On October 13, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that the Company and its research collaborators have been invited to present data regarding the progress of VAL-083 at the following upcoming peer-reviewed scientific conferences (Press release, DelMar Pharmaceuticals, OCT 13, 2016, View Source [SID:SID1234515794]).

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European Association of NeuroOncology (EANO) Annual Meeting (Heidelberg, Germany Oct. 12 – 16, 2016);
AACR DNA Repair: Tumor Development and Therapeutic Response (Montreal, Canada Nov. 2 – 5, 2016);
AACR New Horizons in Cancer Research: Delivering Cures through Cancer Research (Shanghai, China Nov. 2 – 4, 2016);
Society for NeuroOncology Annual Meeting and CNS Anti-Cancer Drug Development Conference (Scottsdale, USA Nov. 16 – 20, 2016);
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Munich, Germany Nov 29 – Dec. 2, 2016); and
IASLC 17th World Congress on Lung Cancer (Vienna, Austria Dec. 4 – 7, 2016).

"We are pleased to accept these invitations to present new data at these prestigious peer-reviewed meetings," said Jeffrey Bacha, DelMar’s chairman & CEO. "Data presented at these global meetings will highlight the continued success of our strategy to leverage historical clinical validation from prior NCI-sponsored research with a modern understanding of VAL-083’s unique anti-cancer mechanism."

VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

"Taken together, these data support VAL-083’s potential to address unmet medical needs in major cancer indications for patients whose tumors have failed, or exhibit features that make them resistant or unlikely to respond to, current standard-of-care chemotherapy," added Mr. Bacha.

Details of DelMar’s upcoming scientific meeting presentations are as follows:

EANO 2016. On October 15, 2016, DelMar and its collaborators from the University of British Columbia will present an abstract entitled: "Dianhydrogalactitol (VAL-083) causes bifunctional alkylation leading to irreparable DNA double-strand breaks, S/G2 phase cell-cycle arrest and tumor cell death in an MGMT independent manner offering a unique treatment paradigm for GBM."
AACR DNA Repair: Tumor Development & Therapeutic Response Conference. On Friday November 4, 2016, DelMar and its collaborators from the University of British Columbia Prostate Cancer Research Center will present an abstract entitled: "Dissecting the Molecular Mechanism of Dianhydrogalactitol (VAL-083) in Cancer Treatment."
AACR New Horizons in Cancer Research: Delivering Cures through Cancer Research. On Friday November 4, 2016, DelMar and its collaborators from the University of Texas MD Anderson Cancer Center and the University of British Columbia will present an abstract entitled: "Assessment of dianhydrogalactitol in the treatment of relapsed or refractory non-small cell lung cancer."
Society for NeuroOncology Annual Meeting and CNS Anti-Cancer Drug Development Conference.
On Thursday November 17, 2016, DelMar will deliver an oral address on the unique mechanism of VAL-083 and its potential as a new treatment for central nervous system tumors including GBM and medulloblastoma during the "Drug Targets and the CNS Micro-Environment" session.
On Saturday November 19, 2016, DelMar and its collaborators from the University of British Columbia, UCSF and the Luxemburg Institute of Health will present an abstract entitled: "Molecular mechanisms of dianhydrogalactitol (VAL-083) in GBM treatment"
On Friday November 18, 2016, DelMar will present an abstract entitled: "Clinical trials of VAL-083 in patients with chemo-resistant glioblastoma"
EORTC-NCI-AACR. On Thursday December 1, 2016, DelMar and its collaborators from the University of British Columbia, UCSF, and the Luxemburg Institute of Health will present an abstract entitled: "Molecular mechanisms of dianhydrogalactitol (VAL-083) in overcoming GBM chemo-resistance"
IASCL World Congress on Lung Cancer. On Wednesday December 7, 2016, DelMar and its collaborators from MD Anderson, the Shanghai Cancer Center and the University of British Columbia will present an abstract entitled: "Assessment of Dianhydrogalactitol (VAL-083) in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer"
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

The Company has completed a successful end of Phase II meeting with the US FDA and plans to advance VAL-083 into a pivotal clinical trial for GBM patients following bevacizumab failure. DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months following bevacizumab (Avastin) failure compared to published literature where survival of approximately two to five months has been reported.

