On June 28, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported dosing of the first patient with newly diagnosed acute myeloid leukemia (AML) in the Phase 2 portion of its ongoing Phase 1/2 study evaluating its novel E-selectin antagonist, GMI-1271, combined with chemotherapy (Press release, GlycoMimetics, JUN 28, 2016, View Source [SID:1234513599]).

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Earlier this month, the company announced it had received Fast Track designation from the U.S. Food and Drug Administration (FDA) for GMI-1271 for treatment of adult patients with relapsed or refractory AML and elderly patients aged 60 years or older with AML. In addition, GlycoMimetics recently announced that the first patient with relapsed or refractory AML has been dosed in the other arm of the Phase 2 portion of this study.
For the study’s Phase 2 portion, the optimal dose of GMI-1271 has been determined, and in this arm of the study clinical investigators will study the effects on newly diagnosed patients receiving the drug candidate to obtain additional safety and efficacy data. Study enrollment in this arm is limited to patients at least 60 years of age who have been newly diagnosed with AML and are eligible to receive treatment with the chemotherapy agents cytarabine and idarubicin (‘7+3′). All patients must be eligible to receive this intensive chemotherapy regimen, and will be given GMI-1271 in addition to this combination chemotherapy. During the Phase 1 portion of the study, patients received a single cycle of treatment including GMI-1271. During this Phase 2 portion, certain patients will be eligible to receive additional cycles of treatment.

"The data from the first cohorts point to both the safety and potential efficacy of GMI-1271 as a treatment for AML," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "We are now enrolling a new group of study participants to evaluate the effects of GMI-1271 on newly diagnosed patients who also are receiving chemotherapy. If the second half of the trial confirms our earlier preclinical and clinical findings, we believe that GMI-1271 could well address the unmet needs of AML patients, beyond what is currently possible with available therapies."

This clinical trial is a multinational open-label study evaluating endpoints for safety, pharmacokinetics (PK) and efficacy of GMI-1271 in combination with induction chemotherapy in patients with high-risk AML. This trial is being conducted at a number of academic medical institutions in the United States, Ireland, and Australia. While the primary objective is to assess safety, additional endpoints include overall response rate, biomarkers of activity, durability of response and overall survival. This Phase 2 portion of the study in newly diagnosed patients is expected to include approximately 25 participants.

GlycoMimetics announced on June 10, presentation of data in patients with relapsed/refractory acute AML from the Phase 1 portion of this ongoing study. Data were reported at the European Hematology Association (EHA) (Free EHA Whitepaper) 21st Congress in Copenhagen, Denmark in a poster entitled "Results of a Phase 1 study of GMI-1271, a potent E-selectin antagonist in combination with induction chemotherapy in relapsed/refractory AML: a novel, well-tolerated regimen with a high remission rate."

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with AML cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

On June 28, 2016 Bayer reported results from the Phase III RESORCE trial investigating its oncology compound regorafenib in patients with unresectable hepatocellular carcinoma (HCC) who progressed during treatment with sorafenib (Nexavar) tablets (Press release, Bayer, JUN 28, 2016, View Source [SID:1234513591]). In this trial, treatment with regorafenib plus best supportive care significantly improved overall survival (OS) compared to the control group receiving placebo plus best supportive care.

The results showed that the Hazard Ratio (HR) for OS in patients who received regorafenib compared with the control group was 0.62 (95% CI 0.50-0.78; p<0.001), which translates to a 38% reduction in the risk of death over the trial period. Median overall survival was 10.6 months for those who received regorafenib versus 7.8 months for those in the control group. The safety and tolerability were generally consistent with the known profile of regorafenib. These data will be presented at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer (WCGC) in an oral abstract session on June 30 at 5.40pm CEST. The congress is taking place on June 29-July 2 in Barcelona, Spain. "The incidence of liver cancer continues to increase globally. There is only one approved systemic treatment option for patients with this disease, and there are currently no proven or approved second-line treatment options for patients with advanced HCC," said Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. Dr. Bruix is the Principal Investigator of the RESORCE study as well as the Phase III study SHARP which investigated sorafenib in HCC. "The regorafenib data seen in RESORCE may translate into additional hope for patients by providing doctors, nurses and other healthcare providers with a much needed second proven option for the treatment of liver cancer. The appropriate and timely start of systemic therapy may be important in improving patients’ treatment outcomes by potentially providing patients with the opportunity of receiving both proven systemic treatment options," Dr. Bruix continued. In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met. Median progression-free survival was 3.1 versus 1.5 months, respectively (HR= 0.46 (95% CI 0.37‒0.56; p<0.001). Median time to progression was 3.2 vs. 1.5 months (HR 0.44; 95% CI 0.36–0.55; p<0.001). Disease control rate (composed of complete and partial responses and stable disease) was 65.2% vs 36.1% (p<0.001). Overall response rate (complete and partial responses) was 10.6% vs 4.1% (p=0.005), respectively. All numerical values of the secondary endpoints are based on mRECIST. The safety and tolerability were generally consistent with the known profile of regorafenib. The most common adverse events (grade 3 or higher) were hypertension (15.2% in the regorafenib group vs. 4.7% in the placebo group), hand-foot skin reaction (12.6% vs. 0.5%), fatigue (9.1% vs. 4.7%), and diarrhea (3.2% vs. 0%). Bayer plans to submit data from the RESORCE study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in 2016. About the RESORCE trial The Phase III data being presented at WCGC are from the RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial, which enrolled 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Patients received 160 mg regorafenib once daily or placebo, for 3 weeks on/1week off, with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary endpoints were time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability were also continuously monitored. About Hepatocellular Carcinoma Hepatocellular carcinoma (HCC) is the most common form of liver cancer and represents approximately 70-85 percent of liver cancer worldwide. Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally. More than 780,000 cases of liver cancer are diagnosed worldwide each year (more than 395,000 in China, 52,000 in the European Union, and 30,000 in the United States) and the incidence rate is increasing. In 2012, approximately 746,000 people died of liver cancer including approximately 383,000 in China, 48,000 in the European Union, and 24,000 in the United States. About Regorafenib (Stivarga) Regorafenib is an oral multi-kinase inhibitor that blocks various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, regorafenib has been shown to inhibit several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3, it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively control tumor growth, formation of a stromal microenvironment and disease progression. Regorafenib is approved under the brand name Stivarga in 90 countries worldwide, including the U.S., countries of the EU and Japan for the treatment of metastatic colorectal cancer. The product is also approved in over 70 countries, including the U.S., countries of the EU and Japan, for the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU, Stivarga is indicated for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

