What Is FDA Expanded Access?
FDA expanded access — also referred to as "compassionate use" — is a potential regulatory pathway for patients with serious or immediately life-threatening conditions to seek an investigational medical product outside a clinical trial when there is no comparable or satisfactory alternative. It does not guarantee that a product is available, medically suitable, or beneficial.
The legal basis for expanded access is found in 21 CFR Part 312, Subpart I (Sections 312.300–312.320), and Section 561 of the Federal Food, Drug, and Cosmetic Act. The FDA has maintained this pathway for decades, and it is one of the most permissive access programs of any regulatory agency worldwide.
Three Types of Expanded Access
| Type | Patients | Relevance to Cancer Vaccines |
|---|---|---|
| Individual Patient | 1 patient at a time | Most relevant. Each personalized vaccine is manufactured for a single patient. This is the pathway currently used by the Jaime Leandro Foundation and academic centers. |
| Intermediate-Size | Smaller groups | May become relevant as programs scale. Allows a coordinated protocol for multiple patients using similar (but individually manufactured) products. |
| Treatment IND | Widespread use | Typically used when a drug is further along in the approval process. Not yet applicable to personalized cancer vaccines. |
FDA says it determines that the vast majority of expanded-access requests may proceed. This is a decision on a request, not approval of the investigational product, and it does not guarantee that a sponsor will provide the product, that access will occur, or that the product will help. Standard and emergency pathways follow different procedures and timing.
Expanded Access vs. Right to Try
The federal Right to Try Act is a separate pathway for certain eligible patients and eligible investigational drugs. FDA explains that an eligible drug must meet statutory conditions, including completion of a Phase 1 trial and active development under an IND. FDA does not review or approve individual Right to Try requests, and a sponsor is not required to provide a product.
Whether a particular personalized product could qualify under either pathway is product- and case-specific. Patients should ask their physician and the relevant sponsor or manufacturer; this page does not provide a legal determination or procedural recommendation.
How Expanded Access Works for Personalized Cancer Vaccines
There is no universal expanded-access workflow or timeline for personalized cancer vaccines. The six sections below use JLF's currently published peptide-vaccine pathway as one educational example where noted; products, sponsors, institutions, regulatory responsibilities, manufacturing, monitoring, cost, and timing can differ.
Tumor Biopsy and Tissue Preservation
What happens: A surgeon removes tumor tissue (either a dedicated biopsy or tissue from a prior surgery). Both tumor tissue and a healthy tissue sample (typically blood) are needed for comparison.
Who does it: The patient's surgical oncologist or interventional radiologist. The tissue must be handled according to specific protocols — flash-frozen or preserved in a validated medium to maintain DNA and RNA integrity.
Timeline: Depends on the patient's surgical schedule. Tissue procurement itself takes hours; preparation for shipping may take 1–3 days.
Cost: Varies widely. If tissue is available from a prior surgery, there may be minimal additional cost. A new biopsy procedure can range from $1,000 to $5,000+ depending on the location and method.
What can go wrong: Insufficient tumor material (the sample is too small for reliable sequencing), degraded tissue (improper preservation), or the tumor biopsy site is inaccessible. If archived tissue from a prior surgery is used, it must be evaluated for DNA quality, which occasionally fails.
Whole Exome Sequencing (WES)
What happens: A specialized sequencing laboratory performs whole exome sequencing on both the tumor DNA and the patient's normal (germline) DNA. This comparison identifies somatic mutations — genetic changes unique to the tumor. Many labs also perform RNA transcriptome sequencing to determine which mutated genes are actually being expressed by the tumor.
Who does it: Sequencing laboratories such as Tempus, Foundation Medicine, or CeGaT (Germany). CeGaT's CancerNeo product is notable because it bundles sequencing, HLA typing, and neoantigen prediction into a single package.
Timeline: Approximately 2–4 weeks for standard turnaround, though some labs offer expedited processing.
Cost: $1,100–$2,800 for WES alone (self-pay). CeGaT's CancerNeo package, which includes vaccine design, costs approximately $11,000. Foundation Medicine's FoundationOne CDx may be covered by Medicare for solid tumors but sequences only 324 genes (a targeted panel, not a full exome), which may be insufficient for comprehensive vaccine design.
What can go wrong: Low tumor purity in the sample (too much normal tissue mixed in), low sequencing depth, or tumors with very few somatic mutations (low tumor mutational burden), which may not yield enough neoantigen targets for a vaccine.