DelMar’s advanced development program will feature a single multi-center randomized Phase III study measuring survival outcomes compared to a "physicians’ choice" control, which, if successful, would serve as the basis for a New Drug Application (NDA) submission for VAL-083. The control arm will consist of a limited number of salvage chemotherapies currently utilized in the treatment of Avastin-failed GBM. The final pivotal trial design will be confirmed with the FDA following further discussions with the Company’s clinical advisors.

In addition to the pivotal trial, DelMar also plans to initiate two separate Phase II clinical trials in earlier-stage GBM patients.

In collaboration with the University of Texas MD Anderson Cancer Center: A non-comparative, biomarker-driven, Phase II study to determine if treatment of MGMT-unmethylated recurrent GBM with VAL-083 or CCNU improves overall survival at 9 months, compared to historical control in bevacizumab naïve patients. (clinicaltrials.gov identifier: NCT02717962)
In collaboration with Sun-Yat Sen University and Guangxi Wuzhou Pharmaceutical (Group) Co.: A single arm Phase II clinical trial to confirm the tolerability of DelMar’s dosing regimen in combination with radiotherapy (XRT) and to explore the activity of VAL-083 in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high levels of MGMT.
DelMar believes that data from these clinical trials, if successful, will form the basis of a new paradigm in the treatment for all GBM patients who fail, or whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy.

In addition to its clinical research in GBM, DelMar believes that its research supports a unique mechanism of action for VAL-083 and that these data support the potential of VAL-083 as a new chemotherapy that may offer improved outcomes in the treatment of GBM and other solid tumors in patients whose tumors have failed or exhibit features that make them resistant to or unlikely to respond to current standard-of-care chemotherapy.

The company and its collaborators from the University of Texas MD Anderson Cancer Center recently presented data at the 11th Biennial Ovarian Cancer Research Symposium demonstrating that VAL-083 was able to overcome cisplatin-resistance in ovarian cancer cell lines with known p53 mutations and displays synergy with both cisplatin and AstraZeneca’s PARP inhibitor Olaparib against ovarian cancer in vitro.

On October 13, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that new clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the combination of OncoSec’s investigational intratumoral therapy, ImmunoPulse IL-12, and Merck’s KEYTRUDA (pembrolizumab) in patients with unresectable metastatic melanoma and a low likelihood of response to an anti-PD1 alone will be presented at an oral poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") Annual Meeting to be held on November 11-13, 2016, in National Harbor, MD (Press release, OncoSec Medical, OCT 13, 2016, View Source [SID:SID1234515795]).

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In August 2016, OncoSec announced the publication of a research assay in the Journal of Clinical Investigation that can be used as a predicative biomarker in melanoma patients. The assay shows that patients with a low frequency of CD8-positive inflamed tumors (that are PD-1 high and CTLA-4 positive) would pre-dispose them to low response rates to PD-1 inhibitor therapy alone. The Company is using this biomarker assay to pre-qualify patients in this ongoing combination study based on quantification of these type of CD8 cells. In the trial, patients deemed to be likely low responders were treated with a combination of systemic pembrolizumab and intratumoral ImmunoPulse IL-12 during the trial period. This presentation will provide an interim update of 15 treated patients.

The key endpoints of the study include: best overall response rate (ORR) by RECIST v1.1 and immune-related Response Criteria (irRC); safety and tolerability; duration of response; 24-week landmark progression-free survival; median progression-free survival; and overall survival.

Eligible patients were concurrently treated with pembrolizumab and ImmunoPulse IL-12 during the trial period.

