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.

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 Senior Director of Corporate Development at Immunomic Therapeutics Inc. Sia Anagnostou will speak at the Precision Lung Cancer World R&D Summit in Boston (Press release, Immunomic Therapeutics, OCT 26, 2018, View Source [SID1234530209]). Anagnostou’s presentation, titled "UNITE Technology as Nucleic Acid & Cell Based Immunotherapy: TERT – LAMP Case Study," will highlight Immunomic’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform and its application in immuno-oncology. Immunomic’s technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response, including antibody production, cytokine release and critical immunological memory, a method that could put UNITE at the crossroads of immunotherapies in a number of illnesses, including cancer. The investigational UNITE technology is currently being applied as a cancer immunotherapy in a Phase II clinical trial targeting glioblastoma multiforme (GBM). Anagnostou’s presentation will explore the broader potential of UNITE through discussion of the LAMP-based immunotherapy technology, AST-VAC2 (VAC2). VAC2 is an allogeneic cancer immunotherapy being developed by Asterias Biotherapeutics, Inc. in collaboration with Cancer Research UK and is currently in a Phase 1 clinical trial for treatment of non-small cell lung cancer.

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Who: Sia Anagnostou, Senior Director of Corporate Development at Immunomic Therapeutics, Inc.

What: Presentation on Activating Immune Responses in Cancer

When: Monday, October 29 at 4:00 p.m. EDT

Where: Wyndam Boston Beacon Hill, 5 Blossom St., Boston, MA 02114

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On October 26, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will host a conference call and webinar today at 11:00 AM ET to provide key updates on the advancement of its CD33 program that is based on the Antibody RadiationConjugate (ARC), Ac-225 – Lintuzumab (Press release, Actinium Pharmaceuticals, OCT 26, 2018, View Source [SID1234530265]). Actinium is developing its CD33 program for hematologic indications including Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM). Today’s call will highlight Actinium’s post-Phase 2 development plans following completion of its Actimab-A trial in patients newly diagnosed with AML who are over the age of 60 and unfit for intensive chemotherapy. In addition, management will provide an update on the regulatory pathway for Actimab-MDS following positive interactions with the U.S. Food and Drug Administration (FDA).

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Conference call and webcast Participation Information

Date: Friday, October 26, 2018
Time: 11:00 AM ET
Webcast Registration: View Source
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831