infinity pharmaceuticals inc (INFI) Key Developments
Infinity Pharmaceuticals, Inc. Reports New Translational Research and Updated Phase 1 Data of Investigational Oncology Compound Duvelisib at American Society of Hematology Annual Meeting
Dec 8 14
Infinity Pharmaceuticals, Inc. presented new preclinical translational data showing the complementary effects of inhibiting both PI3K-delta and PI3K-gamma, two enzymes known to play a role in regulating the growth and survival of certain types of potentially fatal blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukemia (CLL). This translational research also highlights the important role that PI3K-gamma plays in forming and maintaining the protective tumor microenvironment. These data were presented at the 56th Annual Meeting of the American Society of Hematology (ASH). The ability to develop PI3K-delta selective and PI3K-gamma selective inhibitors enabled to identify the roles of these enzymes in the malignant B-cell tumor microenvironment, furthering its understanding of PI3K-delta,gamma biology, stated Vito Palombella, Ph.D., chief scientific officer at Infinity. These preclinical data demonstrate that inhibiting PI3K-delta and PI3K-gamma may have complementary effects on B-cell growth and survival. In an oral presentation, Duvelisib (IPI-145) inhibits malignant B-cell proliferation and disrupts signaling from the tumor microenvironment through mechanisms that are dependent on PI3K-delta and PI3K-gamma (Abstract #328), researchers reported that, in preclinical studies, PI3K-delta is important in the proliferation of CLL cells while PI3K-gamma plays a critical role in the migration and activation of T-cells and polarization of myeloid cells both key support cells that help form and maintain the protective tumor microenvironment. These data, taken together, suggest that PI3K-delta and PI3K-gamma may have complementary effects on malignant B-cell growth and survival. During the meeting, the company also reported updated Phase 1 data from a monotherapy study of duvelisib in 30 evaluable patients with relapsed/refractory CLL dosed at 25 mg twice daily (BID), showing that duvelisib treatment led to an overall response rate of 57%, including one complete response, and was generally well tolerated. Additionally, new data were presented showing early activity of duvelisib in CLL and aggressive non-Hodgkin lymphoma (aNHL) patients who had been previously treated with ibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor. Updated Phase 1 data in patients with relapsed/refractory CLL were reported in a poster presentation, Duvelisib (IPI-145), a PI3K-delta,gamma inhibitor, is clinically active in patients with relapsed/refractory chronic lymphocytic leukemia. Data showed that duvelisib administered at a dose of 25 mg BID was clinically active, with a 57% overall response rate (17 of 30 evaluable patients), including one complete response. The median progression free survival and median overall survival in the 31 patients who received the 25 mg BID dose have not yet been reached with a median time on treatment of 7.6 months (range: 0.9 months 34.1 months). In the study, duvelisib was generally well tolerated, and the majority of side effects were Grade 1-2, reversible and/or clinically manageable. Across all doses evaluated in the study (N = 55), the most common Grade 3 side effects were pneumonia (24%), neutropenia (18%) and anemia (16%). Grade 4 pneumonia was 2% (1 patient), Grade 4 neutropenia was 24% (13 patients) and Grade 4 anemia was 2% (1 patient). Based on encouraging data from the Phase 1 study, Infinity and AbbVie Inc., its global strategic partner for the development and potential commercialization of duvelisib in oncology, are conducting DUOTM, a Phase 3 monotherapy study of duvelisib designed to evaluate the safety and efficacy of duvelisib compared to ofatumumab in patients with relapsed/refractory CLL. Early Phase 1 data in 6 patients with relapsed/refractory CLL and 7 patients with aNHL (5 Richter’s Transformation and 2 diffuse large B-cell lymphoma) previously treated with ibrutinib were reported in a poster presentation, Clinical activity of duvelisib (IPI-145), a phosphoinositide-3-kinase-delta,gamma inhibitor, in patients previously treated with ibrutinib. In this study, patients were treated with duvelisib administered at either 25 mg BID (2 CLL patients) or 75 mg BID (4 CLL and 7 aNHL patients). Early clinical activity was observed, with partial responses in 1 patient with CLL and 2 patients with aNHL. Stable disease was observed in 5 patients with CLL and 1 patient with aNHL. The safety profile of duvelisib in these patients appeared consistent with the safety profile observed in other patients with advanced hematologic malignancies treated with duvelisib in the Phase 1 study (OBrien et al. ASH 2014; Campbell et al. ASH 2013). A Phase 1b clinical study of duvelisib in combination with obinutuzumab in patients with CLL whose disease has progressed following treatment with a BTK inhibitor is expected to start by the end of the year.
Infinity Pharmaceuticals, Inc. Announces Unaudited Consolidated Earnings Results for Third Quarter and Nine Months Ended September 30, 2014; Revises Earnings Guidance for the Full Year of 2014
Nov 6 14
Infinity Pharmaceuticals, Inc. announced unaudited consolidated earnings results for third quarter and nine months ended September 30, 2014. For the quarter, the company reported collaboration revenue of $160,639,000. Income from operations of $107,702,000 against loss from operations of $34,176,000 for the same quarter a year ago. Net income was $103,217,000 or $2.03 per diluted share against net loss of $33,938,000 or $0.71 per basic and diluted share, for the same quarter a year ago.
For the nine months period, the company reported collaboration revenue of $160,639,000. Income from operations of $31,185,000 against loss from operations of $94,592,000 for the same period a year ago. Net income was $22,926,000 or $0.46 per diluted share against net loss of $93,855,000 or $1.96 per basic and diluted share, for the same period a year ago.
The company revised its earnings guidance for the full year of 2014. The company expects revenue for 2014 to range from $160 million to $170 million. Previously, the company did not expect to recognize any revenue in 2014. The company expects net loss for 2014 to range from $20 million to $30 million, compared to prior expectations of $170 million to $180 million. The company expects to end 2014 with a year-end cash and investments balance ranging from $320 million to $330 million, compared to prior expectations of $40 million to $50 million.
Infinity Pharmaceuticals, Inc. Presents at Goldman Sachs Group 2014 US Emerging / SMID Cap Growth Conference, Nov-20-2014 11:30 AM
Oct 30 14
Infinity Pharmaceuticals, Inc. Presents at Goldman Sachs Group 2014 US Emerging / SMID Cap Growth Conference, Nov-20-2014 11:30 AM. Venue: New York Marriott Marquis, New York, New York, United States.
Infinity Pharmaceuticals, Inc. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 01:50 PM
Oct 30 14
Infinity Pharmaceuticals, Inc. Presents at Stifel Healthcare Conference 2014, Nov-19-2014 01:50 PM. Venue: The Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Adelene Q. Perkins, Chairman of the Board, Chief Executive Officer and President, Kate Murray, Senior Investor Relations Associate.
Infinity Presents at Boston Biotech NY/NJ CEO Conference, Nov-12-2014 through Nov-13-2014
Oct 27 14
Infinity Presents at Boston Biotech NY/NJ CEO Conference, Nov-12-2014 through Nov-13-2014. Venue: Apella, 450 East 29th Street, New York, New York, United States. Presentation Date & Speakers: Nov-12-2014, Adelene Perkins.