- Click here for the INFI research homepage for link to webcast
- Here are my notes from the conference call (new updates are in bold):
- Added new CMO 11/2010. Experience with Taxol (BMS), taxotere, tarceva, campath, yondelis (sarcoma)
- Company added molecular pathology group- help translate scientific insights into clinic and vice versa
- Company policy- each trial has molecular pathology /biomarker effort. Ask which pt most likely to benefit?
- IPI926 (Hedgehog inhibitor) ASCO asbtracts
- Saturday morning poster- p1b combo w/ gemcitabine in 1st line metastatic pancreatic cancer. Pleased w/ safety profile to date. Well tolerated with no grade 4-5 adverse events. Most common AE were fatigue and nausea. Evaluated up to 160 mg per day (same MTD as sinlge agent IPI-926). Saw clinical activity: 3 radiographic PR at time of submission (33%...data on full 16 pts will be presented at ASCO). Gemcitabine alone has ORR <10%
- Complete ongoing IPI-926 enrollment in randomized p2 by ye2011
- Also IPI-926 single agent trial in solid tumors, including cohort w/ basal cell carcarcinoma. Promising preliminary data 10/2010. RR is currently similar to what was presented then.
- Plan broad investigator-sponsored trial (IST) pgm in range of potential indications and combinations w/ currently-used and emerging treatments. First: combo w/ Erbitux is now underway in head and neck
- Expect addl IST trials to start later in 2011
- EU orphan drug designation received for IPI-926 in chondrosarcoma.-randomized p2 ongoing
- Expect to start at least one more company sponsored p2 trial in 2011
- IPI-504 (HSP90 inhibitor) ASCO asbtracts
- Preclinical work suggests that the drug will work best as combo. Saw pr in 6/23 pts in p1 combo trial. Docetaxel single agent RR 8% in NSCLC. Higher response in squamous histology (3/7) or history of smoking (6/18)...tiny numbers though
- Completed preliminary analysis of IPI-493 p1 in solid and hematological malignancies- inferior PK/drug exposure vs IPI-504, so will only advance IPI-504.
- Focus on difficult to treat NSCLC pt subpopulations
- ASCO: explored several doses/schedules w/ docetaxel. Then expansion cohort of 23 pts. IV weekly 300 mg/m2. docetaxel every 3 week 75 mg/m2. all 1-3 prior chemo, no prior docetaxel. Observed 6 PR (26%)- fatigue, diahreea, vomitng, neutorpenia most common- more details in poster Monday afternoon
- Recently started randomized p2- Adaptive design to determine which subpopulations will respond best. Control arm receives docetaxel only. 100 pts w/ 1-2 prior therapies (naive to docetaxel) and have smoking hsitory. Then interim analysis of efficacy vs patient characteristics (biomarkers, histology) to determine whether to expand in certain pops.
- PI3K- on triack for IPI-145 IND 3q2011 and p1 trial soon thereafter. Interested in oncology and inflammation indications. More details as trials begin.
- On track with transition activity to Purdue Pharma for pain drug.
- Ongoing disocvery efforts to fuel pipeline.
- Can generate meaningful data before needing to raise money.
- q&a session-one analyst only
- IPI-926 RR better than expected? Company has "guarded optimism."
- IPI-926 p2 in newly diagnosed metastatic pancreatic cancer. No molecular stratification in this trial, but company is doing lots of profiling with pts in this trial (for future information)
- Confirm that company is advancing IPI-504 (IV) instead of oral HSP90 inhibitor (IPI-493) - this is bullish for MYRX in that they have an oral HSP90 inhibitor as well - but we have yet to see phase 1 data
- Mechanism of Actin of docetaxel synergy? We have made clinical discovery, not modelable in lab (related to effect in smoking/squamous subpopulations)...trying to build mouse models to explain this effect. (aka, we have no idea at this point)
Q&A session-one analyst only:
- IPI-926 RR better than expected? Company has "guarded optimism."
- IPI-926 p2 in newly diagnosed metastatic pancreatic cancer. No molecular stratification in this trial, but company is doing lots of profiling with pts in this trial (for future information)
- Confirm that company is advancing IPI-504 (IV) instead of oral HSP90 inhibitor (IPI-493) - this is bullish for MYRX in that they have an oral HSP90 inhibitor as well - but we have yet to see phase 1 data
- Mechanism of Actin of docetaxel synergy? We have made clinical discovery, not modelable in lab (related to effect in smoking/squamous subpopulations)...trying to build mouse models to explain this effect. (aka, we have no idea at this point)