On June 8, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pIL-12, otherwise known as tavokinogene telsaplasmid, for the treatment of unresectable metastatic melanoma (Press release, OncoSec Medical, JUN 8, 2017, View Source [SID1234519481]). Tavokinogene telsaplasmid is the active biologic agent in OncoSec’s lead product candidate, ImmunoPulse IL-12. The Orphan Drug status will provide OncoSec with eligibility for certain development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity. Schedule your 30 min Free 1stOncology Demo! "This is an important regulatory milestone for OncoSec as we advance ImmunoPulse IL-12 toward commercialization," said Punit Dhillon, CEO and President of OncoSec. "We are diligently working to address a significant unmet medical need in melanoma patients who are progressing or have progressed after treatment with anti-PD-1."
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OncoSec is initiating the registration-directed PISCES trial, to evaluate the safety and efficacy of ImmunoPulse IL-12 and the approved anti-PD-1 agent, pembrolizumab, in patients with metastatic melanoma following disease progression on previous treatment with an anti-PD-1 therapy.
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the U.S. at any given time. For a drug to qualify for orphan drug designation both the drug and the disease must meet certain criteria specified in Section 525 of the Federal Food, Drug, and Cosmetic Act (21 USC 360aa). The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
About PISCES
PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study) will be a Phase II multicenter study of ImmunoPulse IL-12 in combination with KEYTRUDA in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. Eligible patients will be those with Stage III/IV metastatic melanoma who are progressing or have progressed on an approved anti-PD-1 therapy. The primary endpoint for this registration-directed trial is best overall response rate (BORR).
First Patient Enrolled in RTOG Trial of Optune® together with Bevacizumab for Patients with Bevacizumab-Refractory Recurrent Glioblastoma
On June 8, 2017 Novocure (NASDAQ: NVCR) reported that the first patient has been enrolled in the RTOG Foundation’s phase 2 pilot trial testing Optune together with bevacizumab for patients with bevacizumab-refractory recurrent glioblastoma (GBM) (Press release, NovoCure, JUN 8, 2017, View Source [SID1234519478]). Schedule your 30 min Free 1stOncology Demo! Optune is an FDA-approved Tumor Treating Fields (TTFields) delivery system for the treatment of newly diagnosed and recurrent GBM. In recurrent GBM, both Optune and bevacizumab are approved as monotherapies. The current trial intends to test the efficacy and safety of Optune in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM.
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"The results of this trial will provide additional information to the brain tumor research community on the safety and effectiveness of using Optune in combination with bevacizumab in patients with bevacizumab-refractory recurrent GBM," said Dr. Manmeet Ahluwalia, Dean and Diane Miller Endowed Chair in NeuroOncology at Cleveland Clinic and Co-Principal Investigator of the trial. "These patients face a dismal prognosis and are in need of treatment options."
The RTOG Foundation Study RTOG 3503 is planned to include 85 patients at 20 institutions in the United States. Patients must have a recurrence or progression of GBM or other grade IV glioma after being treated with bevacizumab. The trial will determine the efficacy of Optune together with bevacizumab measured by overall survival at six months. Additional endpoints include overall and progression-free survival from time of registration, response rates, and toxicities of bevacizumab with Optune.
"This is the first consortium study of TTFields, demonstrating the continued and mounting interest in Optune from the scientific community," said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. "Our EF-11 phase 3 pivotal trial in recurrent GBM patients suggested that in a subgroup of patients who were refractory to bevacizumab Optune monotherapy led to an extension in survival versus chemotherapy. We are excited that RTOG is researching the potential benefit of Optune together with bevacizumab in this difficult-to-treat population of patients."
"For 40 years, RTOG has conducted studies designed to improve the survival and quality of life of cancer patients," said Dr. Jeffrey J. Raizer, Co-Founding-Director of the Northwestern Brain Tumor Institute and Co-Principal Investigator of the trial. "RTOG is excited to partner with Novocure on this important study, and I am pleased to be able to offer Optune to patients in this study."
For more information on the trial designs, visit clinicaltrials.gov and reference NCT02743078. Treatment with TTFields is not approved in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields in combination with bevacizumab for the treatment of patients with bevacizumab-refractory recurrent GBM has not been established.
