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Infinity Announces Enrollment Of 120th Patient In Phase 2 DYNAMO™ Study Evaluating Duvelisib In Indolent Non-Hodgkin Lymphoma

On September 30, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported 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 (Press release, Infinity Pharmaceuticals, SEP 30, 2015, View Source;p=RssLanding&cat=news&id=2091831 [SID:1234507617]). 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.

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"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.

About the AbbVie Collaboration
Under the terms of the agreement announced in September 2014 , Infinity received an upfront payment of $275 million from AbbVie Inc. and will receive a $130 million associated with the completion of patient enrollment for DYNAMO. Additionally, Infinity is eligible additional payments for the achievement of regulatory and commercial milestones. In the U.S., the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the U.S., AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales.

About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Duvelisib is being evaluated in registration-focused studies, including DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUO, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

CTI BioPharma And Fred Hutchinson Cancer Research Center Announce International Research Fellowship To Support Innovative Blood-Related Cancer Research

On October 1, 2015 Seattle-based CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) and Fred Hutchinson Cancer Research Center (Fred Hutch) reported the establishment of a new $1.5 million research endowment fund – The CTI BioPharma International Postdoctoral Research Fellowship – intended to foster international collaboration in translational research and support advancements in the fields of hematology and immunobiology (Press release, CTI BioPharma, SEP 30, 2015, View Source [SID:1234507622]).

"Establishing this endowed international visiting fellowship to Fred Hutch stems from our commitment to translate scientific discoveries into innovative therapies that cure patients with blood-related cancers," said James A. Bianco, M.D., president and CEO of CTI BioPharma. "After all, changing the future of cancer medicine starts with the support of today’s innovative ideas."

Hematology is the study of blood in health and disease and includes problems with red and white blood cells, platelets, blood vessels, bone marrow, lymph nodes, spleen, and the proteins involved in bleeding and clotting (hemostasis and thrombosis). Common blood disorders, affecting millions of people each year in the United States, include sickle cell disease, anemia, bleeding disorders (such as hemophilia and blood clots) and blood cancers (such as leukemia, lymphoma, and myeloma). Immunobiology is the study of the immune factors that affect the growth, development, and health of biologic organisms.

"Endowment funding is essential to keeping our research and clinical programs moving forward in order to find new cures and save lives," said Gary Gilliland, M.D., Ph.D., president and director of Fred Hutchinson Cancer Research Center. "Support, such as through the establishment of this CTI BioPharma fellowship and endowment fund, allows doctors and scientists to develop and manage their programs and to take advantage of emerging opportunities. Without the support from companies such as CTI BioPharma, many potential lifesaving medicines would not make it from the research bench to patients."

The CTI BioPharma fellowship and endowment fund is in memory of E. Donnall Thomas, M.D., a pioneering scientist and Nobel Prize recipient who had a profound and positive impact on the co-founders of CTI BioPharma, Bianco and Jack Singer, M.D., chief scientific officer and global head of Translational Medicine. This fellowship and endowment will provide seed funding to support the research efforts of promising, young physician researchers from around the world. Fred Hutch will receive endowment funding over three years to identify and select proposed research projects from medical researchers currently working at international institutions based outside of the U.S. Both CTI BioPharma and other institutions or organizations can donate additional funding to the endowment at any time, per the approval of Fred Hutch.

For more information about the endowment or to apply or to review the selection criteria, please visit: www.fredhutch.org/CTIfellowship.

Kura Oncology Initiates Phase 2 Study of Tipifarnib in Peripheral T-cell Lymphoma

On September 30, 2015 Kura Oncology, Inc. (OTCQB:KURO), a clinical stage biopharmaceutical company advancing a pipeline of precision medicines for the treatment of solid tumors and blood cancers, reported it has initiated a Phase 2 clinical trial of tipifarnib in patients with peripheral T-cell lymphoma (PTCL) (Press release, Kura Oncology, SEP 30, 2015, View Source [SID:1234507618]).

"I’m delighted that the second of our two planned company sponsored Phase 2 trials for tipifarnib is now underway," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "This study, along with the Phase 2 trial we initiated in May in advanced cancers with HRAS mutations, is an important part of our strategy to identify patients most likely to benefit from tipifarnib, a compound that has previously demonstrated durable responses in subsets of cancer patients."

PTCL consists of a group of rare and usually aggressive forms of non-Hodgkin’s lymphoma (NHL) that develop from mature T-cells. PTCL is estimated to have an annual incidence in the U.S of 2,800-7,200 patients. These patients generally have a poor prognosis with a low response rate to available treatment options and commonly experience repeated treatment failures.

A previous Phase 2 trial of tipifarnib, sponsored by the National Cancer Institute, was conducted at the Mayo Clinic and University of Iowa in adult patients with relapsed or refractory lymphoma (Blood. 2011 Nov 3; 118(18): 4882-4889). That study demonstrated that tipifarnib can be administered for prolonged periods and may produce durable responses as a single agent in relapsed lymphoma in a group of patients who were heavily pretreated, including those with PTCL.

The primary objective of the current Phase 2 study sponsored by Kura Oncology is to evaluate the efficacy of tipifarnib as a treatment for patients with relapsed or refractory PTCL. The Phase 2 trial is designed to enroll up to 18 patients to test the primary study objective, and the study includes a potential extension of up to 30 patients in total. Additional information about this clinical trial is available at clinicaltrials.gov using identifier: NCT02464228.

