Cancer vaccines are a new type of immunotherapy, which have been developed since the discovery of the human papillomavirus (HPV) in the 1980s.（HPV）Since its association with cancer, this therapy has been receiving significant attention. To prevent a series of cancers caused by this virus(such as cervical cancer, head and neck cancer), corresponding vaccines have been developed and eventually obtained approval from the U.S. Food and Drug Administration（FDA）Approval.
In addition to vaccines targeting HPV, there are also vaccines targeting the hepatitis B virus.(Can lead to liver cancer)The preventive vaccine has also been successfully developed. Although these vaccines have been widely used to prevent infections, the research and application of therapeutic cancer vaccines remain urgent.
In 1990,BCG Vaccine(TB Vaccine)Becoming the First FDA-Approved Immunotherapy for the Treatment of Early-Stage Bladder Cancer. Since then, despite the immunogenicity(The ability to stimulate antigen immune response)There are still some challenges in this aspect, but tumor vaccine immunotherapy has been proven to enhance the immune system's ability to attack antigens and has achieved successful application in patients.
Currently, there are numerous Biotech companies around the world.Companies specializing in the production of cancer vaccines. Today, we will introduce some companies that have made progress in the field of cancer vaccines.
Aston Sci. is a South Korean biotechnology company that has made progress in the field of cancer vaccines and is known for its focus on oncology and immunology.September 1, 2022, the company received approval from the US FDACornerStone-001Phase 2 Clinical Study of New Drug(IND)Approval for its candidate vaccineAST-301（HER2-hICD）Conduct clinical trials（NCT05163223）。AST-301 is currently being evaluated forHER2-1+/2+Breast Cancer and Gastric CancerThe efficacy.This vaccine is a plasmid DNA-based therapy that induces cellular immunity against the HER2 protein.. This research was conducted in collaboration with the University of Washington and EpiThany.On September 12, 2023, it was specifically designed forInnovative Cancer Vaccine AST-201 Designed for Ovarian CancerAlso received FDA Phase 2 Clinical Study New Drug（IND）Approved, this study is a randomized controlled trial conducted in patients with Stage III advanced ovarian cancer, aiming to evaluate the plasmid-based DNA vaccine AST-201 in combination with standard adjuvant chemotherapy.(Paclitaxel/Carboplatin)Clinical efficacy and safety of newly diagnosed patients after surgical intervention when used in combination. The primary objective is to evaluate progression-free survival.（PFS）Compare the clinical efficacy of AST-201 and placebo.▲Part of the pipeline (Source: official website)In addition, Aston Sci. has six other candidate vaccines under development, including those for solid tumors.AST-023, for breast cancerAST-302And for ovarian cancerAST-202，All of these therapies are in different clinical trial stages for their respective indications, including preclinical studies.In terms of funding, the five-year-old company completed its Series C financing in March 2022, raising $22.7 million. In terms of manufacturing, the company collaborates with Korean biotech firm Anygen as well as U.S.-based pharmaceutical companies Integrity Bio and VGXI. Regarding clinical research,Aston Sci. is currently conducting multiple clinical studies in the United States, Taiwan, Korea, and Europe.BioNTech presumably needs no extensive introduction. During the COVID-19 pandemic, its BNT162b2 mRNA vaccine, developed in collaboration with Pfizer, brought it great fame. It is a biotechnology company based in Germany, focusing on cancer research and the development of treatments.They currently have more than 15 candidate drugs in development, which are in the first and second phases of clinical trials for the treatment of various cancers, including advanced melanoma, prostate cancer, and ovarian cancer.Most of the candidate drugs are based on mRNA and antibody platforms, as well as cell therapies. The company’s vaccine development could bring a revolutionary impact to oncology research.BioNTech'sFixVac mRNA Cancer Vaccine PlatformMainly by activating immune cells to fight cancer cells, these immune cells can recognize cancer-specific antigens.This vaccine platform uses mRNA encoding non-mutated tumor antigens for the treatment of cancers such as melanoma and non-small cell lung cancer. Compared to other existing vaccine platforms on the market, this candidate may be more effective because it utilizes optimized uridine mRNA.