Biology:GL-ONC1

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GL-ONC1 (USAN: olvimulogene nanivacirepvec; abbreviated as Olvi-Vec) is an investigational therapeutic product consisting of the clinical grade formulation of the laboratory strain GLV-1h68, an oncolytic virus developed by Genelux Corporation.[1] GL-ONC1 is currently under evaluation in Phase I/II human clinical trials in the United States and Europe.[2] GL-ONC1 (CAS Registry Number (CAS RN): 1473430-36-2) is a triple modified and attenuated vaccinia virus (Lister strain) that causes regression and elimination of a wide range of solid tumors in preclinical mouse models.[3] It was generated by insertion of three expression cassettes (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, beta-galactosidase, and beta-glucuronidase) into the F14.5L, J2R (encoding thymidine kinase) and A56R (encoding hemagglutinin) loci of the parental viral Lister strain genome, respectively.[1] The oncolytic virus specifically infects and kills tumor cells which leads to oncolysis, immune activation and triggering anti-tumor immune responses.[4][5][6]

Clinical trials

Regional (cavity) administration

One Phase I/II Study of intraperitoneal administration of GL-ONC1 in patients with advanced peritoneal carcinomatosis has been completed.[7][8] A Phase II study of intraperitoneal administration of GL-ONC1 (Olvi-Vec) in heavily-pretreated patients with platinum-resistant/refractory ovarian cancer was completed.[9][10] Positive clinical data have been reported in IGCS 2020 and ESMO 2020 conferences. [11] [12] A registration trial of Olvi-Vec(aka GL-ONC1)-primed immunochemotherapy is being planned.

In a Phase I study, intra-pleural administration of GL-ONC1 is being evaluated in patients with malignant pleural effusion, which is caused by cancer from malignant pleural mesothelioma, non-small cell lung cancer (NSCLC), or breast cancer.[13] In this trial GL-ONC1 infection of tumor cells was identified in 6 out of 8 patients with epithelioid malignant pleural mesothelioma.[14]

Systemic (intravenous) administration

Systemic administration of GL-ONC1 via intravenous injection was under investigation in multiple clinical trials:

In one study, GL-ONC1 was administered to patients with advanced solid organ tumors as a monotherapy.[15] In another completed study, GL-ONC1 was given in combination with radiation therapy and cisplatin (CDDP) to patients with locoregionally advanced head and neck cancer.[16][17]

References

  1. ↑ 1.0 1.1 "Eradication of solid human breast tumors in nude mice with an intravenously injected light-emitting oncolytic vaccinia virus". Cancer Research 67 (20): 10038–46. October 2007. doi:10.1158/0008-5472.can-07-0146. PMID 17942938. 
  2. ↑ "Search of: GL-ONC1 - List Results - ClinicalTrials.gov". clinicaltrials.gov. https://clinicaltrials.gov/ct2/results?term=GL-ONC1&Search=Search. 
  3. ↑ "Preferential colonization of metastases by oncolytic vaccinia virus strain GLV-1h68 in a human PC-3 prostate cancer model in nude mice". PLOS ONE 7 (9): e45942. 2012. doi:10.1371/journal.pone.0045942. PMID 23049897. Bibcode: 2012PLoSO...745942D. 
  4. ↑ "Thunder and lightning: immunotherapy and oncolytic viruses collide". Molecular Therapy 19 (6): 1008–16. June 2011. doi:10.1038/mt.2011.65. PMID 21505424. 
  5. ↑ "Oncolytic viruses for induction of anti-tumor immunity". Current Pharmaceutical Biotechnology 13 (9): 1750–60. July 2012. doi:10.2174/138920112800958913. PMID 21740355. 
  6. ↑ "Immune recruitment and therapeutic synergy: keys to optimizing oncolytic viral therapy?". Clinical Cancer Research 17 (13): 4214–24. July 2011. doi:10.1158/1078-0432.ccr-10-2848. PMID 21576084. 
  7. ↑ Clinical trial number NCT01443260 for "A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis" at ClinicalTrials.gov
  8. ↑ "Phase I study of oncolytic vaccinia virus GL-ONC1 in patients with peritoneal carcinomatosis". Clinical Cancer Research 24 (18): 4388–4398. May 2018. doi:10.1158/1078-0432.CCR-18-0244. PMID 29773661. 
  9. ↑ Clinical trial number NCT02759588 for "GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian Cancer" at ClinicalTrials.gov
  10. ↑ Holloway RW et al. (March 2020) "Phase II VIRO-15 trial of olvimulogene nanivacirepvec (Olvi-Vec)-primed immunochemotherapy in platinum-resistant/refractory ovarian cancer (PRROC) (NCT02759588)". https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/15668. 
  11. ↑ Holloway RW et al. (September 2020) "Genelux Announces Oral Plenary Presentation of VIRO-15 Phase 2 Trial Data at the 2020 xDigital Annual Global Meeting of the International Gynecologic Cancer Society". https://apnews.com/press-release/pr-newswire/corporate-news-oral-cancer-north-america-products-and-services-cancer-d75d14e0414fee5f643c7dd1af3cfe5e. 
  12. ↑ Holloway RW et al. (September 2020) "Genelux to Present Data from Phase 2 Trial of Olvi-Vec in Heavily Pre-treated Platinum-Resistant/Refractory Ovarian Cancer at ESMO Virtual Congress 2020". https://www.prnewswire.com/news-releases/genelux-to-present-data-from-phase-2-trial-of-olvi-vec-in-heavily-pre-treated-platinum-resistantrefractory-ovarian-cancer-at-esmo-virtual-congress-2020-301131704.html. 
  13. ↑ Clinical trial number NCT01766739 for "Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma" at ClinicalTrials.gov
  14. ↑ Krug, Lee M.; Zauderer, Marjorie Glass; Adusumili, Prasad S.; McGee, Erin; Sepkowitz, Kent; Klang, Mark et al. (May 2015). "Phase I study of intra-pleural administration of GL-ONC1, an oncolytic vaccinia virus, in patients with malignant pleural effusion". Journal of Clinical Oncology 33 (15_suppl): 7559. doi:10.1200/jco.2015.33.15_suppl.7559. 
  15. ↑ Clinical trial number NCT00794131 for "Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors" at ClinicalTrials.gov
  16. ↑ Clinical trial number NCT01584284 for "Safety Study of Attenuated Vaccinia Virus (GL-ONC1) With Combination Therapy in Head & Neck Cancer" at ClinicalTrials.gov
  17. ↑ Mell LK et al. (July 2017) "Phase I Trial of Intravenous Oncolytic Vaccinia Virus (GL-ONC1) with Cisplatin and Radiotherapy in Patients with Locoregionally Advanced Head and Neck Carcinoma". https://clincancerres.aacrjournals.org/content/clincanres/early/2017/08/29/1078-0432.CCR-16-3232.full.pdf. 

External links



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