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Geron Announces Initiation of Janssen Phase 2 Clinical Trial of Imetelstat in Myelofibrosis

On September 16, 2015 Geron Corporation (Nasdaq:GERN) reported the dosing of the first patient in a Phase 2 clinical trial to evaluate imetelstat in patients with myelofibrosis (MF) (Press release, Geron, SEP 16, 2015, View Source [SID:1234507475]). This clinical trial, also referred to as the IMbarkTM study, is being conducted by Janssen Biotech, Inc. (Janssen), under the terms of the exclusive worldwide imetelstat license and collaboration agreement between the companies.

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Phase 2 Clinical Trial Design

The purpose of the Phase 2 clinical trial is to assess the efficacy, safety and tolerability of two dose levels of single-agent imetelstat in patients with MF. The trial is designed to enroll approximately 200 patients (approximately 100 patients per dosing arm) with DIPSS intermediate-2 or high risk MF who have relapsed after or are refractory to Janus Kinase (JAK) inhibitor treatment. At the time of enrollment, patients must have measurable splenomegaly and symptoms of MF. Patients will be assigned randomly on a blinded basis on a 1:1 ratio to one of two dosing arms – 9.4 mg/kg every three weeks or 4.7 mg/kg every three weeks. Dose reductions for adverse events are allowed and will follow protocol-specified algorithms. An interim review of data from the trial is planned after approximately 20 patients per arm have been randomized and followed for at least 12 weeks, in order to assess the adequacy of one or both of the initial dosing arms. As a result of this interim review, one or both dosing arms could continue as planned, be stopped or modified, or alternative doses could be selected.

The co-primary efficacy endpoints for the trial are spleen response rate and symptom response rate. Spleen response rate is defined as the percentage of patients who achieve ≥ 35% reduction in spleen volume from baseline at the Week 24 visit, as measured by imaging scans and assessed at a central imaging facility and by an Independent Review Committee. Symptom response rate is defined as the percentage of patients who have ≥ 50% reduction in Total Symptom Scores from baseline at the Week 24 visit, based on patient-reported outcomes on a modified Myelofibrosis Symptom Assessment Form version 2.0 electronic diary. The primary efficacy analysis of the co-primary endpoints will occur after all treated patients have been followed for at least 24 weeks.

Secondary efficacy endpoints include the number of patients achieving complete remission (CR) or partial remission (PR), clinical improvement (CI), and anemia, spleen and symptom responses as assessed using the modified 2013 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. These secondary endpoints will be assessed at the time of the primary efficacy analysis. Exploratory endpoints include cytogenetic and molecular responses, as well as leukemia-free survival.

Safety outcomes will be monitored throughout the trial and will include enhanced data collection and reporting for adverse events of interest, including hepatobiliary-associated laboratory findings and hepatic adverse events.

Multiple medical centers across North America, Europe and Asia are planned to participate in the trial. For more information about the IMbarkTM study being conducted by Janssen, please visit View Source

About Imetelstat

Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting the progenitor cells of the malignant clone associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies conducted to date include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.

Foundation Medicine Launches Precision Medicine Exchange Consortium™ (PMEC) to Advance the Integration of Molecular Information in Clinical Oncology and Accelerate Adoption of Precision Care

On September 15, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported the launch of its precision medicine partner program, Precision Medicine Exchange Consortium (PMEC), to facilitate data exchange, advance research, and support education and applications of precision medicine in oncology and molecular pathology (Press release, Foundation Medicine, SEP 15, 2015, View Source [SID:1234507471]). PMEC brings together oncology thought leaders from academic medical centers, regional hospital systems, and community oncology networks, initially located in the U.S. and to be expanded internationally, who share a vision for utilizing precision medicine as a means for improving clinical outcomes in oncology treatment. The consortium intends to realize this vision through a collaborative exchange of molecular information and clinical outcomes data, and through a broader integration of comprehensive genomic profiling in cancer treatment.

