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Infinity Pharmaceuticals, Inc.

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In parallel with exploring strategic options for the duvelisib program, Infinity is continuing to focus on filing a new drug application (NDA) for duvelisib with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2016. The company's filing strategy includes the incorporation of data from both DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL). Earlier this month, Infinity reported that the DYNAMO study met its primary endpoint of overall response rate and that duvelisib demonstrated a manageable safety profile in the enrolled patient population. Infinity plans to seek feedback on the DYNAMO data from the FDA. Infinity also expects to report topline data from DUO, predicated on the results of an interim analysis, in the third quarter of 2016.
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Source: press release, 6/28/16. http://phoenix.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticl...

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Julian Adams, Ph.D., President of research and development, announced that the company expected the interim analysis of the DUO study to occur later this year. She stated, "Our second potential path to approval is through DUO, our Phase-III randomized monotherapy study of duvelisib in approximately 300 patients with relapsed/refractory CLL. This study is designed to evaluate the safety and activity in duvelisib compared to ofatumumab, an anti-CD2O antibody approved in this setting. The primary endpoint is progression-free survival or PFS. We completed patient enrollment in DUO last November. As Adelene mentioned, this study has an event driven PFS interim analysis and we expect to – which we expect to occur early in the second half of 2016."
Source: Q4 2015 earnings conference call, 2/23/16

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Infinity Announces Completion Of Target Enrollment In DUO™, A Phase 3 Study Evaluating Duvelisib In Chronic Lymphocytic Leukemia

CAMBRIDGE, Mass. , Nov. 17, 2015 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has reached target enrollment of 300 patients in DUO™, a randomized Phase 3 monotherapy study evaluating the safety and efficacy of Duvelisib compared to ofatumumab (an anti-CD20 antibody) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing Duvelisib with AbbVie , its strategic development and commercialization partner for Duvelisib in oncology.

"Reaching this enrollment milestone for DUO is an important achievement for Infinity and the Duvelisib development program. We are grateful for the support of the DUO investigators, and most importantly the patients and their families, for their participation in this study. We would also like to thank the Infinity and AbbVie teams for their hard work in ensuring completion of enrollment in this trial," said Julian Adams, Ph.D., president, research and development at Infinity. "This achievement follows the recent completion of patient enrollment in DYNAMO, our registration-focused study of Duvelisib in indolent non-Hodgkin lymphoma. We look forward to seeing the data from both of these studies, which could enable us to move forward with global regulatory filings."

Infinity recently completed patient enrollment in DYNAMO™, a global, Phase 2 open-label, single-arm, monotherapy study of Duvelisib in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study is overall response rate. Topline data from the study are anticipated in the third quarter of 2016. The U.S. Food and Drug Administration ( FDA ) has granted Fast Track designation to Duvelisib for both the treatment of patients with follicular lymphoma (FL), the most common form of iNHL, who have received at least two prior therapies and for the treatment of patients with CLL who have received at least one prior therapy.

The DYNAMO and DUO studies are part of DUETTS™, a broad clinical development program evaluating Duvelisib in patients with iNHL and CLL. In addition to DYNAMO and DUO, Infinity is enrolling patients in CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton's tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to be initiated this year: BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; and the first clinical study of Duvelisib in combination with venetoclax, AbbVie's first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity is planning to close enrollment in DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma and is planning to meet with the FDA to ascertain that BRAVURA can serve as a confirmatory study if DYNAMO supports an accelerated approval.

Additional information on clinical studies of Duvelisib is available at http://www.infi.com/research-development/clinical-trials/ or at www.clinicaltrials.gov.
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Source: press release, 11/17/15. http://phoenix.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticl...

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DUO™ enrollment on track for completion by the end of 2015: Infinity expects that DUO, a Phase 3 randomized monotherapy study designed to evaluate the safety and efficacy of duvelisib (25mg BID) compared to ofatumumab in approximately 300 patients with relapsed/refractory chronic lymphocytic leukemia (CLL), will complete patient enrollment by the end of 2015. The primary endpoint of this study is progression-free survival.
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Source: press release, 10/06/15. http://phoenix.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticl...

