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Infinity Pharmaceuticals, Inc.

Partner : AbbVie

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Julian Adams, Ph.D., President of research and development at Infinity, gave an update on the DYNAMO study. She stated, "DYNAMO is our Phase-II monotherapy study designed to evaluate the safety and activity of duvelisib in approximately 120 patients with double refractory iNHL, and we are on track to report topline data from this study early in the third quarter. The primary endpoint is overall response rate."
Source: Q4 2015 earnings conference call, 2/23/16

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120th patient enrolled in DYNAMO: In September, Infinity announced that the 120th patient had been enrolled in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate. Topline data is anticipated in the third quarter of 2016, and Infinity anticipates the submission of global regulatory filings by the end of 2016. This enrollment milestone triggered an obligation for AbbVie Inc. to pay Infinity a $130 million payment. AbbVie is Infinity's global development and commercial partner for duvelisib in oncology.
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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 Announces Enrollment Of 120th Patient In Phase 2 DYNAMO™ Study Evaluating Duvelisib In Indolent Non-Hodgkin Lymphoma

- Topline DYNAMO Data Expected in the Third Quarter of 2016 -

CAMBRIDGE, Mass. , Sept. 30, 2015 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that the 120th patient has been enrolled in DYNAMO™, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL) evaluating the safety and efficacy of duvelisib an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. This enrollment achievement triggers a $130 million milestone payment from AbbVie Inc. , Infinity's global development and commercialization partner for duvelisib in oncology. Infinity expects to report topline data from DYNAMO in the third quarter of 2016.

"The completion of patient enrollment in DYNAMO represents a significant milestone for Infinity," said Julian Adams, Ph.D., president, research and development at Infinity. "We are grateful for the support of the DYNAMO investigators, and most importantly the patients and their families, for their participation in this study. In addition, we would like to thank the Infinity and AbbVie teams for their hard work in ensuring completion of enrollment in this trial. We look forward to sharing topline DYNAMO data next year."

"The duvelisib development program underscores our commitment to developing innovative treatment options for patients with hematologic malignancies, and completing patient enrollment in DYNAMO represents an important step toward advancing the duvelisib program," stated Adelene Perkins, Infinity's president and chief executive officer. "Additionally, the milestone payment provides Infinity with important financial resources as we continue to execute on our strategic development plans as we work with AbbVie to bring duvelisib to patients. Very few therapeutic options exist for patients with relapsed/refractory indolent non-Hodgkin lymphoma, and more oral therapies are needed."

DYNAMO is a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in 120 patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate.
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Source: press release, 9/30/15. http://phoenix.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticl...

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Infinity Reports Updated Phase 1 Data of IPI-145 in Indolent Non-Hodgkin Lymphoma at ASH Annual Meeting

– IPI-145 Monotherapy Highly Active in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma, with 73 Percent Overall Response Rate and 20 Percent Complete Response Rate, and Generally Well Tolerated –

– Data Support DYNAMO, Infinity’s Ongoing Phase 2 Study in Indolent Non-Hodgkin Lymphoma –

– Translational Data Further Support Ongoing Clinical Development in Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia–

NEW ORLEANS--(BUSINESS WIRE)--Dec. 7, 2013-- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced updated Phase 1 data from an ongoing study of IPI-145, its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with relapsed/refractory indolent non-Hodgkin lymphoma (iNHL), a potentially fatal hematologic malignancy (blood cancer). Data from the study showed that IPI-145 was clinically active, with an overall response rate of 73 percent, including three complete responses, among patients receiving IPI-145 dosed at ≤ 25 mg twice daily (BID). Data also showed that 53 percent of patients remained progression free for over one year. These data support DYNAMO, the ongoing Phase 2 study of IPI-145 in patients with refractory iNHL. These findings were presented today at the 55th Annual Meeting of the American Society of Hematology (ASH).

“Despite improvements in the treatment of indolent lymphoma, better therapies are needed for patients with resistant disease. Targeted agents such as IPI-145 have the potential to be used alone and in combination with existing therapies and may replace the use of chemotherapy, possibly changing the way patients with these malignancies are treated,” commented Ian Flinn, M.D., Ph.D., director, hematologic malignancies program, Sarah Cannon Research Institute, and an investigator for the trial. “I’m excited by the activity seen in this heavily pre-treated population of patients in this Phase 1 study with indolent non-Hodgkin lymphoma. The 73 percent overall response rate reported, including complete responses, is promising.”

