On February 12, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its fourth quarter/fiscal year 2018 financial results on Tuesday, February 26, 2019, before the open of the U.S. financial markets (Press release, Clovis Oncology, FEB 12, 2019, View Source [SID1234533259]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss Q4/FY 2018 results on Tuesday, February 26, at 8:30am ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.393.4306, International participants 734.385.2616, conference ID: 6675335.

On February 12, 2019 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported the closing of its previously announced initial public offering of 19,837,500 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 2,587,500 additional shares, at a price to the public of $16.00 per share (Press release, Gossamer Bio, FEB 12, 2019, View Source [SID1234533260]). Including the option exercise, the aggregate gross proceeds to Gossamer Bio from the offering, before deducting the underwriting discounts and commissions and other offering expenses, were $317.4 million. Gossamer Bio’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "GOSS."

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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BofA Merrill Lynch, SVB Leerink, Barclays and Evercore ISI acted as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on February 7, 2019. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

The offering was made only by means of a prospectus. Copies of the final prospectus related to this offering can be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or from SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from Barclays, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected]; or from Evercore ISI, Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected].

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 offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported it is initiating phase 1 clinical development for XL092, the first internally-discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug discovery activities (Press release, Exelixis, FEB 12, 2019, View Source [SID1234533261]). XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, and other kinases implicated in cancer’s growth and spread. The molecule is the subject of an active Investigational New Drug (IND) application Exelixis submitted to the U.S. Food and Drug Administration in December 2018.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Exelixis is building a pipeline of diverse investigational medicines behind cabozantinib through in-house drug discovery activities and targeted in-licensing," said Peter Lamb, Ph.D., Executive Vice President of Scientific Strategy and Chief Scientific Officer of Exelixis. "XL092 is a novel compound that targets key signal transduction pathways in tumors, while potentially addressing tumor-induced immune suppression. Data from the upcoming phase 1 clinical trial will be used to determine the potential for further development of XL092."

The multi-center phase 1 clinical trial is designed to evaluate the pharmacokinetics, safety and tolerability of XL092. The trial is divided into dose-escalation and expansion phases. The dose-escalation phase of the trial will enroll patients with advanced solid tumors, with the primary objective of determining a dose for daily oral administration of XL092 suitable for further evaluation. Assuming positive data from the initial phase of the trial, the expansion phase is designed to further explore the selected dose of XL092 in individual tumor cohorts, where safety, tolerability, and initial clinical activity would be evaluated.

"Supported by revenues from the global cabozantinib franchise, Exelixis is building on our prolific drug discovery history to advance a new generation of Exelixis medicines," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "As the first molecule to enter clinical development from our new laboratories here in Alameda, XL092 represents an important milestone for our company and highlights our commitment to the patients we serve. We look forward to the clinical progress of XL092 and the continued maturation of other earlier-stage molecules currently in development."

On February 12, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, February 19, 2019 at 5pm ET to discuss its financial results and corporate update for the fourth quarter and the year ended December 31, 2018 (Press release, Ultragenyx Pharmaceutical, FEB 12, 2019, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-fourth-quarter-and-full-year-3 [SID1234533266]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or 262-912-6260 (International) and enter the passcode 6689186. The replay of the call will be available for one year.

On February 12, 2019 A team led by Dr. Chi-Huey Wong, Distinguished Research Fellow at Academia Sinica in Taiwan, in collaboration with OBI scientists, has demonstrated in a recent study that the Globo-series glycosphingolipids (GSLs) antigens: Globo-H, SSEA-3, and SSEA-4 are specifically expressed on cancer cells and are found to correlate with tumor survival (Press release, OBI Pharma, FEB 12, 2019, View Source [SID1234533318]). This finding supports the basis of the anti-Globo series pipeline under development by OBI Pharma Inc.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The article entitled "Signaling pathway of globo-series glycosphingolipids and β1,3-galactosyltransferase V (β3GalT5) in breast cancer" was published ahead of print on February 11, 2019 in the Proceedings of the National Academy of Sciences (PNAS)[1]. The study indicates that the GSL antigens can form a complex in membrane lipid raft with protein kinases such as caveolin-1 (CAV1), AKT, FAK and RIP. The reaction can trigger signaling pathways and promote tumor survival.

The study revealed that the expression of b3GalT5 is up-regulated in breast cancer and is highly correlated with tumor progression and poor survival in patients. On the other hand, knockdown of b3GalT5 in breast cancer cells can induce tumor apoptosis. Synthesis of SSEA-3 requires the presence of b3GalT5. SSEA-3 is the precursor of SSEA-4 and Globo H. When the expression of b3GalT5 decreases, expression of SSEA-3 also decreases. Subsequently, expression of SSEA-4 and Globo H are reduced.

When GSL antigens are unavailable or dysfunctional, protein kinases such as CAV1, AKT, FAK and RIP cannot signal to promote tumor survival. OBI’s anti-Globo series pipeline, such as OBI-888 (Globo H mAb) and OBI-898 (SSEA-4 mAb), targets high Globo H and SSEA-4 expressing cancers, suppressing or removing Globo H and SSEA-4 antigens to trigger tumor apoptosis. This study supports the scientific basis for OBI’s anti-Globo series pipeline and use of antibodies against the GSL antigens in treatment of breast and solid tumor cancers.

[1] "Signaling pathway of globo-series glycosphingolipids and β1,3-galactosyltransferase V (β3GalT5) in breast cancer." Proceedings of the National Academy of Sciences (PNAS), Published ahead of print February 11, 2019. View Source