Cancer vaccines: 11 biotechs to keep an eye out for

Newsletter Signup - Under Article / In Page"*" indicates required fieldsSubscribe to our newsletter to get the latest biotech news!By clicking this I agree to receive Labiotech's newsletter and understand that my personal data will be processed according to the Privacy Policy.*Business email* EmailThis field is for validation purposes and should be left unchanged. A kind of immunotherapy, cancer vaccines have been around since the link between human papillomavirus (HPV) and cancer was discovered in the 1980s. For the prevention of cancers caused by the virus, vaccines were developed and later approved by U.S. regulators. Besides the HPV vaccine, therapies to prevent hepatitis B, which can cause liver cancer, were created as well. These vaccines were the first-ever anti-cancer preventative treatments.While these vaccines have been widely used to prevent the spread of infection, cancer vaccines have evolved as a treatment method for the disease. In 1990, Bacillus Calmette-Guérin – a vaccine for tuberculosis (TB) – became the first immunotherapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of early-stage bladder cancer. Since then, the potential for oncological vaccine immunotherapies to boost the immune system’s ability to target antigens has been studied and successfully administered in patients, despite some challenges with regard to immunogenicity – the ability of an antigen to provoke an immune response. As various biotechs across the world specialize in the production of cancer vaccines for different indications, with the major players being multinational companies like Biontech, CureVac, and Moderna, here are 11 companies making progress in the field of vaccine development for cancer.Table of contentsCandel TherapeuticsLocation: U.S.Lead candidate: CAN-2409Recent funding: $92 millionBased in the biotech hub of Massachusetts in the U.S., cancer vaccine developer Candel Therapeutics has seen promising data come from its pipeline in recent times. In prostate cancer, it is testing its phase 3 cancer vaccine candidate CAN-2409. It is an adenoviral replication-defective engineered gene construct encoding the thymidine kinase gene derived from herpes simplex virus (HSV). It is injected directly into the tumor where the adenoviral construct serves as a vector to transport the HSV-thymidine kinase gene into tumor cells at the site of injection.In December 2024, the immunotherapy met its primary endpoint as it showed statistically significant and clinically meaningful benefit in combination with radiation therapy for intermediate-to-high-risk, localized prostate cancer. A 14.5% relative improvement in disease-free survival (DFS) was observed after 54 weeks. As this endpoint has not been used in trials previously, it may not be greenlit by the FDA; however, a special protocol assessment (SPA) with the FDA offers hope that the regulator could accept the DFS endpoint. When the news broke out about CAN-2409’s success in the clinic, stocks soared by 200%. And while the candidate failed a phase 2 clinical trial in 190 patients with low-to-intermediate risk localized prostate cancer, it made a comeback last month with positive final survival data from a pancreatic cancer trial. Three of seven patients treated with CAN-2409 were still alive with survival of 66, 63.6, and 35.8 months after enrollment, respectively. Survival observed in these patients is well beyond the expected median overall survival for pancreatic cancer with standard of care, suggesting a long tail of survival, the company added in the press release.Candel’s other candidate CAN-3110 is an HSV engineered to enhance selective killing of cancer cells while sparing healthy neighboring cells. It targets nestin, a protein that is highly expressed in brain tumor cells, which is why the candidate is currently being evaluated in early-stage brain cancer studies.The biotech closed a $92 million public offering in December, which will fuel the Biologics License Application process for CAN-2409.Elicio TherapeuticsLocation: U.S.Lead candidate: ELI-002Recent funding: $10 millionSituated in the brimming biotech hub in Cambridge, Massachusetts, Elicio Therapeutics specializes in immunotherapeutic research in the field of cancer and infectious diseases. And its amphiphile technology (AMP) platform is the foundation for the various vaccine candidates in its pipeline against cancer and other diseases. The AMP platform, which aims to target the lymph nodes, is based on the potential of amphiphile – a compound with hydrophilic (water-soluble) and lipophilic (fat-soluble) properties – to bind to albumin – a protein found in the plasma – the latter acting as a carrier molecule to direct vaccines to