On October 26, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first clinical site in the United States (in Long Beach, CA) for the pivotal PARADIGME trial has been initiated to enable enrolment of patients (Press release, Nordic Nanovector, OCT 26, 2018, View Source [SID1234553491]).

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PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin (177Lu-satetraxetan-lilotomab) dosing regimens (15 MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20 MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L follicular lymphoma patients who are refractory to anti-CD20 therapy (including rituximab). The trial aims to enrol 130 patients across 80-85 sites in approximately 20 countries.

Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "The enrolment of patients into North American sites is important for the overall clinical development program of Betalutin in NHL. We are pleased to have opened the first US site in the PARADIGME trial and anticipate further clinical sites coming on-board in the coming months."

The objective of PARADIGME is to determine the best dosing regimen for Betalutin as a new treatment option for 3L FL patients. The primary endpoint for the trial is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. The data from this trial are expected to support market authorisation applications for Betalutin as a new treatment option for 3L FL patients.

The initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.

In June, Betalutin received Fast Track designation in the US for the treatment of patients with 3L R/R FL, and on 24 October, the MHRA granted Betalutin a Promising Innovative Medicine Designation in the treatment of advanced relapsed/refractory follicular lymphoma.

About Betalutin

Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20 immunotherapy (including rituximab).

Betalutin is also being investigated in the Phase 1b Archer-1 study in combination with rituximab in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL).

Betalutin has been granted Fast Track designation (in June 2018) in the US for the treatment of patients with R/R FL. Betalutin also received Orphan Drug designations for FL in both the USA and Europe in 2014.

Betalutin is selective for CD37, a novel therapeutic target protein that is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin is internalised, causing DNA damage and cell death.

On October 26, 2018 Amgen (NASDAQ:AMGN) reported that it will report its third quarter 2018 financial results on Tuesday, Oct. 30, 2018, after the close of the U.S. financial markets (Press release, Amgen, OCT 26, 2018, View Source;p=RssLanding&cat=news&id=2373775 [SID1234530308]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 26, 2018 XBiotech Inc. (NASDAQ: XBIT) announced today that it was awarded 11 new patents or patent allowances in the third quarter of 2018. Patents issued relate to the Company’s drug candidates bermekimab and 514G3, which target a crucial mediator of chronic inflammation and Staphylococcus aureus (including MRSA), respectively (Press release, XBiotech, OCT 26, 2018, View Source;p=RssLanding&cat=news&id=2373711 [SID1234530155]). The new patents include those issued from European authorities to protect bermekimab when used in the treatment of dermatological pathologies and cancer-associated cachexia. Patent allowances include one each in Australia, Canada, Israel, Mexico, the Philippines, Russia, and South Korea that include covering: bermekimab in the treatment of cardiovascular disease; the 514G3 antibody to treat Staphylococcus aureus infections; and key aspects of the Company’s True HumanTM antibody discovery platform.

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Stanley Kim, Ph.D., J.D., XBiotech’s Corporate Vice President of Intellectual Property, stated, "These recently issued patents reflect XBiotech’s efforts to develop significant worldwide protection for its emerging candidate therapies. The Company’s patent portfolio currently includes over 100 issued patents."

XBiotech’s substantial patent portfolio supports a diverse drug development platform. The Company is currently conducting clinical research with bermekimab as a combination therapy to treat pancreatic cancer. In addition, ongoing evaluation of results from XBiotech’s colorectal cancer programs continues to be conducted to investigate patient response to bermekimab and to further direct the Company’s oncology program. XBiotech has two separate dermatological clinical trials underway investigating response to bermekimab in patients with atopic dermatitis and hidradenitis suppurativa. Both studies are expected to be completed this year or by first quarter 2019. The Company is also currently exploring possibilities of conducting further clinical studies with 514G3 to prevent and treat Staphylococcus aureus infections, as well as bermekimab to prevent and treat cardiovascular disease. XBiotech continues to advance its pipeline for other infectious disease indications, including Clostridium difficile and varicella zoster virus (shingles).

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.

On October 26, 2018 Tiziana Life Sciences plc (AIM: TILS), a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, reported that it has raised US$1,500,000 by the issue of 1,515,150 new ordinary shares ("Placing Shares") at a price of US$0.99 (75p) per share at a fixed exchange rate of GBP 1 : US$ 1.32 (the "Placing") (Press release, Tiziana Life Sciences, OCT 26, 2018, View Source [SID1234530137]).

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Application will be made to London Stock Exchange plc to admit the Placing Shares to trading on AIM ("Admission") with Admission expected to occur on or around 19 November 2018. The Placing Shares will rank pari passu with the existing ordinary shares of nominal value 3 pence each in the capital of the Company (the "Ordinary Shares").

Following Admission, the fully diluted issued share capital of the Company will consist of 151,790,735 Ordinary Shares (assuming all options and warrants, vested and unvested, exercised and exercisable, were converted).

Total Voting Rights

In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Placing Shares, the total number of Ordinary Shares in issue will be 128,442,449. There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

The figure of 128,442,449 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the FCA’s Disclosure Guidance and Transparency Rules.

The person who arranged for release of this announcement on behalf of the Company was Tiziano Lazzaretti, Chief Financial Officer of Tiziana.

On October 26, 2018 ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for cancer reported that it will present the results of its latest clinical trial in lung cancer patients (Press release, Andarix Pharmaceuticals, OCT 26, 2018, View Source [SID1234530404]). The trial focused on the administration of Tozaride, the company’s lead candidate in neuroendocrine lung cancer patients. The abstract is entitled "Targeted Clinical Study with 188 Re P2045 in lung cancer expressing SSTR and well differentiated Neuroendocrine tumours," and will be presented at the SNMMI Northeast Regional Meeting 2018 in Newport, RI. October 26-27, 2018.

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About Tozaride
Tozaride is a novel, best-in-class cancer therapy based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with enough expression of the peptide’s target Tozaride could provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.