List of Vaccines Companies with Phase 1 Active Clinical Trial - 44

Akamis is a clinical-stage oncology company whose mission is to leverage its groundbreaking T-SIGn® platform to positively impact the lives of people living with cancer. We are developing a portfolio of solid tumor-targeted T-SIGn® therapeutics which aim to enable a patient’s own immune system to recognize, attack, and clear their cancer. Akamis’ growing pipeline of T-SIGn® therapeutics is anchored by its lead clinical-stage program, NG-350A, which is being investigated in an ongoing Phase 1 clinical study in patients with metastatic or advanced epithelial tumors. Akamis has a number of T-SIGn® platform-focused collaborations with leaders in the immuno-oncology field including BMS, Merck, and the Parker Institute for Cancer Immunotherapy (PICI)

Allergy Therapeutics is a visionary immunology business with specialist experience in the research and development of allergy treatments. We have a well-established commercial presence in Europe and are focused on the US market. We specialise in the diagnosis and treatment of allergy. We mainly sell our products in European countries and our pipeline of products in clinical development includes vaccines for grass, tree and house dust mite, as well as a peanut allergy vaccine in pre-clinical development. Adjuvant systems to boost performance of vaccines outside of allergy are also under evaluation.

AMAL aims to tackle the obstacles for effective anti-cancer therapy by stimulating a patient’s immune system in a unique way. KISIMA®, our unique proprietary protein-based immunisation platform is self-adjuvanting and delivers several antigens in one single vaccine. We focus on the development of viable effective cancer therapies. Our most advanced asset is ATP128, a therapeutic vaccine for the treatment of metastatic colorectal cancers.

Anteris Technologies is a structural heart company focused on developing innovative solutions to the biggest challenges facing aortic stenosis patients and their physicians. Our DurAVR™ Transcatheter Heart Valve (THV) System is designed for younger patients who need a heart valve that will last their lifetime. DurAVR™ THV is a unique, single-piece valve and its first-in-class biomimetic design replicates the normal blood flow of a healthy human aortic valve. | $AVR | ASX: AVR | #DurAVR #ADAPT #structuralheart #TAVR #TAVI #cardiology

AstriVax is a privately held spin-off company from the KU Leuven, founded in 2022 based on vaccine technology developed at the Rega Institute. AstriVax is building a first in class Plug & Play vaccine platform with a patented DNA based technology that launches self-amplifying live attenuated viruses. The versatile technology of AstriVax can be used to develop a wide range of vaccines to prevent and treat infectious diseases. AstriVax aims to address major challenges in vaccinology by developing novel vaccines that are easy to produce, have reduced cold chain requirements, and offer broad and long-lasting protection against various viruses and other pathogens.

BioCytics via the Human Applications Lab is focused on bringing personalized oncology treatments to the market. BioCytics has an ongoing IRB-approved clinical trial (BioCytics 0001; NCT00571389) that allows for the collection and study of blood and tissue samples from consenting cancer patients. We are incubated within Carolina BioOncology - a preferred cancer treatment and Phase I drug testing facility. BioCytics was founded by Dr. John Powderly, MD, medical board certified oncologist and a certified physician investigator (CPI), who is also president of Carolina BioOncology Institute (CBOI).

Founded in 2007, we are a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing, and commercial capabilities as well as strong partnerships with organizations globally, we have developed a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable. As we focus on delivering vaccines for a healthier world, we remain steadfast in our dedication to both scientific innovation and equitable access.

Codagenix Inc. is a clinical stage biotechnology company with vaccine products against influenza, respiratory syncytial virus, dengue virus, and others currently under development. Codagenix uses a computer-based algorithm, called SAVE (Synthetic Attenuated Virus Engineering) to design viral genomes that are identical to the wild type strain at the amino acid level, but make less protein in human cells. The highly attenuated viruses make excellent vaccines or oncolytics against solid tumors. Codagenix represents the next wave in vaccine technology, untethered from traditional, time-consuming and unpredictable approaches to attenuating viruses.

