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.

Data From METEOR Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Accepted as Late-Breaker Presentation in Presidential Session at European Cancer Congress 2015

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.

DelMar Pharmaceuticals to Present VAL-083 Lung Cancer Clinical Strategy at the 16th World Conference on Lung Cancer

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).

FDA and EMA accept regulatory applications for Boehringer Ingelheim’s Giotrif® / Gilotrif® (afatinib) for treatment of advanced squamous cell carcinoma of the lung

On August 25, 2015 Boehringer Ingelheim reported that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy (Press release, Boehringer Ingelheim, AUG 24, 2015, View Source [SID:1234507330]). Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition.

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Dr. Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim commented: "Working with the US and EU regulatory authorities marks the next stage in our journey to hopefully provide patients with a new, oral treatment for squamous cell carcinoma of the lung, a condition with an extremely poor prognosis and still limited treatment options. This is an encouraging prospect for Boehringer Ingelheim as we remain fully dedicated to improving and extending the lives of patients with different types of lung cancer."

The submissions are based on data from the Phase III LUX-Lung 8 trial that compared Giotrif / Gilotrif (afatinib) to Tarceva (erlotinib) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy.1 Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS, primary endpoint), reducing the risk of cancer progression by 19%, and superior overall survival (OS, key secondary endpoint), reducing the risk of death by 19% compared to erlotinib in this patient population.1

In the LUX-Lung 8 trial, an improvement in quality of life and control of cancer symptoms was observed with afatinib versus erlotinib.1 More patients had improved overall health-related quality-of-life with afatinib than with erlotinib (36% vs 28%).1 Significantly more patients had an improvement in cough with afatinib than with erlotinib (43% vs 35%).1 Differences in the proportion of patients with improved dyspnoea (51% vs 44%) and pain (40% vs 39%) were not significant for afatinib versus erlotinib.1 Afatinib significantly delayed time to deterioration of dyspnoea compared with erlotinib.1 Time to deterioration of both pain and cough was similar for afatinib versus erlotinib.1

The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects.1 A higher incidence of severe diarrhea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhea: 10% vs. 2%; grade 3 stomatitis: 4% vs. 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs. 6%).1

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85% of lung cancer cases.2,3 Squamous cell lung cancer develops in the cells lining the airways and represents approximately 30% of NSCLC cases.4,5 SCC of the lung is associated with a poor prognosis and limited survival. The median overall survival after diagnosis of advanced SCC is around one year.6,7

Afatinib, an oral, once daily EGFR-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under brand names: Giotrif / Gilotrif). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy.8 In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy.9,10 A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.9,10

RedHill Biopharma Announces Peer-Reviewed Publication Demonstrating Therapeutic Potential of ABC294640 (YELIVA(TM)) in Prostate Cancer

On August 24, 2015 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal (GI) diseases, including gastrointestinal cancers, reported the publication of an article evaluating the therapeutic potential of ABC294640, the Company’s orally-administered first-in-class Sphingosine kinase 2 (SK2) selective inhibitor, in the treatment of prostate cancer (Press release, RedHill Biopharma, AUG 24, 2015, View Source [SID:1234507329]). The article, authored by scientists from Apogee Biotechnology Corporation ("Apogee") and from the Kimmel Cancer Center at Thomas Jefferson University, will be published in Molecular Cancer Research and is available online on the journal’s website. RedHill acquired the rights to YELIVA (ABC294640) in March 2015 from U.S.-based Apogee.

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RedHill has also filed a trademark application with the U.S. Patent and Trademark Office (USPTO) for the new brand name YELIVA for ABC294640. Subject to USPTO and FDA approval, the new brand name for the potential commercial product will be YELIVA.

The article1, entitled "Downregulation of Critical Oncogenes by the Selective SK2 Inhibitor ABC294640 Hinders Prostate Cancer Progression", describes a pre-clinical study conducted with YELIVA (ABC294640) in early stage and advanced prostate cancer models. The findings from the study suggest that oral administration of ABC294640 (YELIVA) disrupts multiple oncogenic signaling pathways that are deregulated in prostate cancer, corresponding with significant inhibition of tumor growth, proliferation and cell cycle progression. In particular, the compound inhibited in vitro several very resistant types of prostate cancer. The authors of the article conclude that these pre-clinical findings support the hypotheses that SK2 activity is required for prostate cancer function and that ABC294640 (YELIVA) could represent a new pharmacological agent for the treatment of early stage and aggressive prostate cancer. The study was supported by a grant from the Pennsylvania Department of Health, a Prostate Cancer Foundation Young Investigator award, and a Prostate Cancer Foundation Mazzone Challenge award.

Charles Smith, Ph.D., President and CEO of Apogee Biotechnology Corporation and one of the authors of the article, said: "This paper provides further definition of the mechanism of the anticancer activities of ABC294640, including the first demonstration of inhibition of signaling through the androgen receptor pathway, which is critical for prostate cancer growth. The growing body of mechanistic and clinical data on ABC294640 suggests that this drug may be useful for the treatment of early-stage and castrate-resistant prostate cancer."

Patricia Bandeira, RedHill’s Product Manager for YELIVA (ABC294640), added: "We are pleased to have these important findings, suggesting that ABC294640 could be effective in treating prostate cancer, published in a peer-reviewed journal. ABC294640, under its new brand name YELIVA, is a novel and promising drug candidate with multiple potential oncology and inflammatory indications. RedHill recently initiated a Phase I/II study of YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma, and is progressing towards a second Phase II study to evaluate YELIVA (ABC294640) as a radioprotectant in cancer patients undergoing therapeutic radiotherapy, and a third Phase II clinical study for the treatment of multiple myeloma."

YELIVA (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple inflammatory, gastrointestinal (GI) and oncology indications. SK2 is an innovative molecular target for anti-cancer therapy because of its critical role in catalyzing the formation of the lipid-signaling molecule sphingosine 1-phosphate (S1P), which is known to regulate cell proliferation and activation of inflammatory pathways. By inhibiting SK2, YELIVA (ABC294640) could potentially be effective in treating multiple inflammatory, gastrointestinal and oncology indications.

RedHill recently initiated a Phase I/II clinical study in the U.S. evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL). The Phase I/II study is intended to evaluate the safety and tolerability of YELIVA (ABC294640), as well as provide a preliminary evaluation of efficacy of the drug in patients with refractory/relapsed DLBCL, primarily patients with HIV-related DLBCL. Up to 33 patients are expected to be enrolled in the study, which will be conducted at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans. The study is supported by a grant from the National Cancer Institute (NCI) Small Business Technology Transfer (STTR) program.

A second Phase II study is planned to evaluate YELIVA (ABC294640) as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy. RedHill also plans a third Phase II clinical study for the treatment of multiple myeloma, subject to a pending grant from the National Cancer Institute.

Numerous successful pre-clinical studies were conducted with YELIVA (ABC294640) in GI, inflammation, radioprotection and oncology models, as well as a successful Phase I clinical study in cancer patients with advanced solid tumors. The open-label, dose-escalation, Phase I clinical study demonstrated the drug’s safety and assessed its pharmacokinetics and pharmacodynamics in cancer patients with advanced solid tumors.

About YELIVA (ABC294640):

YELIVA (ABC294640) is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting multiple potential inflammatory, oncology and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA (ABC294640) blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. YELIVA (ABC294640) was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in inflammatory, GI, radioprotection and oncology models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. A Phase I/II clinical study evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) has been initiated in the U.S. The development of YELIVA (ABC294640) was funded to date primarily through grants and contracts from U.S. Federal and State government agencies.