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Infinity Reports Updated Phase 1 Data Showing Encouraging Clinical Activity of IPI-145 in Chronic Lymphocytic Leukemia and T-Cell Lymphoma at ASH Annual Meeting

– IPI-145 Monotherapy Highly Active in Relapsed/Refractory Patients; Initial Activity Observed in Treatment-Naïve Patients;

- IPI-145 Generally Well Tolerated –

– Data Support DUO, Infinity’s Phase 3 Study in Chronic Lymphocytic Leukemia, Now Enrolling Patients –

– Data in Patients with T-Cell Lymphoma Suggest Broad Potential of IPI-145 in Blood Cancers –

NEW ORLEANS--(BUSINESS WIRE)--Dec. 8, 2013-- Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) today announced updated data from a Phase 1 study of IPI-145, its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with chronic lymphocytic leukemia (CLL), a potentially fatal hematologic malignancy (blood cancer). Data from the study showed that IPI-145 was highly active in patients with relapsed/refractory CLL, with a nodal response rate of 89 percent and an overall response rate of 48 percent as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria1, including one complete response and 12 partial responses, among patients receiving IPI-145 at doses ≤ 25 mg twice daily (BID). Onset of activity was rapid, with the majority of responses occurring in less than two months. These data, along with safety data showing that IPI-145 was generally well tolerated, support DUO, Infinity’s Phase 3 registration study of IPI-145 in patients with relapsed/refractory CLL, which is now enrolling patients.
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Source: press release, 12/08/13. http://phoenix.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticl...

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 8, 2013-- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported its second quarter 2013 financial results and provided an update on its clinical pipeline. Infinity today announced that, in the fourth quarter of 2013, it expects to initiate a Phase 3 trial of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This randomized study is designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg twice daily (BID) compared to ofatumumab in approximately 300 relapsed or refractory patients. In June 2013, Infinity initiated a Phase 2, open-label, single-arm study designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg BID in approximately 120 patients with refractory indolent non-Hodgkin lymphoma (iNHL). These monotherapy trials are supported by encouraging data presented at medical meetings earlier this year that showed IPI-145 was clinically active and well tolerated in a broad range of hematologic malignancies, including CLL/SLL and iNHL.

“With the ongoing Phase 2 trial in patients with iNHL and our planned Phase 3 study in patients with CLL or SLL, Infinity expects to have two important clinical trials of IPI-145 in patients with blood cancer under way by the end of the year. These two clinical trials are key components of Infinity’s strategy for rapidly progressing IPI-145 toward registration with the goal of establishing IPI-145 as the best-in-class PI3K inhibitor for the treatment of patients with blood cancer,” commented Adelene Q. Perkins, Infinity’s chair and chief executive officer. “In addition to the anticipated initiation of our Phase 3 trial of IPI-145, in the second half of the year we expect to report topline data from our Phase 2 study of our Hsp90 inhibitor, retaspimycin HCl, in patients with non-small cell lung cancer and topline data from our Phase 2a study of IPI-145 in patients with mild, allergic asthma.”
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Source: press release, 8/08/13. http://phx.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticle&ID...

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DUO - A Phase 3 Study of IPI-145 Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)
Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT02004522?term=IPI-145&rank=9

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Duvelisib (IPI-145) CLL/SLLOncology HematologicChronic lymphocytic leukemia (CLL)Phosphoinositide-3 kinase (PI3K) delta/gamma inhibitorPI3K delta/gamma

Mechanism of action: Duvelisib (IPI-145) is an orally bioavailable, highly selective and potent small molecule inhibitor of the delta and gamma isoforms of phosphoinositide-3 kinase (PI3K) with potential immunomodulating and antineoplastic activities. Upon administration, PI3K delta/gamma inhibitor IPI 145 prevents the activation of the PI3K delta/gamma-mediated signaling pathways which may lead to a reduction in cellular proliferation in PI3K delta/gamma-expressing tumor cells. Unlike other isoforms of PI3K, the delta and gamma isoforms are overexpressed primarily in hematologic malignancies and inflammatory and autoimmune diseases. By selectively targeting these PI3K isoforms, PI3K signaling in normal, non-neoplastic cells is minimally or not affected which would result in a more favorable side effect profile.

Phase of Development: III

Event Type: Data: Phase III trial results (interim)

Dates: 2016-07-01 - 2016-12-31

Results: Pending