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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"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 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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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 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 Provectus (OTCQB: PVCT) reported that orphan drug designation (ODD) status was granted by the U.S. Food and Drug Administration (FDA) to small molecule oncolytic immunotherapy PV-10 for the treatment of ocular melanoma (to include all melanoma disease affecting the eye and orbit) (Press release, Provectus Biopharmaceuticals, FEB 12, 2019, View Source [SID1234533258]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death (ICD) in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1-4

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Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

Preliminary data from Provectus’ uveal melanoma expansion cohort of its Phase 1 "basket study" of PV-10 for the treatment of cancers metastatic to the liver were presented in a poster presentation at the 15th International Congress of the Society for Melanoma Research (SMR 2018 Congress) in late-2018: a total of four patients had received PV-10 for at least one uveal melanoma liver tumor, two patients had received a second round of PV-10 treatment to an additional liver tumor, and one patient initiated standard of care immunotherapy (Opdivo + Yervoy) between PV-10 treatments; treatment-related adverse events were consistent with established patterns; and, tumor reduction was observed in 5 of 6 PV-10-injected tumors. A copy of the poster presentation is available on the Company’s website.

The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. ODD status qualifies companies for benefits that include seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and waiver of certain administrative fees.

ODD status previously was granted to PV-10 for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, and neuroblastoma in 2018.

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

On February 12, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported an update on its galinpepimut-S (GPS) and nelipepimut-S (NPS) clinical development programs (Press release, Sellas Life Sciences, FEB 12, 2019, View Source [SID1234533257]).

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The Company announces that Richard Maziarz, M.D., Medical Director of the Adult Blood and Marrow Stem Cell Transplant & Cellular Therapy Program at the Knight Cancer Institute and Professor of Medicine at Oregon Health and Science University (OHSU) in Portland, OR, and Roisin O’Cearbhaill, M.D., Assistant Attending Physician in Gynecologic Medical Oncology Service at the Memorial Sloan Kettering Cancer Center (MSKCC), will serve as co-principal investigators of the Company’s Phase 1/2 open-label, non-comparative, multicenter, multi-arm study of GPS in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with selected WT1-positive advanced cancers, including both hematologic malignancies and solid tumors. This study, which is being conducted under a Clinical Trial Collaboration and Supply Agreement (CTSA) with Merck (known as MSD outside the United States and Canada), will assess the efficacy and safety of the combination, with exploratory long-term follow-up for overall survival and safety. The study will enroll approximately 90 patients at up to 20 centers in the United States. The initial tumor types to be treated will be acute myelogenous leukemia (AML) (patients unable to attain deeper morphological response than partial on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant) and ovarian cancer (second or third line), to be followed by triple negative breast cancer (second line), small cell lung cancer (second line), and colorectal cancer (third or fourth line).

"We are thrilled to announce that Drs. Maziarz and O’Cearbhaill will serve as co-principal investigators of this important study," said Dr. Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Both Rich and Roisin will be indispensable in overseeing the scientific rigor of the investigation, helping to interpret both clinical and correlative immuno-response data, and guiding us to optimally advance the development of GPS as a uniquely positioned active immunizer of the peptide vaccine type for the treatment of recalcitrant malignancies in the presence of measurable disease."

Additionally, the Company announces preliminary immune response data in a subgroup of patients with triple-negative breast cancer (TNBC) from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical study of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NPS, NeuVax) targeting HER2 low-expressing breast cancer patient cohorts. These data originate from an analysis of the patterns of induction of antigen (NPS)-specific T-cell responses over time in patients treated in this study. CD8+ cytotoxic T-lymphocytes (CTLs) from peripheral blood samples from study patients with TNBC were measured using specifically designed NPS-specific dextramers in a flow cytometry-based assay in duplicate. In 64 evaluable TNBC patients (39 in the NPS plus trastuzumab arm; 25 in the trastuzumab alone arm) across a median of four time-points (including baseline), NPS + trastuzumab administration generated up to 3-fold higher frequencies of NPS-specific CTLs compared to trastuzumab alone. Moreover, CTL frequencies were much higher among non-recurrent patients compared with those who recurred (on either arm). The complete set of data from these correlative analyses will be presented in an upcoming major scientific meeting.

"These new data provide important insights on the immunobiological mechanism underlying the statistically significant and clinically meaningful decrease in detectable tumor relapses and associated increase in 24-month disease-free survival (DFS) rate with the combination of NPS plus trastuzumab versus trastuzumab alone observed within the TNBC cohort of the Phase 2b study we have previously reported. We are looking forward to completing the underlying correlative analyses in order to further dissect the intriguing association between induction of antigen-specific T-cell immunity and clinical effect post-vaccination, which strongly suggests a contribution of NPS in the emergence of antitumor activity in TNBC patients in the adjuvant treatment setting. We are continuing our discussions with the FDA on the most optimal development path forward for NPS in TNBC and will provide the immune response data to the Agency as well," commented Dr. Stergiou.

Herceptin and Keytruda are registered trademarks of Genentech, Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.