On August 26, 2015 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported oral and poster data presentations at the 16th World Conference on Lung Cancer (WCLC) being held September 6-9, 2015 at the Colorado Convention Center in Denver, CO (Press release, Verastem, AUG 26, 2015, View Source;p=RssLanding&cat=news&id=2082044 [SID:1234507338]).

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The details for the data presentations at WCLC are as follows:

Oral Presentations

Title: Phase 2 study of defactinib, VS-6063, a focal adhesion kinase (FAK) inhibitor, in patients with KRAS mutant non-small cell lung cancer (NSCLC)
Date and time: Wednesday, September 9, 2015, 6:30 pm – 8:00 pm MT
Location: Four Seasons Ballroom F3 and F4
Session info: Mini oral 30: New Kinase Targets; Track: Treatment of Advanced Diseases – NSCLC

Title: FAK inhibitor VS-6063 targets mesothelioma cancer stem cells: Rationale for maintenance therapy after conventional chemotherapy
Date and time: Wednesday, September 9, 2015, 6:30 pm – 8:00 pm MT
Location: Rooms 702, 704 and 706
Session info: Mini oral 38: Biology and Prognosis; Track: Thymoma, Mesothelioma and Other Thoracic Malignancies

Title: The cancer stem cell inhibitors VS-6063 (defactinib) and VS-5584 exhibit synergistic anticancer activity in pre-clinical models of mesothelioma
Date and time: Wednesday, September 9, 2015, 4:45 pm – 6:15 pm MT
Location: Rooms 702, 704 and 706
Session info: Oral session 40: Biology 1; Track: Thymoma, Mesothelioma and Other Thoracic Malignancies

Title: Targeting cancer stem cells in small cell lung cancer
Date and time: Wednesday, September 9, 2015, 4:45 pm – 6:15 pm MT
Location: Rooms 605 and 607
Session info: Mini oral 27: Biology and other issues in SCLC; Track: Small Cell Lung Cancer
Poster Presentations

Title: Trials in progress: A Phase 1 dose escalation study of VS-5584, a PI3K/mTOR inhibitor, administered with VS-6063, a focal adhesion kinase inhibitor, in mesothelioma
Date and time: Tuesday, September 8, 2015, 9:45 am – 10:45 am and 3:45 pm – 4:45 pm MT
Location: Exhibit Hall (Hall B+C); Poster # P2.08.008
Session info: Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma

Title: Trials in progress: COMMAND: A Phase 2 randomized, double-blind, study of defactinib (VS-6063) as maintenance therapy in malignant pleural mesothelioma
Date and time: Wednesday, September 9, 2015, 9:45 am – 10:45 am and 3:45 pm – 4:45 pm MT
Location: Exhibit Hall (Hall B+C); Poster # P3.08.014
Session info: Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma

About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a "Window of Opportunity" study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors as a single agent and a combination trial of VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

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).

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

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On August 24, 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 has been invited to present an overview of DelMar’s clinical strategy with VAL-083 (dianhydrogalactitol) as a potential treatment for non-small cell lung cancer ("NSCLC") at the 16th World Conference on Lung Cancer (WCLC 2015) being held from September 6 – 9, 2015, in Denver, Colorado (Press release, DelMar Pharmaceuticals, AUG 24, 2015, View Source [SID:1234507321]).

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The Company’s abstract entitled, "Post-Market Clinical Trial of Dianhydrogalactitol in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer," will be presented on Tuesday, September 8, 2015 from 9:30 a.m. – 4:30 p.m. PDT during a poster session focused on Treatment of Advanced Diseases – NSCLC.

DelMar plans to initiate a clinical trial in NSCLC in collaboration with Guangxi Wuzhou Pharmaceutical Group Co. Ltd. (Guangxi Wuzhou Pharma). Under the terms of the collaboration Guangxi Wuzhou Pharma will fund the planned study and DelMar will be responsible for protocol development and conduct of the trial. DelMar’s goal is to work with Guangxi Wuzhou Pharma to develop new clinical data to help support product growth of VAL-083 in China and to establish clinical proof of concept to expand its independent drug development efforts with VAL-083 as a potential treatment for NSCLC worldwide.

VAL-083 is a "first-in-class" bi-functional alkylating agent that has been approved by the Chinese Food and Drug Administration ("CFDA") for the treatment of lung cancer. However, use of VAL-083 in China has been limited by a lack of modern data, poor distribution, and preference for targeted therapies such as tyrosine kinase inhibitors ("TKIs") in the modern era.

