December 11, 2016 12:09 AM ET

Biotechnology

Company Overview of Genelux Corporation

Company Overview

Genelux Corporation, a biopharmaceutical company, develops oncolytic virus based technology platform and a pipeline of products with applications for cancer detection and therapy. It provides GL-ONC1 oncology product, a vaccina virus (Lister strain) that results in regression and elimination of a range of solid tumors in animals without damaging healthy tissues or organs, as well as encodes green fluorescent protein to enable selective imaging of tumors and metastases as an aid in the diagnosis and staging of cancer. The company was incorporated in 2001 and is headquartered in San Diego, California. It also has operations in Germany.

3030 Bunker Hill Street

Suite 300

San Diego, CA 92109 5754

United States

Founded in 2001

Phone:

858-483-0024

Fax:

858-483-0026

Key Executives for Genelux Corporation

Chief Executive Officer, President, Chief Compliance Officer and Director
Founder, Chairman Emeritus and Chief Scientific Advisor To The Chief Executive Officer
Chief Financial Officer
Age: 54
Chief Operating Officer, Member of Scientific Advisory Board and Member of Clinical Advisory & Implementation Board
Chief Executive Officer of Genelux Europe and President of Genelux Europe
Compensation as of Fiscal Year 2016.

Genelux Corporation Key Developments

Genelux Initiates Two Clinical Trials of GL-ONC1 in Ovarian Cancer and Solid Organ Cancers with Leading Oncology Institutions

Genelux Corporation announced that it has initiated two new Phase 1b clinical trials of its lead oncolytic virotherapy GL-ONC1 with leading oncology institutions, Florida Hospital Cancer Institute (FHCI) in Orlando and Moores Cancer Center at UC San Diego Health. The initiation of these two trials with is a significant milestone in the clinical advancement of GL-ONC1 and will provide Genelux with significant near-term data milestones. Following positive results in four completed clinical trials including the two Phase 1 trials in head and neck cancer and mesothelioma presented at the 2015 ASCO Annual Meeting, which confirmed the safety and favorable trend of clinical benefits of GL-ONC1 administered either intravenously (IV) or intrapleurally. A Genelux-sponsored dose-escalation clinical trial of GL-ONC1 (NCT02759588) is being conducted at Florida Hospital Cancer Institute and is being led by Dr. Robert Holloway, a world-renowned gynecologic oncologist, to evaluate the safety, tolerability and antitumor effect of GL-ONC1 in female patients with recurrent ovarian cancer. The first two patients have been dosed, with the second patient dosed this week and, to date, both show the treatment was well-tolerated. GL-ONC1 is administered intraperitoneally at high doses over a condensed schedule. Additionally, a Phase 2a expansion portion of the study is anticipated following interim data analysis. In subsequent stages of the trial, GL-ONC1 will be administered as combination therapy to further augment the clinical effect. Furthermore, Genelux expects that the results of this trial will establish the optimal parameters to propose a Phase 2 clinical trial design focusing on the registration pathway in ovarian cancer. An investigator-initiated dose-escalation clinical trial (NCT02714374) is being conducted at Moores Cancer Center and led by Dr. Kaitlyn Kelly, a surgical oncologist trained at the prestigious Memorial Sloan-Kettering Cancer Center (MSKCC), to evaluate the safety and efficacy of GL-ONC1 alone or in combination with eculizumab (marketed as Soliris®) prior to surgery in patients with advanced solid organ cancers. The study is designed to answer fundamental questions regarding the optimal systemic administration of GL-ONC1. GL-ONC1 is administered intravenously in the form of an aggressive dosing regimen. The first three patients have been dosed and have shown the treatment to be well-tolerated. Genelux anticipates the results of this trial will inform dosing parameters to further augment the anti-tumor activity of GL-ONC1 virotherapy, particularly in targeting dispersed and difficult-to-treat metastatic diseases, which would provide an important clinical advantage over other virotherapies. A Phase 2a expansion portion of the study is anticipated following interim data analysis.

Genelux Corporation Announces Two Phase I Trials of GL-ONC1 in Head & Neck Cancer and Mesothelioma

Genelux Corporation announced that data from two Phase I trials evaluating its lead oncolytic virotherapy GL-ONC1 in head and neck cancer and malignant pleural mesothelioma demonstrate a favorable safety profile and support further investigation of the therapy in both indications. The results will be presented by lead investigators from Memorial Sloan Kettering Cancer Center and UC San Diego Moores Cancer Center at the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29-June 2 in Chicago, IL. Data from the two Phase I trials are outlined. Abstract 6026 (Poster 349) Phase I trial of intravenous administration of attenuated vaccinia virus (GL-ONC1) with concurrent chemoradiotherapy (CRT) for locoregionally advanced head and neck carcinoma. The open-label, single-arm, dose-escalation study (NCT01584284) evaluated increasing doses of GL-ONC1 plus radiation and cisplatin in five cohorts of patients with late-stage disease (IVA or IVB), without reaching the maximum tolerated dose, indicating increased doses of GL-ONC1 may be feasible within the well-tolerated safety profile. Enrollment focused mostly on patients who have HPV-negative head and neck cancer, who are known to have poorer responses to standard of care than those with HPV-positive cancer.

Genelux Corporation Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-14-2015 09:20 AM

Genelux Corporation Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-14-2015 09:20 AM. Venue: Westin Grand Central Hotel, New York, New York, United States.

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