Genelux Corporation Announces Publication of Positive Topline Data from Phase 2 VIRO-15 Trial Evaluating Olvimulogene Nanivacirepvec (Olvi-Vec) in Platinum-Resistant or Refractory Ovarian Cancer in the Journal of the American Medical Association (JAMA) Onc
25 Mai 2023 - 10:01PM
Genelux Corporation (NASDAQ: GNLX), a late clinical-stage
immuno-oncology company, today announced the publication of
positive topline results from its Phase 2 VIRO-15 trial of
Olvi-Vec-primed immunochemotherapy in heavily pretreated patients
with platinum-resistant or -refractory ovarian cancer (PRROC) in
JAMA Oncology. The article by Holloway et al. was published in
print and online and is available here.
“We are incredibly pleased to have the Phase 2
trial data featured as an Original Investigation in such a
prominent peer-reviewed journal. The results published in JAMA
Oncology add to the body of evidence supporting the
clinically-meaningful efficacy and safety of Olvi-Vec," said Thomas
Zindrick, President, Chairman and CEO of Genelux. “Furthermore, we
were privileged to have a companion Editorial of our Phase 2 data
which we believe further validates the use of our proprietary
oncolytic virus in the treatment paradigm of ovarian cancer.”
Patients with PRROC have limited therapeutic
options, representing a considerable unmet medical need. In this
Phase 2 clinical trial of 27 patients [platinum-resistant (n=14) or
platinum-refractory (n=13)] and median 4 prior lines of therapy,
Olvi-Vec followed by platinum-based chemotherapy ± bevacizumab as
immunochemotherapy demonstrated objective response rate (ORR) of
54% and a median progression-free survival (PFS) of 11.0 months
with a manageable safety profile.
Key Findings
- All patients completed both Olvi-Vec infusions and
chemotherapy. Median follow-up duration was 47.0 months (95% CI,
35.9 months to NA, upper limit not reached).
- ORR by RECIST1.1 was 54% (95% CI, 33%-74%), with Duration of
Response of 7.6 months (95% CI, 3.7-9.6 months). Disease Control
Rate was 88% (21/24). Overall, 19 of 22 evaluable patients (86%)
showed tumor shrinkage. ORR by tumor biomarker CA-125 was 85% (95%
CI, 65%-96%), and 25 of 26 evaluable patients (96%) exhibited
decreased CA-125 levels.
- Median PFS by RECIST1.1 was 11.0 months (95% CI, 6.7-13.0
months), and 6-month PFS rate was 77% in all patients. Median PFS
was 10.0 months (95% CI, 6.4-NA months) in the platinum-resistant
group and 11.4 months (95% CI, 4.3-13.2 months) in the
platinum-refractory group.
- Median overall survival (OS) was 15.7 months (95% CI, 12.3-23.8
months) in all patients, with median OS of 18.5 months (95% CI,
11.3-23.8 months) in platinum-resistant group and 14.7 months (95%
CI, 10.8-33.6 months) in platinum-refractory group.
- Most frequent treatment-related adverse events (TRAEs) (any
grade, grade 3) were pyrexia (63.0%, 3.7%) and abdominal pain
(51.9%, 7.4%). There were no grade 4 treatment-related adverse
events and no treatment-related discontinuations or deaths.
Robert W. Holloway, MD, the lead investigator
and the Medical Director of the Gynecologic Oncology Program at
AdventHealth Cancer Institute, Orlando said, “The
results from the Phase 2 trial suggest potential survival
benefits of this
novel immunochemotherapy approach for women with
recurrent platinum-resistant or -refractory disease. This
patient population represents a considerable unmet medical
need in gynecologic oncology. The data also demonstrated
modification of the tumor immune microenvironment with oncolytic
virus Olvi-Vec in ways that reverse platinum resistance, and
in addition induce tumor specific T-cell response. We believe
the currently enrolling Phase 3 OnPrime/GOG-3076 clinical
trial will hopefully provide more evidence that we can produce
a life changing therapy."
Dr. Holloway further discussed the article
“Clinical Activity of Olvimulogene Nanivacirepvec–Primed
Immunochemotherapy in Heavily Pretreated Patients With
Platinum-Resistant or Platinum-Refractory Ovarian Cancer - The
Nonrandomized Phase 2 VIRO-15 Clinical Trial” on the JAMA Oncology
podcast series interviewed by Dr. Jack West, Clinical Executive
Director for AccessHope and an Associate Professor in Medical
Oncology at City of Hope. The podcast is available on iTunes ,
Spotify and other streaming platforms.
About Olvimulogene Nanivacirepvec
(Olvi-Vec)Olvi-Vec is a proprietary, oncolytic vaccinia
virus, modified to increase its safety, tumor selectivity and
therapeutic potential. Vaccinia virus is a non-human pathogen
utilized as a vaccine to eradicate smallpox. Virus-mediated
oncolysis results in immunogenic cell death and triggers immune
activation and memory for long-term immunotherapy against cancer.
Olvi-Vec has been administered to more than 150 patients in
clinical studies. In these studies, Olvi-Vec was generally well
tolerated and the data provided evidence of clinical benefit.
About Genelux
CorporationGenelux is a late clinical-stage
biopharmaceutical company focused on developing a pipeline of
next-generation oncolytic immunotherapies for patients suffering
from aggressive and/or difficult-to-treat solid tumor types. The
Company's most advanced product candidate, Olvi-Vec (olvimulogene
nanivacirepvec), is a proprietary, modified strain of the vaccinia
virus (VACV), a stable DNA virus with a large engineering capacity.
Olvi-Vec currently is being evaluated in Phase 3 OnPrime/GOG-3076,
a multi-center, randomized, open-label registrational trial,
evaluating the efficacy and safety of Olvi-Vec in patients with
platinum-resistant/refractory ovarian cancer. The core of Genelux'
discovery and development efforts revolves around the company's
proprietary CHOICE™ platform from which the Company has developed
an extensive library of isolated and engineered oncolytic vaccinia
virus immunotherapeutic product candidates, including Olvi-Vec. For
more information please visit www.genelux.com.
Forward-Looking StatementsThis
release contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, and such
forward-looking statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
“Forward-looking statements” describe future expectations, plans,
results, or strategies and are generally preceded by words such as
“believes,” “anticipates,” “expect,” “may,” “plan” or “will”.
Forward-looking statements in this release include, but are not
limited to, statements related to Olvi-Vec being a life-changing
therapy for patients with PRROC. Such statements are subject to a
multitude of risks and uncertainties that could cause future
circumstances, events, or results to differ materially from those
projected in the forward-looking statements. These and other risks
are identified under the caption “Risk Factors” in Genelux’ filings
with the Securities and Exchange Commission. All forward-looking
statements contained in this press release speak only as of the
date on which they were made and are based on management’s
assumptions and estimates as of such date. Genelux does not
undertake any obligation to publicly update any forward-looking
statements, whether as a result of the receipt of new information,
the occurrence of future events or otherwise.
Investor and Media Contacts
Ankit Bhargava, MDAllele Communications,
LLC815.721.4912
Source: Genelux Corporation
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