DelMar previously presented a preclinical abstract on VAL-083 in NSCLC at the annual meeting of the American Association of Cancer Research ("AACR") entitled, "In vitro activity of dianhydrogalactitol alone or with platinum drugs in the treatment of NSCLC." These data demonstrate that VAL-083’s mechanism is distinct from platinum-based chemotherapy, the current standard of care for NSCLC and that VAL-083 retains its high level of anti-cancer activity in NSCLC phenotypes, which are highly resistant to current therapy. The data also suggest that the combination of VAL-083 with either cisplatin or oxaliplatin provides a super-additive (synergistic) effect against NSCLC cell lines, including those resistant to TKI therapy in vitro.

DelMar believes these data suggest the potential of VAL-083 to address the modern unmet medical needs in the treatment of NSCLC, especially where other therapies have failed or are predicted to give sub-optimal outcomes. In addition, VAL-083 readily crosses the blood brain barrier suggesting that it may be possible for VAL-083 to treat patients whose lung cancer has metastasized to the brain.

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 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) at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO). 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 is implicated chemotherapy resistance and poor outcomes following front-line treatment with Temodar (temozolomide).

On August 24, 2015 Exelixis, Inc. (NASDAQ:EXEL) reported that data from clinical trials of cabozantinib and cobimetinib will be the subject of three presentations at the European Cancer Congress (ECC) 2015, which will be held September 25-29, 2015, in Vienna, Austria (Press release, Exelixis, AUG 24, 2015, View Source;p=RssLanding&cat=news&id=2081424 [SID:1234507323]).

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METEOR Data Accepted for Oral Presentation in Presidential Session

Detailed data from METEOR, the phase 3 pivotal trial of cabozantinib in advanced renal cell carcinoma, will be presented at the ECC as a late-breaking abstract in the Presidential Session I on Saturday, September 26, 2015. In July 2015, Exelixis announced that the trial met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for cabozantinib versus an active comparator, everolimus, in a population of patients who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.

The details of the presentation are as follows:

Abstract 4LBA: Late-Breaking Abstract: Cabozantinib versus Everolimus in Patients with Advanced Renal Cell Carcinoma: Results of the Randomized Phase 3 METEOR Trial

Toni K. Choueiri, M.D.
Presidential Session I
Saturday, September 26, 2015
Session from 14:30-16:40 CEST (8:30-10:40 a.m. EDT); presentation expected to begin at 16:20 CEST (10:20 a.m. EDT)

Cobimetinib Data Accepted for Proffered Paper and Poster Sessions

Also at the meeting, Exelixis’ collaborator Genentech, a member of the Roche Group, will present data on cobimetinib, an Exelixis-discovered compound, in combination with vemurafenib in previously untreated patients with advanced malignant melanoma harboring the BRAF V600 mutation.

The details of the cobimetinib presentations are as follows:

Abstract 25LBA: Late-Breaking Abstract: Impact of Baseline Genetic Heterogeneities on Progression-Free Survival (PFS) in Patients (pts) with Advanced BRAFV600-mutated Melanoma Treated with Cobimetinib (COBI) + Vemurafenib (VEM) in the phase 3 coBRIM Study

Professor Grant McArthur
Proffered Paper Session: Melanoma and Skin Cancer I
Sunday, September 27, 2015
Session from 11:30-12:30 CEST (5:30-6:30 a.m. EDT); presentation expected to begin at 12:10 CEST (6:10 a.m. EDT)
Hall A2

Abstract 3340: Treatment beyond Progression in Advanced BRAF-mutated Melanoma with Vemurafenib and Cobimetinib: Results from the BRIM7 Trial

Karl Lewis, M.D.
Poster Session: Melanoma and Skin Cancer
Sunday, September 27, 2015
Session from 16:45-18:45 CEST (10:45 a.m. – 12:45 p.m. EDT)
Hall C, Poster 217

About Cabozantinib

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

COMETRIQ (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

Important Safety Information, including Boxed WARNINGS

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients.

Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.

COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.

Wound complications have been reported with COMETRIQ.

COMETRIQ treatment results in an increase in hypertension.

Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.

Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.

The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ.

Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.
Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
COMETRIQ can cause fetal harm when administered to a pregnant woman.

Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.

Please see full U.S. prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf

Please refer to the full European Summary of Product Characteristics for full European Union prescribing information, including contraindication, special warnings and precautions for use at www.sobi.com once posted.

About the Cobimetinib Development Collaboration

Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments in connection with signing the agreement and submitting the IND. Exelixis was responsible for development of cobimetinib through the determination of the maximum tolerated dose in phase 1, at which point Genentech exercised its option to further develop the compound.

In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the United States. Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in the U.S. marketing and commercialization costs. Exelixis is eligible to receive royalties on any sales of the product outside the United States.