（uRNA）To enhance immune stimulation.In addition, BioNTech also owns a platform namediNeST's Cancer Vaccine Platform, for the treatment of various solid tumors, including colorectal cancer. In addition, the company is also committed to developing a vaccine platform for infectious diseases.On March 11, 2024, BioNTech announced that it will present the latest advancements at this year's AACR Annual Meeting, includingBased onPersonalized Neoantigen mRNA Cancer Vaccine （“iNeST”）Candidate ProductBNT122，The candidate drug is currently undergoing a randomized Phase 2 trial in PDAC patients.（NCT05968326）Evaluation, jointly developed by BioNTech and Genentech, a member of the Roche Group.In addition, it will also announce based onTumorShared Relevant AntigensmRNA Therapeutic Cancer Candidate VaccineBNT116Combination with Docetaxel for the Treatment of Advanced Unresectable or Metastatic NSCLC（NCT05142189）Preliminary results of the patients.BioNTech, founded in 2008, is a company with a 15-year history. They have completed nine rounds of financing, raising a total of 1.7 billion US dollars. The most recent round occurred in April 2022, led by the German Federal Ministry of Education and Research.（BMBF）Temasek Holdings is one of the investors. In addition, the company also announced that it will cooperate with OncoC4 to jointly commercialize the latter's cancer candidate drugs.Mentioning Dendreon, it is不得不提具有里程碑意义的Prostate Cancer VaccineSipuleucel-T（Provenge®）Provenge® isThe world's first cancer vaccine therapy approved by the FDA in 2010, Composed of antigen-presenting cells(APCs)Autologous Peripheral Blood Mononuclear Cells(Peripheral blood mononuclear cells，PBMCs)Composition, autologous peripheral blood mononuclear cells are treated with a recombinant fusion protein in vitro.(PA2024)Activation.
PA2024 is derived from prostatic acid phosphatase(PAP, a prostate cancer antigen, expressed in approximately 95% of prostate cancers)The carboxyl terminus with Granulocyte-Macrophage Colony-Stimulating Factor(GM-CSF, an immune cell activator)The amino-terminal fusion, which isPAP-GM-CSFAPCs can capture PAP and process it into a form recognizable by T cells.However, Provenge performed disappointingly in marketing, leading to Dendreon's bankruptcy announcement in 2014, but the therapy later experienced a revival.As of 2021, more than 40,000 patients with prostate cancer have received this therapy.。In 2021, Dendreon launched a campaign on racial disparities in prostate cancer as part of the Provenge marketing initiative. Headquartered in Seattle, USA, Dendreon was acquired by China’s Sanpower Group in 2017 and later became...Resold to Chinese retailer Nanjing Xinhua Department Store for $868 million（600682.SH）, becoming a holding subsidiary under the group（Dendreon China）。On July 28, 2022, Dendreon China applied for the Phase III pivotal registration clinical trial of Provenge in China and officially announced it on the Drug Clinical Trial Registration and Information Disclosure Platform. The clinical registration number isCTR20221644This means that Provenge has officially launched its Phase III clinical trial in China, and its market entry in the country is entering an accelerated phase, potentially offering a new option for prostate cancer patients in China.Elicio Therapeutics is a biotechnology company located in Cambridge, Massachusetts, focusing on immunotherapy research, primarily in the fields of cancer and infectious diseases.Recommended Reading:Latest Research from Elicio TherapeuticsThe company's main technology is amphiphilicity.（AMP）Peptide Platform, which serves as the foundation for the development of various candidate vaccines targeting cancer and other diseases. The design concept of the AMP platform is to utilize amphiphilicity.(With both hydrophilic and lipophilic properties)Binding to albumin in the plasma, these albumin act as carrier molecules to guide the vaccine to the lymph nodes.▲Pipeline (Figure source: official website)
