Genelux and Newsoara Announce Positive Preliminary Phase 1b/2 Data of Olvi-Vec in Advanced Small-Cell Lung Cancer
Genelux and Newsoara BioPharma have announced promising preliminary data from their Phase 1b/2 trial of Olvi-Vec immunochemotherapy in platinum-relapsed/refractory small cell lung cancer patients. The trial showed a 71% disease control rate (5/7 patients), with two achieving partial responses.
Key highlights include:
- One participant achieved ~79% tumor reduction
- Three participants reached stable disease with tumor reductions of 24-29.2%
- All patients with disease control experienced reductions in all target lesions
- Treatment demonstrated favorable safety profile with mostly mild to moderate side effects
The data suggests Olvi-Vec's potential as a platinum resensitizing agent beyond ovarian cancer. The trial continues enrollment for dose escalation to determine the recommended intravenous dose for Phase 2.
Genelux e Newsoara BioPharma hanno annunciato dati preliminari promettenti dal loro studio di Fase 1b/2 su Olvi-Vec immunochemioterapia in pazienti con cancro polmonare a piccole cellule in recidiva/rifrazione al platino. Lo studio ha mostrato un tasso di controllo della malattia del 71% (5/7 pazienti), con due che hanno raggiunto risposte parziali.
I punti salienti includono:
- Un partecipante ha ottenuto una riduzione tumorale di circa il 79%
- Tre partecipanti hanno raggiunto una malattia stabile con riduzioni tumorali del 24-29,2%
- Tutti i pazienti con controllo della malattia hanno mostrato riduzioni in tutte le lesioni target
- Il trattamento ha dimostrato un profilo di sicurezza favorevole con effetti collaterali per lo più lievi o moderati
I dati suggeriscono il potenziale di Olvi-Vec come agente di risensibilizzazione al platino oltre il cancro ovarico. Lo studio continua a reclutare per l'aumento della dose per determinare la dose endovenosa raccomandata per la Fase 2.
Genelux y Newsoara BioPharma han anunciado datos preliminares prometedores de su ensayo de Fase 1b/2 sobre Olvi-Vec inmunoquimioterapia en pacientes con cáncer de pulmón de células pequeñas en recaída/refractario al platino. El ensayo mostró una tasa de control de la enfermedad del 71% (5/7 pacientes), con dos logrando respuestas parciales.
Los puntos destacados incluyen:
- Un participante logró una reducción tumoral de aproximadamente el 79%
- Tres participantes alcanzaron enfermedad estable con reducciones tumorales del 24-29.2%
- Todos los pacientes con control de la enfermedad experimentaron reducciones en todas las lesiones objetivo
- El tratamiento demostró un perfil de seguridad favorable con efectos secundarios mayormente leves a moderados
Los datos sugieren el potencial de Olvi-Vec como un agente de resensibilización al platino más allá del cáncer de ovario. El ensayo continúa reclutando para la escalación de dosis para determinar la dosis intravenosa recomendada para la Fase 2.
Genelux와 Newsoara BioPharma는 백금 재발/불응 소세포 폐암 환자를 대상으로 한 Olvi-Vec 면역화학요법의 1b/2상 시험에서 유망한 초기 데이터를 발표했습니다. 이 시험은 질병 조절율이 71% (7명 중 5명)로 나타났으며, 그 중 두 명이 부분 반응을 보였습니다.
주요 하이라이트는 다음과 같습니다:
- 한 참가자가 약 79%의 종양 감소를 달성했습니다.
- 세 명의 참가자가 24-29.2%의 종양 감소로 안정적인 질병에 도달했습니다.
- 질병 조절이 된 모든 환자는 모든 목표 병변에서 감소를 경험했습니다.
- 치료는 대부분 경미하거나 중등도의 부작용을 가진 유리한 안전성 프로필을 보여주었습니다.
데이터는 Olvi-Vec이 난소암을 넘어 백금 재감작제로서의 잠재력을 제시합니다. 이 시험은 2상에 대한 권장 정맥 투여 용량을 결정하기 위해 용량 증가를 위한 등록을 계속 진행하고 있습니다.
Genelux et Newsoara BioPharma ont annoncé des données préliminaires prometteuses de leur essai de Phase 1b/2 sur Olvi-Vec immunochimiothérapie chez des patients atteints de cancer du poumon à petites cellules en rechute/réfractaire au platine. L'essai a montré un taux de contrôle de la maladie de 71% (5/7 patients), avec deux ayant atteint des réponses partielles.
Les points saillants incluent:
- Un participant a obtenu une réduction tumorale d'environ 79%
- Trois participants ont atteint une maladie stable avec des réductions tumorales de 24-29,2%
- Tous les patients avec contrôle de la maladie ont connu des réductions dans toutes les lésions cibles
- Le traitement a montré un profil de sécurité favorable avec des effets secondaires principalement légers à modérés
Les données suggèrent le potentiel d'Olvi-Vec en tant qu'agent de resensibilisation au platine au-delà du cancer de l'ovaire. L'essai continue de recruter pour l'escalade des doses afin de déterminer la dose intraveineuse recommandée pour la Phase 2.
Genelux und Newsoara BioPharma haben vielversprechende vorläufige Daten aus ihrer Phase 1b/2-Studie zu Olvi-Vec Immunochemotherapie bei Patienten mit platin-resistentem/refraktärem kleinzelligem Lungenkrebs veröffentlicht. Die Studie zeigte eine Krankheitskontrollrate von 71% (5/7 Patienten), wobei zwei teilweise Ansprechen erzielten.
Wichtige Highlights sind:
- Ein Teilnehmer erzielte eine Tumorreduktion von etwa 79%
- Drei Teilnehmer erreichten eine stabile Erkrankung mit Tumorreduktionen von 24-29,2%
- Alle Patienten mit Krankheitskontrolle erfuhren Reduktionen aller Zielherde
- Die Behandlung zeigte ein günstiges Sicherheitsprofil mit überwiegend milden bis moderaten Nebenwirkungen
Die Daten deuten auf das Potenzial von Olvi-Vec als platinresensibilisierendes Mittel über den Eierstockkrebs hinaus hin. Die Studie setzt die Rekrutierung zur Dosissteigerung fort, um die empfohlene intravenöse Dosis für die Phase 2 zu bestimmen.
- 71% disease control rate in initial cohorts (5/7 patients)
- Significant tumor reduction (up to 79%) in target patients
- Demonstrated efficacy in heavily pre-treated patients
- Favorable safety profile with mainly mild to moderate side effects
- Potential expansion beyond ovarian cancer to multiple solid tumor types
- Small initial patient sample size (only 7 evaluable patients)
- Maximum tolerated dose not yet determined
- Phase 2 recommended dose still under investigation
Insights
These preliminary Phase 1b results for Olvi-Vec in platinum-relapsed/refractory small-cell lung cancer (SCLC) show surprisingly encouraging activity in a notoriously difficult-to-treat population. The 71% disease control rate with two partial responses is noteworthy, especially considering all participants with disease control experienced reductions across all target lesions. The 79% tumor reduction in one patient at the current dose level suggests potential dose-dependent activity.
SCLC typically shows rapid resistance development after platinum therapy, with extremely poor outcomes. Standard second-line treatments rarely achieve disease control rates above 20-30%, making this early signal particularly interesting. The observation that even heavily pretreated patients (including one with three prior therapy lines) achieved stable disease with 24-29% tumor reductions indicates meaningful biological activity.
The potential platinum-resensitizing mechanism, if proven across multiple tumor types, represents a significant therapeutic approach. This aligns with previous signals in platinum-resistant ovarian cancer, suggesting a consistent mechanism of action. The favorable safety profile with primarily mild-to-moderate adverse events is crucial for this fragile patient population.
While these results are promising, the small sample size (7 evaluable patients) necessitates caution. The ongoing dose escalation without reaching maximum tolerated dose suggests potential for improved efficacy at higher doses. The true clinical value will depend on response durability and translation to survival benefit in the Phase 2 portion.
This preliminary data represents a significant positive development for Genelux (market cap: $134.5M). The 71% disease control rate and tumor reduction in all responding patients provide strong validation for Olvi-Vec's mechanism beyond its original ovarian cancer application, potentially establishing it as a platform technology rather than a single-indication asset.
Small-cell lung cancer represents a substantial market opportunity with approximately 30,000 new cases annually in the US alone. The second-line/relapsed setting has few effective options, creating a clear unmet need. If Olvi-Vec continues to demonstrate efficacy as a platinum-resensitizing agent across multiple tumor types, this significantly expands its commercial potential and licensing opportunities.
The co-development partnership with Newsoara reduces Genelux's development costs while maintaining significant economic interest. Importantly, these positive signals in a second difficult-to-treat indication substantially de-risk the overall Olvi-Vec program and support the broader development strategy.
For a micro-cap company, achieving consistent efficacy signals across multiple cancer types is crucial for valuation expansion. The favorable safety profile further strengthens the risk-benefit proposition. While still early-stage (Phase 1b), these results justify continued investment in the program.
With enrollment continuing in dose escalation cohorts and no maximum tolerated dose reached yet, there's potential for even stronger efficacy at higher doses. The upcoming Phase 2 portion design will be critical for determining registration strategy and potential accelerated approval pathways given the unmet need in this population.
– Systemic administration of Olvi-Vec in the initial dose escalation cohorts achieved a
– Additionally, three participants, including one individual with three prior lines of treatment, achieved stable disease at lower dose cohorts, with tumor size reductions ranging between
– Data are supportive of Olvi-Vec being a platinum resensitizing agent beyond ovarian cancer and, consistent with earlier studies, being systemically administered in multiple solid tumor types which underscore the current clinical development strategy.
– Olvi-Vec was generally well-tolerated with a favorable safety profile. Participant enrollment into dose escalation cohorts continues to investigate safety and the recommended intravenous dose of Olvi-Vec for the Phase 2 trial.
WESTLAKE VILLAGE, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, and Newsoara BioPharma Co., Ltd., a pre-commercial-stage biopharmaceutical company, today 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.
“We are encouraged by the Phase 1b trial data which suggests preliminary anti-tumor activity. Consistent reductions in all individual target lesions in participants experiencing disease control (5/7), combined with encouraging anti-tumor activity of the first evaluable participant in the most recent dose-escalation cohort, highlights the potential of systemically administered Olvi-Vec to provide meaningful clinical benefit for patients with relapsed or refractory extensive small cell lung cancer,” said Thomas Zindrick, President, CEO, and Chairman of Genelux. “These results are consistent with our previous Phase 2 results in platinum-resistant/refractory ovarian cancer and, with further investigation in our ongoing trials in relapsed/refractory lung cancer, we anticipate demonstrating the potential of Olvi-Vec as a platinum resensitizing immunotherapeutic agent across multiple types of recurrent cancers with significant unmet medical needs.”
Preliminary Dose Escalation Results Update
The primary objectives of this trial are to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of systemically administered Olvi-Vec in the target population. The data cutoff for this announcement was February 19, 2025, with enrollment currently ongoing. Genelux anticipates providing updates on the trial's progress as it continues to advance, whether through future publications or conference presentations.
Key findings from the ongoing Phase 1b trial include:
Favorable Safety and Tolerability Profile:
- 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, including fever, anemia, reduced lymphocyte counts, and nausea. No maximum tolerated dose has been reached to date.
Antitumor Activity:
- Preliminary evidence indicates anti-tumor effect from Olvi-Vec immunochemotherapy. Five of the seven (
71% ) evaluable participants for anti-tumor response achieved disease control as the best response. The five participants with disease control showed reductions in all of their individual target lesions. All seven evaluable participants had documented disease progression at baseline before joining this study. - 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% . Additionally, the three remaining participants with disease control, including one individual with three prior lines of treatment, achieved stable disease at lower dose cohorts, with tumor size reductions ranging from24% to29.2% .
"The initial results are promising, especially considering the challenging and fragile nature of this patient population with extensive-stage disease and poor prognosis. What stands out is the anti-tumor responses in these participants, some who have been heavily pre-treated and have failed prior platinum-based therapy, which offers significant potential for Olvi-Vec to provide meaningful clinical benefits in small cell lung cancer, even in a patient population with complex and late-stage disease,” said Dr. Benny Li, CEO of Newsoara. “Ongoing evaluation of the Phase 1b results is consequentially informing the design elements of the Phase 2 portion of the clinical trial."
About the Olvi-Vec-SCLC-202 Trial
Olvi-Vec-SCLC-202 is a Phase 1b/2, open-label, multicenter clinical trial evaluating the safety, tolerability, pharmacokinetics and efficacy of intravenously delivered Olvi-Vec combined with platinum and etoposide in the treatment of platinum-relapsed or platinum-refractory extensive small cell lung cancer patients. The Phase 1b trial is currently enrolling patients in China at Shanghai Chest Hospital, the lead clinical site, and Zhejiang Provincial People's Hospital.
Patients receive a single cycle of Olvi-Vec treatment for three consecutive days and, 21 days after the last dose of Olvi-Vec, receive platinum chemotherapy plus etoposide until disease progression or intolerable toxicity occurs.
The dose escalation part of the trial is assessing the safety and tolerability of increasing doses of Olvi-Vec to determine the recommended dose and dosing regimen for Phase 2 expansion. Additionally, safety data may be evaluated to support the potential for Olvi-Vec to be safely combined with other agents, such as an immune checkpoint inhibitor, to further drive deep and durable responses in the Phase 2 portion of the trial.
The Phase 2 portion of the trial is planned to follow and further evaluate the safety and tolerability as well as efficacy of Olvi-Vec at the recommended dose.
About Olvi-Vec
Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s most advanced product candidate is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity. Genelux is developing Olvi-Vec for the treatment of multiple types of cancer based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response. Genelux granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan). To date, Olvi-Vec has been administered to more than 150 patients in seven completed clinical trials. In these trials, Olvi-Vec was observed to be generally well tolerated with data demonstrating clinical benefit.
About Genelux Corporation
Genelux 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. In addition to Olvi-Vec-SCLC-202, Olvi-Vec currently is being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and, VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & Platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer. The core of Genelux's discovery and development efforts revolves around its’ 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 and follow us on Twitter @Genelux_Corp and on LinkedIn.
About Newsoara
Newsoara is a pre-commercial-stage biopharmaceutical company with a mission to develop and commercialize life changing medicines for cancer, autoimmune, metabolic and other major diseases to patients in China and around the world. Since its founding, Newsoara has developed a fully integrated platform which includes R&D, CMC and clinical development capabilities and built a robust and broad pipeline in major therapeutics areas. Newsoara has assembled a world-class management team with extensive experience in innovative drug development that is motivated to improve and impact human health worldwide.
Forward-Looking Statements
This 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, the potential capabilities, advantages, safety and efficacy of Olvi-Vec to treat small cell lung cancer and other indications and the trial design of the Phase 2 portion of the Phase 1b/2 clinical trial. 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’s 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, MD
Allele Communications, LLC
genelux@allelecomms.com
Source: Genelux Corporation
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