Founding members of PMEC include The Cleveland Clinic’s Taussig Cancer Institute, Hackensack University Medical Center, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Sidney Kimmel Cancer Center at Thomas Jefferson University, UC Davis Health Comprehensive Cancer Center, the University of North Carolina Lineberger Comprehensive Cancer Center, and Vanderbilt-Ingram Cancer Center and The Wake Forest Baptist Comprehensive Cancer Center.

"Progress in cancer care will be achieved by breaking down the information silos that exist in healthcare and collaborating towards clinically robust and relevant data exchange," said Brian Bolwell, MD, chairman of the Cleveland Clinic Cancer Institute and founding member of PMEC. "We applaud Foundation Medicine and our partner institutions in PMEC for their innovative thinking, for valuing the exchange of information, and for taking a leadership role to effect a positive change for our patients with cancer."

PMEC is being established on the guiding principles of innovation, education and the exchange of highly validated molecular information and outcomes data to improve cancer care. PMEC members will have access to a suite of innovative information tools and programs tailored to fit the needs of the individual cancer centers who are members of PMEC.

A selection of these planned offerings include:

access to a shared data exchange platform of de-identified, matched clinical outcomes and genomic data contributed by Foundation Medicine and PMEC members to support research and clinical innovation;
access to clinical research programs that integrate comprehensive genomic profiling to improve cancer care; and
programs to support the advancement of precision medicine and molecular oncology through training, education and streamlined member services.
Additionally, PMEC members can elect to participate in best practices exchanges, where members will have the opportunity to share ideas advancing precision medicine.

"The promise of precision medicine rests on these national and international initiatives, including PMEC, which enable investigators to share crucial data. Only through that data sharing can we understand the implications of genomics for patient care," said Mary Zutter, M.D., assistant vice chancellor for Integrative Diagnostics at Vanderbilt University Medical Center.

"The Precision Medicine Exchange Consortium is being developed as the most comprehensive program of its kind and will align innovators in cancer care around molecular information and clinical data curation and exchange," said Vincent A. Miller, M.D., chief medical officer at Foundation Medicine. "Collectively, PMEC is poised to fuel innovation, support cancer research and extend valuable information and education in a way that heretofore has not happened within the cancer community. We’re proud to be launching this initiative with so many thought leaders across a broad spectrum of cancer institutions and practices. We’re actively seeking new members who share PMEC’s vision, and we welcome conversations with additional cancer centers, data and informatics organizations and payers who embrace the opportunity to collaborate for the betterment of cancer care."

Foundation Medicine Expands Molecular Information Decision Support Offerings with GeneKit™, a Genomic Solutions Portal for Pathologists

On September 15, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported the expansion of its suite of molecular information-based products with GeneKitTM, a genomics solutions portal for pathologists (Press release, Foundation Medicine, SEP 15, 2015, View Source [SID:1234507470]). Uniquely differentiated by the power of FoundationCORETM, Foundation Medicine’s ever-growing comprehensive cancer genomics knowledgebase of more than 50,000 genomic profiles, GeneKit facilitates the interpretation of genomic data generated by pathologists from targeted next generation sequencing (NGS) and "hot spot" assays. This integration will help pathologists to more effectively support clinical diagnosis and treatment strategies via the rapid interpretation and efficient reporting of genomic information to oncology care teams.

"To ensure that molecular information is used to inform therapeutic decisions and improve patient care, we are offering pathologists a sophisticated clinical interpretation system. GeneKit will allow pathologists to assess a patient’s specific tumor alterations against a knowledgebase of curated genomic variants, relevant scientific research, targeted therapy and clinical trial information, enabling the creation of actionable reports in a timely fashion for care teams," said David J. Daly, chief commercial officer of Foundation Medicine. "Today, a large number of institutions use manual interpretation procedures that can be incredibly arduous, technical and time-consuming. GeneKit overcomes these challenges of manual reporting and furnishes pathologists with highly relevant clinical and scientific data for the betterment of patient care."

