On October 26, 2017 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that Dr. Monica Mita of Cedars-Sinai Medical Center and Principal Investigator of the RGX-104-001 study, will present at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Rgenix, OCT 26, 2017, View Source [SID1234523090]). The conference is scheduled to take place from Thursday, October 26 to Monday, October 30 in Philadelphia.

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The details of Rgenix’s presentation are as follows:

Event: AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper): Discovery, Biology, and Clinical Applications

Date: October 29, 2017

Time: 12:30 P.M. – 4:00 P.M. EST

Description: Poster B001, "A phase 1 trial of RGX-104, a first-in-class immunotherapy targeting the liver-X nuclear hormone receptor (LXR), in patients with refractory malignancies"

Location: Hall E, Pennsylvania Convention Center, 1101 Arch St, Philadelphia, PA 19107

Dr. Mita will present data from the Phase 1 trial of RGX-104, a first-in-class investigational immunotherapy.

About RGX-104

RGX-104 is a potent small molecule agonist of the Liver X Receptor (LXR). Activation of the LXR-ApoE pathway by RGX-104 stimulates the innate immune response in cancer via depletion of myeloid-derived suppressor cells and activation of dendritic cells, leading to stimulation of T cells and anti-tumor immunity in tumor models. LXR activation also blocks the ability of tumors to recruit blood vessels. These combined effects result in suppression of tumor growth and metastasis in a broad array of pre-clinical models. The LXR-ApoE pathway was originally identified as a cancer target using a novel microRNA-based discovery platform developed by Rgenix’s scientific co-founders at The Rockefeller University.

Rgenix is conducting a Phase 1a/b clinical trial of RGX-104 in patients with advanced solid malignancies and lymphoma—for more information about the clinical trial, please visit: View Source

On October 26, 2017 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the Credit Suisse 26th Annual Healthcare Conference taking place November 6-8 in Scottsdale, AZ (Press release, Exelixis, OCT 26, 2017, View Source;p=RssLanding&cat=news&id=2311868 [SID1234521212]). The Exelixis presentation is scheduled for 5:20 PM EST / 2:20 PM PST on Tuesday, November 7, 2017.

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Know more, wherever you are:
Latest on Exelixis Cancer Pipeline, book your free 1stOncology demo here.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On October 26, 2017 Transgene (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, reported that the first patient with recurrent glioblastoma has been treated at La Pitié-Salpêtrière hospital, Greater Paris University Hospitals,AP-HP (Paris), in the first-in-human clinical trial (Oncovirac trial) of TG6002, a novel oncolytic virus (Press release, Transgene, OCT 26, 2017, View Source [SID1234521244]). TG6002 represents the next generation of oncolytic virus(OV), which is administered intravenously and has multiple functions. It has been engineered to combine oncolysis (the breakdown of cancer cells) with the local
production of 5-FU chemotherapy agent in the tumor. It is also expected to induce an immune response
following the antigen spreading that is caused by the cancer cells’ breakdown.

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TG6002: a novel oncolytic virus allowing the targeted production of chemotherapy in the tumor
TG6002 is a next generation oncolytic immunotherapy, which has a double mechanism of action. It has been
designed by Transgene to:
1. induce the breakdown of cancer cells (oncolysis) by tumor-selective viral replication. In preclinical
experiments, TG6002 was able to induce response in the primary tumor and an immune-mediated
regression of distant metastases (immunogenic cell death);
2. allow the local production of chemotherapy (5-FU), a widely used cancer chemotherapy, in the
tumor. TG6002 expresses the proprietary Fcu1 gene in the cancer cells it has infected, leading to
the local conversion of the 5-FC into 5-FU.

First-in-human trial to deliver first readouts in H2 2018
Oncovirac is an open-label Phase 1/2a trial evaluating the safety and tolerability of multiple-ascending doses
of TG6002 administered intravenously in combination with oral 5-FC, a non-cytotoxic pro-drug, flucytosine,
that can be converted in 5-FU. The anti-tumor activity of this novel oncolytic virus will also be monitored.
The study will enroll patients suffering from recurrent glioblastoma, who have failed standard of care
treatment.

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière Hospital (Paris, France), is the principal
investigator of the study. He is involved in several clinical trials dedicated to primary brain tumor patients. He
also coordinates "GlioTex", a research group focused on glioblastoma and experimental therapeutics at ICM (The
Institut du Cerveau et de la Moelle épinière – Brain & Spine Institute). AP-HP Paris Greater Hospitals, is the
sponsor of Oncovirac, a trial also supported by INCa (French National Cancer Institute). More information on the
trial is available on clinicaltrials.gov (NCT03294486). The first readouts of the study are expected in the second
half of 2018.

