DelMar Pharmaceuticals to Present at the 17th Annual Rodman & Renshaw Global Investment Conference on September 9, 2015

On August 25, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it will be presenting at the 17th Annual Rodman & Renshaw Global Investment Conference being held September 9-10, 2015, at the St. Regis Hotel in New York, New York (Press release, DelMar Pharmaceuticals, AUG 25, 2015, http://ir.delmarpharma.com/news/detail/775/delmar-pharmaceuticals-to-present-at-the-17th-annual-rodman-renshaw-global-investment-conference-on-september-9-2015 [SID:1234507331]).

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Jeffrey Bacha, DelMar’s president and CEO, will present on Wednesday, September 9, 2015 at 3:50 p.m. Eastern Time. As part of his presentation, Mr. Bacha will present a corporate overview, including recent progress of DelMar’s Phase II clinical trial of VAL-083 (dianhydrogalactitol) for the treatment of refractory glioblastoma multiforme (GBM) and future plans to initiate clinical trials with VAL-083 as a potential treatment for non-small cell lung cancer (NSCLC) and other solid tumors in collaboration with Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.

The Company presented interim data from its ongoing study in GBM at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting confirming the completion of the Phase I dose-escalation portion of the VAL-083 trial and a promising dose-response trend in patients with recurrent GBM: Patients receiving a dose greater than or equal to 30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses less than 10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar recently announced that the Company will present the next formal update of its clinical trial in GBM at the 2nd International Symposium on Clinical and Basic Research in Glioblastoma, being held September 9-12, 2015 in Toledo, Spain.

A live webcast of the presentation will be available by accessing the DelMar’s IR Calendar in the Investors section of the Company’s website (www.DelMarPharma.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.

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 safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).

MorphoSys and Immatics Biotechnologies Enter Strategic Alliance in Immuno-oncology

On August 25, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Immatics Biotechnologies GmbH reported a strategic alliance to generate novel antibody-based therapeutics against multiple proprietary cancer antigens recognized by T cells (Press release, MorphoSys, AUG 25, 2015, View Source [SID:1234507332]).

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The collaboration agreement provides MorphoSys with access to several proprietary tumor-associated peptides (TUMAPs) discovered using Immatics’ XPRESIDENT platform to develop novel antibody-based therapeutics against these targets in a number of solid and hematological cancers. XPRESIDENT enables access to novel antibody targets associated with proteins that are present inside cancer cells. In return, Immatics will be provided with MorphoSys’ Ylanthia antibodies against a number of its TUMAPs, with proprietary development rights. The companies will pay each other milestones based on their respective development progress as well as royalties on marketed products. Financial details of the agreement were not disclosed.

Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG, commented: "We are delighted to join forces with Immatics, a world leader in discovering truly novel cancer targets that would be otherwise inaccessible for antibody-based therapies. This alliance opens up the intracellular target space for us and thus complements the therapeutic approaches we use in other oncology programs. We believe this collaboration will create several unique product opportunities for us based on truly differentiated compounds."

Dr. Harpreet Singh, Chief Scientific Officer of Immatics Biotechnologies GmbH, added: "The alliance with MorphoSys marks an important strategic milestone for Immatics. We are now entering the field of antibody-based therapeutics complementing our existing cancer immunotherapy pipeline. The combination of MorphoSys’ outstanding capabilities to create antibodies and the unique access to intracellular targets through our XPRESIDENT discovery engine provides both partners the opportunity to jointly deliver the next generation of transforming antibody drugs for cancer patients with high unmet medical need."

Tumor cells differ from healthy cells in the expression of tumor-associated proteins. These proteins are degraded inside living cells into shorter fragments, called peptides, which are then shuttled to the cell surface. Specialized receptors on the cell surfaces, so-called major histocompatibility complex (MHC) receptors, display these peptides to the external environment thereby providing a snapshot of the cell’s interior. The therapeutic programs now being pursued by Immatics and MorphoSys aim to discover Ylanthia antibodies against these MHC-bound peptide targets in order to kill the tumor cells. Immatics’ XPRESIDENT discovery platform is the only known high-throughput research technology to directly identify, quantify, and prioritize these cancer-related peptides.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Nuvilex, AUG 24, 2015, View Source [SID:1234507333])

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8-K – Current report

On August 24, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of its VistaSeq Hereditary Cancer Panel, a novel, 27-gene panel designed to identify patients with increased risk of breast, ovarian, melanoma, pancreatic, colorectal, endometrial, gastric, prostate, and other cancers (Filing, 8-K, LabCorp, AUG 24, 2015, View Source [SID:1234507327]). These cancers are projected to result in approximately 900,000 new diagnoses of cancer, and almost 200,000 deaths, annually in the U.S.

