olvimulogene nanivacirepvec (GL-ONC1) / Genelux, Newsoara Biopharma - LARVOL DELTA

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) - P1b | "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."

Clinical • Journal • P2 data • Oncology • Ovarian Cancer • Pain • Refractory Ovarian Cancer • Solid Tumor

Killing to cure: harnessing poxvirus-driven cell death for viral immunotherapy. (PubMed, Immunol Lett) - "We discuss the development of Olvimulogene nanivacirepvec (Olvi-Vec), Pexastimogene devacirepvec (Pexa-Vec), and other candidates; the basic biology of poxviruses; their manipulation of host antiviral defences; and the pathways of regulated cell death they can induce, including apoptosis, necroptosis, pyroptosis, and ferroptosis. We examine the potential for optimising oncolysis through targeted genetic modification and combination therapy, with the aim of enhancing the immunogenicity of cell death to overcome the immunosuppressive tumour microenvironment and to enhance adaptive antitumour immune responses."

Journal • Review • Oncology

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 | Sponsor: Genelux Corporation | Trial completion date: Oct 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Platinum resistant • Trial completion date • Trial primary completion date • Clear Cell Carcinoma • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

Olvi-Vec oncolytic immunotherapy and reversal of platinum resistance in ovarian cancer. (PubMed, Gynecol Oncol Rep) - P1/2 | "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."

IO biomarker • Journal • Platinum resistant • Immune Modulation • Immunology • Infectious Disease • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • CD8

Genelux Announces Publication of Translational Analysis Supporting Immune Activation and Chemotherapy Sensitization with Olvi‑Vec in Ovarian Cancer (GlobeNewswire) - "Tumor microenvironment modulation: Olvi‑Vec treatment was associated with an influx of CD8+ tumor-infiltrating lymphocytes and immune activation within tumor tissue; Direct viral activity: Viral infection and killing of tumor cells were observed in patient-derived samples; Gene expression changes: RNA profiling identified coordinated transcriptional changes associated with immune activation, tumor cell killing, and enhanced sensitivity to subsequent platinum-based chemotherapy, supporting the potential role of Olvi-Vec as a tumor-priming immunotherapy; Clinical context: Translational findings provide mechanistic support for the observed restoration of platinum sensitivity following Olvi-Vec treatment....provide additional biological rationale for the ongoing registrational Phase 3 OnPrime/GOG-3076 study evaluating Olvi-Vec-primed immunochemotherapy in PRROC."

P1/2 data • Platinum resistant • Trial status • Ovarian Cancer • Refractory Ovarian Cancer

Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=46 | Completed | Sponsor: Genelux Corporation | Phase classification: P1b ➔ P1/2

IO biomarker • Phase classification • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor • MUC16

Olvi-Vec in Platinum-Resistant/Refractory Ovarian Cancer (GlobeNewswire) - "The ongoing OnPrime Phase 3 registrational trial (NCT05281471) of Olvi-Vec in platinum-resistant/refractory ovarian cancer is enrolling patients at sites across the United States, with topline data now anticipated in the second half of 2026."

P3 data: top line • Platinum resistant • Ovarian Cancer

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 | Sponsor: Genelux Corporation | Trial primary completion date: Aug 2025 ➔ Jun 2026

Platinum resistant • Trial primary completion date • Clear Cell Carcinoma • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Refractory Ovarian Cancer • Solid Tumor

Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: Newsoara Biopharma Co., Ltd.

New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Genelux Corporation Reports Second Quarter 2025 Financial Results and Provides General Business Updates (GlobeNewswire) - "In the ongoing Phase 1b/2 trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in platinum-relapsed or platinum-refractory extensive-stage small cell lung cancer, previously disclosed preliminary data showed a 71% disease control rate in initial dose escalation cohorts, with a favorable safety profile and no dose-limiting toxicities observed as of the February 19, 2025 data cutoff. Enrollment into dose escalation cohorts remains active, which will support determination of an intravenous dose for Phase 2. Updated interim results are expected in the second half of 2025. A Phase 2 trial (NCT06463665) in recurrent non-small cell lung cancer is also progressing. Interim data from this study are anticipated in the second half of 2025."

P1/2 data • P2 data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Genelux Corporation Reports First Quarter 2025 Financial Results and Provides General Business Updates (GlobeNewswire) - "The first quarter of 2025 has been highly productive and sets a strong foundation for the year ahead. We are well positioned to advance Olvi-Vec across multiple high-need cancer indications, with encouraging regulatory feedback from the FDA on our OnPrime Phase 3 registrational trial in resistant/refractory ovarian cancer, promising early lung cancer clinical data from our ongoing Phase 1b/2 study, and increasing patient enrollment in our U.S. Phase 2 lung cancer trial"

FDA event • P1/2 data • Trial status • Refractory Ovarian Cancer • Small Cell Lung Cancer

Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "On March 26, 2025, the Company closed an underwritten offering of 3,000,000 shares of its common stock at an offering price of $3.50 per share. The gross proceeds from the offering are expected to be $10.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The net proceeds from the offering are to be used for working capital and for general corporate purposes, including the continued clinical development of Olvi-Vec."

Commercial • Non Small Cell Lung Cancer • Ovarian Cancer • Small Cell Lung Cancer

Genelux Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Phase 2 VIRO-25 is actively enrolling recurrent non-small cell lung cancer (NSCLC) patients (NCT06463665), with interim data VIRO-25anticipated in second half of 2025."