Since hotspot panels are most widely used in pathology laboratories, GeneKit has been designed to seamlessly integrate into a pathologist’s standard workflow. GeneKit differs from other pathology reporting tools because of the following key features:

Integrates with any NGS assay that interrogates the variant status of up to 50 cancer-related genes that are known to be involved in the development, progression and/or treatment of cancers;

Relies upon FoundationCORE, Foundation Medicine’s knowledgebase of comprehensive genomic cancer information;
Efficiently and rapidly organizes and reports information on up to 50 genes using data from FoundationCORE, as well the customer’s proprietary data;

Easily integrates with other IT systems;

Offers a user-friendly interface that gives pathologists customized reporting options; and,

Provides a reflex option to Foundation Medicine’s comprehensive genomic profiling assays, FoundationOne and FoundationOne Heme.

GeneKit is a cloud-based software solution and is a component of Foundation Medicine’s molecular information-based suite of decision support solutions. GeneKit complements Interactive Cancer Explorer (ICE 2) with PatientMatchTM, the company’s innovative physician-facing decision support portal. Together, GeneKit and ICE 2 provide an unparalleled offering of molecular information-based solutions that empower cancer care teams to make informed diagnostic and therapeutic care choices based on the unique genomic drivers of each person’s cancer.

Cancer Research UK launches three new funding schemes for cancer doctors

On September 15, 2015 Cancer Research UK reported it is launching three new funding schemes to support the careers of cancer doctors researching new ways to prevent, diagnose and treat the disease (Press release, Cancer Research UK, SEP 15, 2015, View Source [SID:1234507469]).

Over the next few years, the charity’s Clinical Careers Committee hopes to fund twice as many fellowships as were previously available. And three schemes will be available for clinicians at different stages of their careers.

The Postdoctoral Research Bursary is available to clinicians to carry out research while completing speciality medical training. This bursary covers research costs for up to two years but does not cover salary.

The Clinician Scientist Fellowship is available to researchers with no previous post-doctoral fellowship experience. It provides the successful candidate’s salary and research costs for up to five years.

And the Advanced Clinician Scientist Fellowship is available to researchers with more than three years post-doctoral research experience. This fellowship provides up to five years funding for the successful candidate’s salary, the salary of another post-doctoral researcher and an assistant or technician in addition to equipment and running costs.

Dr Karen Noble, head of research training and fellowships at Cancer Research UK, said: "We’ve listened to the needs of the community and we’re tailoring our funding accordingly. These new schemes will allow us to support talented clinicians and help to advance research into new cancer treatments.

"Clinical research is the key to finding out if a new approach to cancer treatment works well – and is safe – in patients. It also helps us discover which treatments or strategies work best for certain types of cancer or groups of patients."

Professor Peter Johnson, Cancer Research UK’s chief clinician, said: "Finding the next generation of clinical research leaders is one of our highest priorities at Cancer Research UK. People who can turn our amazing discoveries into things that will help patients in the clinic are vital to our future. We’re excited to further invest in the best clinical research taking place in the UK."

ARIAD Announces Full Enrollment in Phase 2 ALTA Trial of Brigatinib

On September 15, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it has achieved full enrollment in the pivotal Phase 2 ALTA trial of its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib (Press release, Ariad, SEP 15, 2015, View Source [SID:1234507472]). This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia.

"We are proud to have completed patient enrollment in the ALTA trial in the timeframe we established at the outset," stated Timothy P. Clackson, president of research and development and chief scientific officer of ARIAD. "We expect data from this trial to form the basis for an NDA filing of brigatinib in patients with refractory non-small cell lung cancer in the third quarter of next year."

The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of brigatinib (previously known as AP26113) in refractory non-small cell lung cancer (NSCLC) patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy. The primary endpoint of the trial is objective response rate (ORR) as measured by RECIST criteria. Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014.

Median time on treatment for patients in the ALTA trial is less than 4 months, and follow-up data are limited at this time. As a result, ARIAD now expects that first data from the trial will be submitted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2016. Presenting data at ASCO (Free ASCO Whitepaper) will also align more closely with the anticipated filing for marketing approval of brigatinib in the U.S. in the third quarter of 2016.

A randomized front-line clinical trial of brigatinib is expected begin in early 2016. This Phase 3 trial will compare brigatinib to crizotinib in approximately 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors.

About Brigatinib

Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC that is resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review.