"This innovative new offering enhances our industry-leading portfolio of genetic and genomic testing, which we seamlessly integrate with the largest cohort of board-certified genetic counselors in the industry," said David P. King, Chairman and Chief Executive Officer. "VistaSeq is an important advancement in precision medicine, and represents the latest example of our strategic focus on delivering world-class diagnostics and using the resulting information to change the way care is provided."

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The VistaSeq Hereditary Cancer Panel provides an assessment of genetic mutations within a panel of 27 genes known to be associated with hereditary cancer syndromes. The information provided is used to determine an increased cancer risk in patients with an associated personal or family history. Mutations in different genes may cause the same type of cancer; conversely, one gene may be associated with multiple hereditary cancer syndromes. VistaSeq will give healthcare providers and patients additional information to assist in understanding further monitoring and appropriate medical management options.

NCCN Guidelines and The Society of Gynecologic Oncology (SGO) note that hereditary multi-gene panels may be an efficient and cost-effective approach to genetic cancer testing when used in appropriate clinical settings.

"LabCorp’s VistaSeq testing capabilities and services provide physicians and patients with powerful tools for the assessment of hereditary cancers," stated Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer. "VistaSeq was developed based on our strong in-house expertise in genomics and the latest advancements in science. LabCorp is a leader in genetic testing and counseling services, and we continue to expand our innovative menu of focused genetic tests."

The VistaSeq test is available nationwide through any LabCorp account, and will be performed by Integrated Genetics, a member of LabCorp’s Specialty Testing Group. In addition, LabCorp offers a complete range of complementary services to the testing for patients and physicians, including insurance pre-authorization support and access to genetic counselors, who are professionally trained to analyze, assess, and interpret genetic test results.

Five Prime Therapeutics Announces Oral Presentation of Initial Data From Ongoing Phase 1b Trial of FP-1039/GSK3052230 in Squamous Non Small Cell Lung Cancer and Mesothelioma at World Conference on Lung Cancer

On August 24, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported that initial data from GlaxoSmithKline (GSK)’s ongoing Phase 1b trial of FP-1039/GSK3052230, an FGF ligand trap, in patients with squamous non small cell lung cancer (sqNSCLC) and mesothelioma will be featured in an oral presentation by study investigators during the upcoming World Conference on Lung Cancer 2015 in Denver (September 6-9, 2015) (Press release, Five Prime Therapeutics, AUG 24, 2015, View Source [SID:1234507326]).

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Abstract #2879 entitled, "FP1039/GSK3052230 with Chemotherapy in Patients with Fibroblast Growth Factor (FGF) pathway deregulated squamous NSCLC or MPM," published today at View Source and includes data through the time of submission in April 2015. The oral presentation is scheduled on Wednesday, September 9, 2015 in the "Mini 38: Biology and Prognosis" session [6:30-8:00 pm] and is expected to include study data up to August 2015, which will be detailed in a press release at that time.

The Phase 1B trial being conducted by GSK is evaluating the safety and efficacy of FP-1039/GSK3052230 weekly infusion in combination with paclitaxel + carboplatin in previously untreated FGFR1 gene amplified metastatic squamous NSCLC (Arm A), in combination with docetaxel in FGFR1 gene amplified metastatic squamous NSCLC that has progressed after at least 1 line of chemotherapy (Arm B), or in combination with pemetrexed + cisplatin in patients with untreated and unresectable malignant pleural mesothelioma (Arm C). GSK continues to enroll patients in the study. Arm A and Arm C have advanced into the expansion phase and dose escalation is ongoing for Arm B.

Five Prime licensed development and commercialization rights for FP-1039/GSK3052230 in the U.S., Europe and Canada to GSK, which funds clinical development. Five Prime retains rights outside of these regions as well as an option to co-promote FP-1039/GSK3052230 in the U.S.

About FP-1039/GSK3052230

FP-1039/GSK3052230 is a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039/GSK3052230 binds to FGF ligands circulating in the extracellular space, preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells where they would otherwise stimulate cancer cell division and/or angiogenesis. However, FP-1039/GSK3052230 does not bind to certain "hormonal" FGFs, including FGF23, which regulates phosphate levels in the blood. As a result, treatment with FP-1039/GSK3052230 treatment has not been shown to cause hyperphosphatemia, a side effect seen with small molecule inhibitors of FGF receptors, which block the activity of both cancer-associated FGFs and FGF23.

Five Prime licensed development and commercialization rights for FP-1039/GSK3052230 in the U.S., Europe, and Canada to GSK, which funds clinical development. The Phase 1B clinical trial is investigating treatment with FP-1039/GSK3052230 combined with standard doses of chemotherapy in patients with newly-diagnosed or recurrent FGFR1 amplified metastatic squamous non-small cell lung cancer as well as patients with malignant pleural mesothelioma, a tumor in which the FGF2 ligand is overexpressed.