Results from Genelux Corporation's Phase 1b Trial of GL-ONC1 in Recurrent Ovarian Cancer to be presented at the ASCO Annual Meeting 2018
Promising safety data, immune activation and anti-tumor activity are documented in this trial.
SAN DIEGO, June 4, 2018 /PRNewswire/ -- Genelux Corporation, a privately-held biopharmaceutical company focused on the development of its proprietary oncolytic immunotherapy platform, today announced data from its Phase 1b trial evaluating its lead product candidate, GL-ONC1, in recurrent ovarian cancer. GL-ONC1 demonstrated a favorable safety profile and clinical benefits, which support further investigation in its ongoing Phase 2 VIRO-15 Study: Oncolytic Vaccinia Immunotherapy in Recurrent Ovarian Cancer.
The results will be presented by lead investigator, Dr. Robert Holloway, from Florida Hospital Cancer Institute at the upcoming 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 1-5, 2018, in Chicago, IL.
"Heavily pretreated patients with late-stage platinum-resistant/refractory ovarian cancer face a poor prognosis, and would otherwise be considered for palliative care versus continuing drug therapies with diminishing clinical response," said Paul Scigalla, M.D., Ph.D., Chief Medical Officer of Genelux. "The positive results from this trial along with supporting data demonstrating mechanisms of action are therefore very encouraging. We look forward to the completion of VIRO-15."
Data from the Phase 1b trial are outlined below.
Abstract Number: 5577
Abstract Title: Phase 1b study of oncolytic vaccinia virus GL-ONC1 in recurrent ovarian cancer
Session Title/Date/Time: Gynecologic Cancer, 6/4/2018, Poster Session 1:15-4:45 PM
Abstract Highlights: The open-label, single-arm, monotherapy, dose-escalation study (https://clinicaltrials.gov/ct2/show/NCT02759588) treated eleven heavily pretreated patients (pts) with end-stage recurrent ovarian cancer (ROC). Patient characteristics include: # of prior lines: 3-4 (n=3), ≥ 5 (n=8); ECOG 0 (n=7) or 1 (n=4); ascites/pleural effusion (n=9); and having progressive disease at baseline (n=10). There were two dose cohorts: 3 × 109 (Cohort 1: n=6) or 1 × 1010 (Cohort 2: n=5) plaque forming units of GL-ONC1 administered per day on 2 consecutive days.
- Safety
- GL-ONC1 treatments are well tolerated, with no dose limiting toxicities, and did not reach maximum tolerated dose.
- Adverse reactions of transient overnight flu-like symptoms included Grade 1-2 chills (n=7), nausea (7), fever (6), abdominal pain/distention (4), & vomiting.
- Mechanisms of Action
- Direct lysis: Virus colonized and replicated in the tumor, killed tumor cells in the ascites of all 5 tested patients provided samples, and reduced circulating tumor cells in blood in 6/8 (75%) pts.
- Immunotherapy: Virus-induced immune activation with enhanced tumor infiltration of CD8+ T cells and generation of tumor-specific T-cell response in patient with objective response were observed.
- Anti-tumor Activity
- Clinical significant disease control rate (DCR = objective response + stable disease ≥ 15 weeks) based on RECIST1.1 criteria was observed in 6/11 (55%) pts and extended PFS, more than doubling of PFS compared to the last chemotherapy regimen, were documented in 4/11 (36%) pts.
- Extended progression-free survival (PFS) of 23, 35, 59 (with confirmed objective response) & 71 weeks were observed in 4 pts, respectively.
A Phase 2 trial (VIRO-15) is currently enrolling, and future studies combining GL-ONC1 and other immune therapies and/or chemotherapy are under consideration.
About GL-ONC1
GL-ONC1 is an attenuated therapeutic vaccinia virus. Clinical results in over 100 subjects treated in Genelux studies have shown GL-ONC1 is well tolerated with documented antitumor activities and clinical benefits.
About Genelux Corporation
Headquartered in San Diego, California, Genelux Corporation is a leader in oncolytic immunotherapy, utilizing its potent CHOICE™ discovery platform to develop a library of proprietary, oncolytic vaccinia virus-based diagnostic and therapeutic candidates in oncology.
For more information please visit www.genelux.com.
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