GlobeNewswire by notified

XBiotech Announces First Patient Enrolled in Phase I Clinical Trial for Novel Arthritis Therapy Natrunix-SQ

Share

Natrunix-SQ, A True Human Antibody Therapy Discovered and Manufactured at XBiotech, Is Aimed as a Breakthrough Treatment for Arthritic Disease

AUSTIN, Texas, Jan. 26, 2022 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) enrolled the first patient in a randomized, double-blind, placebo-controlled clinical study to evaluate safety and pharmacokinetics of Natrunix-SQ. Natrunix-SQ targets a crucial inflammatory pathway involved in pain and joint destruction in various forms of arthritis. XBiotech believes that Natrunix-SQ may be the most effective means of blocking the inflammatory pathway involved in arthritis and thus could represent a breakthrough treatment for arthritides.

The Phase I study represents the launch of the clinical program for Natrunix-SQ for the treatment of rheumatological diseases. The Phase I study will evaluate Natrunix-SQ blood levels in the context of increasing doses. These findings will guide follow-up studies with Natrunix-SQ. Upon successful completion of the Phase I study, multiple Phase II studies to evaluate Natrunix-SQ in rheumatology are planned.

Natrunix-SQ is an antibody derived from a human donor where it was acting to naturally neutralize inflammation. Natrunix-SQ binds and neutralizes the action of one of the most potent inflammation-causing substances known to be produced by the body—interleukin-1. The body’s production of interleukin-1 has for decades been viewed as a key target for treating inflammatory disease. To date, therapies that block interleukin-1 have been successfully developed and marketed. However, no therapy to date has been developed that neutralizes interleukin-1 like Natrunix-SQ.

Interleukin-1 is made up of two distinct components: IL-1a and IL-1b. Natrunix-SQ is the first therapeutic to directly and specifically target and neutralize the activity of IL-1a. In recent years, world-class research has shown that IL-1 a may in many cases be the crucial target in blocking the disease-causing activities of interleukin-1. The unique approach of Natrunix-SQ to blocking interleukin-1-driven inflammation holds promise as a new generation of anti-inflammatory therapy in arthritis. As a naturally derived human antibody, it is also by design expected to be among the safest and best tolerated medicines possible.

Natrunix-SQ was discovered and developed by XBiotech researchers in Austin, Texas. XBiotech also produces the drug product and manufactures the completed pre-filled syringes at its operation in Austin. XBiotech has the manufacturing capability to produce drug product used for the clinical programs and for commercialization of the candidate therapy for arthritis.

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

Wenyi Wei
wwei@xbiotech.com
Tel. 512-386-2934

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

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

https://notified.com

GlobeNewswire by notified 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 by notified

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

Latest releases from GlobeNewswire by notified

Maha Energy: Borrningen av Tie-5 slutförd efter att 240 meter produktiv reservoar genomborrats28.5.2022 23:30:00 CEST | Pressemelding

Maha Energy AB (publ) ("Maha" eller "Bolaget") meddelar att horisontal-borrningen av Tie-5 i Brasilien nu är klar. Slutligt djup för sex tums hålet nåddes den 3 maj och ett 4-1/2 tums produktionsrör har nu sänkts ner och säkrats i brunnen. Längden på horisontalhålet reducerades i slutskedet på grund av försämrade borrhålsförhållanden. Totalt penetrerades 240 meter av produktiv Agua Grande (AG) reservoar med hjälp av nedsänkta elektriska loggningsverktyg. Den horisontella sektionen kommer nu att stimuleras och saneras innan den sätts i produktion. Borrningen av Tie-5 nådde ett djup om 2 548 meter den 3 maj 2022. Totalt har 240 meter (netto) av AG-sand exponerats och ett 4-1/2 tums perforerat produktionsrör har nu sänkts och säkrats i hålet. Det kan jämföras med 14 meter (netto) AG-reservoar som exponerades i den vertikala brunnen Tie-4. Innan Tie-5 sätts i produktion kommer brunnen att genomgå en rad stimulerings- och saneringsoperationer för att rensa horisontalhålet från borrslam. Jon

Maha Energy: Tie-5 reaches Total Depth (TD) with 240 m of net reservoir penetrated28.5.2022 23:30:00 CEST | Press release

Maha Energy AB (publ) (“Maha” or the “Company”) is pleased to announce that drilling of the Tie-5 horizontal production well is now complete. TD of the 6-1/8” horizontal hole was reached on 3 May and a 4-1/2” completion liner has now been run. The length of the horizontal leg was reduced due to deteriorating hole conditions. A total of 240 m. of net Agua Grande (AG) sand has been logged using measurement while drilling tools and the horizontal section will now be stimulated and cleaned up before being placed on production. Drilling of the Tie-5 horizontal production reached a measured depth of 2,548 m on 3 May, 2022. A total of 240 m of net AG sand has been drilled and a 4-1/2” pre-perforated production liner has now been run in the hole. The exposed length of sand in Tie-5 should be compared with the 14 m. of net sand penetrated in Tie-4. Prior to the well being placed on production, the well will undergo a series of stimulation and clean out operations to enhance production. Jonas Li

FRO – Private acquisitions of Euronav shares in exchange for Frontline shares completed28.5.2022 12:01:09 CEST | Press release

FRO – Private acquisitions of Euronav shares in exchange for Frontline shares completed Frontline Ltd. (“Frontline” or the "Company") (NYSE: FRO – OSE: FRO) announces that it has agreed to acquire a total of 5,955,705 shares in Euronav N.V. (NYSE: EURN & Euronext: EURN) (“Euronav”) representing 2.95% of the outstanding shares in privately negotiated share exchange transactions with certain shareholders of Euronav N.V. where such shareholders of Euronav N.V. receive consideration shares in Frontline. Frontline will issue a total of 8,337,986 new shares as a result of these transactions, equivalent to an exchange ratio of 1.4. Frontline will be entitled to the declared USD 0,06 dividend to be paid by Euronav on the acquired shares on 8 June 2022. Settlement is expected to take place on or about 1 June 2022 by delivery of existing shares through a share lending arrangement with Frontline's main shareholder Hemen Holding Ltd. Following completion of the issue of the new Frontline shares, F

FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma28.5.2022 00:58:29 CEST | Press release

68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile1 Sustained clinical benefit from Kymriah treatment demonstrated – of patients who achieved a complete response, 85% were still in response at 12 months1 Kymriah can be administered in the outpatient setting, offering increased flexibility and potentially reducing the burden of therapy for patients and their care teams1,2 Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings1 Basel, May 28, 2022 — Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. In accordance with the Accelerated Approval Program, continued approval for this indicati

ObsEva Announces Corporate Updates27.5.2022 22:01:00 CEST | Press release

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange GENEVA, Switzerland– May 27, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, announced today that it has entered into a waiver and amendment agreement (Amendment Agreement) with respect to its amended and restated securities purchase agreement (Securities Purchase Agreement) with certain funds and accounts managed by JGB Management, Inc. (JGB), which is structured to provide up to $135 million in borrowing capacity, available in nine tranches. The third tranche under the Securities Purchase Agreement was due to be funded on May 25, 2022. However, the tranche has not been funded as a result of ObsEva not meeting the funding condition that its volume-weighted average share price would not trade below $3.00 per share for five or more trading days during the 30 days prior to the funding date for the third tranche. Pursuant to the Am