Additionally, Infinity presented translational data showing that IPI-145 affects key signaling molecules in the tumor microenvironment, providing a potential mechanistic rationale underlying the clinical activity of IPI-145 observed in both iNHL and chronic lymphocytic leukemia (CLL).

“These results in patients with relapsed/refractory indolent non-Hodgkin lymphoma reinforce Infinity’s vision for IPI-145,” stated Julian Adams, Ph.D., president of R&D at Infinity. “We believe IPI-145 has the potential to become the best treatment for patients with indolent non-Hodgkin lymphoma, which is why we’re excited about continuing to advance IPI-145 in DYNAMO.”

Infinity is currently enrolling patients in DYNAMO, a Phase 2 study evaluating the safety and efficacy of IPI-145 in approximately 120 patients with refractory iNHL whose disease is refractory to radioimmunotherapy or to both rituximab and chemotherapy and who have progressed within six months of receiving their last therapy. The primary endpoint of the study is response rate according to the International Working Group (IWG) criteria.1
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Source: press release, 12/07/13. http://phx.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticle&ID...

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Infinity Reports Updated Phase 1 Data Showing Encouraging Clinical Activity of IPI-145 in B-Cell and T-Cell Lymphomas at ASCO Annual Meeting and Announces Initiation of Phase 2 Clinical Study in Indolent Non-Hodgkin Lymphoma

– Early Data Show that IPI-145 Is Well Tolerated and Has Activity in a Broad Range of B-Cell and T-Cell Lymphomas, with a 68 Percent Response Rate in Indolent Non-Hodgkin Lymphoma –

– Rapid Onset of Clinical Activity Observed, with a Median Time to Response of 1.8 Months –

CHICAGO--(BUSINESS WIRE)--Jun. 3, 2013-- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced updated Phase 1 data from an ongoing study of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma in patients with relapsed/refractory lymphoma, a group of potentially fatal hematologic malignancies, or blood cancers. Data from the study showed that IPI-145 was well tolerated and clinically active in patients with B-cell or T-cell lymphomas, including indolent non-Hodgkin lymphoma (iNHL), T-cell lymphoma, mantle cell lymphoma (MCL) and Hodgkin lymphoma (HL). These findings were presented today at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting.

“I’m encouraged by the early data seen in this Phase 1 study of IPI-145. So far, IPI-145 appears to be well tolerated, with responses seen across a broad range of B-cell and T-cell lymphomas,” commented Steven Horwitz, M.D., assistant attending physician, department of medicine, Memorial Sloan-Kettering Cancer Center, and an investigator for this trial. “Many hematologic malignancies are difficult to treat and new agents are clearly needed. Targeted therapies, including IPI-145, have the potential not only to add therapeutic options for our patients but also to reduce or delay the need for chemotherapy, possibly changing the way many of these malignancies are treated.”

Infinity today also announced that its first Phase 2 study of IPI-145 in hematologic malignancies, which is enabled by data from the Phase 1 trial, is open for enrollment. This Phase 2, open-label, single-arm study is designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg twice daily (BID) in approximately 120 patients with refractory iNHL. In the Phase 1 study, among the 19 patients with iNHL evaluable for activity, 13 patients (68 percent) responded, with three complete responses and 10 partial responses. The majority of patients who responded were treated at doses ≤ 25 mg BID.

“Infinity is pleased to begin its first Phase 2 study of IPI-145 in patients with indolent non-Hodgkin lymphoma, which is supported by the early, encouraging, data from our ongoing Phase 1 study reported today at ASCO,” stated Julian Adams, Ph.D., president of research and development at Infinity. “Infinity believes IPI-145 has the potential to be the best-in-class PI3K inhibitor for the treatment of blood cancers, and we are rapidly advancing IPI-145 in the clinic with a goal of addressing significant medical needs.”
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Source: press release, 6/03/13. http://phx.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticle&ID...