Maud Brandely, M.D., PhD, Chief Medical Officer of Transgene, added: "TG6002 is a very promising new
generation of oncolytic virus, which has the potential to be administered intravenously. Based on our
compelling preclinical data, we have established that its replication induces immunogenic cell lysis and the
local production of chemotherapy. We are excited to see this novel immunotherapy with multiple modes of
action enter the clinic and look forward to obtaining results that will allow further development of TG6002
in several solid tumors indications."

Dr. Ahmed Idbaih, M.D., PhD, neuro-oncologist at La Pitié-Salpêtrière hospital, AP-HP, and principal
investigator of the trial, added: "Current treatments of recurrent glioblastoma are insufficient. By combining
the immunogenic lysis of cancer cells with the targeted production of chemotherapy in the tumor, TG6002
has the potential to show anti-tumor efficacy and to avoid systemic side effects of chemotherapy. We are
very pleased to be conducting this first in human clinical trial evaluating this novel immunotherapy that we
believe could improve the overall survival of recurrent glioblastoma patients while preserving their quality
of life."

On October 26, 2017 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that the company will present data describing the mechanism of action of BT1718, Bicycle’s lead molecule, which is being developed to target cancers of high unmet need including triple negative breast cancer and non small cell lung cancer (Press release, Bicycle Therapeutics, OCT 26, 2017, View Source [SID1234521249]). The data will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held in Philadelphia, Pennsylvania from October 26 – 30, 2017.

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On October 26, 2017 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2017 (Press release, Ipsen, OCT 26, 2017, View Source [SID1234521180]).

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Financial highlights

Q3 2017 Group sales growth of 22.6%1 driven by Specialty Care sales growth of 26.5%1 reflecting continued Somatuline momentum and increasing contribution of new products Cabometyx and Onivyde, and solid Consumer Healthcare sales growth of 5.0%1
YTD Group sales growth of 20.1%1 fueled by Specialty Care sales growth of 24.3%1 and Consumer Healthcare back to growth at 2.5%1
Full Year 2017 guidance confirmed: Specialty Care sales growth greater than 24%1, Consumer Healthcare back to growth1 and a Core Operating Income margin greater than 25% of net sales
Recent pipeline highlights

Approval of Somatuline by FDA2 for the treatment of carcinoid syndrome in the U.S.
Approval of Xermelo by EMA2 for the treatment of carcinoid syndrome diarrhea in combination with SSA2 therapy
Validation by EMA2 of the application of Cabometyx for the addition of a new indication in first-line treatment of advanced renal cell carcinoma (RCC)
Phase 3 CELESTIAL trial of cabozantinib meets primary endpoint of overall survival in patients with advanced hepatocellular carcinoma
Key figures

Third quarter and nine months 2017 unaudited IFRS consolidated sales

1st table



David Meek, Chief Executive Officer of Ipsen stated: “The excellent performance in the third quarter reflects the continued execution against our 2017 objectives with an accelerated momentum of our Specialty Care business. We achieved several important pipeline milestones during the quarter, notably in Oncology, further strengthening our leadership position in the neuroendocrine tumor market and increasing the potential value of the Cabometyx franchise. We remain focused on the launch execution of our new products and building an innovative and sustainable pipeline.”



Third quarter 2017 sales highlights

Note: Unless stated otherwise, all variations in sales are stated excluding foreign exchange impacts.

Third quarter 2017 unaudited IFRS consolidated sales

2d table



Consolidated Group sales grew 22.6% to €470.1 million.

Sales of Specialty Care products reached €396.2 million, up 26.5% year-on-year.

Somatuline sales reached €173.0 million, up 29.9%, year-on-year, driven by the continued excellent growth in the United States, and by strong performance in Europe, notably in the UK, Germany and France.

Decapeptyl sales reached €88.2 million, up 6.4% year-on-year, supported by strong volume growth in China despite some pricing pressure as well as good sales trends in France and Spain.

Cabometyx sales reached €14.3 million, driven primarily by the performance in France and Germany and also in the Netherlands and in the UK.

Onivyde sales reached €17.9 million, stable versus the second quarter.

Dysport sales reached €77.4 million, up 6.1% year-on-year, led by a solid performance in the United States, notably in aesthetics through the Galderma partnership (despite some unfavorable phasing of shipments) and in the Middle East.

Consumer Healthcare product sales totaled €73.9 million, up 5.0% year-on-year, supported by the good performance of Tanakan in Russia, as well as Bedelix and Forlax in Algeria, offset by a new contractual set up in China which started to impact Etiasa in the third quarter.

Smecta sales reached €23.3 million, down 6.4% year-on-year, mainly affected by a negative stocking impact in China and the performance in Russia.

Forlax sales reached €10.4 million, up 16.7% year-on-year, positively impacted by a favorable basis of comparison in Algeria where import programs were suspended in the third quarter of 2016.

Tanakan sales reached €11.2 million, up 24.7% year-on-year, driven by a rebound of sales in Russia as compared to 2016 which was impacted by challenging market conditions.