ASCO and Foundation Medicine Announce Collaboration to Help Research Sites Identify Potential Participants for the Targeted Agent and Profiling Utilization (TAPUR) Study
On June 8, 2017 The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. (ASCO) (Free ASCO Whitepaper) and Foundation Medicine (NASDAQ: FMI) reported entry into an agreement to create efficiencies for research sites participating in ASCO (Free ASCO Whitepaper)’s TAPUR Study in identifying potential participants for the study. ASCO (Free ASCO Whitepaper) is announcing that reports from Foundation Medicine’s comprehensive genomic profiling (CGP) assays, FoundationOne, FoundationOne Heme and FoundationACT will receive the new "optimized for TAPUR reporting" designation available to entities that demonstrate reporting of nearly 75% of TAPUR-specific genes in a format that meets criteria established for the TAPUR Study. The TAPUR Study is a first-of its-kind clinical trial designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the Food and Drug Administration. Schedule your 30 min Free 1stOncology Demo! As part of this pilot program, Foundation Medicine will use its SmartTrials technology to create reports for TAPUR sites that identify patients who may qualify to participate in the TAPUR Study. SmartTrials is a molecularly-matched, location-specific, clinical trials database that informs physicians about clinical trials to accelerate patient enrollment. Early use of the SmartTrials report by one TAPUR site was associated with a significant increase in patient accrual with the site reporting identification of more than 60 patients whose genomic profiles matched TAPUR drug targets within a few months of implementing the SmartTrials technology. As part of this arrangement, Foundation Medicine will be launching its SmartTrials reporting to an initial pilot set of the TAPUR Study’s participating clinical sites.
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"We are excited to designate Foundation Medicine’s CGP assays as providing reports that are optimized for TAPUR participation and work with Foundation Medicine to allow TAPUR Sites to incorporate SmartTrials reporting to streamline identification of patients who may qualify for the TAPUR study," said ASCO (Free ASCO Whitepaper) Chief Medical Officer and TAPUR Study Principal Investigator, Richard L. Schilsky, MD, FACP, FASCO, FSCT. "It is our hope that Foundation Medicine’s unique expertise in genomics will enable many more patients to access investigational therapies through the TAPUR Study clinical trial."
"The TAPUR Study’s innovative, biomarker-driven design will expand access for patients to innovative new targeted therapies, while enhancing the collective understanding of the genomic basis of cancer biology," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Applying the SmartTrials reporting to the TAPUR Study can facilitate rapid and accurate patient identification, accelerating patient enrollment."
About the TAPUR Study
The TAPUR Study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The TAPUR Study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials.
TG Therapeutics, Inc. Announces Clinical Data Presentations at the Upcoming 14th International Conference on Malignant Lymphoma
On June 8, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 14th International Conference on Malignant Lymphoma (ICML), to be held from June 14 – 17, 2017, in Lugano, Switzerland (Press release, TG Therapeutics, JUN 8, 2017, View Source [SID1234519476]). The abstracts were made public yesterday, and are included in the Abstract Book available through the ICML meeting website at www.lymphcon.ch. Schedule your 30 min Free 1stOncology Demo! Details of the data presentations are outlined below.
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Oral Presentations:
Title: Updated results of a multicenter phase I/Ib study of TGR-1202 in combination with ibrutinib in patients with relapsed or refractory MCL or CLL
Abstract Number: 040
Presentation Date & Time: Wednesday, June 14, 2017 17:50 CEST
Session Title: Chemotherapy-Free Combinations
Presenter: Matthew S. Davids, MD, Dana-Farber Cancer Institute
Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
Abstract Number: 101
Presentation Date & Time: Friday, June 16, 2017 11:20 CEST
Session Title: Session 7 – Advances in CLL
Presenter: Anthony R. Mato, MD, University of Pennsylvania, Abramson Cancer Center
Title: Chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib is well tolerated and highly active in patients with advanced CLL and NHL
Abstract Number: 102
Presentation Date & Time: Friday, June 16, 2017 11:35 CEST
Session Title: Session 7 – Advances in CLL
Presenter: Loretta J. Nastoupil, MD, MD Anderson Cancer Center
Poster Presentation:
Title: Combination of TGR-1202, Ublituximab, and Bendamustine is safe and highly active in patients with advanced DLBCL and Follicular Lymphoma
Abstract Number: 277
Presentation Date: Friday, June 16, 2017 (Poster Session)
Presenter: Mathew Lunning, DO, University of Nebraska, Omaha, NE
Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.
