{"title":"Serova","summary":"Serova designs a personalized mRNA cancer vaccine from your tumor data and helps your doctor seek FDA permission to give it. The first review of your reports is free. The vaccine is experimental, and as of September 2026 no patient had received it.","body":"Serova is a small London-based company that designs a personalized mRNA cancer vaccine for one patient at a time. It reviews your existing reports for free, picks targets from your tumor's data and, if a case goes ahead, arranges manufacture and helps your doctor ask for permission to treat. The vaccine, SRV-001, is experimental and not FDA approved. Serova said that as of September 3, 2026 no patient had received it.\n\n## What the vaccine is\n\n- **mRNA in a fat particle,** injected into the upper arm, like the mRNA COVID shots but with a different purpose and recipe.\n- **Built for one person.** The targets come from changes found only in your cancer (neoantigens). Serova says a cancer with few mutations can sometimes still work if it has a usable fusion or other abnormal sequence.\n- **Picked with computer models, checked by people.** Serova says its models rank candidates, and the team reviews the evidence before a design is final.\n- **A long course.** The proposed adult schedule is 13 injections over about 11 months, given at a hospital or clinic, never at home.\n\n## How it works\n\n1. Email Serova's clinical team for secure upload instructions (see Contacts). Send a recent oncology summary, pathology and tumor or blood test reports, scan reports, and what you know about stored tissue. The review is free and doesn't commit you to anything.\n2. Serova checks what your data can support. Raw sequencing files (FASTQ, BAM or CRAM) help, and Serova can arrange the transfer with the lab. You may need more sequencing, such as tumor RNA, normal DNA or HLA typing. That costs money.\n3. If Serova can propose a design, you get a report listing the targets and why each was chosen. You and your oncologist review it. You can ask an independent doctor to look too.\n4. If you go ahead, an outside manufacturer makes the vaccine. Serova has planned about 12 weeks for this after the design is final. Getting samples, sequencing and agreeing the design all come before that.\n5. In the U.S., the expected route is single-patient expanded access: your treating doctor files an individual IND with FDA, with product support from Serova. It also needs ethics board (IRB) review and a hospital willing to give it. FDA usually allows 30 days after it receives the request.\n6. Your care team gives each dose, watches you for an hour or two afterward and follows you with scans and blood tests. Serova can also arrange tumor DNA blood tests (ctDNA) and immune tests.\n\n## Who it's for\n\nSerova says it can discuss adult and childhood cancers, including rare solid tumors and some blood cancers. You don't have to wait for other treatments to fail to ask for a review.\n\nIt isn't a fast rescue. If your cancer is moving quickly, there may not be time to make the vaccine and for your immune system to respond. Autoimmune disease, an organ transplant, past immune-related side effects or a PEG allergy all need review and may rule it out. A vaccine can also keep you out of some clinical trials, so ask those trial teams first.\n\nOutside the U.S., Serova checks each country's rules case by case. The UK has no direct equivalent of a single-patient IND.\n\n## Research status\n\n- SRV-001 is investigational. Serova says its safety and whether it helps are not established.\n- As of its September 3, 2026 update, Serova had prepared designs but hadn't treated anyone, so there's no human data on its vaccine yet.\n- Serova's physician page says its regulatory records through that date showed no Serova-held IND for SRV-001. Your doctor would file an individual one.\n- I found no Serova or SRV-001 study on ClinicalTrials.gov.\n- Expanded access is not FDA approval and doesn't show that a treatment works.\n\n## Cost\n\nIn 2026 I paid $200,000. Serova prices each case on the work, the design and the manufacturing it needs, but expect about the same. As of October 2026, Serova's own site says recent estimates have been around US$200,000 for manufacture, regulatory preparation and monitoring. The first review of your reports is free. Extra lab tests, sequencing, manufacture, regulatory prep and monitoring cost money, and hospital fees, scans and travel can be billed separately. Insurance may not pay for an investigational drug, and under U.S. expanded access FDA has to authorize any charge for the drug itself. Serova says to get a written description of the work, the price and the cancellation and refund terms before you pay for anything.\n\n## My experience\n\nI have stage 4 ALK-positive lung cancer, diagnosed in July 2024. I've never smoked. In 2026 Serova designed a personalized vaccine for me that targets 25 changes in my tumor. I paid $200,000.\n\n## Before you commit, ask\n\n1. What can you tell from the reports I already have, and what extra testing would cost?\n2. Which targets are in my design, and how strong is the evidence for each one?\n3. Which doctor and hospital would give the vaccine, and who files with FDA?\n4. How long from today to a first dose, and is that realistic for where my cancer is?\n5. Would getting this vaccine keep me out of any trial I might want later?\n6. What's the written price, and what happens to my money if manufacturing fails or I can't be treated?