You can also find #ASCO13 PI3K abstracts here.
Courtesy of @zDonShimoda, this post features PI3K inhibitor presentations upcoming at the International Conference on Malignant Lymphoma to be held June 19-22, 2013 in Lugano, Switzerland. Featured companies include Infinity Pharma INFI, Gilead GILD, and Pharmacyclics PCYC (partnered with Johnson & Johnson JNJ).
You can also find #ASCO13 PI3K abstracts here.
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It is that time again.... the annual meeting of the American Society of Clinical Oncology (ASCO) is just around the corner in early June. Abstracts will be released May 15th, so we will begin to feature key presentations both here at BiotechDueDiligence and at HSP90 Central.
Featured in this post are the phosphatidylinositol-3-kinase (or PI3K) inhibitors. Featured drugs include IPI-145 (Infinity Pharmaceuticals $INFI, BYL719 and BKM120 (Novartis $NVS), idelalisib (a.k.a. GS-1101, CAL-101; Gilead Sciences $GILD via Calistoga Pharma), and SAR245409 (Sanofi $SNY). Thanks to @zDonShimoda for compiling this list and allowing me to share it with you. You can find similar compilations related to ALK and HSP90 inhibitors. In this post I will continue to highlight AACR abstracts relevant to the small-cap biotech companies that covered here at BiotechDueDiligence and/or may be of interest to readers.
Full coverage: Introduction Preview Part 1 (SNTA, ASTX, NVS, INFI) Preview Part 2 Preview Part 3 (ARRY, ASTX) Preview Part 4 (ASTX, ARQL, BPAX) Preview Part 5 (TKMR, EXEL, PCYC, IMMU, VRTX) What a 12 months it has been for Infinity Pharma (NASDAQ: INFI), with the stock rising more than six-fold from it's low following the failure of the saridegib pancreatic cancer trial. Since then, all eyes have focused on INIF's PI3K delta/gamma inhibitor IPI-145, in development for hematological malignancies and inflammatory diseases. I have assembled some selected slides from the company's JP Morgan presentation as well as added my own notes from the webcast. Continue reading here for the annotated Infinity Pharma IPI-145 notes.
Infinity Pharma $INFI will present the following saridegib (aka IPI-926) data at #ASCO12 in June. This is a different combination regimen for pancreatic cancer, but it appears unlikely that they will continue development in this indication after their phase 2 saridegib plus gemcitabine trial had to be halted early due to excess mortality. Abstract #3105 A phase Ib trial of FOLFIRINOX plus saridegib, an oral hedgehog (Hh) inhibitor, in pts with advanced pancreatic cancer (PDAC). Andrew H. Ko, MD Background: FOLFIRINOX has emerged as the optimal 1st-line treatment option for pts with advanced PDAC and good performance status; whether it can serve as the backbone upon which to add targeted agents in clinical trial design remains uncertain. The goal of this multicenter phase Ib study is to evaluate FOLFIRINOX in combination with saridegib, a novel oral agent that inhibits the Hh signaling pathway. In preclinical models of PDAC, saridegib increases chemotherapy delivery by depleting peritumoral stroma and increasing vascularity. Methods: Pts with previously untreated metastatic or locally advanced PDAC and ECOG PS 0-1 were eligible. Treatment consists of once-daily saridegib with concurrent administration of biweekly FOLFIRINOX (omitting the 5-FU bolus). A 3+3 dose escalation design was used (see dose levels below). Prophylactic WBC growth factor support is mandated. DLT definitions include ALT/AST ≥10x ULN, grade 4 plts or ANC ≥5 d, or grade 3-4 nonheme toxicity. CT scans are obtained every 4 cycles. Limited PK analyses are performed. Results: Seven pts have been enrolled at the first 2 dose levels. Grade 1-2 AEs include GI (N/V/D), dehydration, fatigue, and LFT abnormalities. There was one DLT (grade 3 ALT elevation) at DL2. Other serious toxicities seen include grade 3 nausea (DL1) and grade 3 diarrhea (DL2). Tumor shrinkage has been observed in all 4 pts at DL1, ranging from 17-54%, with 2 unconfirmed PRs. Final MTD determination and updated safety and efficacy data will be presented at the meeting. Conclusions: A modified FOLFIRINOX regimen can be safely administered in combination with novel agents in clinical trials of PDAC. While saridegib was not beneficial when added to gemcitabine in a separate randomized phase II study, early evidence of significant responses on the current trial suggests that a more intensive chemotherapy platform may represent a preferable strategy in PDAC trial design. |
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