- Below find my notes from the Synta Pharma webcast at Jefferies on 6/9/11. The NSCLC field is abuzz after ASCO with more optimism than ever, and ganestespib's place as the leading HSP90 inhibitor in development opens many opportunities for Synta (click here for the complete SNTA research page).
- As I tweeted live yesterday, I added substantially to my SNTA holdings on 6/10/11, and it now represents one of my top three biotech holdings (along with MNTA and SNMX).
- Here are my notes:
- ganetespib has now been used in >400 pts (>150 in p1), is being evaluated in >15 trials
- ASCO 2011 was transformative for the lung cancer field, like has happend to breast cancer past 5-10 yrs. especially with regards to the ALK subpopulation
- There are just 2 drugs in the world in advanced development for this population: crizotinib (PFE)- which is very likely to be approved in next several months, and ganetespib (note INFI also is entering p2 in ALK and other subpopulations with their HSP90 inhibitor IPI-504...click here for details)
- slide 7- new pt scan data not even presented at ASCO
- ALK rearrangement represents about 5-12% of lung cancer (equals 12-28k treatable pts in US, just starting to test for this, population is larger than realized), KRAS mutant makes up 20-25% of lung cancer
- Generally in advanced NSCLC see response rates of a couple percent, tumor shrinkage in 30-40% of pts with active drugs- here with gantespib see 62-75% shrinkage as a single agent
- In ALK population with ganetespib, 7/8 pts had tumor shrinkage, may represent and role to play for the high unmet medical need in pts that are resistant/refractory to crizotinib - that drug is great beakthru but 40-50% of pts don't respond (similar to early days of HER2 and EGFR)...the two drugs have distinct and complementary mechanims of action so could be combined
- Following the data presentation Saturday 6/4, company has been in continuous meetings w/ pt, research, etc groups for last 72 hrs.
- First 50 yrs of cancer therapy was about chemotherapy, and the last 20 yrs has been about more specific therapies that interupt oncogenic pathways via:
2) Tyrosine kinase inhibitors (TKI's) inhibit kinase activity - limitations: only binds one pocket of protein; can have mutations
3) HSP90 is a new way: chaperone degrades the kinase protein itself. These oncoproteins need HSP90 for activation via binding
- Depending on client protein, can use ganetespib as single agent to induce apoptosis (ie, ALK), or combo as sensitization agent (ie, cell cycle proteins)
- Have had 1st site intiiated for p2b/3 trial. Interim data expected by 1q2012.
- almost every lung cancer field participant has approached SNTA about doing combo w/ crizotinib. Both drugs are well tolerated, have different mechanisms. other TKIs also very attractive as combo therapies
- Should the soon to start p2b trial be positive, there is interest in moving to 1st line
- randomzed AML p2b trial being organized now w/ cooperative group
- quite a few more trials will start before end of 2011
- Elesclomol- only covered briefly today. Targets cancer metabolism- much more popular field in last 24 months
- SNTA has discovered additional new biomarkers that are even more relevant that previously described LDH
- Cash to 2h2012 (slide)... "towards end of next year" (verbal phrase)
- Very active partnership discussions. Today SNTA is in best position they have ever been in (seemed to be hinting that ganetespib deal could be bigger than previous GSK elesclomol deal which had $50m upfront). 4 pgms under active discussion. Confident one or more deals 2h2011
- Expect an official p2b trial initiation announcement shortly
- Expect additional p2 NSCLC data 2h2011
- Mid 2012 final data p2b stage 1 NSCLC data expected
- Gantespib- may well partner some asian rights, plan to maintain ownership as long as can (I expect an impressive Asian deal this year, but it is clear though that a US deal for ganetespib is not in SNTA's plans at this time...they want to wait for more data, as has been the trend with many cancer companies lately, such as MYRX).