GlobeNewswire

XBiotech Announces Enrollment Completion, Positive Findings for Bermekimab in Pancreatic Cancer Study

Share

XBiotech and Cedars-Sinai Medical Center Evaluate Bermekimab in Combination with Chemotherapy in Patients with Pancreatic Cancer and Cachexia

AUSTIN, Texas, May 02, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today enrollment of the final patient into its Phase I study1 evaluating bermekimab in patients with advanced pancreatic adenocarcinoma and cachexia. The study is being conducted and led by principal investigator Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai Medical Center2.  A total of 18 patients are enrolled in the study.

1 NCT03207724 2 This research was partially supported through an external research grant from the US marketer of the chemotherapy product.

The purpose of the study is to assess the safety and tolerability of bermekimab in combination with chemotherapy.  The study will also assess progression-free survival and overall survival of patients, as well as evaluate the relationship between treatment tolerance and patient functional status. Various health-related secondary measures, including changes in lean body mass, weight stability, and levels of systemic inflammation are also being assessed. Chemotherapy is being given intravenously with bermekimab every two weeks until disease progression. Extensive historical data on the pancreatic cancer population will be used to evaluate secondary endpoints in this study. 

Dr. Hendifar commented, “We have seen excellent tolerability with bermekimab in combination with the chemotherapy regimen.  Therapeutic activity and patient outcomes appear to be favorable when compared to similar pancreatic cancer patient populations refractory to therapy.”

John Simard, President & CEO of XBiotech, said, “This is our first combination therapy for bermekimab and we are very happy to see this regimen may improve the tolerability and efficacy of treatment for pancreatic cancer patients. We are grateful to Cedars-Sinai, Dr. Hendifar, and especially the courageous patients for participating in the study.”

The prognosis for advanced pancreatic cancer remains poor despite decades of studies [1].  The 5-year survival has remained close to 5%, unchanged despite improvements in chemotherapeutics, surgical outcomes, and diagnostic techniques [1, 2].  Other than multi-agent cytotoxic therapy, there have been no treatment advances for pancreatic cancer or its associated cachexia. Bermekimab was found to improve clusters of symptoms and led to improvements such as reduced pain and fatigue, improved appetite, and increased lean body mass in advanced cancer patients. Patients who had these improvements were found to have less tumor progression, substantially reduced serious adverse events related to disease, and approximately a three-fold improvement in survival [3].

About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930

[1] Li, D., et al., Pancreatic cancer. Lancet, 2004. 363(9414): p. 1049-57.
[2] Panagiotarakou, M., et al., Use of supportive care for symptom management in pancreatic cancer: application of clinical research to patient care. Jop, 2012. 13(4): p. 342-4.
[3] Hickish T., et al., MABp1 as a novel antibody treatment for advanced colorectal cancer: a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2017 Feb;18(2):192-201. 

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Schibsted ASA (SCHA/SCHB) - Invitation to the presentation of Q3 2019 Results18.10.2019 08:30:00 CESTPress release

We hereby invite you to participate at the presentation of the Q3 2019 reports of Schibsted Media Group on 25 October 2019 Quarterly Earnings Release Time: 25 October 2019 at 07.00 CET Interim report, presentation materials, and spreadsheet with key figures and analytical information will be made available on the investor relations pages at https://www.schibsted.com/ir/. Results Presentation Time: October 2019 at 09.00 CET Location: Schibsted’s premises in Akersgata 55, Oslo, Norway. The presentation will be webcasted live at https://www.schibsted.com/ir/. It will be presented in English. Participants can send in written questions through the webcast player. CEO Kristin Skogen Lund and EVP CFO Trond Berger will present. A recording of the presentation will be available on our web site shortly after the live webcast has ended. Conference call for investors and analysts - Q&A session Time: 25 October 2019 at 14.00 CET Questions relating to the results will be answered in a conference cal

Hofseth Biocare ASA: ENTERS INTO A CONSULTANCY AGREEMENT WITH JAMES BERGER – CONTEMPLATED US LISTING18.10.2019 08:05:00 CESTPress release

Hofseth BioCare ASA ("HBC") has today entered into a consultancy agreement with James Berger (through his company Nevera AG). Mr. Berger is a dual British and Italian citizen currently residing in Switzerland who has previously worked as an investment banker with Goldman Sachs International (London), JP Morgan (London), MAN Investments PLC and Millennium Capital Management LLC. He has a broad network with the largest investment banks and institutional investors in Europe and globally. Mr. Berger has already successfully assisted HBC with its oversubscribed private placement of NOK 118 million that was directed towards international private investors and institutional funds. He has recently also facilitated the sale of additional shares in HBC from certain existing shareholders to new international investors. Under the consultancy agreement, Mr. Berger will assist HBC with certain intermediary services, in establishing a wider base of international investors. Mr. Berger and HBC believe