P2 data • Non Small Cell Lung Cancer

Genelux and Newsoara Announce Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer (GlobeNewswire) - P1b/2 | N=7 | "Genelux...and Newsoara...announced preliminary safety and anti-tumor activity data from the dose escalation Phase 1b portion of the companies’ co-sponsored ongoing Phase 1b/2 clinical trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer...Key findings from the ongoing Phase 1b trial include...Systemic administration of Olvi-Vec via intravenous delivery demonstrated a manageable safety and tolerability profile, consistent with previous findings in other clinical studies of the investigational immunochemotherapy. Treatment-related adverse events were mostly mild to moderate....Of the five participants with disease control, two participants exhibited a partial response according to RECIST 1.1. Notably, the first participant in our current dose escalation cohort, who remains on treatment, experienced a tumor reduction of approximately 79%."

P1 data • Small Cell Lung Cancer

Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease (GlobeNewswire) - "Genelux Corporation...today announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration (FDA) for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer (PRROC)...In response to a question seeking the FDA’s guidance on their expectations regarding a confirmatory trial using the ongoing OnPrime/GOG-3076 trial, the FDA responded that 'As stated previously, an interim analysis of overall survival (OS) should be planned at the time of the primary PFS analysis. If a clinically meaningful PFS advantage is demonstrated in the absence of a decrement in OS, this could potentially support traditional approval.' The FDA further recommended Genelux request a pre-BLA meeting with FDA with topline safety and efficacy data following completion of the study to discuss next steps....'we look forward to reporting topline safety and efficacy data in the first half of 2026.'"

FDA event • P3 data: top line • Ovarian Cancer • Refractory Ovarian Cancer

Genelux Corporation to Participate in a Fireside Chat with H.C. Wainwright (GlobeNewswire) - "The discussion will focus on the company’s clinical program of its lead candidate, Olvi-Vec, including its ongoing Phase 3 registration trial in platinum resistant/refractory ovarian cancer (PRROC), Phase 1b/2 trial in small-cell lung cancer (SCLC) and Phase 2 trial in non-small cell lung cancer (NSCLC)."

Clinical • Non Small Cell Lung Cancer • Ovarian Cancer • Small Cell Lung Cancer

Genelux Corporation Reports Third Quarter 2024 Financial Results and Provides General Business Updates (GlobeNewswire) - "Pipeline Highlights:...(i) Patient enrollment continues to progress in the Phase 3 OnPrime/GOG-3076 trial for PRROC, now active at over 25 sites (NCT05281471). Topline results are anticipated in the latter half of 2025; (ii) Phase 2 VIRO-25 is actively enrolling recurrent NSCLC patients (NCT06463665), with interim data expected by mid-2025; (iii) Interim results from the Phase 1b portion of a Phase 1b/2 SCLC trial projected by end of 2024."

Enrollment status • P1 data • P2 data • P3 data: top line • Non Small Cell Lung Cancer • Ovarian Cancer • Small Cell Lung Cancer

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 | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer (GlobeNewswire) - "Genelux Corporation...today announced that the first patient has been dosed in the U.S.-based Phase 2 (VIRO-25) trial evaluating systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies....Genelux expects interim data readout in mid-2025."

P2 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer

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 | Sponsor: Genelux Corporation | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Genelux shares gain on Roth/MKM Buy rating, $10 price target (Investing.com) - "Tuesday, Genelux Corp...received a positive outlook from Roth/MKM as the firm initiated coverage on the biopharmaceutical company's stock. The analyst set a Buy rating with a price target of $10.00, signaling confidence in the company's cancer treatment pipeline...The endorsement comes with a focus on Genelux's lead product candidate, Olvi-Vec, particularly for its application in treating platinum-resistant/refractory ovarian cancer...The current price target of $10.00 represents a notable increase from Genelux's recent trading levels, though the specific current stock price was not provided in the context. This target is based on the potential success of Olvi-Vec in its upcoming clinical trials and the anticipated response of the market to positive trial outcomes....The company also plans to launch a Phase 2 study in Non-Small Cell Lung Cancer in the second quarter of 2024."

New P2 trial • Stock price • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Genelux Corporation Reports Second Quarter 2024 Financial Results and Provides General Business Updates (GlobeNewswire) - "The ongoing Phase 3 OnPrime/GOG-3076 registrational trial in PRROC continues to enroll patients with over 23 sites activated...The Company anticipates topline results in the second half of 2025....The United States based Phase 2 trial in recurrent non-small cell lung cancer (NSCLC) is expected to report interim results in mid-2025. The Company anticipates an interim readout in the second half of 2024 for the Phase 1b part of the Phase 1b/2 trial in patients with recurrent small cell lung cancer in China."

P1 data • P2 data • P3 data: top line • Trial status • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Andrew Lowy | Phase classification: P1b ➔ P1

Oncolytic virus • Phase classification • Surgery • Oncology • Solid Tumor

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 | Sponsor: Genelux Corporation

Checkpoint inhibition • New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Genelux Corporation Announces Pricing of Approximately $27.5 Million Underwritten Offering of Common Stock and Accompanying Warrants (GlobeNewswire) - "Genelux Corporation...announced the pricing of an underwritten offering of 6,875,000 shares of its common stock and accompanying warrants to purchase 6,875,000 shares of its common stock at a combined offering price of $4.00 per share and accompanying warrant, in each case before underwriting discounts and commissions....The net proceeds from the offering are expected to provide working capital into the first quarter of 2026 for general corporate purposes, including the continued clinical development of Olvi-Vec, with topline results of the OnPrime Phase 3 registrational trial anticipated in the second half of 2025. The offering is expected to close on or about May 29, 2024, subject to customary closing conditions."

Commercial • P3 data: top line • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor