Genelux Corporation Initiates Pivotal Phase 3 Trial, Evaluating Olvi-Vec for the Treatment of Platinum Resistant/Refractory Ovarian Cancer
Company’s First Phase 3 Trial, OnPrime (GOG-3076), Will Evaluate Modified Vaccinia Virus Olvi-Vec as Immunochemotherapy
WESTLAKE VILLAGE, Calif., Sept. 21, 2022 (GLOBE NEWSWIRE) — Genelux Corporation, a clinical-stage immunotherapy company, today announced that it has initiated OnPrime, a multicenter, randomized, open-label, registrational Phase 3 trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum doublet + bevacizumab versus platinum doublet + bevacizumab in patients with platinum resistant/refractory ovarian cancer (PRROC).
OnPrime is a US-based trial that will be conducted at approximately 30 sites across the country and has a planned enrollment of 186 women with PRROC, randomized 2:1 to an investigational arm of Olvi-Vec and platinum-doublet + bevacizumab and an active platinum + bevacizumab doublet comparator arm.
“The launch of the OnPrime trial represents a major milestone for Genelux,” said Thomas D. Zindrick, President and CEO of Genelux. “Based on the positive results from our Phase 2 VIRO-15 trial, we believe Olvi-Vec-primed immunochemotherapy has the potential to address the high unmet need of patients living with PRROC. Our goal in phase 3 is to replicate these positive results and transform the treatment paradigm for this particularly difficult-to-treat cancer. We look forward to advancing our study and sharing updates on Olvi-Vec’s clinical development program. »
To date, Olvi-Vec has been the subject of several early and mid-phase clinical trials through regional, local and systemic administrations, as monotherapy and in combination with other therapies, in approximately 150 patients with various types of cancer. In the phase 2 VIRO-15 trial, twenty-seven PROC patients with a median of four prior lines and disease progression past the last prior line were enrolled. Olvi-Vec has met pre-established efficacy and safety criteria, as shown by data presented during an oral plenary session at the 2020 Global Annual Meeting of the International Gynecologic Cancer Society. Median progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 was 11.0 months (95% CI, 6.7-13.0 months), overall response rate ( ORR) according to RECIST1.1 was 54% and the ORR according to GCIG CA-125 was 85%. The most common Grade 3 treatment-related adverse event was abdominal pain (7.4%), with no treatment-related discontinuations or patient deaths observed. Our clinical trials have provided data that have informed future clinical strategy and trial design involving multiple indications and delivery methods.
OnPrime Study Eligibility: Eligible patients will have a minimum of 3 prior lines of therapy, but there is no limit on the maximum number of prior therapies. The primary endpoint is RECIST 1.1-based progression-free survival as assessed by blinded independent central review, with overall response rate, overall survival and safety as key secondary endpoints.
About platinum-resistant/refractory ovarian cancer
Ovarian cancer is the fifth most common cause of cancer death in women. In 2019, there were approximately 233,565 women living with ovarian cancer in the United States (including those who had been cured of the disease) 1. A majority who respond to treatment will relapse, with few treatment options. Median overall survival after disease recurrence is 12 months or less with chemotherapy monotherapy.2 No approved treatment has been shown to significantly prolong the overall survival of patients with platinum-resistant/refractory ovarian cancer compared to standard chemotherapy.3
1Surveillance, Epidemiology and End Results (SEER) Program Database, 2019
2Therapeutic advances in medical oncology (Luvero et al., Ther Adv Med Oncol. 2014 Sep;6(5):229-39)
3Journal of Clinical Oncology (Pujade Lauraine et al., J Clin Oncol. 2014 May 1;32(13):1302-8)
About Olvimulogen Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus modified to increase its safety, tumor selectivity and therapeutic potential. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term cancer immunotherapy. Olvi-Vec has been administered to over 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and demonstrated evidence of clinical benefit.
About Genelux Corporation
Genelux is a clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients with hard-to-treat solid tumor types. The Company’s most advanced product candidate, Olvi-Vec (olvimulogen nanivacirepvec), is a modified proprietary strain of vaccinia virus, a stable DNA virus with high engineering capability. The core of Genelux’s 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 vaccinia virus oncolytic immunotherapeutic product candidates, including Olvi-Vec.
About the GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. (GOG) is a non-profit organization whose purpose is to promote excellence in the quality and integrity of clinical and basic scientific research in the field of gynecological malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials, development, execution, analysis and distribution of results. The GOG Foundation is the only clinical trial group in the United States that focuses its research on patients with pelvic malignancies, such as cancers of the ovaries, uterus, cervix, vagina, and of the vulva.
GOG Partners, a program of the GOG Foundation, are structured to work directly with pharmaceutical organizations and conduct clinical trials outside of the National Cancer Institute (NCI) framework. GOG Partners share the same mission of the GOG Foundation dedicated to transforming care in gynecological oncology. By providing an alternate venue for patient recruitment and site infrastructure support, GOG Partners has helped provide additional trials and opportunities for patients outside of the National Gynecology Clinical Trials Network.