To date, 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 approximately 150 patients with a variety of cancer types.
Intraperitoneal administration of Olvi-Vec is an attractive approach for high and condensed dosing.
Platinum Resistant/Refractory Ovarian Cancer (PRROC)
We have met the preestablished endpoint of our Phase 2 clinical trial evaluating the intraperitoneal delivery of Olvi-Vec for the treatment of platinum-resistant/refractory ovarian cancer and are preparing for a Phase 3 registration trial. Subject to Regulatory approval we plan to initiate the trial by the end of 2021.
PRROC represents a difficult-to-treat disease with significant unmet medical need. According to GlobalData (2019), the ovarian cancer market was valued at $1.8 billion in 2018 across the seven major markets – U.S., EU5 (UK, Germany, France, Italy, Spain) and Japan, and it is expected to grow to $6.7 billion in the following ten years with a compound annual growth rate (CAGR) of 14.4%. North America dominates the global market for ovarian cancer diagnostics and therapeutics, and Europe is the second largest market. Asia-Pacific is expected to show high growth rates in the next few years due to the large aging population, with China and India representing the fastest growing markets.
The intravenous administration of Olvi-Vec is an attractive approach for potentially improving the standard of care for many oncology patients because it allows for all tumors in a patient to be treated, including micro-metastases that are often difficult to detect and treat.
Non-Small Cell Lung Cancer (NSCLC)
We are preparing to initiate a Phase 2 trial in NSCLC. Subject to regulatory approval, we plan to initiate the trial by the end of 2021.
Despite advances in treatment and management of recurrent advanced NSCLC, NSCLC represents a high unmet medical need and novel therapies are needed to improve therapeutic outcomes, especially in patients who do not have driver mutations for targeted therapies and/or immunotherapy, or who have developed resistance to their previous treatment(s).
According to Datamonitor (2021), the market for NSCLC is expected to reach $39 billion by 2029 in seven major markets (U.S., EU5 and Japan). The growth of the NSCLC market will be driven partly by increasing incident cases as the population ages. In addition, premium-priced immuno-oncology and targeted pipeline agents are expected to drive the uptake of new therapies and prolong the duration of treatment in the first-line and beyond.
V2ACT Pancreatic Cancer
V2ACT Therapeutics LLC, a joint venture with TVAX Biomedical, which holds an active IND, plans to conduct a Phase 1/2a trial for the treatment for newly diagnosed patients with surgically resectable pancreatic cancer.
According to GLOBOCAN 2020, the market for pancreatic cancer in the eight major markets (U.S., EU5, Japan and urban China) is expected to increase to $4.1 billion in 2029 at a moderate compound annual growth rate (CAGR) of 8.2%.
A Phase 1 study has been completed and evidence of antitumor responses and disease control was documented in patients with different tumor types. We believe the results of this study warrant further development of this novel treatment strategy, alone and in combination with existing therapeutics.
Cancer is the leading cause of death for dogs and the number one pet health concern for dog owners in theUnited States. In addition to surgery, currently available canine cancer treatment typically provides limitedsurvival benefit.
The National Cancer Institute’s Center for Cancer Research Comparative Oncology Program has reportedthat as many as six million pet dogs and six million pet cats are diagnosed with cancer annually inthe UnitedStates. The veterinary oncology market is estimated to reach $909.4 million by 2026, with North Americaexpected to hold a dominant position.
We intend to out-license this program to a leading animal health company, allowing us to retain a financial stake in its future development and potential collaborations.
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.