A: The Jaime Leandro Foundation (JLF) is a private nonprofit created to help patients access personalized neoantigen peptide vaccines. The expanded access program gives individuals the right to try a medical treatment when no comparable alternative options are available. Serving as the hub, JLF brings the critical components together, partnering with expert academic and commercial institutions to use advanced genetic sequencing, to identify the best patient-specific neoantigen targets, and to manufacture, assemble, vial, and ship the personalized vaccine to the treating physician for administration.

A: There are many different types of cancer vaccines, including DNA, peptide, and mRNa vaccines. JLF helps patients access personalized neoantigen peptide vaccines. Personalized neoantigen peptide vaccines are being studied in clinical trials and are considered an experimental therapy.

A: A personalized neoantigen peptide vaccine is a type of immunotherapy that attempts to use small pieces of proteins, called peptides, to stimulate a specific component of the immune system (t-cells) to recognize cancer cells. Cancer cells often have proteins (neoantigens) on their surface that are different from those of healthy cells. Using whole exome sequencing and algorithms, the unique changes (mutations) predicted to be recognized by the immune system can be prioritized and included in the vaccine. When a person receives a personalized neoantigen peptide cancer vaccine, their immune system recognizes the peptides as foreign and mounts an immune response. Personalized neoantigen peptide vaccines are being studied in clinical trials and are considered an experimental therapy.

A: JLF leverages the FDA’s expanded access cost-recovery program to provide personalized neoantigen peptide vaccines to eligible patients.

Eligibility is determined on a case-by-case basis, but in general patients must:

• Have a diagnosis with no curative therapies available

• Have a projected 5-year overall survival of less than 50%.

• Be physically able to carry out self-care and light daily activities without significant assistance.

• Not have pre-existing autoimmune conditions requiring immunosuppressive therapy.

• The potential benefits of vaccination outweigh the potential risks.

A: On average, it takes 4-5 months from receipt of whole exome sequencing to deliver the series of vaccines to the treating physician. A breakdown of the timeline is as follows:

1. Whole exome sequencing (if needed): 4 weeks

2. Vaccine neoantigen target identification: 4-6 weeks

3. Vaccine manufacturing: 12-14 weeks

A: Patients receive seven vaccines to be administered following the administration protocol. Additional doses may be appropriate, but are decided in partnership with the treating physician and involve additional cost.

A: JLF leverages the expanded access patient pay cost recovery program to help make personalized cancer vaccines available to qualifying patients. JLF fees include the cost to design, manufacture, and ship a series of vaccines for administration. The cost for a series of personalized neoantigen cancer vaccines is roughly $92,000 before. A breakdown of the costs are as follows:

1. Neoantigen target identification and vaccine design: $23,000

2. Vaccine manufacturing and vialing: $53,500

3. Shipping and immune monitoring / testing: $17,210

4. Additional administrative costs to store, prepare, and administer the vaccine are charged by the treating physician. These fees are at the discretion of the physician and vary, but administration costs range from $7,000 - $25,000 for the series of vaccines.

A: Choosing to pursue vaccination through expanded access is a significant decision, and families should only move forward if the financial commitment will not create hardship. Because this program operates on a cost-recovery model, funds are transferred directly to our partner organizations responsible for vaccine design, manufacturing, and vialing. Once these processes begin, payments cannot be refunded.

To make this commitment more manageable, JLF divides the total cost into three invoices, with each payment corresponding to a specific stage of vaccine development. This ensures that families are only billed for services actively being performed. However, once a payment is made, the associated costs are immediately incurred and therefore nonrefundable.

A: JLF has a network of physicians approved to administer vaccines according to the JLF protocol. Currently, JLF has administration sites available in San Francisco, CA; Los Angeles, CA; St. Louis, MO; Miami, FL; and Dallas, TX

JLF is always open to adding new physicians to our network. We are happy to assist any interested physicians in understanding the requirements for serving as a vaccine administrator.

A: The side effects and risk of personalized neoantigen peptide vaccines are not known. The treatment protocol and consent form are available upon request and should be reviewed with the patient’s oncologist.

A: The patient and treating physician have the discretion to use any combination of therapies they deem appropriate based on the latest science and relevant personalization approaches.

A: Personalized neoantigen peptide vaccines are considered experimental therapies that come with no guaranteed outcome. Clinical trial data continues to be the best sources for researching efficacy of personalized cancer vaccines. In general, the effectiveness of personalized therapies may vary by cancer type, stage of disease, and the patient’s overall health.

A: JLF has worked with patients with a variety of cancer diagnoses, including breast, ovarian, glioblastoma, pancreatic, lung, and sarcoma. As of August 2025, a total of 48 patients have completed the JLF protocol and an additional 24 patients are in the queue for vaccine development or manufacturing.

A: No, not all clinical trials must be registered on ClinicalTrials.gov. If information is not included on about expanded access availability for a particular investigational drug, physicians or patients may wish to contact the sponsor (or manufacturer of the investigational drug, if different from the sponsor) about possible availability.

So, there are some things to be said. There is a nice presentation from Covington here.

https://www.fdli.org/wp-content/uploads/2017/05/annual17-thursday-Communicating-Emerging-Drug-Therapies.pdf

A: Information about the availability of expanded access to an investigational drug may be available on the website of the relevant drug manufacturer or distributor. The enactment of the 21st Century Cures Act added section 561A to the Federal Food, Drug, and Cosmetic Act (FD&C Act); that section requires a manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions to make its policy for evaluating and responding to expanded access requests submitted under section 561(b) of the FD&C Act both public and readily available, such as by posting the policy on a publicly available website.

Additionally, information on publicly and privately supported clinical trials on a wide range of diseases and conditions is available at ClinicalTrials.gov, a Web-based resource maintained by the National Library of Medicine for patients, their families, health care professionals, researchers, and the public.

JLF’s F&A rate is 11%.