On June 28, 2016 Bayer reported results from the Phase III RESORCE trial investigating its oncology compound regorafenib in patients with unresectable hepatocellular carcinoma (HCC) who progressed during treatment with sorafenib (Nexavar) tablets (Press release, Bayer, JUN 28, 2016, View Source [SID:1234513591]). In this trial, treatment with regorafenib plus best supportive care significantly improved overall survival (OS) compared to the control group receiving placebo plus best supportive care.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The results showed that the Hazard Ratio (HR) for OS in patients who received regorafenib compared with the control group was 0.62 (95% CI 0.50-0.78; p<0.001), which translates to a 38% reduction in the risk of death over the trial period. Median overall survival was 10.6 months for those who received regorafenib versus 7.8 months for those in the control group. The safety and tolerability were generally consistent with the known profile of regorafenib. These data will be presented at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer (WCGC) in an oral abstract session on June 30 at 5.40pm CEST. The congress is taking place on June 29-July 2 in Barcelona, Spain.

"The incidence of liver cancer continues to increase globally. There is only one approved systemic treatment option for patients with this disease, and there are currently no proven or approved second-line treatment options for patients with advanced HCC," said Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. Dr. Bruix is the Principal Investigator of the RESORCE study as well as the Phase III study SHARP which investigated sorafenib in HCC.

"The regorafenib data seen in RESORCE may translate into additional hope for patients by providing doctors, nurses and other healthcare providers with a much needed second proven option for the treatment of liver cancer. The appropriate and timely start of systemic therapy may be important in improving patients’ treatment outcomes by potentially providing patients with the opportunity of receiving both proven systemic treatment options," Dr. Bruix continued.

In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met. Median progression-free survival was 3.1 versus 1.5 months, respectively (HR= 0.46 (95% CI 0.37‒0.56; p<0.001). Median time to progression was 3.2 vs. 1.5 months (HR 0.44; 95% CI 0.36–0.55; p<0.001). Disease control rate (composed of complete and partial responses and stable disease) was 65.2% vs 36.1% (p<0.001). Overall response rate (complete and partial responses) was 10.6% vs 4.1% (p=0.005), respectively. All numerical values of the secondary endpoints are based on mRECIST.

The safety and tolerability were generally consistent with the known profile of regorafenib. The most common adverse events (grade 3 or higher) were hypertension (15.2% in the regorafenib group vs. 4.7% in the placebo group), hand-foot skin reaction (12.6% vs. 0.5%), fatigue (9.1% vs. 4.7%), and diarrhea (3.2% vs. 0%).

Bayer plans to submit data from the RESORCE study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in 2016.

About the RESORCE trial
The Phase III data being presented at WCGC are from the RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial, which enrolled 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.

Patients received 160 mg regorafenib once daily or placebo, for 3 weeks on/1week off, with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary endpoints were time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability were also continuously monitored.

About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and represents approximately 70-85 percent of liver cancer worldwide. Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally. More than 780,000 cases of liver cancer are diagnosed worldwide each year (more than 395,000 in China, 52,000 in the European Union, and 30,000 in the United States) and the incidence rate is increasing. In 2012, approximately 746,000 people died of liver cancer including approximately 383,000 in China, 48,000 in the European Union, and 24,000 in the United States.

About Regorafenib (Stivarga)
Regorafenib is an oral multi-kinase inhibitor that blocks various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, regorafenib has been shown to inhibit several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3, it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively control tumor growth, formation of a stromal microenvironment and disease progression.