Sophiris Bio Announces that the First Patient Has Been Dosed in Phase 2b Study of Topsalysin in Patients with Clinically Significant Localized Prostate Cancer
On June 8, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris") reported that the first patient has been dosed in its Phase 2b study to evaluate the safety and tolerability of topsalysin in focally treating men with clinically significant localized prostate cancer (Press release, Sophiris Bio, JUN 8, 2017, View Source [SID1234519475]). Topsalysin (PRX302) is an innovative, first-in-class pore-forming protein engineered to be activated only in the presence of enzymatically-active PSA, which is only found within the prostate. Schedule your 30 min Free 1stOncology Demo! Sophiris Bio Logo
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This Phase 2b study will build on the successful Phase 2a proof-of-concept study for the treatment of localized prostate cancer which demonstrated that a targeted intraprostatic administration of topsalysin has the potential to safely ablate prostate tumor cells.
"Topsalysin has the potential to provide a much-needed opportunity to treat the patients who have clinically significant localized prostate cancer in a targeted focal manner, ablate pre-identified lesions and downgrade the patient to non-significant cancer," said Dr. Hashim Ahmed, professor and chair of urology, Imperial College London. "This would be extremely exciting and clinically meaningful for men, as it could help them either avoid or delay the need for radical therapies and significant side effects associated with radical therapy."
"We have the potential to provide an efficacious, less invasive treatment option for patients with clinically significant localized prostate cancer," said Randall E. Woods, president and CEO of Sophiris Bio. "Our goal with this international Phase 2b clinical study is to confirm the dose and optimize the delivery of topsalysin and to evaluate the safety and efficacy of a second dose of topsalysin in a clinical setting."
About the Phase 2b Study
The study is a multi-center, open-label, Phase 2b study evaluating the safety and efficacy of targeted intraprostatic administration of topsalysin for the treatment of histologically proven, clinically significant, localized prostate cancer. Approximately 40 patients will be enrolled in the study at multiple sites in the United States and the United Kingdom. The study will utilize previously obtained MRI images of each patient’s prostate mapped to real time 3D ultrasound to target the delivery of topsalysin directly into and around a pre-identified clinically significant tumor. Safety and tolerability will be assessed post-treatment over 26 weeks. Efficacy will be assessed by biopsy and imaging (mpMRI) at 24 weeks. The Company expects to receive six month biopsy data for all patients in the first quarter of 2018 assuming enrollment is completed as expected.
Importantly, the Phase 2b study includes an option to re-treat patients with a second dose of topsalysin, with a targeted biopsy to occur six months following the second dose. In order to be eligible for a second dose, the patient cannot have experienced a significant adverse event attributable to topsalysin or the dosing procedure from the first dose and the patient will need to have had a clinical response from the first dose but still have the presence of a clinically significant lesion area. The Company expects to have final biopsy data on all patients who receive a second dose in the fourth quarter of 2018.
About Localized Prostate Cancer
Prostate cancer is the second most common form of cancer in men in the US with an estimated 161,000 new cases in 2017. Approximately 80 percent of patients in the US are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence, and rectal toxicity.
About Topsalysin
Topsalysin (PRX302), an innovative, "First-in-Class" pore-forming protein, was engineered to be activated only by enzymatically-active PSA, which is produced in large quantities exclusively within the prostate of men with prostate cancer. The targeted focal treatment of prostate cancer is in line with current treatment trends for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ and organ function as possible.
Topsalysin has the potential to provide a focal targeted therapy for the ablation of localized prostate cancer while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in mapping previously obtained mpMRI images with real-time three-dimensional ultrasound images enables urologists to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.