Details of the presentation are as follows:

Abstract Title: Phase II Study of Intratumoral plasmid Interleukin 12 (pIL-12) with Electroporation in Combination with Pembrolizumab in Stage III/IV Melanoma Patients with Low Tumor Infiltrating Lymphocytes (Abstract #203921)
Lead Author: Alain Algazi, MD, Clinical Instructor, Department of Medicine (Hematology/Oncology), UCSF
Poster Number: 466
Date and Time: November 11, 2016 at 12:15 pm EDT (Oral poster presentation to be defined)
Location: Prince George’s Exhibition Hall AB, Gaylord National Resort & Convention Center

For more information about this trial, please visit:
View Source;rank=3

On October 12, 2016 Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) reported each company has entered into collaboration agreements with Abbott (NYSE: ABT), a leader in diagnostic technologies, to develop and commercialize companion diagnostic tests on Abbott’s m2000 RealTime System to identify isocitrate dehydrogenase (IDH) mutations in acute myeloid leukemia (AML) patients (Press release, Celgene, OCT 12, 2016, View Source [SID:SID1234515761]). Celgene is currently developing enasidenib (AG-221/CC-90007), an IDH2 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH2 mutation. Agios is developing AG-120, an IDH1 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH1 mutation.

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IDH1 and IDH2 mutations occur in approximately 20% of AML patients. An article published online this week in the journal Leukemia (Medeiros, Leukemia 2016) concluded that advances in the understanding of the genetics underlying myeloid malignancies are driving an era of development for targeted treatments such as IDH mutant inhibitors. The authors recommend that IDH mutational analysis should become part of the routine AML diagnostic workup and repeated at relapse to identify patients who may be eligible for targeted investigational treatments currently under clinical study.

"AML is a complex and heterogeneous disease, making it difficult to treat," said Han Myint, M.D., Vice President, Global Medical Affairs, Myeloid for Celgene. "IDH mutations lead to aberrant DNA methylation, causing a block in myeloid differentiation that leads to disease progression. Molecular profiling is important to identify genomic mutations which may have prognostic and potential treatment implications for patients with AML."

Abbott’s m2000rt RealTime System, is a polymerase chain reaction (PCR) instrument designed to enable clinical laboratories to automate PCR and results analysis, simplifying the complex and manual steps often associated with molecular diagnostics. Both Celgene and Agios have incorporated this screening into clinical trial designs, including the recently initiated Phase 3 IDHENTIFY trial comparing enasidenib with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML (NCT02577406).

"The field of personalized medicine is advancing at a rapid pace for a broad range of medical conditions, especially within hematology-oncology," said Chris Bowden, M.D., chief medical officer at Agios. "Our collaboration with Abbott will provide a test to help identify AML patients with IDH mutations who are in need of treatment options."

The m2000 system has not been FDA cleared or approved for use with enasidenib or AG-120.

Enasidenib and AG-120 have not been approved for any use in any country.

On October 12, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that five clinical sites in Europe have been activated and are open for patient enrollment in the Company’s FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial) (Press release, Delcath Systems, OCT 12, 2016, View Source;p=RssLanding&cat=news&id=2211160 [SID:SID1234515764]). The sites are the first centers in Europe to begin enrolling patients in the FOCUS Trial. One center, Charité University Hospital in Berlin, Germany, has treated its first patient. Delcath now has 13 centers in the U.S. and Europe open for patient recruitment, and expects up to 30 centers will participate in the FOCUS Trial.

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The following highly-accredited European centers are now open for patient enrollment:

Austria

University Hospital, Graz
Germany

Charité University Hospital, Berlin
University Hospital, Marburg
University Hospital, Regensburg
United Kingdom

University Hospital Southampton
"We are pleased to add these highly respected European cancer centers to our FOCUS Trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "This expansion allows Delcath to work with the some of Europe’s top universities and institutes while providing some of Europe’s leading clinicians with first-hand knowledge of our therapy, which will continue to be of great value as we expand our commercial footprint for CHEMOSAT as a treatment for ocular melanoma in Europe."