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

ExpreS2ion Biotechnologies is a clinical-stage DK based biotech company specialised in the development of new vaccines and immunotherapy products. The company has a discovery platform built around a proprietary recombinant expression system, ExpreS2 TM, developed especially for fast and efficient development and production of complex proteins required for innovative new vaccines, immunotherapy and diagnostics. The system also includes functionally modified glycosylation variants. For the clinical Phase III-stage COVID-19 vaccine, ABNCoV2, the Company employs a novel plug-&-play capsid virus-like particle (cVLP) platform, that offers competitive advantages in terms of long-term efficacy, safety, stability, and costing. The cVLP and ExpreS2 TM platforms are also basis for a proprietary HER2-cVLP breast cancer vaccine, ES2B-C001, which has proven preclinical proof of concept and is on path towards clinical investigations. The development pipeline also has projects based on the ExpreS2 platform alone, including multiple clinical-stage malaria vaccine projects sponsored by academic partners, as well as novel preclinical-stage influenza and CMV vaccines, the latter in a research collaboration with Evaxion Biotech. Since founded in 2010, ExpreS2ion has produced more than 500 proteins and virus-like particles (VLPs) in collaboration with a high number of leading research institutions, biotech and pharma companies, demonstrating superior efficiency and success rates. The cVLP platform resides in its 34%-owned associated company AdaptVac that was founded in 2017. ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary and operational unit of ExpreS2ion Biotech Holding AB, listed on Nasdaq First North Growth Market, Stockholm (Ticker: EXPRS2).

HDT Bio is a vaccine and immunotherapy Biotechnology company developing drugs for immunotherapy of cancers and infectious diseases with next-generation approaches designed to enable the body’s immune system to prevent and cure disease. We have engineered our technologies to Access, Activate, and Amplify the immune system’s natural ability to create antibodies and T-cells that fight cancer and infectious diseases such as SARS-CoV-2. We are developing multiple product candidates from our proprietary discovery platforms, including LION™, which has the potential to provide health benefits to a broad patient population. Our products are designed to be cost-effective solutions to unmet medical needs and complementary to existing, cutting-edge immunotherapies. HDT Bio offers a comprehensive compensation plan which includes health insurance for employees and dependents (inclusive of multiple plants to choose from, including a $0 premium plan with HSA and company contribution), generous PTO (11 observed holidays and week long year-end closure), stock options with Carta Tax Advisory for equity and tax support, flexible spending accounts (FSAs), commuting benefits (ORCA or paid parking), and retirement benefits with company match. HDT Bio Corp. is an equal opportunity employer committed to a diverse and inclusive workforce. This environment is encouraged by HDT's culture, which supports women in science through our Women+ group, creates inclusive events to highlight the diverse cultures represented by our staff, and with the adoption of an open office environment for all.

The company is focusing on research and development of immunotherapies for cancers, inflammatory and infectious diseases based on its patented PD-1-enhanced DNA vaccine and Anti-Δ42PD1 Antibody Immuno Blocking technology platforms; with 2 vaccines in first-in-human clinical trials.

Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the Universal Intracellular Targeted Expression (UNITE) nucleic acid immunotherapy platform. This investigational technology has the potential to alter how we use immunotherapy for a number of diseases, including cancer, allergy and infectious diseases.

Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our product pipeline includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies.

Innovac Therapeutics is a biotechnology company dedicated to developing innovative vaccines for patients with unmet medical needs, using our proprietary RNA technology.

Formerly ADGI -Adagio Therapeutics, Inc., Invivyd is a biopharmaceutical company on a mission to protect humanity from serious viral respiratory diseases.​ The company is developing antibodies to transcend the limits of naturally occurring immunity and provide superior protection from viral diseases, beginning with COVID-19. ​Invivyd’s technology works at the intersection of evolutionary virology, predictive modeling, and antibody engineering, and is designed to identify high-quality, long-lasting antibodies with a high barrier to viral escape.​ The company is generating a robust pipeline of products for use in both prevention and treatment of disease. Invivyd’s most advanced pipeline candidate is adintrevimab, an investigational monoclonal antibody which has demonstrated clinically meaningful results in global Phase 3 clinical trials against multiple variants of concern for the prevention and treatment of COVID-19. Adagio Therapeutics, Inc. was incorporated in 2020 and is based in Waltham, Massachusetts.