Currently, the company is conducting research and development on four cancer vaccines based on AMP technology, includingELI-002 for KRAS Gene Mutation-Induced Cancer、Anaplastic Lymphoma Kinase（ALK）ELI-003 for Mutational Cancer、Based on Gene Fusion ELI-011 in Lung Cells and ELI-004 for Blood Cancer。Recently, the Phase 1 clinical trial of its candidate product ELI-002 (NCT04853017) The results were published in "Nature Medicine" magazine, titled "Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial "。The results showed that among 25 patients, 84% exhibited T-cell responses specific to mKRAS, along with tumor biomarker responses. Additionally, biomarker clearance was observed in six patients. ELI-002 2P was demonstrated to be safe in refractory patients with KRAS-mutant tumors and capable of inducing significant T-cell responses.Elicio Therapeutics, founded in 2011, has raised over $212 million to date, with the latest investors including U.S.-based pharmaceutical company Angion and the Chicago Gastroenterology Research Foundation.Immunomic Therapeutics is a privately held clinical-stage biotechnology company dedicated to developing innovative immunotherapies to combat cancer and other diseases.Founded in 2005, it has raised over 75 million US dollars through 8 rounds of financing and collaborated with American institutions such as Duke University and the University of Florida to commercialize its immunotherapy platform.The core technology of the company isUNITE Platform，What makes UNITE vaccines unique is that they combine two components:Nucleic Acid Constructs Encoding Specific Antigens and Endogenous Lysosome-Associated Membrane Proteins（LAMP-1）Sequence,Effectively enhances antigen transport and presentation。▲UNITE Vaccine Mechanism (Source: Official Website)The company was the first to develop LAMP-mediated nucleic acid-based immunotherapy, itsCandidate ProductITI-3000 inGranted FDA Fast Track Designation in November 2022（FTD）。On October 23, 2023, the Phase 1 clinical trial of this product was announced (NCT05422781) Safety and Tolerability Results.ITI-3000 is a plasmid DNA（pDNA）Vaccine,With the help of the company's research universal UNITE platform,WillGene Sequence Encoding LAMP-1 ProteinIntegrated intoMCPyV Large T Antigen（LT）In the mutant sequence, toTreatment of Merkel Cell Carcinoma（MCC）Patients, this is a rare but aggressive skin cancer, usually caused by the Merkel cell polyomavirus.（MCPyV）。Another candidate productITI-1001, has been used to treat glioblastoma multiforme（GBM）In the Phase 1 clinical trial, and the first patient was dosed on August 24, 2023.。ITI-1001 is designed to target cytomegalovirus.（CMV）The pp65, IE-1, and gB viral antigens, which are expressed in GBM, but not expressed in normal brain cells.Imugene is a clinical-stage biotechnology company located in Sydney, Australia, focusing on the development of immuno-oncology treatments. The company was founded 10 years ago and has raised over 80 million US dollars for the research and development of its product pipeline.Imugene's product pipeline includes B-cell immunotherapy, CAR-T cell therapy, and oncolytic virus therapy. B-cell immunotherapy is a method that links immunogenic proteins with B-cell epitopes and combines them with adjuvants to create a B-cell cancer vaccine. This vaccine can induce the body to produce antibodies against normal self-proteins.(such as HER2 or PD-1)Antibodies, after vaccination, the antibodies produced are a mixture composed of various antibodies, capable of binding to different parts of the vaccine antigen.Imugene owns patented cancer vaccines such as HER-Vaxx, PD1-Vaxx, and B-Vaxx. The company obtained a U.S. patent for PD1-Vaxx in March 2023 and is currently conducting research on non-small cell lung cancer.（NSCLC）Clinical research.In addition, the company's oncolytic virus and CAR-T therapy have also entered clinical trials as of January 17, 2024.It announced the oncolytic virusCF33-hNIS（VAXINIA）Phase 1 clinical data, showing positive clinical efficacy and safety. It is worth mentioning that,VAXINIAOn November 28 last year, it received the FDA Fast Track designation for cholangiocarcinoma.▲onCARlytics Combination Immunotherapy (Image Source: Official Website)And its CAR-T candidate productAzer-cel Completes First Patient Dosing in Phase 1b Allogeneic CAR T Clinical Trial, Reaching Key Milestone. Interestingly,The company has also developed a technology that combines CAR-T with oncolytic viruses.（onCARlytics）, utilizing oncolytic viruses to deliver and present antigens on the surface of cancer cells, combined with CAR-T to combat cancer cells, this methodSimilar to BioNTechCAR-T+CARVac（BNT211）。References: VariousOfficial WebsiteScan the WeChat QR code to add.Medicine Space-TimeEditor
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