Pipeline

Overview

We are dedicated to developing a pipeline of next-generation immunotherapies for patients suffering with aggressive and/or difficult-to-treat solid tumor types. Information about our investigational products and clinical trials can be found here and clinicaltrials.gov

 

A robust clinical pipeline advancing two programs with significant potential:

  • A Regional Program (ovarian cancer) with delivery into the abdominal cavity that maximizes pharmacokinetics & tumor tissue exposure
  • A Systemic Program (solid tumors) with intravenous delivery which looks to maximize the addressable indications

Pipeline will need to be swiped left and right on smaller devices (Phones and tablets)

Human
Therapeutics
Therapeutic
Indication
Design
Pre-clinical
Phase 1
Phase 2
Phase 3
Clinical
Sites
Clinical
Sponsors

Olvi-Vec

Regional Program

Ovarian Cancer
(resistant / refractory)
Olvi-Vec (i.pe)
+Chemotherapy
Active
US
In September 2022, first patient enrolled in our OnPrime trial, a Phase 3 registration trial in platinum resistant/refractory ovarian cancer (NCT05281471). OnPrime is an open-label, randomized controlled design (2:1 randomization), enrolling patients who received their last platinum within six months from enrollment (i.e., patients who would not be responsive to platinum re-challenge).

The Experimental Arm patients receive a single cycle (two doses) of Olvi-Vec administered intraperitoneally and, approximately four weeks later, a regimen of a platinum-based doublet plus bevacizumab followed by maintenance therapy. The Active Comparator Arm patients receive a regimen of platinum-based doublet plus bevacizumab followed by maintenance therapy. The estimated enrollment will be approximately 186 patients.

Commercial Rights: Genelux – Worldwide (excluding Great China); Newsoara (Greater China).

Systemic Program

NSCLC
(recurrent)
Olvi-Vec (i.v.)
+Chemotherapy
Planned
US
Based on the results of our previously completed Phase 1 clinical trials of Olvi-Vec administered intravenously to patients with solid tumors, we are planning to initiate a Phase 2 clinical trial of Olvi-Vec in recurrent NSCLC.

Subject to FDA authorization, the trial will be an open-label, randomized, and controlled clinical trial designed to evaluate the efficacy and safety of intravenously delivered Olvi-Vec followed by treatment as per the National Comprehensive Cancer Network (NCCN) Guidelines for patients with recurrent NSCLC in the United States. The estimated enrollment will be 138.

Commercial Rights: Genelux – Worldwide (excluding Great China); Newsoara (Greater China)

NSCLC
(recurrent)
Olvi-Vec (i.v.)
+Chemotherapy

SCLC
(recurrent)
Olvi-Vec (i.v.)
+Chemotherapy
CHINA

Ovarian Cancer
(recurrent)
Olvi-Vec (i.iv.)
+Chemotherapy
Regulatory Submission
We anticipate Newsoara will initiate a Phase 1 clinical trial of Olvi-Vec in patients with recurrent SCLC, and thereafter initiate trials in recurrent NSCLC and recurrent ovarian cancer in China. An IND and protocols have been submitted to the Chinese National Medical Products Administration.

Commercial Rights: Genelux – Worldwide (excluding Great China); Newsoara (Greater China)

V2ACT
Immunotherapy

Pancreatic Cancer
(newly diagnosed, surgically resectable)
Olvi-Vec (i.v.)
+Adoptive Cell Therapy
Regulatory Submission
US
V2ACT Therapeutics, LLC holds an active IND for the clinical investigation of V2ACT Immunotherapy in a Phase 1/2a trial for the treatment of newly diagnosed surgically-resectable pancreatic cancer. This clinical trial is not yet scheduled to be initiated.

Commercial Rights: V2ACT Immunotherapy – Worldwide (excluding Great China)
Animal
Therapeutics
Therapeutic
Indication
Design
Safety
Preliminary
Efficacy
Pivotal Efficacy
Clinical
Sites
Clinical
Sponsors

V-VET1

Hematologic &
Solid Cancer(S)
V-VET1 (i.v.)
+/- standard of care
Active
US
We granted ELIAS the exclusive worldwide license to our V-VET1 clinical program in November 2021. Planning activities are ongoing to initiate an efficacy trial.

Commercial Rights: ELIAS – Worldwide

Clinical Trial Phases:

Phase 1

A phase of research to describe clinical trials that focus on the safety of a drug.

Phase 2

A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (the drug’s effectiveness).

Phase 3

A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA).
Genelux Policy

“Our work focuses on patient benefit.  It’s about finding solutions for cancer patients with difficult to treat diseases, and committing long-term to ensure that our solutions ultimately improve patients’ experiences and outcomes.”  – Rob Holloway, M.D.

Expanded Access Policy

Genelux Corporation is committed to developing safe and effective next-generation immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Our goal is to ensure access to our investigational therapies at the appropriate time and in a clinically appropriate manner for patients.

Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Genelux, we recognize and understand the need for an early/expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.

The request for access to a Genelux investigational drug will be considered only if the patient is an eligible patient, meaning:

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies; and
  • The patient is not eligible for or unable to participate in a clinical trial

In addition, prior to setting up an expanded access program or granting a request from an eligible patient’s physician, Genelux will consider whether:

  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition;
  • Providing the investigational therapy as part of an expanded access program will interfere with clinical trials that could support the investigational therapy’s development or marketing approval for the treatment indication; and
  • We have adequate supply of investigational drug.

At this time, based on these factors, Genelux believes that participation in one of our clinical trials is the only appropriate way to access our investigational therapies.

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.