D3 Bio Policy on Expanded Access Program for Investigational Drugs
D3 Bio, Inc., hereafter D3 Bio, is dedicated to developing innovative medicines for patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible.
At the same time, 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, D3 Bio is willing to provide our investigational drug, D3S-001, for the treatment of eligible patients with KRASG12C-mutated advanced Colorectal cancer (CRC), in compliance with FDA’s Expanded Access (Compassionate Use) to investigational drugs regulations.
The purpose of this policy is to describe the requirements for Expanded Access to D3 Bio’s investigational products under the 21st Century Cures Act for the use of investigational drugs outside of clinical trial settings, when certain conditions are met.
Scope of Expanded Access
This policy applies to provision of access to a D3 Bio’s investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country. All expanded access programs must be conducted in agreement with applicable country-specific legal and regulatory requirements related to providing an investigational drug under expanded access.
D3 Bio believes that participation in one of our clinical trials is the best way to access our investigational drug. Whenever possible, D3 Bio’s investigational drug should be used as part of a clinical trial. Therefore, we encourage patients to speak with their physicians regarding participating in clinical trials. In rare cases where it is not feasible for patients with serious diseases to participate in clinical trials (e.g., patient ineligibility, lack of ongoing clinical trials, etc.) and have exhausted all available treatment options, D3 Bio will consider providing a requesting physician with pre-approval access to the investigational drug, for the treatment of an individual patient outside of a clinical trial, when following conditions are met.
Criteria for Consideration of a Request for EAP
- The patient has a serious or immediately life-threatening or chronically debilitating disease.
- There is no comparable or satisfactory alternative therapy to treat the disease or condition.
- The potential benefit justifies the potential risks, and those risks are not unreasonable within the context of the disease or condition.
- The patient is ineligible for, or otherwise unable to participate in, an ongoing clinical trial with the investigational drug.
- The investigational drug is under active development in the indication and expanded access will not interfere with drug development.
- The treating physician must complete FDA Form 3926 and is willing to open an IND with the FDA, including filing paperwork with FDA and IRB, and is responsible for patient care and monitoring as well as safety reporting.
- The treating physician should provide the completed Form 3926 to D3 Bio for review prior to submission to FDA.
- There is adequate supply of the investigational drug to meet all needs for patients enrolled in ongoing clinical studies, and designating investigational drug for an expanded access treatment use will not compromise supply or otherwise postpone providing the new treatment, once approved, to the broader patient population.
Requesting Procedure
- A licensed physician may apply for access to a D3 Bio’s investigational drug in the pre-approval stage of development by contacting this email: EAP@D3bio.com
- The requestor may expect to receive acknowledgment of the request within 3 business days.
- D3 Bio may request more detailed information from the physician or institution in order to fully evaluate a request. The decision to grant access is solely at the discretion of D3 Bio.
- Any physicians or institutions participating under an EAP must agree to comply with all relevant laws, regulations and requirements, including any reporting requirements (such as relating to the maintenance and release of treatment records and data to Regulatory Agencies, and to D3 Bio, as specified/required), supervise administration of the investigational drug, obtain informed consent and/or assent, adhere to Good Clinical Practice guidelines, and other procedures as outlined by D3 Bio. If D3 Bio believes that a single-patient IND should be pursued, a Letter of Authorization (LOA) will be issued to the licensed physician to reference the existing IND under which the investigational drug is being studied. The program should be discontinued as soon as feasible when the drug is approved for the relevant use.
Additional information about D3 Bio’s clinical trials is available on the NIH’s website by searching “D3 Bio” at www.clinicaltrials.gov.
D3 Bio shall reserve the right to revise the policy from time to time.
For EAP contact:
EAP@D3bio.com