At ImmuneOnco, our mission is "TO DEVELOP BEST-IN-CLASS AND/OR FIRST-IN-CLASS ANTI-CANCER DRUGS FOR CANCER PATIENTS AROUND THE WORLD". We also are committed to providing access to therapies that are not yet approved for use to people who are suffering from a serious or life-threatening illness or condition and might potentially benefit from our medicines.
To do that, ImmuneOnco has developed the Access to Investigational Drugs Policy. It outlines important considerations we take into account when evaluating a doctor's request to use investigational drugs in a patient with a serious or life-threatening illness or condition.
We cover two areas in this document:
1) Where patients participate in one of our clinical studies, we explain how we may provide continued treatment for patients after their study treatment, or after the whole study, has completed.
2) Where patients are suffering from a disease that is not possible to be treated with existing medicines, or patients are not able to participate in one of our clinical studies, we explain how we handle requests for compassionate or emergency use of our new medicines.
Our policy applies to requests on behalf of individual patients (Single-Patient Access) and to certain groups of patients with similar characteristics (Multi-Patient Protocol Access). The Pre-Approval Access program may also be referred to as Expanded Access, Compassionate Use or Named Patient Basis programs, as defined by local regulations. While our policy outlines the general criteria for consideration, each case is unique and will be considered on an individual basis.
We understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, ImmuneOnco will consider providing a requesting physician with pre-approval access to a specific investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option.
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient's specific condition.
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician's assessment of the individual patient's condition and history, supports making the investigational drug available.
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access.
• Adequate supply of the investigational drug is available.
We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.
Where it is expected that there is a need for ongoing treatment with one of our new medicines, we recognize that this must be through normal health services once the new medicine is available for prescription. As such we will only conduct clinical studies and provide early access outside of studies, in those countries where we intend to make the medicine available through normal prescription channels after its approval. And any early access programs we provide will be in line with the laws and requirements of the country involved.
3.2 Continued treatment after clinical studies
To be sure that our new medicines will work effectively and be safe enough to be prescribed for the diseases patients are suffering from, we study them rigorously to see whether they provide adequate relief. The results of these clinical studies allow the regulatory authorities to independently assess whether to allow the new medicines to be prescribed. As this can take several years, patients who participate in our clinical studies may have to wait for a new medicine to become available on prescription.
Where there may be a benefit for a patient to continue to be treated after the clinical study has ended, but before it is available on prescription, we will decide if we have enough information to justify early access. This will depend on the severity of the disease we are studying, how much evidence we have that the medicine works as expected and is sufficiently safe, and whether alternative effective medicines are already available on prescription.
We understand that it can be difficult to decide to participate in a clinical study, so will ensure we make this information as clear as possible. To be sure we can assess whether the new medicine continues to work effectively and is safe enough to continue to be used during early access, we will ask for the patient's consent for their physician to collect some relevant information from them on an ongoing basis while they receive the medicine.
3.3 Compassionate or emergency use outside of clinical studies
The best way to see if a new medicine is sufficiently safe and effective is to run clinical studies. As such we prefer that, where possible, patients have the opportunity to participate in our clinical studies. We recognize however that not everyone has this opportunity. Where patients who cannot enroll in a clinical study are suffering from serious or immediately life threatening diseases, and there are no satisfactory alternative treatments available, we will consider early access if they meet the application criteria described in the previous section（Section 3.1）.
In the same way as after a clinical study, we want to be sure we can assess whether the new medicine continues to work and is safe enough to continue to be used. As such we will ask for the patient's consent for their physician to collect some relevant information from them on an ongoing basis while they receive the medicine.
3.4 Discontinuation of early access
When a new medicine receives approval from the regulatory authorities for the disease we are studying, and is available for prescription in the patient's country, we will phase out the early access to allow the health system to prescribe the new medicine in the normal manner.
4. Communication and Application
ImmuneOnco is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient's treating physician; ImmuneOnco may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by ImmuneOnco whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to the mailbox(info@Immuneonco.com). We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 7 working days after receipt.
ImmuneOnco has the right to revise and interpret this policy.