- Infinity Pharma released 2q2011 earnings on 8/9/2011 - click here for press release.
- Click here for complete INFI research page.
- My complete notes from the earnings webcast are below:
- by ye2011, expect 4 candidates in clinic and at least 4 phase 2 trials underway.
- The phase 2 studies are set up for data that will inform design of registational studies
- Focus on unmet medical needs/difficult to treat disease: NSCLC, pancreatic cancer, chrondrosarcoma, myelofibrosis
- phase 1b combo w/ gemcitabine in pancreatic cancer data was presented at ASCO 2011 (click here for abstract details - click here for my notes from CC discussing the data):
--Median PFS >5.5m - not yet reached. Compare to gemcitabine alone <3m.
--Overall survival (OS) ~6m.
--no SAE >grade 3. 160mg MTD same as single agent.
--We continue to follow patients. Will report on mature data set after mature OS data is reached.
- Ongoing phase 2 - 120 metastatic pancreas cancer first line pts will receive gemcitabine +/- IPI-926. Primary endpoint is OS. We expect to compelte enrollment by ye2011. No guidance on when topline data will be available.
- Initiating exploratory p2 trial in myelofibrosis patients in 3q2011. Other treatment options like JAK2 inhibitors only treat symptoms and don't target malignant fibrosis. Trial will be single arm, up to 45 patients. Primary endpoint of hematological RR according to international working group standards.
- Phase 2 chrondrosarcoma: will enroll ~ 100 patients, >40 sites globally. No update given on timeline
- Two investigator sponsored trials: 1) phase 1b/2 combo w/ FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in approximately 20 patients w/ locally advanced or metastatic pancreatic cancer, at UCSF; 2) Combo w/ Erbitux (cetuximab) in head and neck squamous cell carcinoma, at Univ. of Colorado.
- Also presented data at ASCO 6/2011 from phase 1b combo w/ docetaxel (Click here for abstract - click here for my notes from CC discussing results).
--High response rates in squamous cell histology, and in patients with history of smoking. Note these subgroups have tiny numbers. Also saw response in 2 of 3 patients with ALK+, but this was not mentioned here.
- Initiated adaptive NSCLC phase 2 randomized, double-blind, placebo controlled trial in 100 patients with history of smoking w/ 1-2 prior treatments (naive to docetaxel).
- The above trial will have an interim analysis to examine relationship between response and baseline histology/tobacco exposure/biomarkers. Then may expand the size of the trial in specific patient populations
- Data suggest that combo is best approach for IPI-504/
- Today announced p1b/2 combo w/ Affinitor (everolimus, an mTOR inhibitor) in kRAS mutant NSCLC patients. Endpoint is ORR. Synergy/tumor regression seen in mouse model.
- IPI-145 PI3K inhibitor. This molecule is a more potent delta isoform inhibitor than other drugs in class. Recently filed US FDA IND and CTA in EU, will provide additional phase 1 details later this year.
- No update on pain drug (preparing for phase 2).
- Updating guidance for year-end 2011 cash balance to $110-120m due to expected drawdown in 2011 of $50m in prime interest balloon [mature 4/2019] notes.
- Plus have $110m in commited funding from Mundipharma in 2012
- Reaffirm cash burn and net loss of $30-40m in 2011 for HSP90 inhibitor program.
- $82.3m cash 6/30/11
- R&D cost reimbursement up to $85m cap in 2011, and expenses for transition of FAAH pain program to Purdue can be reimbursed above this capcash runway into 2014
Question and answer session:
1) piper jaffrey. plans for PI3k? repeated that they will give phase 1 details later. Excited for this program in inflammatory and autoimmune diseases
1) piper jaffrey. plans for PI3k? repeated that they will give phase 1 details later. Excited for this program in inflammatory and autoimmune diseases
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