the lymph nodes.Suggested Articles The rise of cancer vaccines: A new era in immunotherapy World Cancer Day: trends in cancer therapeutics to look forward to in 2025 Pancreatic cancer: Oncolytics Biotech, Candel, and CytomX bring promising therapies to the clinic Ovarian cancer: BioNTech, Curelab, OvarianVax and more bring vaccines to the clinic Revolving around the AMP technology, the company has four cancer vaccine candidates in its pipeline, namely ELI-002 for KRAS-driven cancers – caused by a mutation in the KRAS gene, which drives 25% of all solid tumors – ELI-007 targeting mBRAF in gastrointestinal (GI) tumors, and ELI-008 targeting mTP53 in GI tumors.A phase 1 solid tumor study of ELI-002 found that the candidate induced robust, polyfunctional, and durable KRAS-specific CD4+ and CD8+ T cell responses. Tumor biomarker reduction was observed in 84% of patients, correlating with a median relapse-free survival of 16.3 months. A phase 2 study in pancreatic ductal adenocarcinoma (PDAC) – the most common type of pancreatic cancer – began last year.Elicio kicked off 2025 with a $10 million registered direct offering. EvaxionLocation: DenmarkLead candidate: EVX-01Recent funding: $10.8 millionDanish biotech Evaxion has been leveraging artificial intelligence (AI) to simulate the immune system and generate predictive models to identify and develop personalized immunotherapies for patients. It has developed EVX-01, a peptide-based neoantigen cancer therapy for the first-line treatment of metastatic and unresectable melanoma. The phase 1/2 trial of EVX-01 along with a PD-1 inhibitor saw 67% of patients with melanoma – eight out of 12 – achieve objective clinical responses with two complete and six partial responses. To add to that, vaccine-induced T cells were detected in all patients. The phase 2 trial began in January, and it was reported that all the patients had been dosed.Another one of Evaxion’s cancer vaccines is EVX-02, which is a DNA vaccine. It works by encoding multiple melanoma patient-specific neoepitopes, which are highly immunogenic tumor-associated antigens (TAAs). In a phase 1/2 trial, all 10 patients who received EVX-02 were relapse-free at their last assessment. Of these 10 patients, nine completed the full study and were relapse-free at the 12-month end of study visit. One patient discontinued the trial due to non-EVX-02-related adverse events (AEs) and was relapse-free at the last visit at nine months, according to the report.Late last year, Evaxion signed a deal with pharma giant Merck, offering the latter the option to license two of its preclinical vaccines for treating infectious diseases such as gonorrhea. It also cashed in $10.8 million upon closing a public offering.Immunomic TherapeuticsLocation: U.SLead candidate: ITI-1000Recent funding: $61.3 millionA rare form of skin cancer, Merkel cell carcinoma (MCC) occurs when Merkel cells on the top layer of the skin turn cancerous. The cells, which grow rapidly at an early stage, can spread to the lymph nodes and other parts of the body. Current forms of palliative treatment include radiation therapy and chemotherapy to improve the quality of life in patients.Now, vaccine immunotherapies are being studied to broaden the treatment options for people with MCC. U.S.-based Immunomic Therapeutics is conducting clinical trials for its DNA-based vaccine ITI-3000, a plasmid DNA vaccine targeting the large T antigen (LT) of Merkel cell polyomavirus (MCPyV). It is currently being tested in a phase 1 trial at the University of Washington and Fred Hutchinson Cancer Research Center. In a study, the candidate showed a favorable safety profile, and patients showed encouraging immunological responses. Another clinical candidate of Immunomic is ITI-1000, a dendritic cell therapy vaccine comprising autologous dendritic cells (DCs). In collaboration with the University of Florida, it is conducting a phase 2 study in patients with newly diagnosed glioblastoma (GBM), the most common and aggressive primary brain tumor in adults. Patients’ white blood cells are removed, matured into dendritic cells, vaccinated against the pp65 viral protein, and then returned to the patient.Its most recent funding round was worth $61.3 million back in 2020.ImugeneLocation: AustraliaLead cancer vaccine candidate: VaxiniaRecent funding: $12.56 millionLocated in Sydney, Australia, Imugene is a clinical-stage biotech that focuses on a range of treatments under immuno-oncology. Founded a decade ago, the company has raised more than $80 million in funding for the development of its pipeline.Imugene’s pipeline consists of two B cell immunotherapies as well as an oncolytic virus therapy – a kind of immunotherapy that uses viruses to target cancer cells. The B-cell