In the preclinical study, durable antitumor effect was achieved through combination treatment with Olvi-Vec and cisplatin in mouse model of PROC. Combination therapy of Olvi-Vec and platinum-doublet chemotherapy resulted in a clinically meaningful benefit in the VIRO-15 study, reversing the typical trend of deteriorating PFS, and with clinical reversal of platinum resistance. Olvi-Vec treatment can favorably modify the TME in OC and may explain the apparent reversal of platinum resistance following platinum rechallenge.Trial Registration:ClinicalTrials.gov Identifier: NCT02759588.

1 month ago

Journal • IO biomarker

CD8 (cluster of differentiation 8)

cisplatin • olvimulogene nanivacirepvec (GL-ONC1)

2ms

Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (clinicaltrials.gov)

P1/2, N=46, Completed, Genelux Corporation | Phase classification: P1b --> P1/2

2 months ago

Phase classification • IO biomarker

MUC16 (Mucin 16, Cell Surface Associated)

Avastin (bevacizumab) • carboplatin • albumin-bound paclitaxel • olvimulogene nanivacirepvec (GL-ONC1)

11ms

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) (clinicaltrials.gov)

P3, N=186, Recruiting, Genelux Corporation | Trial primary completion date: Aug 2025 --> Jun 2026

11 months ago

Trial primary completion date • Platinum resistant

Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • olvimulogene nanivacirepvec (GL-ONC1)

12ms

Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC (clinicaltrials.gov)

P1/2, N=27, Recruiting, Newsoara Biopharma Co., Ltd.

12 months ago

New P1/2 trial

cisplatin • carboplatin • etoposide IV • olvimulogene nanivacirepvec (GL-ONC1)

almost2years

Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma (clinicaltrials.gov)

P1, N=18, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed

almost 2 years ago

Trial completion

olvimulogene nanivacirepvec (GL-ONC1)

almost2years

Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's of Choice Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer (VIRO-25) (clinicaltrials.gov)

P2, N=142, Recruiting, Genelux Corporation | Not yet recruiting --> Recruiting

almost 2 years ago

Enrollment open • Checkpoint inhibition

Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • docetaxel • albumin-bound paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • olvimulogene nanivacirepvec (GL-ONC1)

2years

Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's of Choice Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer (VIRO-25) (clinicaltrials.gov)

P2, N=142, Not yet recruiting, Genelux Corporation

2 years ago

New P2 trial • Checkpoint inhibition

over2years

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076) (clinicaltrials.gov)

P3, N=186, Recruiting, Genelux Corporation | Trial primary completion date: Aug 2024 --> Aug 2025

over 2 years ago

Trial primary completion date

Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • olvimulogene nanivacirepvec (GL-ONC1)

over2years

Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma (clinicaltrials.gov)

P1, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

over 2 years ago

Trial completion date • Trial primary completion date

olvimulogene nanivacirepvec (GL-ONC1)

over2years

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076) (clinicaltrials.gov)

P3, N=186, Recruiting, Genelux Corporation

over 2 years ago

Trial completion date • Trial primary completion date

Avastin (bevacizumab) • cisplatin • carboplatin • gemcitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin • olvimulogene nanivacirepvec (GL-ONC1)

almost3years

A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer. (PubMed, Int J Gynecol Cancer)

Expected complete accrual in 2024 with presentation of primary endpoint results in 2025. NCT05281471.

almost 3 years ago

Clinical • P3 data • Clinical Trial,Phase III • Journal

Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)

3years

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. (PubMed, JAMA Oncol)

To assess antitumor activity and safety of intraperitoneal (IP) olvimulogene nanivacirepvec (Olvi-Vec) virotherapy and platinum-based chemotherapy with or without bevacizumab in patients with PRROC. These hypothesis-generating results warrant further evaluation in a confirmatory phase 3 trial. ClinicalTrials.gov Identifier: NCT02759588.

3 years ago

Clinical • P2 data • Journal

Avastin (bevacizumab) • olvimulogene nanivacirepvec (GL-ONC1)