On September 6, 2019 Novartis reported that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC)," said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.

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Recent research concludes that the cMET gene is an oncogenic driver[1],[2], and the investigational lung cancer therapy capmatinib has been shown to be a highly potent and selective MET inhibitor. The MET mutation is seen in an estimated 3% – 4% of all patients with NSCLC[3]. These patients are generally older and often have a poor prognosis that can limit lung cancer treatment options[4-6]. "As we continue to reimagine medicine and place a renewed focus on the development of innovative lung cancer treatments, we look forward to working with the FDA and global health authorities to bring capmatinib to patients who currently have no available targeted therapy options," continued Dr. Tsai.

According to FDA guidelines, treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints. The FDA granted Breakthrough Therapy Designation for capmatinib based on positive primary results from the GEOMETRY mono-1 study presented at the 2019 meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Please click link for complete study results [http://bit.ly/2L7L3ta]

Capmatinib (INC280) is an investigational, oral, highly potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

On September 6, 2019 Medigene AG (FSE: MDG1, Prime Standard) reported its participation at the following upcoming scientific and investor conferences. Medigene’s management and/or scientists will be available for one-on-one meetings at these events.

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CAR TCR Summit
Date: 10 – 13 September 2019
Location: Boston, USA

DG-GT Theme Day "CAR-T cells and beyond"
Date: 16 – 17 September 2019
Location: Leipzig, Germany

Berenberg Bank and Goldman Sachs German Corporate Conference
Date: 23 – 25 September 2019
Location: Munich, Germany

ESMO – European Society for Medical Oncology Congress
Date: 27 September – 01 October 2019
Location: Barcelona, Spain

On Septemner 6, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that its management will be presenting at and attending the following upcoming conferences (Press release, Evotec, SEP 6, 2019, View Source;announcements/press-releases/p/evotec-to-attend-upcoming-investor-conferences-5845 [SID1234539355]):

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J.P. Morgan Cazenove Pan-European Small/Mid Cap Conference, London, UK

Date: Wednesday, 11 September 2019
Venue: London, UK
Attendee: Enno Spillner, Chief Financial Officer

Bank of America Merrill Lynch Global Healthcare Conference 2019, London, UK

Date: Wednesday, 18 September 2019,
Presentation: 18 September 2019, 4.25 pm BST
Venue: London, UK
Attendee: Werner Lanthaler, Chief Executive Officer

Baader Investment Conference, Munich, Germany

Date: Monday, 23 September 2019,
Presentation: 23 September 2019, 5.15 pm CEST
Venue: Munich, Germany
Attendee: Enno Spillner, Chief Financial Officer

Berenberg and Goldman Sachs Eighth German Corporate Conference, Munich, Germany

Date: Tuesday, 24 September 2019,
Presentation: 24 September 2019, 2.30 pm CEST
Venue: Munich, Germany
Attendee: Enno Spillner, Chief Financial Officer

Ladenburg Thalmann Healthcare Conference, New York, NY, USA

Date: Tuesday, 24 September 2019,
Presentation: 24 September 2019, 10.30 am EDT
Venue: New York, NY, USA
Attendee: Dr Werner Lanthaler, Chief Executive Officer

2019 Cantor Global Healthcare Conference, New York, NY, USA

Date: Wednesday, 02 October 2019,
Presentation: 02 October 2019, 3.00 pm EDT
Venue: New York, NY, USA
Attendee: Dr Werner Lanthaler, Chief Executive Officer

On September 5, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that data from the Company’s INVICTUS pivotal Phase 3 study of ripretinib in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) has been selected as an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress to be held September 27 – October 1, in Barcelona, Spain (Press release, Deciphera Pharmaceuticals, SEP 5, 2019, View Source [SID1234539302]).

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"We look forward to the first presentation of the INVICTUS Phase 3 data in an oral session at ESMO (Free ESMO Whitepaper) later this month," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The INVICTUS data have given us confidence that ripretinib has the potential to fundamentally transform the treatment paradigm for patients with advanced GIST who have no approved treatment options. We expect that these data will serve as the basis for our first NDA, which we plan to submit in the first quarter of 2020."

Presentation information is as follows:

Session Type: Late-Breaking Abstract, Proffered Paper Session
Session Title: Proffered Paper – Sarcoma (ID 249)
Title: INVICTUS: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ripretinib as ≥4th-Line Therapy In Patients With AdvanCed Gastrointestinal Stromal TUmorS (GIST) Who have Received Treatment With Prior Anticancer Therapies (NCT03353753) (ID 4794)
Presentation Number: LBA87
Date and Time: Monday, September 30, 2:45 – 2:57 PM CET
Location:Malaga Auditorium (Hall 5)
Speaker: Margaret von Mehren, MD, Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania

About Ripretinib

Ripretinib is an investigational KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and other cancers. Ripretinib was specifically designed to improve the treatment of patients with GIST by inhibiting a broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that inhibits initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary D816V exon 17 mutation involved in SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In June 2019, the U.S. FDA granted Fast Track Designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.

Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (MainlandChina, Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.

On September 5, 2019 OncoNano Medicine, Inc. reported that ONM-100 will be featured at the World Molecular Imaging Congress (WMIC), which is being held September 4-7, 2019 in Montreal (Press release, OncoNano Medicine, SEP 5, 2019, View Source [SID1234539319]). The presentation will include results from a Phase 1 clinical trial of ONM-100 as an intraoperative tumor imaging agent as well as information about OncoNano’s pH-sensitive micelle technology platform.

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"We are excited to share these promising clinical trial results for ONM-100 at WMIC this year, as many of the world’s foremost experts in molecular imaging will be in attendance," commented Ravi Srinivasan, Ph.D., CEO of OncoNano. "ONM-100 is designed to take advantage of one of cancer’s simplest biomarkers – acidic pH – to image tumor resection borders regardless of tissue origin and meaningfully improve the accuracy of tumor detection."

OncoNano’s proprietary pH-sensitive micelles exploit a unique feature of cancer cell metabolism – excess acid. This metabolic defect creates a tumor microenvironment that is acidic relative to normal tissue and enables pH to be used as a stable biomarker of the diseased tissue. OncoNano is developing multiple product candidates using their pH-sensitive micelle platform, which are ultra-sensitive to subtle changes in pH that trigger dissociation when exposed to acidic environments. Thus, the micelle is activated preferentially in the tumor microenvironment to initiate tagging of the tumor but remains intact when exposed to normal physiological pH levels.

Full details of the presentation are listed below:

TITLE:

Metabolic Acidosis in Cancer: A New Strategy Using a pH Transistor Nanoprobe for Fluorescence-Guided Surgery in Humans

PRESENTER:

Pieter J. Steinkamp, M.D., University Medical Center Groningen, the Netherlands

DATE:

September 7, 2019

TIME:

2:30 PM EDT

LOCATION:

Palais des congrès de Montréal, Room 519a

About ONM-100
Surgical tumor resection remains a critical tool of oncology medicine, but detection of tumor borders and residual tumors is notoriously difficult. ONM-100, which utilizes OncoNano’s ultra pH-sensitive micelle platform, is a tumor-agnostic intraoperative tumor imaging agent currently in Phase 2 clinical trials. ONM-100 is designed to be injected intravenously prior to surgery and tags diseased cancerous tissue to provide real-time detection of tumor borders and residual tumors with commercially available imaging equipment. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas.