Olvi-Vec has been studied in multiple early- and mid-phase clinical trials via regional and systemic deliveries, as a monotherapy and in combination with other therapies, in a total of 148 patients with a variety of cancer types.
There are several key documented takeaways from all our trials that apply, irrespective of the route of administration, dosing regimen or cancer type. Olvi-Vec was:
There were also several key documented takeaways from our trials in which Olvi-Vec was systemically administered. Olvi-Vec was shown to::
The following tables summarize the seven human clinical trials conducted with Olvi-Vec.
Protocol Number
GL- ONC1-002/MA (United Kingdom: Phase 1 – NCT00794131)
Indication
Advanced solid tumors
Modality & Route
Monotherapy as intravenous infusion
Results
(A) demonstrated to be feasible:
(i) extended PK (overcoming neutralizing antibodies), (ii) confirmed viral infection, replication at tumor sites distal to site of administration and in circulating tumor cells, (iii) induction of proinflammatory response and triggering activation of adaptive immunity
(B) demonstrated to generate antitumor activity and clinical benefits, including a virus-dose-dependent overall survival benefit, especially in patients with primary lung cancer or other tumor types with lung metastases. Of the 22 evaluable patients with such lung disease, 11 patients who received the lower cumulative dose had a mOS of 4.6 mos vs. a mOS of 16.8 mos for the 11 patients who received the higher cumulative dose (p = 0.026); when further extending the analysis, the five patients who received the lowest cumulative dose had a mOS of 4.6 months vs a mOS of 20,9 mos for the 11 patients who received the highest cumulative dose (p = 0.002).
Protocol Number
GL-ONC1-003/MSK (United States: Phase 1 (Investigator Sponsored) – NCT01766739)
Indication
Malignant pleural effusion related either to malignant pleural mesothelioma
Modality & Route
Monotherapy as intrapleural catheter delivery
Results
The median overall survival (mOS) was 22.3 mos vs. historical 14 mos in all epithelioid subtype patients: for those who did not have subsequent surgery, the mOS was 23.4 mos vs. historical 10 mos; and for those who had subsequent surgery, the mOS was 22.3 mos vs. historical 19 mos.
Protocol Number
GL- ONC1-004/TUE (Germany: Phase 1 – NCT01443260)
Indication
Peritoneal carcinomatosis
Modality & Route
Monotherapy as intraperitoneal catheter delivery
Results
Protocol Number
GL-ONC1-005/UCSD (United States: Phase 1 – NCT01584284)
Indication
Newly diagnosed head and neck cancer
Modality & Route
Combination therapy with intravenous or bolus injection with cisplatin and radiotherapy
Results
Protocol Number
GL- ONC1-011/UCSD (United States: Phase 1 (Investigator Sponsored) – NCT02714374)
Indication
Solid Organ Cancer
Modality & Route
Neoadjuvant monotherapy as intravenous bolus infusion followed by surgical resection of tumor
Results
Protocol Number
GL- ONC1-021/AHCI (United States: EAP – NCT03420430)
Indication
Advanced cancers (solid tumors & blood cancer)
Modality & Route
Monotherapy as intravenous bolus infusion
Results
Protocol Number
GL–ONC1-015/AHCI (United States: Phase 1b/2 – NCT02759588)
Indication
Platinum resistant/ refractory ovarian cancer, fallopian cancer or primary peritoneal carcinomatosis
Modality & Route
IP Infusion as Monotherapy or as combination therapy with carboplatin doublet chemotherapy + bevacizumab
Results
Exploratory Objectives:
Demonstrated viral infection and replication in tumor tissues, and oncolysis of tumor cells
Demonstrated virus-mediated modulation of tumor immune microenvironment; induction of antitumor immune response
The diverse Olvi-Vec clinical program has yielded data that informs our clinical development strategy and trial design for multiple indications. For more information download our Corporate Deck Here. (PDF)
Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. The request for access to a Genelux investigational drug will be considered only if all the following criteria are met.
If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.
Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at EAP@genelux.com. We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.
The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.
For more information on expanded access from the FDA, click here.