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 – cervical, vaginal, vulvar and anal cancers – caused by the virus, vaccines were developed, and later approved by the Food and Drug Administration (FDA).
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 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, here are 10 companies, presented in alphabetical order, making progress in the field of vaccine development for cancer.
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Renowned for its focus on oncology and immunology, South Korean biotech Aston Sci has advanced in the cancer vaccine sector, with the company recently being granted Investigational New Drug (IND) clearance from the FDA in the U.S. for phase 2 of its CornerStone-001 clinical trial for its candidate AST-301.
AST-301, which is being evaluated for breast and gastric cancer, is a plasmid DNA-based therapy that induces cellular immunity against the protein HER2. The studies are being conducted in partnership with the University of Washington and EpiThany, both in the U.S.. The company has six other vaccine candidates in its pipeline, including AST-023 for solid cancers, AST-302 for breast cancer, and AST-201 and AST-202 for ovarian cancer.
All of its therapies are in various phases of clinical trials for their respective indications, including preclinical studies. In March 2022, the five-year-old company closed series C funding, having raised $22.7 million. For manufacturing, the company has collaborated with South Korea-based biotech Anygen and U.S.-based pharmaceuticals Integrity Bio and VGXI.
Established in Germany, BioNtech has made its name in the field of cancer research and therapeutic development. With more that 15 candidates in its pipeline – in phases one and two of clinical trials – for the treatment of various cancers including advanced melanoma, prostate cancer and ovarian cancer – most of them classified as mRNA- and antibody-based platforms and cell therapies – the company’s gateway into cancer vaccine development could be transformative in oncological research.
Its FixVac mRNA cancer vaccine platform is based on activating immune cells that recognize cancer-specific antigens to counter cancer cells. The platform consists of mRNA-encoded non-mutated tumor antigens, for the treatment of melanoma and non-small cell lung cancer, among others. The candidate, which works in a way that triggers the immune response against cancer cells, and targets tumors, could prove to be more efficacious than other current vaccine platforms in the market, as it uses optimized uridine mRNA (uRNA) to enhance its immunostimulatory effect.
The company also has another cancer vaccine platform called iNeST, to target solid tumors, including colorectal cancer. In addition, it specializes in vaccine platform development for infectious diseases like COVID-19 as well.
Founded in 2008, the 15-year-old company has raised $1.7 billion in nine rounds of funding, with the latest that took place in April 2022, with German Federal Ministry of Education and Research (BMBF) and Temasek Holdings, being its most recent investors. In March 2023, the company announced its partnership with OncoC4 for the commercialization of the latter’s cancer drug candidate.
The list cannot be complete without mentioning Dendreon’s landmark prostate cancer vaccine Provenge, the first-ever cancer vaccine therapy approved by the FDA in 2010.
Although Provenge was hailed a victory for cancer immunotherapy, partly due to marketing challenges, the company declared bankruptcy in 2014. However, the therapy has made a revival since, and as of 2021, more than 40,000 people with prostate cancer have been prescribed the therapy.
The vaccine uses a patient’s own immune cells, which are collected, processed and infused back into the individual through an intravenous infusion that is completed in three cycles.
In 2021, Dendreon launched an awareness program on racial disparities in prostate cancer as part of its marketing campaign for Provenge.
Headquartered in Seattle in the U.S., the company, which was acquired by China’s Sanpower Group in 2017, was resold for $868 million to Chinese retailer Nanjing Cenbest.
Bang in the middle of 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.
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 the KRAS gene – ELI-003 for cancers involving an anaplastic lymphoma kinase (ALK) mutation – a condition where the genes in the lung cells become fused together – ELI-011 for hematological cancers, and ELI-004.
Founded in 2011, Elicio Therapeutics has obtained more than $212 million in funding, with its most recent investors being U.S.-based pharmaceutical Angion and Gastro-Intestinal Research Foundation in Chicago.
A 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, where participants who were confirmed to have no evidence of active disease (NEAD), were dosed with 4 mg of the vaccine following standard radiotherapy or surgery, one year prior to the trial.
Having been around for 18 years, the company has raised more than $75 million in eight rounds, and has partnered with U.S.-based institutes like Duke University and the University of Florida for the commercialization of its immunotherapy platform.
Located 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 eight B cell immunotherapies as well as oncolytic virus therapies – 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 it 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.
Recently, in March 2023, the company was granted the patent in the U.S. for PD1-Vaxx, which is currently in clinical development for non-small cell lung cancer (NSCLC).
Been 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 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 cells tumor-associated peptide epitopes in which the lysine residues are converted to homocitrulline, and will address various cancer indications including tumors.
To further enhance its pipeline, the company has raised £82 million to date ($102.24 million) with the last two funding rounds in 2020 raising £46 million ($57.35 million), and its most recent investors being Redmile and Vulpes.
Situated in the capital city of Rome in 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-001, TK-002, TK-005 and NEOMATRIX, all of which are in their developmental stages. Having completed preclinical trials, TK-001 – for breast, ovarian, head and neck cancers – and TK-002 – for colon, prostate and stomach cancers – are based on adeno vector-prime DNA-boost platform technology, while NEOMATRIX works against neoantigens, which arise from gene mutations in malignant cells, for the treatment of melanoma and lung cancer.
The company has collaborated with molecular biology and genetics institute Biogem in Italy and Veterinary Oncology Services in New York, for further developing its extensive pipeline of cancer vaccine candidates.
Having been operational since 2009, the company also has a dedicated portfolio for treating infectious diseases, with the latest candidate to the roster being the COVID 19 vaccine COVID-eVax.
Norwegian biotech Ultimovacs has been making waves since 2011, for its immunotherapeutic research in oncology. The company’s lead candidate is the cancer vaccine UV1, which is currently undergoing five sets of clinical trials in phases 1 and 2, for various indications across more than 650 patients.
UV1, which is administered through intradermal injections, is based on the ability of telomerase – an enzyme that adds DNA to telomeres (ends of chromosomes) – to act as an antigen for immunotherapy, as it causes the proliferation of cancer cells. The vaccine is designed to induce a T cell response against the gene human telomerase reverse transcriptase (hTERT), which forms a crucial part of the enzyme.
The vaccine is being studied as a potential therapy for malignant melanoma, mesothelioma, ovarian cancer, head and neck cancer and NSCLC in phase 2 trials.
Ultimovacs has collaborated with multinational biopharmas like Bristol Myers Squibbs and AstraZeneca for the continuation of the clinical trials for UV1 across countries such as the U.S., Belgium, Spain, Germany and Norway. The company completed its latest funding round in 2021, having raised more than NOK270 million ($25.95 million) since its foundation.
A 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 under 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.
The company has obtained more than $3 million in funding, with the latest round completed in 2022, the year it was founded. Earlier this year, VacV attended the annual BIOEurope Spring conference in Basel, Switzerland.