cancer vaccines are meant to induce antibody production against proteins like HER2 and PD-1, which can in turn bind to the vaccine’s antigens to stimulate the patient’s immune system. Cutting down on manufacturing costs when compared to monoclonal antibody (mAb) drugs, Imugene’s vaccines are also potentially safer as they could avoid toxic side effects of mAb administration like congestive heart failure or anaphylaxis. HER-Vaxx, PD1-Vaxx, and B-Vaxx are Imugene’s proprietary cancer vaccines that take after the B cell therapy mechanism for targeting tumors.HER-Vaxx has been found to stimulate a potent polyclonal antibody response to the cancer target HER-2/neu in preclinical and phase 1 studies.In February, Imugen bagged A$20 million ($12.56 million), which will be directed toward advancing Imugene’s immuno-oncology clinical pipeline, including its CAR-T program azer-cel, onCARlytics, and VAXINIA candidates.InfinitopesLocation: U.K.Lead cancer vaccine candidate: ITOP1Recent funding: $17.05 millionA spinout of the University of Oxford in the U.K., Infinitopes is a cancer vaccine startup that has a discovery platform that uses machine learning workflows. It has been validated in preclinical models and has shown superior tumor protection compared to known antigens. These vaccines are designed to induce T cell immunity. Its lead vaccine candidate ITOP1 is a precision-targeted, immunologically durable, off-the-shelf cancer vaccine designed to prevent disease recurrence in first-line patients with surgically resectable cancers. It triggers T-cell protection to stop tumor progression. This has been observed in preclinical mouse models.The biotech has collaborated with various institutions in recent times. It has received backing from Cancer Research UK, Cancer Research Horizons, and Innovate UK. Last year, it collaborated with American life science company Bruker to identify cancer antigens. It also secured £12.8 million ($17.05 million) in seed funding, which will finance the ongoing phase 1/2a study ITOP1 as a first-line therapy in patients with cancer.NouscomLocation: Switzerland and ItalyLead cancer vaccine candidate: NOUS-209Recent funding: $72 millionImmunotherapy company Nouscom is developing engineered viral vector vaccines against cancer. The Swiss-Italian startup has two vaccine candidates in its pipeline, namely, NOUS-209 and NOUS-PEV. Phase 1b studies in gastrointestinal (GI) tumors showed that NOUS-209, which encodes 209 neoantigens, along with the checkpoint inhibitor pembrolizumab was well-tolerated and generated potent and broad immune responses and durable tumor shrinkage. This included strong and long-lasting induction of CD8 and CD4 T cells in 90% of patients. The efficacy results will be released later this year.Moreover, NOUS-209 is also in the clinic to treat Lynch Syndrome, a common hereditary condition that increases the risk of developing various cancers, particularly colorectal and endometrial cancers.Its other candidate NOUS-PEV, a personalized neoantigen cancer vaccine, is in early-stage clinical trials to address solid tumors. It exhibited good safety and immunogenicity, and induced durable neoantigen-specific T cell responses that were detected for over six months as well as increased T-cell infiltration in tumors.It last raised €67.5 million ($72 million) in a series C round in late 2023 to advance its two vaccine candidates through the clinic.OSE ImmunotherapeuticsLocation: FranceLead cancer vaccine candidate: TedopiFrench vaccine company OSE Immunotherapeutics has quite a few candidates up its sleeve. Its most advanced candidate Tedopi (OSE2101) currently awaits approval for the treatment of people with non-small cell lung cancer (NSCLC) who have previously been treated with a checkpoint inhibitor. It is a T-cell epitope-based cancer vaccine targeting five tumor-associated antigens, and its possible approval will be based on positive phase 3 trial results.The drug had demonstrated a significant therapeutic benefit in patients with secondary resistance to checkpoint inhibitors. It showed a favorable benefit-risk ratio versus the standard of care (SoC) chemotherapy in patients with advanced HLA-A2+ NSCLC.More recently, Tedopi met the primary endpoint in a phase 2 trial in patients with advanced pancreatic cancer. Further details of the trial will be published soon. The trial was sponsored by the French GERCOR Oncology Clinician Group.In non-cancer vaccine programs, the biotech has partnered with pharma giants like AbbVie and Boehringer Ingelheim, and Danish company Veloxis Pharmaceuticals, and could snap up to €2.1 billion ($2.29 billion) in milestone payments, out of which €180 million ($196.65 million) has already been received.ScancellLocation: U.K.Lead cancer vaccine candidate: SCIB1/iSCIB1+Recent funding: $13.38 millionBeen around since 1996, Scancell is a U.K.