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A Phase 2 Study of IPI-145 in Subjects With Refractory Indolent Non-Hodgkin Lymphoma
Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01882803?term=IPI-145&rank=3

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Duvelisib (IPI-145) NHLOncology HematologicNon-Hodgkin lymphoma (NHL) IndolentPhosphoinositide-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: II

Event Type: Data: Phase II trial results

Dates: 2016-07-01 - 2016-09-30

Results:

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Infinity Reports Topline Results From DYNAMO™, A Phase 2 Monotherapy Study Of Investigational Molecule Duvelisib In Refractory Indolent Non-Hodgkin Lymphoma
- Infinity and AbbVie in Discussions to Explore Possible Options for the Duvelisib Collaboration -
- Undertakes Strategic Restructuring, Closing Down Discovery Research Organization -
- Updated 2016 Financial Guidance to Be Provided Following Resolution of Strategic Activities -
- Conference Call Today at 8:30 a.m. ET -
CAMBRIDGE, Mass., June 14, 2016 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that DYNAMO™, a registration-focused Phase 2 monotherapy study evaluating the efficacy and safety of duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with refractory indolent non-Hodgkin lymphoma (iNHL) met its primary endpoint of overall response rate. In the study, duvelisib demonstrated an overall response rate (ORR) of 46 percent, all of which were partial responses, among 129 patients with iNHL. The majority of reported side effects were reversible and clinically manageable.

"While the DYNAMO study met its primary endpoint, we hoped that treatment with duvelisib as a monotherapy would have provided a larger clinical benefit for patients with advanced indolent non-Hodgkin lymphoma, a difficult-to-treat disease," stated Adelene Perkins, president and chief executive officer at Infinity. "We plan to seek feedback from the U.S. Food and Drug Administration to determine our next steps with respect to duvelisib in indolent non-Hodgkin lymphoma."

In addition, Infinity and AbbVie are in ongoing, collaborative discussions to explore next steps for the parties' collaboration. Pending the resolution of these business discussions, AbbVie and Infinity have also agreed to pause the AbbVie-sponsored Phase 1b/2 study evaluating duvelisib in combination with venetoclax.

Infinity is also undertaking a strategic restructuring that will close down its discovery research organization, impacting 46 members of the Infinity team, or 21 percent of the workforce.

"This restructuring is a necessary step to preserve financial resources as we explore options for duvelisib and the advancement of IPI-549, our second clinical program," stated Adelene Perkins, president and chief executive officer. "These were very difficult decisions that were undertaken, and I would like to personally express my deep appreciation to the very talented and dedicated Citizen-Owners impacted by the restructuring for their tremendous contributions to Infinity."

Infinity expects to provide updated 2016 financial guidance following the resolution of these strategic activities. The previous financial guidance for 2016 should no longer be relied upon.

DYNAMO Study Details
DYNAMO, a Phase 2 single-arm study, evaluated the efficacy and safety of duvelisib (25 mg twice daily) as a monotherapy in 129 patients with follicular lymphoma (n = 83), small lymphocytic lymphoma (n = 28) or marginal zone lymphoma (n = 18) whose disease has progressed and who are refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study was overall response rate as assessed by an independent review committee.

In the study, the overall response rate was 46 percent, all of which were partial responses. The overall response rate was 41 percent among patients with follicular lymphoma, 68 percent among patients with small lymphocytic lymphoma and 33 percent among patients with marginal zone lymphoma.

In the overall study population, the majority of side effects were reversible and clinically manageable. The most common ≥ Grade 3 side effects that occurred in at least 10 percent of patients in the study were neutropenia (28 percent), diarrhea (15 percent), thrombocytopenia (13 percent) and anemia (12 percent). Twenty percent of patients experienced ≥ Grade 3 infection.

Infinity expects to submit data from the DYNAMO study for presentation at an upcoming scientific conference.

Conference Call Information
Infinity will host a conference call today, June 14, 2016, at 8:30 a.m. ET to discuss the duvelisib data, the restructuring and other corporate developments. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) and 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 33224813. An archived version of the webcast will be available on Infinity's website for 30 days.
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Source: press release, 6/14/16. http://phoenix.corporate-ir.net/phoenix.zhtml?c=121941&p=irol-newsArticl...

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