Neoantigen Identification and Vaccine Design
What happens: Bioinformatics algorithms analyze the sequencing data to identify which somatic mutations produce "neoantigens" — abnormal proteins that can be recognized by the patient's immune system. The algorithms consider factors including HLA type (which determines which peptides can be presented to T-cells), binding affinity, and expression level. The output is a ranked list of the most immunogenic targets, from which 10–20 are typically selected for inclusion in the vaccine.
Who does it: Bioinformatics companies such as NoRD Bio (Cambridge, MA) using pipelines like pVAC-Seq, or CeGaT as part of their CancerNeo package. Academic centers like Washington University (St. Louis) and Mount Sinai also have neoantigen prediction capabilities.
Timeline: Approximately 4–6 weeks.
Cost: Typically included in the overall vaccine design fee. As part of the JLF protocol, neoantigen identification and vaccine design costs approximately $23,000.
What can go wrong: The tumor has too few somatic mutations for effective targeting (common in some pediatric cancers and certain tumor types). The predicted neoantigens may not provoke a strong immune response in practice, despite algorithmic predictions. HLA typing errors can lead to the selection of peptides the patient's immune system cannot present effectively.
Vaccine Manufacturing (GMP Synthesis)
What happens: A contract manufacturing organization (CMO) synthesizes the personalized vaccine under Good Manufacturing Practice (GMP) conditions. For peptide vaccines, this involves synthesizing 10–20 long peptides (typically 20–30 amino acids each), performing purity and identity testing, vialing the product under sterile conditions, and conducting release testing (including a 14-day sterility test that is itself a major bottleneck). For mRNA vaccines (as used by Moderna and BioNTech), the process involves encoding the selected neoantigens into a single mRNA construct, encapsulating it in lipid nanoparticles, and performing analogous quality testing.
Who does it: GMP-certified peptide CMOs. The Jaime Leandro Foundation currently uses CSBio (San Jose, CA). Other capable manufacturers include GenScript, AnaSpec (Fremont, CA), Biosynth (Netherlands), and CPC Scientific (Sunnyvale, CA).
Timeline: Approximately 12–14 weeks. This is typically the longest step in the process and the primary bottleneck.
Cost: Manufacturing and vialing costs approximately $53,500 under the current JLF protocol, plus approximately $17,210 for shipping and immune monitoring materials.
What can go wrong: Manufacturing can be delayed or fail, and some peptide sequences may be difficult to synthesize. A patient's condition can also change during design and manufacturing. These risks and the program's current cancellation, stage-payment, and refund terms should be discussed directly with the treating team and program before funds are committed.
FDA Filing and Vaccine Administration
What happens: The treating physician completes the applicable individual-patient expanded-access and IRB responsibilities. If the request may proceed and the product is available, administration follows the product- and protocol-specific plan. JLF's current public peptide-vaccine protocol lists seven doses; other products and trials can differ. Any combination treatment is a decision for the treating oncology team and the governing protocol.
Who does it: The treating physician (typically an oncologist experienced in immunotherapy) files the IND and administers the vaccine. Current JLF administration sites include San Francisco, Los Angeles, St. Louis, Miami, and Dallas. Academic medical centers may also serve as administration sites.
Timeline: FDA authorization typically takes up to 30 days. The injection series itself spans several months.
Cost: Physician administration fees range from $7,000 to $25,000, depending on the physician, facility, and geographic location.
What can go wrong: Sponsor availability, FDA or IRB requirements, institutional review, manufacturing, timing, cost, and changes in the patient's condition can all prevent or delay access. Investigational products may not help and may cause unexpected serious side effects.
Immune Monitoring and Follow-Up
What happens: After vaccination, the patient undergoes regular monitoring to assess whether the immune system is responding. This includes CT scans or other imaging to track tumor size, blood tests to measure T-cell receptor (TCR) activity against the vaccine targets, and standard oncology follow-up. The physician reports adverse events to the FDA as required under the expanded access IND.
Who does it: The treating oncologist and their clinical team. Some specialized monitoring (such as TCR sequencing) may be performed by external laboratories.
Timeline: Follow-up duration is protocol- and case-specific.
Cost: Coverage and patient responsibility vary by insurer, institution, sponsor, and service. Verify them in writing.