\n\n## Contacts\n\n- Website: [Serova for patients and families](https://info.serova.bio/01_PATIENTS_AND_FAMILIES)\n- For doctors: [Serova physician information](https://info.serova.bio/02_PHYSICIANS)\n- Email: clinical@serova.bio (clinical team, free first review)","topics":["emerging-research"],"capabilities":["emerging-research","research-support"],"sources":[{"id":"patients","label":"Information for patients and families (updated September 6, 2026)","url":"https://info.serova.bio/01_PATIENTS_AND_FAMILIES","publisher":"Serova","checkedAt":"2026-10-22","supports":"What Serova does; free report review; mRNA lipid nanoparticle vaccine SRV-001; investigational; no patient treated as of September 3, 2026; records to send; raw data; targets incl. fusions; ~12 weeks manufacture after final design; expanded access; 13-injection adult schedule; observation times; who can be assessed; risks and exclusions; costs and written terms.","type":"official"},{"id":"physicians","label":"Clinical and technical information for physicians (updated September 6, 2026)","url":"https://info.serova.bio/02_PHYSICIANS","publisher":"Serova","checkedAt":"2026-10-22","supports":"Physician-sponsored single-patient IND as anticipated U.S. route; no Serova-held IND for SRV-001 identified through September 3, 2026; IRB and 30-day FDA wait; external manufacturers; unmodified mRNA with lipid nanoparticle; UK has no direct single-patient IND equivalent.","type":"official"},{"id":"companies-house","label":"Serova Bio Limited, company 16745124","url":"https://find-and-update.company-information.service.gov.uk/company/16745124","publisher":"Companies House (UK)","checkedAt":"2026-10-22","supports":"Private limited company registered in London, incorporated September 26, 2025, active.","type":"research"},{"id":"ctgov","label":"ClinicalTrials.gov search for SRV-001","url":"https://clinicaltrials.gov/api/v2/studies?query.term=SRV-001","publisher":"U.S. National Library of Medicine","checkedAt":"2026-10-22","supports":"No registered studies for SRV-001 (a search for Serova also returned no Serova-sponsored study) as of the check date.","type":"research"},{"id":"fda-ea-patients","label":"Expanded access: information for patients","url":"https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients","publisher":"U.S. FDA","checkedAt":"2026-10-22","supports":"What expanded access is and who must agree.","type":"research"},{"id":"fda-ea-physicians","label":"Physician's guide to non-emergency single-patient expanded access","url":"https://www.fda.gov/drugs/investigational-new-drug-ind-application/physicians-guide-non-emergency-single-patient-expanded-access-submissions","publisher":"U.S. FDA","checkedAt":"2026-10-22","supports":"How a treating physician submits a single-patient expanded access IND.","type":"research"},{"id":"nci-vaccines","label":"Cancer treatment vaccines","url":"https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/cancer-treatment-vaccines","publisher":"National Cancer Institute","checkedAt":"2026-10-22","supports":"Background on how cancer treatment vaccines work and their side effects.","type":"research"}],"applicability":"For people with cancer and their care teams who are looking into personalized cancer vaccines outside a clinical trial. Inclusion is not a recommendation or a finding that it is right for your cancer.","limitations":"Service, product and timing details are reported by Serova unless noted. SRV-001 is investigational and not FDA approved, and Serova had no human safety or efficacy data for it as of September 2026. Expanded access is not approval. Confirm current access, requirements and costs directly. A company profile does not establish clinical benefit. My experience reflects my design as of October 2026.","disclosure":{"type":"none","text":"I'm a paying patient. I have no other financial or business relationship with Serova."},"reviewedAt":"2026-10-22","relatedIds":["966ad3d5-e20a-40de-ba3d-cb072e57ebef","f7221927-6b87-4be3-9a7c-906768a192a5","892119f9-0439-4e43-b467-66c99bc7be7c"],"assetIds":["fd5f629d-c76e-4980-9942-5712a8c8d04e","78f85816-bb7d-4ac0-8e09-1030cf293732"],"relatedX":[],"website":"https://serova.bio/","serviceStatus":"research","access":{"label":"Information for patients and families","url":"https://info.serova.bio/01_PATIENTS_AND_FAMILIES"},"facts":[{"label":"Service","value":"Free review of your existing reports, then possible vaccine design, manufacture through an outside maker, help with treatment permission, and ctDNA and immune monitoring.","sourceIds":["patients","physicians"]},{"label":"Data needed","value":"Oncology summary, pathology and molecular test reports, scan reports and details of stored tissue. Raw sequencing files help. More sequencing (tumor RNA, normal DNA, HLA) may be needed.","sourceIds":["patients"]},{"label":"Product","value":"SRV-001: patient-specific mRNA in lipid nanoparticles, injected into muscle. Proposed adult course is 13 injections over about 11 months.","sourceIds":["patients","physicians"]},{"label":"Timing","value":"About 12 weeks to manufacture after the design is final, per Serova. Sample retrieval, sequencing, design and permissions add time.","sourceIds":["patients","physicians"]},{"label":"FDA status","value":"Investigational, not FDA approved. No patient treated as of September 3, 2026. Expected U.S. route is a single-patient expanded access IND filed by your doctor. No ClinicalTrials.gov listing found.","sourceIds":["patients","physicians","ctgov","fda-ea-physicians"]},{"label":"Cost","value":"In 2026 I paid $200,000; expect about the same. Serova prices each case on workload, design and manufacturing, and as of October 2026 its site cites recent estimates around US$200,000. Report review is free. Hospital and travel costs are extra.","sourceIds":["patients"]},{"label":"Company","value":"Serova Bio Limited, a private company registered in London in September 2025.","sourceIds":["companies-house"]}],"id":"45dd3750-3fe0-4621-9723-fc49fdeaffc2","kind":"company","slug":"serova","revision":"35e59e9a-908a-45a6-b962-3da4e21bba52","canonicalUrl":"https://kevinwimer.com/companies/serova/","publishedAt":"2026-10-23T00:19:04.477Z","updatedAt":"2026-10-23T02:28:08.787Z","previewOnly":false,"logoAssetId":"fd5f629d-c76e-4980-9942-5712a8c8d04e","logoBackground":"light","logoSource":{"pageUrl":"https://serova.bio/","assetUrl":"https://serova.bio/serova-logo-cream.svg","checkedAt":"2026-10-23T00:15:04.507Z"},"shareImageAssetId":"78f85816-bb7d-4ac0-8e09-1030cf293732"}