 2010 and then in first half of 2011. My notes/slides definitely confirm this]
5) Will there be ganetespib trials in both ALK and kRAS patient populations? A number of people are excited about both of this indications and have come to us about this.
Crizotinib-failure and combo, could this be done together in one trial? No, this couldn't be in the same trial. Both have been proposed, we are evaluating and following up re combo trial. There is interest after progression on crizotinib - both using ganetespib as single agent therapy or combo trials there. We are in active discussions on both.
Looks like the elesclomol phase 2 lung cancer trial is delayed? We have interesting biomarker findings that we want to flesh out first to incorporate into trial design. There is also a bandwith/resource issue [I think the money is the overriding factor at the moment...waiting for partner or for gantespib Asia deal].
So as you can see, this story is focused on ganetespib, which is right in the middle of a resurgence of excitement in the lung cancer field. In addition to the numerous investigator sponsored exploratory clinical trials already underway, it is clear that there will be additional trials started in the next 6-12 months that are larger and more late-stage. SNTA cannot currently pay for these, so the question is a matter of how this will sort out. Does a large oncology cooperative group sponsor a trial with Crizotinib? Does SNTA use Asian proceeds to fund the ALK combo trial? Does PFE simply buy SNTA?
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