Yara announces share buy-backs18.10.2019 08:02:00 CESTPress release

Oslo, 18 October 2019: Yara International ASA plans to buy back 0.5% of its outstanding shares by the end of 2019. Including the proportional redemption of shares owned by the Norwegian state, the total buyback and redemption will amount to approximately 0.8% of shares outstanding, equivalent to approximately NOK 800 million at today’s share price. Yara's targeted capital structure is a mid- to long-term Net debt/EBITDA range of 1.5-2.0 and a net debt/equity ratio below 0.60. Subject to these requirements, Yara's ordinary dividend shall be 50% of net income. Shareholder returns are distributed primarily as cash, with share buy-backs as a supplemental lever. Yara’s net debt/EBITDA as of 30 September 2019 would be close to 2.0 including the full effect of the announced buyback. The buy-backs are part of a program authorized by the Annual General meeting held 7 May 2019, which authorized Yara to buy back up to 5% (13,620,131 shares) of its share capital before its 2020 Annual General Meet

Yara med høyere resultat, operasjonell og kommersiell forbedring18.10.2019 08:00:00 CESTPressemelding

Oslo, 18. oktober 2019: Nettoresultat etter minoritetsinteresser for tredje kvartal var på USD 74 millioner (USD 0,27 per aksje), mot USD 98 millioner (USD 0,36 per aksje) for samme periode i fjor. Korrigert for valutaeffekter og spesielle poster var resultatet på USD 0,94 per aksje, mot USD 0,50 per aksje i tredje kvartal 2018. EBITDA eksklusive spesielle poster for tredje kvartal var på USD 630 millioner, opp fra USD 402 millioner ett år tidligere, og reflekterer høyere nitrogen oppgraderingsmarginer og sterke premium-leveranser. «Yara leverer betydelig bedre resultater i andre kvartal, med EBITDA eksklusive spesielle poster og IFRS 16 opp 49 %. Resultatet reflekterer lavere energikostnader, høyere produksjon og sterke premium-leveranser» sier Svein Tore Holsether, konsernsjef i Yara. «Jeg er fornøyd med at vi leverer resultatforbedring innen alle forretningsområder, med sterkest økning i New Business. Yaras avkastning fortsetter å øke, og hovedprioriteten fremover vil fortsatt være

Yara reports higher results, delivering operational and commercial improvement18.10.2019 08:00:00 CESTPress release

Oslo, 18 October 2019: Third-quarter net income after non-controlling interests was USD 74 million (USD 0.27 per share), compared with USD 98 million (USD 0.36 per share) a year earlier. Excluding currency effects and special items, the result was USD 0.94 per share compared with USD 0.50 per share in third quarter 2018 . Third-quarter EBITDA excluding special items was USD 630 million, up from USD 402 million a year earlier, mainly reflecting higher nitrogen upgrading margins and strong premium product deliveries. “Yara delivers significantly improved results in third quarter, with EBITDA excluding special items and IFRS 16 up 49%. The results reflect lower energy cost, higher production and strong premium product deliveries,” said Svein Tore Holsether, President and Chief Executive Officer of Yara. "I am pleased to see our results improve within all business segments, with the strongest increase in New Business. Our return on capital continues its positive trend, and our main priorit

SBM Offshore successful bidder for partner’s minority ownership in SBM Offshore operated FPSO companies18.10.2019 07:30:00 CESTPress release

October 18, 2019 Further to the announcement dated September 30, 2019 confirming its participation in the public sale auction of the equity ownership of Serviços de Petróleo Constellation S.A. (“Constellation”) in the lease and operating companies related to five Brazilian FPSOs (“the entities”), SBM Offshore confirms it has been formally designated as the successful bidder. Completion of the transaction remains subject to various conditions precedent, including consent from client Petrobras and approval by the local antitrust authority CADE (“Conselho Administrativo de Defesa Econômica”). The total consideration for the equity ownership, excluding associated non-recourse project debt, is c. US$150 million. The transaction includes the minority stake held by affiliated companies of Constellation in the entities related to the following five FPSOs (with Constellation’s ownership percentage in brackets): Cidade de Paraty (20%), Cidade de Ilhabela (12.75%), Cidade de Marica (5%), Cidade d