T3011 Intratumoral Injection in Patients With Advanced Solid Tumors
ImmVira is a biotechnology company focused on development of new generation novel drug vectors driven by clinical benefits in oncology and non-oncology fields. T3011 is a replication-competent, genetically modified virus derived from herpes simplex virus type 1 expressing IL-12 and PD-1 antibody.
ImmVira recognizes that some patients with serious or life-threatening disease may lack other treatment options and be unable to participate in a clinical trial. Under these circumstances, a healthcare professional (HCP) may request access to ImmVira's investigational medicines for patient treatment. This access is called "compassionate use" or "expanded access" and allows the use of an unapproved drug outside of a clinical trial.
This policy outlines ImmVira's process for reviewing requests from HCP for compassionate use of our investigational drugs. To be considered, the patient's condition must be:
• Severity of the patient's condition: The illness must be life-threatening or significantly impact daily life.
• Lack of alternatives: The doctor treating the patient must confirm there are no other suitable treatments available.
• Potential benefit outweighs risk: There must be evidence suggesting the potential benefits of the investigational drug are greater than the potential risks for this specific patient.
Beyond the initial criteria, several factors influence our decision on supplying investigational drugs:
• Treatment Guidance: Clear instructions for dosage and treatment duration are necessary for safe use.
• Clinical Trials: We evaluate if access might affect ongoing clinical trials or the drug's regulatory path.
• Medical Infrastructure: The treatment can only be provided in countries with facilities to safely administer it.
• Broad Access Programs: We prioritize countries where we plan to seek approval and make the drug commercially available. This might not apply to individual patients.
• Ethical Considerations: We ensure fair treatment principles are followed for all patients.
• Legal Compliance: The treatment must comply with local regulations.
• Drug Availability: We must have sufficient supply of the investigational drug to fulfill the request.
We strongly believe that participation in one of our clinical trials is the most effective way to access T3011.
ImmVira will also consider providing a requesting physician with pre-approval access to T3011, for the treatment of an individual patient outside of a clinical trial. ImmVira is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s physician. Each request will be given careful consideration by ImmVira whose decisions are final.
HCPs seeking to request unlicensed medicines for treatment use should file the treatment IND to FDA and submit relevant information to IRB.
For further information on submitting a request for treatment use of our investigational medicines, HCPs are directed to follow this link https://www.immviragroup.com/.