- EDIT: Crizotinib (tradename is Xalkori) from Pfizer $PFE was approved Friday 8/26/11 by the FDA - click here for press release.
- Here are my quick notes from the Synta Pharma presentation at the Canaccord Genuity conference on 8/11/2011. As always, more detailed information and resources can be found on the full SNTA research page.
- Note that portions of the discussion overlap with that of the recent 2q11 earnings conference call on 8/4/11 - click here for my notes from that webcast.
- My complete notes are below the jump:
- HSP90 inhibitor for inflammation listed as preclinical asset in pipeline chart [I thought there was just a backup program for ganestepib. Now not sure what molecule that is referring to]
- Ganetespib (aka STA-9090) integrated safety database shows <3% ocular issues vs 50% + for competitors
- Ocular toxicity has been associated with compounds that are water soluble. Ganetespib is not.
- If we get positive data from phase 2b/3 2nd line trial (combination with docetaxel, referred to as GALAXY trial), would move to first line and phase 3 trials in other tumor types
- Active partnership discussions, centered around HSP90 and CRACM programs, optimistic for one or both deals by ye2011. Either would substaintilly extend cash runway. [Note that they did not refer to discussions around elesclomol, a third program as they usually have in recent months. This does not surprise me, for reasons I alluded to recently]
- At EMCC meeting late September will present phase 1 docetaxel combo trial, emphasized that this will be safety data only, all comers not just NSCLC, not expecting efficacy signal in NSCLC [this is a walk back from comments made on the 2q11 CC regarding efficacy data included in the presentation - see link above for my notes].
Can you run trial w/ Xalkori (aka crizotinib, PFE drug nearing approval for ALK subset of NSCLC) before approval? This drug will receive US approval in the next couple months and EU not long thereafter- so not sure that will be relevant. But there is a mechanism thru the FDA in which we can present a joint plan cooperatively between the two companies to combine two unapproved drugs.
--The 8 ALK pts shown in phase 2 data at ASCO were Xalkori (crizotinib)-naive. A couple patients that did have Xalkori (crizotinib) pretreatment did not show a response [They did not make clear whether these patients tested negative for ALK vs not being tested at all]
--Generally in a combo you don't give both drugs at full strength. For ganetespib, any dose at or above 100 mg/m2 is in the therapeutic range. Control arm needs to be SOC dose of docetaxel (for registrational nature of trial this is required, so can't lower that dose...same would seem to apply for potential Crizotinib combo)
--Phase 2b stage of trial is not blinded. Will look at ALK, RAS, other biomarkers
--Expect phase 2b data by March or early April 2012
--Partnership factors: economics, geographical scope (Japan vs all of asia), commitment/assets the partner can contribute to the program, experience/drugs that complement ganetespib in the field
--ALK+ population size estimates in literature range from 3-13%, average guess 5% or a bit higher. Corresponds to estimated 45k patients worldwide
--KRAS mutants make up closer to 25% of NSCLC population.
--Two totally different HSP90 inhibitors show responses in ALK (mentioned "all 3 showed shrinkage, 2 confirmed responses"...I think refering to the INFI drug IPI-504 - click here for more info)