Hope for the Future
Every day, we are inspired to create cell and gene therapies with the capacity to cure. From research and development to delivery in the clinic, our teams are driven to develop product candidates that are safe and effective, while improving quality of life. Ultimately, we envision a world where patients have access to off-the-shelf therapies with the potential for single treatment cures.
For patients and their healthcare providers, finding the best course of treatment is critical. At Poseida we are finding new ways to harness the power of a patient’s own immune system – including CAR-T therapies for the treatment of cancer and gene therapies with the potential to deliver a cure with a single treatment. As we develop new approaches to cell and gene therapy, we take very seriously the consideration of patient safety, efficacy, and quality of life, both during and after treatment.
We are advancing product candidates with potential to deliver single treatment cures for cancer and rare genetic diseases, and may in the future work to address infectious disease, autoimmune disease, and other conditions. We don’t believe it is necessary to make a choice between efficacy and quality of life. From the moment we enter the lab, our goal is to develop new therapies that cure disease without the damaging toxicities and side effects that have become so routine for cancer treatment. As we create the next wave of cell and gene therapies, the patient experience is always front and center.
Learn more about our cell and gene therapies.
Expanded Access Policy
Expanded access, also known as compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational drug or other medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
According to the FDA’s published guidelines, expanded access may be appropriate when all the following apply:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
Poseida is committed to developing safe and effective therapies for patients and strives to put patients first. Our goal is to provide best-in-class CAR-T therapies and gene therapies to patients as soon as possible through efficient drug development and patient accessibility. Poseida does not currently have an expanded access program. We hope to offer one in the future, and information will be provided here if one is opened.