What can go wrong: The vaccine may fail to produce a detectable immune response. Even when immune responses are measurable in blood tests, the tumor may not regress clinically. The disease may progress despite vaccination, requiring the patient to transition to alternative treatments.
Personalized neoantigen vaccines are an active area of clinical research. Evidence, risks, manufacturing methods, and access differ by product and cancer setting. The products discussed here remain investigational unless an official source for a specific product says otherwise.
What FDA Considers
A treating physician and the relevant sponsor or manufacturer must evaluate a specific case. ImmunaPath cannot determine eligibility. FDA describes the following general conditions for individual-patient expanded access; a sponsor or protocol may have additional medical criteria.
General Federal Conditions
- The patient has a serious or immediately life-threatening disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the condition.
- The potential benefit justifies the potential risks, and those risks are reasonable in the context of the disease.
- Providing the product will not interfere with clinical investigations that could support development or approval.
- A licensed physician is willing to oversee care, and the sponsor or manufacturer is willing to provide the product.
Source: FDA expanded access information for physicians. This summary is educational and is not a case determination.
Where the Evidence Stands
The evidence cannot be reduced to a universal ranking of tumor types. Results are specific to a product, disease setting, treatment combination, and study design. For example, randomized Phase 2b evidence exists for intismeran autogene plus pembrolizumab after surgery in high-risk melanoma, while confirmatory Phase 3 studies remain ongoing. Other platforms and cancer settings have separate, often earlier-stage evidence.
| Tumor Type | Evidence Level | Key Data |
|---|---|---|
| Product-specific evidence | Varies by study | Confirm the exact product, cancer setting, phase, status, endpoints, and results in the trial record and peer-reviewed publication. |
Questions Only a Clinical Team Can Answer
Medical suitability, product availability, timing, protocol-specific exclusions, and whether another treatment or clinical trial is preferable require review by the treating oncology team and the relevant study or sponsor. Do not delay established care while researching expanded access.
The Key Players
Organizations Facilitating Expanded Access
Jaime Leandro Foundation (JLF)
JLF publishes information about a personalized peptide-vaccine expanded-access program. Program details, participating physicians or sites, medical criteria, timing, and costs can change; verify the current information directly and involve the treating oncology team.
Website: jaimeleandrofoundation.org
Academic Medical Centers
Several academic institutions run their own neoantigen vaccine programs, primarily through clinical trials but occasionally through expanded access:
- Mount Sinai — Developed PGV001, a multi-peptide personalized vaccine. Phase 1 results published in Cancer Discovery and indexed on PubMed.
- Dana-Farber Cancer Institute — Operates the Center for Cancer Vaccines with multiple active programs.
- MD Anderson Cancer Center — Involved in various neoantigen vaccine clinical trials.
- Washington University (St. Louis) — Provides vaccine design support in collaboration with JLF.
Sequencing and Manufacturing Partners
| Company | Role | Key Detail |
|---|---|---|
| Tempus | Sequencing | Full exome + RNA transcriptome. Physician orders via Tempus Hub. |
| CeGaT (Germany) | Sequencing + Vaccine Design | CancerNeo: end-to-end WES + HLA typing + neoantigen prediction. ~$11,000. Patients can order directly. |
| Foundation Medicine | Sequencing (targeted panel) | FoundationOne CDx: 324 genes. Medicare-covered for solid tumors. Not full exome. |
| CSBio | Vaccine Manufacturing | JLF's current GMP manufacturing partner. San Jose, CA. |
| GenScript | Vaccine Manufacturing | End-to-end: design through GMP production. China + US operations. |
| AnaSpec | Vaccine Manufacturing | Expedited turnaround. ISO 7 cleanrooms. Fremont, CA. |
Active Clinical Trials (Not Expanded Access, but Related)
While expanded access operates outside of clinical trials, the trial landscape is important context for understanding the maturity of the science:
| Trial | Phase | Indication | Key Detail |
|---|---|---|---|
| Moderna/Merck V940 + Keytruda (INTerpath-001) | Phase 3 | Adjuvant melanoma | 1,089 patients. Primary completion Oct 2029. NCT05933577 |
| BioNTech BNT122 (iNeST) | Phase 2 | Multiple solid tumors | Individualized mRNA vaccine. Active at multiple sites globally. |
| Mount Sinai PGV001 | Phase 1 | Various solid tumors | 13 of 14 enrolled patients received vaccine; 11 completed treatment; targeted immune responses reported. Small Phase 1 feasibility/immunogenicity evidence, not proof of survival benefit. Published 2025. |
| Moderna/Merck KEYNOTE-942 | Phase 2b | Adjuvant melanoma | Completed. 49% reduced recurrence. Led to Phase 3. NCT03897881 |
How Much Does It Cost?