KaliVir Immunotherapeutics was founded in 2019 to pioneer a unique and novel approach to cancer treatment that engages a virus' natural ability to replicate in and kill cancer cells. This modality is known as oncolytic viral immunotherapy. KaliVir's cutting-edge, next generation oncolytic viral immunotherapy programs combine technologies developed in-house and licensed from University of Pittsburgh's world-class oncolytic virus and immunotherapy research programs.

Marker Therapeutics, Inc., a clinical stage immuno-oncology company, engages in the development and commercialization of various T cell-based immunotherapies and peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. Its MultiTAA-specific T cell technology is based on the expansion of non-engineered tumor-specific T cells that recognize tumor associated antigens and kill tumor cells expressing those targets. The company’s MultiTAA-specific T cell therapies include autologous T cells for the treatment of lymphoma, multiple myeloma, and various solid tumors; and allogeneic T cells for the treatment of acute myeloid leukemia and acute lymphoblastic leukemia. It is also developing TPIV100/110, which is in Phase II clinical trial for the treatment of breast cancer; and TPIV200 that is in Phase II clinical trial for the treatment of breast and ovarian cancers. Marker Therapeutics, Inc. is headquartered in Houston, Texas.

Applying breakthrough science to develop life-saving vaccines for people in need around the globe

Memgen is a clinical-stage biotech company developing viral immunotherapies to harness the power of the immune system to potentially cure cancer and to protect people from infectious diseases. The Company’s pipeline products all utilize its proprietary CD40L transgene, MEM40, which has already demonstrated the ability to elicit powerful, antigen-specific immune responses. The Company’s lead cancer immunotherapy, MEM-288, was developed in collaboration with Moffitt Cancer Center. It is an oncolytic virus engineered to selectively target cancer cells and to supercharge the immune system through expression of two unique and powerful immune modulators: MEM40 and the powerful cytokine interferon beta. MEM-288 generates a strong systemic anti-tumor immune response following intra-tumoral vaccination in multiple tumors. Memgen is close to completing the monotherapy part of a clinical trial in advanced/metastatic NSCLC. Memgen's vaccine adjuvant, MemVax, is designed to be used in combination with other vaccines to generate a strong, durable immune response. MemVax is a highly specific immune stimulant that can work with antigens across a range of delivery approaches. Memgen has over 100,000 doses of MemVax ready to go into clinical trials, and an active file with the US FDA. Memgen plans to soon begin clinical trials of MemVax in collaboration with other companies developing complementary vaccines.

Micron Biomedical, Inc. is a clinical-stage biopharmaceutical company on a rapid path to bring to market drugs and vaccines that are formulated into a proprietary patch technology that simplifies and improves the way actives are delivered, stored, and distributed. This technology is designed to increase patient access to drugs and vaccines that would otherwise require expert injection and to improve safety and efficacy by skin targeting.

Najít Technologies is dedicated to the development of safe and effective vaccines against infectious diseases of global importance.

NANOGEN BIOPHARMACEUTICAL is a leading company that is doing research and development of active Biopharmaceutical ingredients (APIs), and specific therapeutic injections in Asia Pacific region, based on advance in recombinant DNA and protein technologies. Nanogen offers a variety of gene-to-therapy biopharmaceuticals for the treatment of hepatitis B, hepatitis C, anemia due to chronic renal failure, oncology, etc. Our departments and facilities are integrated in the area of 15 000 square meters, located in Saigon Hi-tech Park Ho chi Minh City Vietnam. We research, develop, manufacture and market a wide range of therapeutic injection products under the strict compliance with current GMP and tight QC/QA procedures. Nanogen’s team consists of high-qualified scientists and graduates in diversity of biotechnology, pharmaceutical and healthcare. We have an international business network with the aim to produce high quality, affordable biotherapeutics.

