- Here are my notes from the Infinity Pharma $INFI webcast 6/8/11 at the Jefferies conference. Note this slide deck had a number of new slides and I will get these loaded to the Infinity research page as soon as possible:
- "We are building a fully integrated sustainable biotech company"
- In 2012 will have 5 or more p2 trials underway. Use rigorous adaptive trial designs with companion biomarker strategies (new trial by then include additional for IPI-926, additional for IPI-504, purdue p2 pain trial)
- Have preclinical justification for a numner of additional IPI-926 indications
- 35k pancreatic cancer deaths per year in US. Median OS <6 months. <5% 5 yr survival rate. Gemcitabine is SOC, approved based on 6 wk improvement in survival
- Slide listing numerous pancreatic cancer trial failures- many have been 1x/2x/3x combined chemotherapy agents. Due to strong tumor stroma around these tumors, chemo doesn't penetrate thru the "dense shell". IPI-926 breaks down this shell
- In p1b trial saw PR at each of 3 doses. 5 PR's total (31% response rate)
- Side effects included reversible grade 1-2 elevated liver transaminases
- p2 portion of trial is "enrolling beautifully"
- No approved drug for chondrosarcoma- surgery is only option. IPI-926 p2 trial design was reviewed prior to initiation w/ FDA and EMEA. PFS is primary endpoint to allow placebo progressors to crossover
- IPI-504 (now more often calling it by retaspimycin HCl) HSP90 inhibitor
- docetaxel response rate (RR) is 8%, PFS 3 months in advanced NSCLC
- See poorest prognosis in squaous cell histology and in pts with a history of smoking, but these subgroups did best in 23pt p1b trial in combo w/ docetaxel (caution, extremely small numbers involved!)
- p1b no significant ocular toxicity seen (not sure what this means...this is NOT saying no ocular toxicity), no discontinuations for toxicity
- Adaptive design for newly initiated p2 trial- can enroll additional pts in groups w/ highest response
- 200k per yr diagnosed w/ stage 3-4 lung cancer
- Will be starting an additional trial in NSCLC in 2011 (no other details given)
- PI3K inhibitor IPI-145 (inhibits delta and gamma isoforms) ...working hard to file IND and expect p1 trial will begin 2h2011
- IPI-940 inhibitor of fatty acid amide hydrolase (FAAH)..MofA is basis thru which medical marijuana works
- This candidate is now handled by Purdue Pharma and its ex-US affiliate Mundipharma. p2 to start 2011
- INFI has $195m committed funding for 2011 and 2012- more possible, but allocated in 2 yr increments
- Also still have untapped $50m line of credit- accrues interest at prime rate, balloon payment in 2019
- Committed to robust discovery engine- will name another development candidate in 2011
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