On July 11, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release second-quarter 2019 financial results before the market opens on Thursday, July 25, 2019, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, JUL 11, 2019, View Source [SID1234537481]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 6143018.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the West website three hours after the live call and will be available through Thursday, August 1, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 6143018.

On July 11, 2019 IDEAYA Biosciences, Inc., an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics to treat cancer, reported initiation of its Phase 1/2 study evaluating IDE196 in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions (ClinicalTrials.gov Identifier: NCT03947385) (Press release, Ideaya Biosciences, JUL 11, 2019, View Source [SID1234537497]). The first patient dosing was in June 2019 and clinical trial sites are now enrolling in the U.S. and Australia.

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IDEAYA previously announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for the development of IDE196 as a treatment for metastatic uveal melanoma and other solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations. "IDEAYA’s tissue-type agnostic strategy provides a genetic biomarker driven approach to treat patients whose tumors harbor GNAQ or GNA11 hotspot mutations across multiple solid tumors, including uveal melanoma, cutaneous melanoma, and colorectal cancer," said Meredith McKean, MD, MPH, Melanoma and Skin Cancer Research Program, Sarah Cannon Research Institute.

"We are delighted to announce our first patient dosing for IDE196 in our tissue type agnostic GNAQ and GNA11 basket trial, and the opportunity to advance IDE196 in its dose escalation with the goal of enabling the optimal dose selection for the Phase 2 portion of the trial," said Julie Hambleton, M.D., Chief Medical Officer, Head of Development at IDEAYA Biosciences.

IDE196 is a potent small molecule protein kinase C (PKC) inhibitor demonstrating clinical activity and tolerability in a separate ongoing Phase 1 trial of IDE196 in patients with Metastatic Uveal Melanoma (MUM). Approximately 90% of uveal melanoma patients harbor activating mutations in GNAQ or GNA11 (GNAQ/11). Mutations in GNAQ/11 have also been observed in other solid tumors, such as cutaneous melanoma, colorectal, pancreatic, stomach, cervical, lung adenocarcinoma and bladder. The clinical focus of IDEAYA’s Phase 1/2 basket trial will be on treatment of patients having tumors with likely pathogenic GNAQ/11 hotspot mutations, which are known to activate the PKC signaling pathway. GNAQ/11 hotspot mutations are not generally known to overlap with other oncogenic driver mutations, such as BRAF and NRAS mutations, in certain solid tumors.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 11, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the third dose cohort in the Phase Ib/II SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) (Press release, 4SC, JUL 11, 2019, View Source [SID1234537482]).

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The SENSITIZE study is a dose escalation study of domatinostat in combination with the checkpoint inhibitor pembrolizumab – an anti-PD-1 antibody approved in the US and the EU as a cancer immunotherapy – to evaluate the safety and tolerability of the combination treatment. The study is being conducted in patients with advanced-stage melanoma who are non-responding or refractory to prior treatment with checkpoint inhibitors.

The combination of domatinostat and pembrolizumab was confirmed as safe and well tolerated by the SRC at this, the third and highest predefined dose cohort.

Frank Hermann, M.D., Chief Development Officer of 4SC, said: "The SENSITIZE study is a key study to evaluate the safety and tolerability of domatinostat in combination with checkpoint inhibitors such as pembrolizumab. We are pleased to see that the highest predefined dose of domatinostat in combination with checkpoint blockade was safe and well tolerated.

In addition, from the sequential biopsies taken in SENSITIZE, we will be able to generate important biological data on the patient’s tumor microenvironment to investigate and support our preclinical data and proposed immuno-modulatory mechanism of action for domatinostat. Data analysis is ongoing, and we intend to publish the clinical and translational data set at an upcoming scientific conference."

Jason Loveridge, Ph.D., CEO of 4SC, added: "Based on the positive safety and tolerability outcome of the first three dose cohorts we will expand the SENSITIZE study and initiate further two cohorts. Taken together, the data from all cohorts will give us important information on how to optimally combine domatinostat with checkpoint blockade and inform our planned clinical studies of domatinostat in other indications.

We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."

Related articles
8 April 2019, Domatinostat’s mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

27 December 2018, Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma

On July 11, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us") (OTCPK: DCTH) reported that it has entered into a definitive agreement for gross proceeds of approximately $20 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, JUL 11, 2019, View Source;p=RssLanding&cat=news&id=2403505 [SID1234537498]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split.

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Roth Capital Partners is acting as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company expects to receive net proceeds of approximately $18.35 million. The offering is expected to close on July 15, 2019, subject to customary closing conditions.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On July 11, 2019 SOTIO and Cytune Pharma, members of the PPF Group, reported the first dosing of cancer patients with SO-C101, a superagonist fusion protein of interleukin IL-15 (Press release, SOTIO, JUL 11, 2019, View Source [SID1234537483]). The phase I/Ib study (SC103) will evaluate the safety and preliminary efficacy of SO-C101 in patients with selected advanced/metastatic solid tumors.

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The first patient was treated with SO-C101 at the Institute Gustave Roussy (France). The SC103 clinical trial will also enrol patients in the Vall d’Hebron cancer center (Spain) and, subject to obtaining all the necessary approvals, at the Yale Cancer Center in New Haven, CT and MD Anderson Cancer Center in Houston, TX. Cytune Pharma is responsible for the clinical development of SO-C101, SOTIO is sponsor of the SC103 clinical trial.

Aurélien Marabelle, M.D., Ph.D., coordinating investigator of the phase I/Ib trial said: "I am very pleased that our medical center has enrolled the first patient in this important clinical trial. We believe that SO-C101 has the potential to make a life-changing difference to many patients with difficult-to-treat forms of cancer. I am looking forward to further advancing this innovative therapy."

"SO-C101 is a very innovative approach which has been validated for its efficacy and safety in preclinical experiments. Since SO-C101 is an ideal combination partner for checkpoint inhibitors, monoclonal antibodies and other well established therapies, the planning for additional combination trials is already ongoing," said Radek Spisek, M.D., Ph.D., CEO of SOTIO.

"I’m excited that after 12 years of research and development at Cytune Pharma, which was based on previous research from INSERM and the University of Nantes and supported by Bpifrance and Atlanpole Biotherapies, our invention has now entered the clinical development phase. I hope that SO-C101 will become a treatment for cancer patients in the future," adds David Bechard, Ph.D., President and COO of Cytune Pharma.

Description of clinical trial
SC103 (Eudra CT: 2012-002814-38): A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in selected patients with advanced/metastatic solid tumors. SOTIO received a positive decision allowing launch of SC103 clinical trial within the EU Voluntary Harmonisation Procedure (VHP) in February 2019.