What Patients and Families Ask Most

Expanded access programs generally require all of the following:

• A cancer diagnosis with no curative therapies available
• Life expectancy of 12+ months (time needed for vaccine manufacturing)
• Five-year overall survival below 50% for the cancer type and stage
• Ability to carry out self-care and light daily activities (ECOG performance status 0-2)
• No pre-existing autoimmune conditions requiring immunosuppressive therapy

Eligibility is determined case-by-case. Use our free eligibility assessment for a preliminary evaluation, then discuss results with your oncologist. (Source: Jaime Leandro Foundation FAQ)

Personalized neoantigen vaccines are not limited to a specific cancer type. They work by targeting mutations unique to the individual patient's tumor, which means any solid tumor with sufficient mutations could theoretically be a candidate. The Mount Sinai Phase 1 trial treated patients across 5 cancer types: non-small cell lung cancer, head and neck cancer, urothelial cancer, breast cancer, and multiple myeloma.

That said, cancers with higher tumor mutational burden (more mutations) tend to produce more neoantigen targets, which may improve vaccine effectiveness. Your oncologist and the sequencing lab can assess whether your specific tumor has enough targetable mutations.

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)

Approximately 4 to 5 months from tumor biopsy to first vaccine dose:

• Whole exome sequencing: ~4 weeks
• Neoantigen identification and vaccine design: ~4-6 weeks
• Vaccine manufacturing (GMP): ~12-14 weeks
• Administration: 7 doses over several weeks

This timeline is a significant consideration. The manufacturing phase alone takes 12-14 weeks because each vaccine is custom-built in a cleanroom facility with individual quality testing. (Source: JLF FAQ)

This is one of the most serious risks of the current process. According to a 2023 STAT News investigation, 4 of 26 early JLF patients (approximately 15%) died before their vaccine was manufactured. The 4-5 month timeline from biopsy to treatment can be too long for rapidly progressing cancers.

Patients can continue other treatments (chemotherapy, radiation, immunotherapy) during the manufacturing period with their physician's guidance. Maintaining functional status (ECOG 0-2) during this window is critical to remaining eligible for vaccine administration. (Source: STAT News, Mar 2023)

In most cases, yes. In fact, personalized vaccines are often administered alongside checkpoint inhibitors (such as pembrolizumab/Keytruda) to enhance the immune response. The Moderna/Merck trial specifically studied the vaccine in combination with pembrolizumab, not as a standalone treatment. Your oncologist will determine whether your current treatment regimen is compatible with vaccine administration.

Based on the Jaime Leandro Foundation's published cost structure (the only program currently facilitating expanded access), the total cost is approximately $92,000 to $119,000:

Costs are invoiced in three stages. Once payment is made at each stage, it is nonrefundable. Use our cost calculator for a detailed estimate. (Source: JLF FAQ)

No. As of March 2026, no insurance company covers personalized cancer vaccines. Without FDA approval, there are no billing codes for these treatments, and insurers have no mechanism to reimburse them. The entire cost is currently out of pocket. This may change after the first FDA approval (estimated 2029-2030 at the earliest), but coverage would likely be limited to the specific cancer type approved.

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.

A licensed physician files an Investigational New Drug (IND) application on the patient's behalf. The FDA reviews and approves over 99% of individual patient requests. The process does not require the treatment to have completed any specific clinical trial phase.

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

Yes. Any licensed physician can file an individual patient IND application for expanded access. The physician determines that the potential benefit to the patient justifies the potential risks, and submits Form FDA 3926 (a simplified, single-page form for individual patient requests). There is no specialty restriction — the filing physician does not need to be an oncologist, though an oncologist's involvement is recommended for treatment planning and adverse event management. (Source: FDA)

The federal Right to Try Act (21 USC 360bbb-0a) does not apply to personalized cancer vaccines in their current form. Right to Try requires a treatment to have completed a Phase 1 clinical trial. Because each personalized vaccine is manufactured uniquely for one patient, "the drug" has never been tested on anyone else — it was just created. This is a fundamental structural incompatibility.

This is why the Jaime Leandro Foundation and other programs use the expanded access pathway instead — it has no Phase 1 completion requirement.

Some states are working to fix this gap. New Hampshire (HB 1292, HB 1735) and Texas (SB 984) have introduced legislation to explicitly include "individualized investigational treatments" in their right-to-try frameworks. (Source: NH HB 1292)