About the FOCUS Trial

The FOCUS Trial is a global Phase 3 clinical study evaluating the safety, efficacy and pharmacokinetic profile of the Company’s Melphalan/HDS system versus best alternative care in 240 patients with ocular melanoma liver metastases. The FOCUS Trial’s primary endpoint is a comparison of overall survival between the two study arms; secondary and exploratory endpoints include progression-free survival, overall response rate and quality-of-life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS.

On October 12, 2016 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported strategic leadership appointments to support the advancement of its portfolio of DNA-based cancer immunotherapies and infectious disease vaccines (Press release, Inovio, OCT 12, 2016, View Source;to-Advance-its-DNA-Immunotherapy-Product-Portfolio/default.aspx [SID:SID1234515766]). Inovio has an extensive pipeline of clinical-stage cancer immunotherapies highlighted by VGX-3100, which is entering phase III this year; and DNA vaccines in development for Zika, MERS and HIV, among others.

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Inovio adds two oncologists and a plasmid manufacturing expert reporting to Inovio’s Chief Medical Officer, Dr. Mark Bagarazzi:

Dr. Ildiko Csiki will serve Inovio as Vice President, Clinical Development, Oncology, responsible for advancing Inovio’s cancer programs. Prior to joining Inovio, Dr. Csiki had been clinical lead and senior director of clinical research at Merck & Co. where she guided Merck’s global solid tumor development program and was lead for several registration studies. Dr. Csiki also served as GSK’s director of clinical development and lead physician for the follicular lymphoma program. Dr. Csiki earned her MD and PhD degrees from Vanderbilt University School of Medicine and her BS in Biology and BA in Psychology from the University of Arkansas.

Dr. Jeffrey Skolnik, Vice President, Clinical Development, Oncology, will also direct Inovio’s cancer immunotherapy programs. Dr. Skolnik was previously vice president of clinical research at TetraLogic Pharmaceuticals, where he oversaw all global clinical assets. He also served as a medical director at GSK and AstraZeneca. Dr. Skolnik earned his MD at New York University, with honors in pathology, and his undergraduate degree from the University of Pennsylvania.

Robert J. Juba Jr. has been promoted to Vice President, Biological Manufacturing and Clinical Supply Management, and is responsible for ensuring the provision of Inovio’s SynCon plasmid DNA therapeutic and prophylactic vaccine candidates for clinical use. He has 22 years of experience in the pharmaceutical industry managing cGMP processes and operations, with extensive technical expertise in bacterial vaccine manufacturing. He led plasmid manufacturing at VGXI, Inc. and held several positions at Merck in bulk vaccine manufacturing operations and strategy. He holds Masters and BS degrees in Chemical Engineering from the Massachusetts Institute of Technology.
Inovio has also bolstered its manufacturing and business development functions with two additional staff reporting to Dr. Niranjan Sardesai, Inovio’s Chief Operating Officer:

Daniel Jordan will serve as Inovio’s Vice President, Device Manufacturing Operations. Previously he was vice president of U.S. and Canadian operations at Verisk Analytics, a 3M company. He has over 25 years of medical device manufacturing operations experience in early growth to mature organizations. Most recently he served as executive director of global operations at Teleflex Medical, a diversified medical device manufacturer. He earned an MBA in Finance from Weber University and a BS in Business Management at San Diego State University.

Dr. Paul Stead, Inovio’s Vice President, Business Development, will lead business development and partnering activities. He was vice president, business development at Nimbus Therapeutics, a company developing novel treatments for metabolic and immunological diseases, and oncology. For more than 20 years he served GSK in roles of increasing responsibility including business development, competitive intelligence and discovery chemistry. He holds an MBA from Lehigh University, a PhD in pharmaceutical sciences from the University of Nottingham, and a BS in Pharmacy from the University of Bath.
Dr. J. Joseph Kim, Inovio’s President & CEO, said, "We welcome these talented and experienced technical and business leaders to Inovio as we work to bring new breakthrough cancer medicines and vaccines to patients. It is gratifying that Inovio’s corporate culture, validated platform, and important product pipeline are attracting such accomplished executives to help us execute our product development and commercialization strategy."