There is no universal expanded-access price. The table below reflects the Jaime Leandro Foundation's current published peptide-vaccine model, not a quote or typical price for every personalized cancer vaccine pathway. JLF describes roughly $92,000 before treating-physician administration and lists administration separately.
| Component | Estimated Cost |
|---|---|
| Neoantigen identification & vaccine design | $23,000 |
| GMP vaccine manufacturing & vialing | $53,500 |
| Shipping & immune monitoring materials | $17,210 |
| Physician administration fees (7 doses) | $7,000 – $25,000 |
| Total | $100,710 – $118,710 |
Source: Jaime Leandro Foundation FAQ, checked July 2026. The itemized pre-administration figures total $93,710 even though JLF summarizes the amount as roughly $92,000. Costs are subject to change and other programs can differ.
Insurance Coverage
Coverage can be limited or unavailable for investigational personalized neoantigen vaccines, but an absolute statement about every insurer or case is not supportable here. Ask the insurer, treating institution, and relevant program which services may be covered, excluded, or billed separately before making a financial commitment.
Cost Recovery Is Legal
Under 21 CFR 312.8, the sponsor of an expanded access IND may charge patients for the direct costs of providing the investigational drug, with prior FDA written authorization. This is how JLF and similar programs are able to charge patients — they are recovering the actual costs of manufacturing, not generating profit on the drug itself.
Before Making a Financial Commitment
Request a current written breakdown of product charges, clinical-care charges, testing, travel, monitoring, refund terms, and what an insurer or trial sponsor may cover. Recruiting status and covered expenses vary by study. Do not borrow against a home or retirement account based on this page; consider independent financial and tax advice.
The Legal Framework
The legal and regulatory infrastructure for accessing personalized cancer vaccines through expanded access is well-established, though complex. Here are the key laws and regulations governing this space.
Federal Laws and Regulations
Section 561 of the FD&C Act
Establishes the statutory authority for expanded access to investigational drugs for individual patients. This is the foundational law that enables the entire expanded access pathway.
21 CFR 312.310 — Individual Patient IND
The specific regulation governing individual patient expanded access. Requires the treating physician to determine that the patient has a serious or life-threatening condition, that no comparable or satisfactory alternative therapy is available, and that the potential benefit justifies the potential risks. The physician files FDA Form 3926.
21 CFR 312.8 — Charging for Investigational Drugs
Permits sponsors to charge patients for the direct costs of providing investigational drugs under expanded access, with prior FDA written authorization. For individual patient access, only direct costs (manufacturing, materials, labor, shipping) may be recovered. The FDA's February 2024 finalized guidance on charging provides detailed clarification. Notably, the regulations make no distinction between nonprofit and for-profit sponsors — any entity that qualifies as a "sponsor" under 21 CFR 312.3 may seek cost-recovery authorization.
Right to Try Act (2018) — 21 USC 360bbb-0a
An alternative pathway that bypasses FDA pre-authorization but requires the drug to have completed a Phase I trial. As discussed above, this is generally not applicable to personalized neoantigen vaccines due to their one-of-a-kind nature. Some state-level legislation (New Hampshire, Texas) is working to address this gap.
State-Level Considerations
State laws add additional complexity. The most relevant consideration is the definition of "practice of medicine," which varies by state. For example, New York's Education Law Article 131 defines the practice of medicine broadly, which means that any service that could be construed as medical practice (such as interpreting sequencing results for patients or recommending specific treatment protocols) requires a medical license.
Entities that facilitate expanded access as administrative coordinators — handling logistics, paperwork, and scheduling without making medical decisions — generally operate outside the scope of medical practice requirements. However, this distinction should be reviewed with a healthcare attorney for each state of operation.
HIPAA and Privacy
HIPAA duties depend on an entity's role and data relationships. Covered entities and business associates should obtain qualified privacy and security guidance for medical records, sequencing data, consent, contracts, storage, communications, and breach-response obligations.
