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2X ONCOLOGY OBTAINS INVESTIGATIONAL NEW DRUG APPLICATION FOR 2X-111 GLUTATHIONE ENHANCED PEGYLATED LIPOSOMAL DOXORUBICIN

On June 8, 2017 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in women’s cancer, reported that it has obtained the Investigational New Drug (IND) application for 2X-111 (doxorubicin hydrochloride and glutathione) from 2-BBB Medicines B.V., assuming all future development and ownership of the drug (Press release, 2X Oncology, JUN 8, 2017, View Source [SID1234526104]).

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2X-111 is being developed as a new treatment option for women with brain metastases from breast cancer and for patients with recurrent glioblastoma multiforme (GBM), an orphan-designated condition.

George O. Elston, CEO of 2X Oncology, said, "Having this IND in place is an important step as we focus on initiating Phase 2 clinical trials of 2X-111 in GBM and brain metastases from breast cancer later this year.

"These studies will employ our proprietary DRP companion diagnostic to identify patients based on their unique tumor mRNA expression and treat those most likely to respond to and benefit from therapy," Mr. Elston added.

"Patient selection based on the unique genetic properties of a tumor is an important new direction in the treatment of cancer, and we are pleased to have this capability for our programs and patients."

The Drug Response Predictor (DRP) technology utilizes messenger RNA (mRNA) from patient biopsies and uses proprietary analytics to create a unique fingerprint of relevant genes based on a tumor’s sensitivity, or resistance, to a compound. DRPs are specific for each product and have been validated in over 40 clinical studies.

"We expect data from these studies in 2018 which, if positive, can position this program for possible accelerated approval filings shortly thereafter," Mr. Elston concluded.

Formerly known as 2B3-101, 2X-111 improves on commercially available PEGylated liposomal doxorubicin products with an additional glutathione coating that safely enhances drug delivery across the blood-brain barrier. Doxorubicin is an anthracycline that inhibits the growth of many cancerous cell lines, including glioblastoma and breast cancer cell lines. It is among the most widely used anti-cancer agents.

An abstract on the predictive ability of the DRP in treating advanced breast cancer with a similar anthracycline, epirubicin, was presented in a poster session at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

The abstract describes a retrospective-prospective blinded study which evaluated the ability of the DRP to predict the efficacy of epirubicin in a cohort of 135 metastatic breast cancer patients. The DRP was significantly associated with progression free survival in this study. The estimated median time to progression for a patient with a DRP value of 25% was 7 months, versus 13 months for a patient with a DRP value of 75%.

Mr. Elston will discuss 2X-111 and other 2X pipeline drugs at the Jefferies 2017 Global Healthcare Conference on June 9, 2017, at 10:00am EDT. The presentation will be available as a live webcast and archived for post-listening on the Company’s website.

About Breast Cancer Brain Metastases

Breast cancer is the second most common common cause of brain metastases, with metastases occurring in 10–16 % of patients[1]. Patients who develop brain metastases tend to have poor prognosis with short overall survival. Furthermore, brain metastases are a major cause of morbidity, associated with progressive neurologic deficits that result in a reduced quality of life.

About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common class of malignant primary brain tumors and one of the most aggressive forms of cancer. This highly invasive and proliferative cancer resists standard chemotherapy and radiotherapy. Current therapeutic strategies for the treatment of GBM fail to demonstrate adequate efficacy and/or are generally palliative. Median overall survival is 12 to 14 months

OncoSec Granted Orphan Drug Designation from the U.S. FDA for the Treatment of Unresectable Metastatic Melanoma

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.

"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."

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]).

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.

"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.

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.

"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.

Details of the data presentations are outlined below.

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.