Regorafenib is approved under the brand name Stivarga in 90 countries worldwide, including the U.S., countries of the EU and Japan for the treatment of metastatic colorectal cancer. The product is also approved in over 70 countries, including the U.S., countries of the EU and Japan, for the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU, Stivarga is indicated for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

On June 28, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that AbbVie Inc. has exercised its right to end its collaboration with Infinity to develop and commercialize duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, JUN 28, 2016, View Source [SID:1234513585]). The companies had been in discussions regarding a potential restructuring of the partnership but were unable to find a mutually attractive financial structure for continuation of the collaboration. With the termination of this agreement, Infinity has regained worldwide rights to duvelisib and neither Infinity nor AbbVie have future financial obligations to the other party.

“Our partnership with AbbVie and the significant, previously disclosed, funding was critical to our advancement of duvelisib through registration-focused clinical studies in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia,” stated Adelene Perkins, president and chief executive officer. “Data reported to date have demonstrated that duvelisib is clinically active with a manageable safety profile, and we believe that it could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients. We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib.”

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.

At this time, Infinity is continuing to focus resources on the DYNAMO and DUO studies, as well as SYNCHRONY, a combination study of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor and FRESCO, a combination study in patients with relapsed/refractory follicular lymphoma designed to evaluate the potential of duvelisib to replace chemotherapy. Infinity plans to discuss with the FDA the potential for FRESCO to serve as a confirmatory study for full approval in follicular lymphoma should duvelisib receive an accelerated approval based on the DYNAMO study.

Infinity will also reduce its workforce by 58 percent, impacting 100 of Infinity’s team members in order to align corporate resources with the company’s strategic decisions which include closing BRAVURA, a Phase 3 study of duvelisib in patients with relapsed iNHL, and CONTEMPO, a Phase 1b/2 study of duvelisib in treatment-naïve patients with follicular lymphoma. Infinity will not proceed with the Phase 1b/2 study of duvelisib in combination with venetoclax.

“We have incredibly talented and dedicated Citizen-Owners at Infinity, and I would like to personally express my gratitude and appreciation for all of their hard work and contributions. The decisions we have made are difficult but necessary to enable a path forward for duvelisib and IPI-549, our second development program. The team we have in place is deeply committed to exploring strategic opportunities for duvelisib, and ultimately IPI-549, to bring benefit to patients,” said Ms. Perkins.

IPI-549 is Infinity’s wholly owned immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.

About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3

Duvelisib is being evaluated in several studies, including DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL)4, DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)5, SYNCHRONY, a Phase 1b combination study designed in patients with CLL or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor6 and FRESCO, a Phase 2 combination study in patients with relapsed/refractory follicular lymphoma.7

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On June 28, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that AbbVie Inc. has exercised its right to end its collaboration with Infinity to develop and commercialize duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, JUN 28, 2016, View Source [SID:1234513585]). The companies had been in discussions regarding a potential restructuring of the partnership but were unable to find a mutually attractive financial structure for continuation of the collaboration. With the termination of this agreement, Infinity has regained worldwide rights to duvelisib and neither Infinity nor AbbVie have future financial obligations to the other party.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our partnership with AbbVie and the significant, previously disclosed, funding was critical to our advancement of duvelisib through registration-focused clinical studies in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia," stated Adelene Perkins, president and chief executive officer. "Data reported to date have demonstrated that duvelisib is clinically active with a manageable safety profile, and we believe that it could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients. We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib."

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.

At this time, Infinity is continuing to focus resources on the DYNAMO and DUO studies, as well as SYNCHRONY, a combination study of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor and FRESCO, a combination study in patients with relapsed/refractory follicular lymphoma designed to evaluate the potential of duvelisib to replace chemotherapy. Infinity plans to discuss with the FDA the potential for FRESCO to serve as a confirmatory study for full approval in follicular lymphoma should duvelisib receive an accelerated approval based on the DYNAMO study.

Infinity will also reduce its workforce by 58 percent, impacting 100 of Infinity’s team members in order to align corporate resources with the company’s strategic decisions which include closing BRAVURA, a Phase 3 study of duvelisib in patients with relapsed iNHL, and CONTEMPO, a Phase 1b/2 study of duvelisib in treatment-naïve patients with follicular lymphoma. Infinity will not proceed with the Phase 1b/2 study of duvelisib in combination with venetoclax.

"We have incredibly talented and dedicated Citizen-Owners at Infinity, and I would like to personally express my gratitude and appreciation for all of their hard work and contributions. The decisions we have made are difficult but necessary to enable a path forward for duvelisib and IPI-549, our second development program. The team we have in place is deeply committed to exploring strategic opportunities for duvelisib, and ultimately IPI-549, to bring benefit to patients," said Ms. Perkins.

IPI-549 is Infinity’s wholly owned immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.

About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3

Duvelisib is being evaluated in several studies, including DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL)4, DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)5, SYNCHRONY, a Phase 1b combination study designed in patients with CLL or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor6 and FRESCO, a Phase 2 combination study in patients with relapsed/refractory follicular lymphoma.7

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.