What the Research Shows
Clinical evidence for personalized neoantigen cancer vaccines is growing rapidly. However, it is important to understand the context of the data: most results come from the adjuvant (post-surgical) setting, meaning the vaccines were given to patients after their tumors were surgically removed, to prevent recurrence. Data on treating active metastatic disease with neoantigen vaccines is more limited.
Moderna/Merck: V940 (Intismeran Autogene) + Pembrolizumab
Phase 2b Results (KEYNOTE-942)
In the completed Phase 2b trial (KEYNOTE-942), 157 patients with resected high-risk melanoma (Stage III/IV) received either V940 + pembrolizumab (Keytruda) or pembrolizumab alone. At approximately 3-year follow-up, the combination demonstrated:
- 49% reduction in recurrence or death (hazard ratio 0.51)
- 62% reduction in distant metastasis or death
These results were published in The Lancet (2024;403:632-644). The product remains investigational, and Phase 3 confirmation is ongoing.
Sources: Lancet 2024;403:632-644 (3-year data); Merck press release (Jan 20, 2026) (5-year update)
Phase 3 (INTerpath-001) — Ongoing
The Phase 3 trial (NCT05933577) studies the combination in resected high-risk melanoma. Check the trial record for current status, enrollment, dates, and outcomes; ImmunaPath does not forecast approval.
Mount Sinai: PGV001
Mount Sinai's Phase 1 trial of PGV001, a personalized multi-peptide vaccine, enrolled patients with mixed solid and hematologic malignancies at high risk of recurrence. The study reported:
- 13 of 14 enrolled patients received the vaccine
- 11 patients completed treatment
- Vaccinated patients developed targeted T-cell and B-cell responses
Results were published in Cancer Discovery and are indexed on PubMed and summarized by Mount Sinai Scholars. This was a very small Phase 1 study focused on safety, feasibility, and immunogenicity across mixed cancer types. It should not be read as proof that PGV001 improves survival or treats active disease.
BioNTech: Pancreatic Cancer
In a small study of patients with resected pancreatic ductal adenocarcinoma, BioNTech's individualized neoantigen mRNA vaccine demonstrated:
- 8 of 16 patients showed strong T-cell responses to the vaccine
- Responders had a median recurrence-free survival of 27.1 months
- 50% of responders remained recurrence-free at 18 months
- Non-responders had a median recurrence-free survival of only 8.6 months
Reported by the National Cancer Institute. Pancreatic cancer is one of the most difficult cancers to treat, making these results particularly notable despite the small sample size.
Important Caveats
- Most data is from the adjuvant setting — Patients had their tumors surgically removed before vaccination. Results may differ significantly for patients with active, measurable disease.
- Sample sizes are small — The largest completed trial (Phase 2b) had 157 patients. The Phase 1 studies had 13-16 patients. Larger Phase 3 trials are needed to confirm efficacy.
- Combination therapy confounds results — Most studies combined the vaccine with checkpoint inhibitors. It is difficult to isolate the vaccine's contribution from the checkpoint inhibitor's contribution.
- Expanded access outcomes are not published — JLF and other expanded access programs have not published peer-reviewed survival data for their patients. Individual outcomes through expanded access may differ from clinical trial results.
- Patient selection bias — Patients who qualify for and can afford expanded access tend to be healthier and wealthier than the general cancer patient population, which may inflate apparent outcomes.
Frequently Asked Questions
How long does the expanded access process take for a personalized cancer vaccine?
JLF currently estimates roughly 4 to 5 months from receipt of whole exome sequencing to delivery of its peptide-vaccine series to the treating physician. It lists approximately 4 weeks for sequencing if needed, 4–6 weeks for target identification, and 12–14 weeks for manufacturing. Other products, sponsors, trials, and programs can differ. FDA review is only one part of the pathway and does not determine the manufacturing timeline.
Does insurance cover personalized cancer vaccines under expanded access?
Coverage can be limited or unavailable for investigational personalized neoantigen vaccines, but it varies by insurer, institution, program, and service. JLF's public cost model is one program-specific example, not a universal price. Confirm coverage, exclusions, stage-payment rules, refund terms, and treating-physician fees directly before committing funds.
What are the side effects of personalized neoantigen cancer vaccines?
In clinical trials, the most commonly reported side effects include injection site reactions (pain, redness, swelling), fatigue, flu-like symptoms (fever, chills, muscle aches), and nausea. When combined with checkpoint inhibitors like pembrolizumab (Keytruda), the side effect profile may include immune-related adverse events such as colitis, hepatitis, or thyroid dysfunction. Serious adverse events have been reported but are relatively uncommon in published trial data. Your oncologist will monitor for and manage side effects throughout the treatment course.