About Tipifarnib

Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown compelling and durable anti-cancer activity in certain patient subsets and a well-established safety profile. Preclinical and clinical data suggest that, in the right genetic context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics, Kura Oncology will seek to identify patients most likely to benefit from tipifarnib. Kura Oncology holds an exclusive license to develop and commercialize tipifarnib in the field of oncology, under an agreement with Janssen Pharmaceutica NV.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On September 30, 2015 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has completed the manufacture of clinical-grade drug product, concluded a comprehensive IND-enabling non-clinical safety assessment program, and has proposed a design for its first-in-human clinical trial with TTI-621 (SIRPaFc) (Filing, 6-K, Trillium Therapeutics, SEP 30, 2015, View Source [SID:1234507616]).

The Company plans to conduct a Phase I trial with a dose-escalation stage that will enroll patients with relapsed or refractory lymphoma who are transfusion independent with relatively normal baseline blood counts, thus better enabling characterization of potential changes in hematologic parameters that could occur upon CD47 blockade. Once the optimal dose and schedule of TTI-621 administration have been established, the Company expects to study safety and anti-tumor activity in a variety of expansion cohorts of patients. These will include patients with acute myeloid leukemia, myelodysplastic syndrome, as well as several other advanced hematologic malignancies.

"The Investigational New Drug application was submitted as planned and we have secured enthusiastic commitments from multiple investigators at key cancer treatment centers in the United States," commented Dr. Eric Sievers, Trillium’s Chief Medical Officer. "We have been gratified by considerable interest from the oncology community to evaluate a novel checkpoint inhibitor of the innate immune system."

Additional in vitro and in vivo preclinical studies have been completed. These have demonstrated that TTI-621 has potent anti-tumor activity across a range of hematological tumors, and have provided guidance for the expansion cohorts in the first-in-human clinical study. The Company expects to present some of these data at an upcoming scientific meeting.

The Company also continues to explore the therapeutic potential of TTI-621 in a variety of solid tumor models, both as monotherapy and in combination with other therapeutic agents. Based on the results of these studies, as well as on third party data reported in the literature, additional clinical trials will be designed.

OncoGenex Announces Completion of Patient Enrollment in Borealis-2™ Clinical Trial Evaluating Apatorsen in Relapsed or Refractory Metastatic Bladder Cancer

On September 30, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported that Borealis-2, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients (Press release, OncoGenex Pharmaceuticals, SEP 30, 2015, View Source [SID:1234507615]). Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is sponsored by Hoosier Oncology Group and is being conducted at 27 sites across the United States.

Patients enrolled in Borealis-2 were randomized to receive either apatorsen plus docetaxel or doecetaxel alone. Patients could continue weekly apatorsen infusions as maintenance treatment until disease progression or unacceptable toxicity if they completed all 10 planned cycles of docetaxel or discontinued from docetaxel due to toxicity. Evaluation of overall survival is the primary study objective.

"Patients with advanced metastatic bladder cancer, who have failed initial therapies, typically have a poor prognosis with very limited therapeutic options. This is clearly an unmet therapeutic need," said overall principal investigator Toni Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute. "Recently reported apatorsen data have shown that Hsp27 inhibition improves survival in patients with poor prognosis. We hope to confirm those findings with the Borealis-2 trial results."

Data from the Borealis-1TM trial previously reported at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting earlier this year showed that metastatic bladder cancer patients with poor prognostic features (low performance status, liver involvement, low hemoglobin and high alkaline phosphatase) showed a potential survival benefit with apatorsen 600mg added to first-line chemotherapy (HR = 0.72) compared to chemotherapy alone. Patients in the trial with a Karnofsky Performance Status of 80 percent or less, a common indicator of poor prognosis, experienced a 50 percent reduction in risk of death with the addition of apatorsen therapy (HR = 0.50). Based on findings from the Borealis 1 trial, OncoGenex and the Hoosier Oncology Group plan to evaluate overall survival in patients with poor prognostic factors in the Borealis-2 trial.

"Patients in Borealis-2 are at an increased risk for poor outcomes given their disease has progressed after first-line treatment. Based on recent findings, we are seeing evidence that apatorsen may work in a variety of treatment settings within the bladder cancer paradigm," said Scott Cormack, President and CEO of OncoGenex. "We are thankful to the trial investigators and patients for their participation and we are eager for the results of this trial to inform our broader apatorsen program. We are working closely with investigators to determine next steps given the need and urgency for new bladder cancer treatments."

About Bladder Cancer

Worldwide, more than 429,000 cases of bladder cancer are diagnosed each year, and nearly 75,000 cases of bladder cancer will be diagnosed in the U.S. in 2015. Approximately 70 percent of patients present with superficial or non-muscle-invasive bladder cancer, with about 30 percent of patients having locally invasive or metastatic disease at the time of diagnosis. Of patients with locally invasive disease, 50 percent will relapse with metastases within two years. Limited options exist for both first- and second-line treatment of advanced bladder cancer and there continues to be a high unmet need for additional therapeutic options for this patient population.

About Apatorsen and ORCA

Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27 (Hsp27), disable cancer cells’ defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival.

The ORCA (Ongoing Studies Evaluating Treatment Resistance in CAncer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com or www.orcatrials.com.