What Patients and Families Ask Most

There is no universal eligibility rule for every personalized cancer vaccine. A clinical trial has protocol-specific criteria. Individual-patient expanded access generally requires a serious or immediately life-threatening condition, no comparable or satisfactory alternative, a reasonable risk-benefit assessment, a willing treating physician, and a sponsor or manufacturer willing to provide the product.

Medical suitability and product availability are case-specific. Use the oncology question checklist to prepare for a conversation with your doctor and the relevant trial or program. (Source: FDA)

The answer depends on the exact product, trial or program, cancer type, stage, treatment setting, tissue and sequencing requirements, and current protocol. Evidence from one cancer setting cannot be assumed to apply to another.

For example, the randomized Phase 2b intismeran evidence is in high-risk melanoma after complete resection, while PGV001 was a small Phase 1 study across multiple malignancies. Neither establishes that every solid tumor or patient is a candidate. Check current trial criteria and ask the treating oncology team.

The Jaime Leandro Foundation (JLF), the primary organization coordinating expanded access for personalized cancer vaccines, reports that 48 patients have completed the vaccine protocol with 24 additional patients in queue, as of August 2025. JLF operates administration sites in San Francisco, Los Angeles, St. Louis, Miami, and Dallas. (Source: JLF FAQ, Aug 2025)

For JLF's current published peptide-vaccine pathway, the organization estimates roughly 4 to 5 months from receipt of whole exome sequencing to delivery of the vaccine series to the treating physician:

• Whole exome sequencing: ~4 weeks
• Neoantigen identification and vaccine design: ~4-6 weeks
• Vaccine manufacturing (GMP): ~12-14 weeks
• Administration: JLF currently describes a seven-dose protocol after delivery

Other sponsors, trials, platforms, and programs can use different timelines and dosing schedules. Patients should verify timing directly with the treating team and relevant sponsor or program. (Source: JLF FAQ)

Disease can change while an individualized treatment is being designed and manufactured. Whether a pathway remains medically appropriate, and whether other treatment continues during that time, are decisions for the treating oncology team and the relevant trial or expanded-access protocol.

Before committing to a program, ask who reassesses eligibility, what happens if the disease progresses, which costs become nonrefundable at each stage, and whether the manufacturing timeline fits the medical situation.

That depends on the vaccine product, protocol, cancer setting, and treating team. KEYNOTE-942 studied intismeran autogene in combination with pembrolizumab in high-risk resected melanoma, but that does not establish compatibility for another vaccine, cancer, or treatment regimen. Ask the treating oncologist and relevant trial or expanded-access program before changing any treatment.

JLF currently publishes a cost of roughly $92,000 before treating-physician administration for its own peptide-vaccine pathway. It separately says administration commonly ranges from approximately $7,000 to $25,000:

These figures are JLF-specific, access-date-sensitive, and not a universal price. JLF says its program invoices in stages and that paid stage costs are nonrefundable once work begins. Use our cost calculator only as an educational model, then confirm current figures directly. (Source: JLF FAQ)

Coverage can be limited or unavailable for investigational personalized cancer vaccines, but an absolute statement about every insurer or case is not supportable here. Ask the insurer, treating institution, and relevant program what may be covered, excluded, or billed separately before making a financial commitment.

Currently, there are no established financial assistance programs specifically for personalized cancer vaccines. Some patients have funded treatment through savings, home equity, retirement accounts, family contributions, and crowdfunding platforms like GoFundMe. JLF invoices in three stages, which allows patients some time between payments. We are tracking this space and will update this page as options develop.

FDA expanded access (also called "compassionate use") is a regulatory pathway that allows patients with serious or life-threatening conditions to access investigational treatments outside of clinical trials. It is authorized under Section 561 of the Federal Food, Drug, and Cosmetic Act.

FDA says the vast majority of expanded-access requests may proceed. That determination is not approval of the product and does not guarantee sponsor willingness, access, benefit, coverage, timing, or medical suitability. A licensed physician, sponsor or manufacturer, IRB review, informed consent, and FDA process can all be required.

For a complete guide, see our Expanded Access Guide. (Source: FDA)

A licensed physician must be willing and able to oversee treatment and fulfill the applicable sponsor-investigator, patient-care, consent, IRB, FDA-submission, safety-reporting, and follow-up responsibilities. The manufacturer or sponsor must also be willing to provide the investigational product. Patients should discuss the pathway with their treating oncology team; ImmunaPath cannot determine whether a physician or product is suitable. (Source: FDA)

The federal Right to Try Act and FDA expanded access are different pathways. Right to Try has statutory conditions, including requirements concerning completion of a Phase 1 trial and active development of the eligible investigational drug. A manufacturer is not required to provide a product under either pathway.

Whether a particular individualized product could meet Right to Try's legal definition is product- and fact-specific. This site does not make that legal determination.

Patients and physicians should use current FDA Right to Try information and current expanded-access instructions, and seek qualified legal or regulatory guidance when needed.