What is the success rate of personalized cancer vaccines?
There is no single success rate for personalized cancer vaccines. A peer-reviewed five-year Phase 2b update reported recurrence-free- and distant-metastasis-free-survival benefits for intismeran plus pembrolizumab in high-risk melanoma after complete resection. PGV001 supplied small Phase 1 feasibility and immunogenicity evidence across mixed malignancies. Neither result can be generalized to every cancer, active metastatic disease, another vaccine platform, or an individual patient. Phase 3 confirmation for intismeran is still pending.
How do I start the process of getting a personalized cancer vaccine?
Begin with the treating oncology team and current information from the relevant trial, sponsor, or manufacturer. A physician and sponsor or manufacturer must evaluate medical suitability and product availability. Do not order testing or change care based on this page.
What does a physician need to do for an expanded-access request?
The treating physician must be willing to oversee treatment and complete the applicable FDA submission, IRB, informed-consent, safety-reporting, and follow-up responsibilities. The sponsor or manufacturer must be willing to provide the product. FDA says the vast majority of requests may proceed, but that does not approve the product or guarantee access or benefit. Physicians should use current FDA instructions rather than this educational summary as a procedural guide.
Can I access a personalized cancer vaccine outside the United States?
Possibly, but product availability, trial sites, eligibility, regulation, tissue transport, manufacturing, administration, follow-up, and cost differ by country and program. Check the current trial registry and official program information, then discuss cross-border implications with the treating oncology team. ImmunaPath does not arrange international access.
What if I am not eligible for expanded access for a personalized cancer vaccine?
Ask your oncology team about approved standard-of-care options and whether any clinical trial is appropriate for the exact cancer type, stage, treatment setting, location, and health status. Trial statuses and criteria change; search ClinicalTrials.gov and verify the current record with the trial site. ImmunaPath does not recommend a treatment or determine trial eligibility.
Next Steps
If you or a loved one is considering a personalized cancer vaccine through expanded access, here are the concrete next steps.
Prepare for Your Oncology Visit
Bring a non-scoring question list about evidence, trials, tissue, timing, risks, and costs. No medical details are collected.
Open the Question ListEstimate Your Costs
Estimate the main cost variables by location, cancer type, sequencing needs, and manufacturing pathway.
Estimate CostsGet Careful Research Updates
New developments in neoantigen science emerge monthly. Subscribe to receive clinical trial updates, regulatory changes, and program availability.
Subscribe FreeTalk to Your Oncologist
Your oncologist is the critical first step. Here is a brief script to start the conversation:
"I've been reading about personalized neoantigen vaccines available through FDA expanded access. Given my diagnosis, I'd like to discuss whether I might be a candidate. Would you be willing to explore this with me, or refer me to an oncologist experienced in this area?"
Medical Disclaimer: This guide is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. The information provided is based on publicly available sources, published clinical trial data, and regulatory documents. Individual medical decisions should be made in consultation with a qualified oncologist or treating physician.
ImmunaPath does not diagnose, prescribe, provide medical treatment, determine eligibility, or coordinate access. It provides general educational information to help readers understand public sources and prepare questions for a clinical team.
Sources and Further Reading
- 21 CFR 312, Subpart I — Expanded Access to Investigational Drugs
- 21 CFR 312.8 — Charging for Investigational Drugs
- FDA Guidance: Charging for Investigational Drugs Under an IND (Feb 2024)
- FDA Expanded Access Submission Data
- Weber JS et al. — Individualized neoantigen therapy mRNA-4157 (V940) plus pembrolizumab in resected melanoma. Lancet 2024;403:632-644
- Mount Sinai PGV001 Phase 1 Results — PubMed
- Mount Sinai PGV001 Phase 1 Results — Mount Sinai Scholars
- ClinicalTrials.gov — INTerpath-001 (NCT05933577)
- ClinicalTrials.gov — KEYNOTE-942 (NCT03897881)
- Jaime Leandro Foundation FAQ
- Triage Cancer — Expanded Access vs. Right to Try
- American Cancer Society — Cancer Facts & Figures 2025
- Harvard Medical School — When Will Patients See Personalized Cancer Vaccines?