On September 9, 2026 Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported the publication of a case report from the ongoing Phase 1b dose escalation portion of its Phase 1b/2 OLVI-VEC-202-SCLC trial (NCT07136285). The report was published in Frontiers in Oncology, a peer-reviewed journal published by Frontiers Media S.A., available here.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
This is an open-label trial evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in patients with platinum-relapsed or platinum-refractory small cell lung cancer (SCLC) after failing previous first-line treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co. (Shanghai), Ltd. (Newsoara), in China.
"This compelling case published in Frontiers in Oncology provides clinically relevant evidence that strengthens our commitment to evaluating systemic (intravenous) administration of Olvi-Vec in combination with platinum-based chemotherapy and potentially other treatment regimens," said Thomas Zindrick, President, CEO, and Chairman of Genelux. "We are encouraged by the consistency between our preclinical and clinical data with Olvi-Vec-primed immunochemotherapy which supports a mechanism of action by which Olvi-Vec-mediated changes to the tumor microenvironment may enhance responsiveness to therapies in both first-line and recurrent settings."
In this case report, a 58-year-old woman was previously treated for extensive stage SCLC with four cycles of frontline standard treatment with platinum and etoposide, followed by radiotherapy to the lung and prophylactic brain radiotherapy resulting in a 14.3-month progression-free survival (PFS) and a duration of response (DOR) of 13.0 months.
After progressing from standard frontline therapy, the patient received a single course of systemically administered Olvi-Vec, which was well tolerated, and then was re-challenged with eight cycles of platinum and etoposide. The patient achieved a deep and durable partial objective response (84.6% reduction in target lesion size), a PFS of 16.7 months and a DOR of 14.3 months, exceeding those observed during her first-line platinum-based treatment. Moreover, the patient achieved a deeper tumor reduction after 4 cycles of platinum re-challenge as compared to after 4 cycles of first-line treatment (-78.9% vs -67.8%), representing an absolute reduction of 22.0 mm (from a 27.9 mm baseline before initiation of 2nd line therapy) versus 11.6 mm (from a 17.1 mm baseline before initiation of 1st line therapy).
This patient’s experience exceeds historical outcomes reported with platinum rechallenge and support the hypothesis that Olvi-Vec-mediated changes in the tumor microenvironment may contribute to renewed sensitivity to platinum-based therapy.
"Small cell lung cancer is known for its aggressive nature and poor prognosis once it recurs after initial chemotherapy," said Jason Litten, M.D., Chief Medical Officer of Genelux Corporation. "Although this case report reflects the outcome of a single patient and does not establish safety or efficacy or predict similar outcomes in other patients, the magnitude and duration of tumor regression are highly encouraging and align with our scientific rationale for combining Olvi-Vec with platinum-based therapy in various clinical settings."
Patient enrollment is ongoing in the dose-escalation cohorts of OLVI-VEC-202-SCLC and in the VIRO-25 trial, a Phase 2 trial evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) who failed standard first-line treatment of platinum chemotherapy and an ICI. Additional dose‑finding updates from both the Phase 1b/2 SCLC trial and Phase 2 VIRO‑25 NSCLC trial are expected in 2026. Together, these dose‑finding studies are intended to inform the Company’s lung cancer development strategy and the potential for broader systemic use of Olvi-Vec across additional solid tumor types.
Pursuant to a license agreement entered into in September 2021, Genelux granted to Newsoara BioPharma Co. Ltd. an exclusive license to research, develop, commercialize or exploit Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and therapeutic uses. In October 2025, Newsoara BioPharma Co. Ltd. assigned all of its rights and obligations under the agreement to an affiliate, Newsoara HYK Biopharmaceuticals Co., Ltd. Genelux and Newsoara co-sponsor the Olvi-Vec-SCLC-202 Phase 1b/2 study, which Newsoara is conducting in China.
About Olvi-Vec
Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s lead investigational asset, is a proprietary, modified vaccinia virus being evaluated as an oncolytic immunotherapy. Olvi-Vec’s differentiated mechanism of action (MoA) is designed to directly kill cancer cells, stimulate a tumor-specific immune response, remodel the tumor microenvironment, and re-sensitize tumors to platinum-based chemotherapy with or without ICIs. Genelux is developing Olvi-Vec immunotherapy for multiple cancer types in a strategically integrated program based on robust preclinical data and clinical evidence of its differentiated MoA, feasibility of repeat dosing and a dose-dependent overall survival benefit in cancer patients with primary or metastatic lung diseases. To date, Olvi-Vec has been administered to more than 150 patients across seven completed clinical trials, where Olvi-Vec has been generally well tolerated and demonstrated clinically meaningful benefits. Genelux has granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan).
(Press release, Genelux, SEP 9, 2026, View Source [SID1234670680])