-based biotech company that is focused on oncological treatments with its antibody-based platforms and cancer vaccine platform Moditope. In addition, the company has also developed the vaccine technology ImmunoBody for the prevention of COVID-19.  The Moditope platform – characterized by the induction of CD4 cytotoxic T cells – has two vaccines in its lineup. The first, Modi-1 is composed of two target antigens, one being the cytoskeletal protein vimentin and the other being the metalloenzyme alpha-enolase, which is involved in the process of glycolysis – the pathway that breaks down glucose. The vaccine aims to treat melanoma, ovarian, lung, pancreatic, and breast cancer.The second vaccine, Modi-2, stimulates the production of CD4 T-cell tumor-associated peptide epitopes in which the lysine residues are converted to homocitrulline, and will address various cancer indications, including tumors. Scancell’s most advanced vaccine candidate is SCIB1/iSCIB1+, which is currently being evaluated in a phase 2 study in patients with advanced unresectable melanoma receiving checkpoint inhibitor therapy. It is a plasmid vaccine encoding two CD8 epitopes from the melanoma antigens tyrosinase-related protein-2 and glycoprotein 100 (gp100), plus two CD4 epitopes from gp100. The vaccine has shown potent vaccine-specific T cell responses and positive clinical responses.Recently, the company announced that the drug had an 84% disease control rate, 80% progression-free and 20% complete response rate in patients with advanced melanoma. Last year, it raised £10.3 million ($13.38 million) to push its lead candidate SCIB1/iSCIB1+ through the clinic.TakisLocation: ItalyLead cancer vaccine candidate: TK-003Situated in the capital city of Rome, Italy, Takis’ goal is to wield the capacity of the immune system in the fight against cancer and infectious diseases. In particular, the company has four frontline cancer vaccine candidates for a range of indications.In its pipeline for cancer vaccines are TK-003 and TK-004. TK004 is a DNA plasmid vaccine encoding a secreted monomeric form of the SARS-CoV-2 spike protein, delivered via intramuscular electroporation – a technique to enhance vaccine delivery by brief electrical pulses to temporarily increase cell membrane permeability.TK-003 is designed to trigger a robust immune response, and it induces high levels of anti-SARS-CoV-2 neutralizing antibodies. It is currently in phase 1 studies.The company has collaborated with the molecular biology and genetics institute Biogem in Italy and Veterinary Oncology Services in New York in the past.VacV BiotherapeuticsLocation: U.K.Lead cancer vaccine candidate: VacV001Recent funding: $3 millionA spin-out of Queen Mary University of London, VacV Biotherapeutics is a U.K.-based company that has developed an oncolytic virus vaccine platform to induce long-term responses against tumor antigens.The platform is derived from the Vaccinia virus – a poxvirus similar to the smallpox virus – which is genetically engineered to favorably alter the tumor microenvironment. VacV’s lead candidate VacV001 is being investigated in preclinical trials for its therapeutic efficacy for glioblastoma and pancreatic cancer, as well as VacV002 for colorectal cancer with liver metastasis. To further enhance intravenous delivery of the vaccines, pre-treatment with the PI3Kδ-selective inhibitor IC87114 in mice demonstrated improved results with regard to anti-tumor efficacy. VacV was awarded the Innovate UK Grant in October 2024. The company has obtained more than $3 million in funding, with the latest round completed in 2022, the year it was founded. Cancer vaccines: could they prevent cancer?While most cancer vaccines in the clinic at present are designed to be a potent immunotherapy against existing cancer cells, research and development (R&D) in the field is looking into preventing the onset of the disease altogether. Researchers at the University of Oxford have designed OvarianVax to train the immune system to detect and get rid of cells that are prone to developing into ovarian cancer. The focus of OvarianVax at the moment is on people who have a BRCA1/2 gene mutation. Although not yet in the clinic, it would be a pivotal milestone in cancer care if it is successful in the clinic. The global cancer vaccine market size was estimated at $7.31 billion in 2022, and as R&D expands globally, the market is poised to grow at a compound annual growth rate (CAGR) of 11.04% from 2023 to 2030, according to a report by Grand View Research. Explore other topics: biotech startupCancerClinical trialImmunotherapyScancellVaccines ADVERTISEMENT

Read full news in source page