NeoCura is a high-tech enterprise that relies on AI technology to create an RNA technology platform and conduct R&D of innovative drugs. The company has built multi-omics big data acquisition platforms and multiple bioomics databases. It uses AI and bioinformatics technology to conduct in-depth drug target mining and fully automated drug design for innovative RNA technology platform upgrades and drug research. It has established leading R&D centers and production centers in Beijing, Shenzhen, and Guangzhou to support pipelines development, platform upgrades, and clinical demand.

Northwest Biotherapeutics, Inc. is a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. Currently approved cancer treatments are frequently ineffective, can cause undesirable side effects and provide marginal clinical benefits. The Company’s approach in developing cancer therapies utilizes its expertise in the biology of dendritic cells, which are a type of white blood cell that activate the immune system. The Company’s cancer therapies have been demonstrated in clinical trials to significantly extend both time to recurrence and survival, whilst providing a superior quality of life with no debilitating side effects when compared with current therapies. The Company’s platform technology, DCVax®, uses a patient’s own dendritic cells, the starter engine of the immune system. The dendritic cells are extracted from the body, loaded with tumor biomarkers or ‘‘antigens’’, thereby creating a personalized therapeutic vaccine. Injection of these cells back into the patient initiates a potent immune response against cancer cells, resulting in delayed time to progression and prolonged survival. The Company’s lead product candidate is DCVax®-Brain which targets Glioblastoma Multiforme (‘‘GBM’’), the most lethal form of brain cancer. DCVax®-Brain has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval). Following this trial, the Company anticipates filing a biologic license application (or ‘‘BLA’’) with the FDA for DCVax®-Brain. DCVax®-Prostate, which targets hormone independent (i.e. late stage) prostate cancer, has also been cleared by the FDA to commence a Phase III clinical trial, which is also designed and powered as a pivotal trial.

Our mission is to develop effective and affordable preventive vaccines for Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative disorders. Using our universal vaccine platform for Alzheimer’s, our goal is to induce antibody titers high enough to penetrate the blood-brain barrier and prevent pathological plaques, fibrils, and oligomers to delay disease onset in cognitively unimpaired people at risk of Alzheimer’s.

Through targeting multiple tumor-associated antigens with an investigational multi-peptide vaccine and a multi-tumor antigen adoptive (MTAA) T cell therapy, OncoPep’s T cell focused technologies are designed to be used on their own or in combination with other immunotherapeutics.

OncoTherapy Science, Inc. provides pharmaceutical companies with yielded drug candidates by using outcomes obtained from joint research with universities and companies. These outcomes include oncogene information isolated by comprehensive analysis of genes specifically expressed in cancer cells and functional analysis information of proteins produced by oncogenes and other gene products. We have also been performing research and development business regarding medications.

4Clinics is a Contract Research Organization (CRO) providing Data management, Biostatistics, Scientific Writing, Regulatory Affairs and Clinical Operations services for clinical and epidemiological studies with a particular expertise in vaccines, immunology, immuno-oncology and medical devices. 4Clinics serves pharmaceutical, biotechnology and medical devices companies as well as NGOs, hospitals and researchers with tailor-made services including remote biometry and medical writing platforms. 4Clinics has offices in Belgium, France and Morocco and has a global coverage. For more information, please visit www.4Clinics.com

PhotonPharma is an immuno-oncology company with a break-through technology that stimulates a patient's own immune system to seek out and destroy their cancer cells. We have a patent protected process that precisely inactivates DNA/RNA of a patient's own tumor cells while leaving the cells alive with all of unique tumor specific antigen targets (neoantigens) intact. The process is simple, fast and inexpensive. A patient's tumor cells can be extracted, inactivated and administered back on the same day. Efficacy and safety has been demonstrated in a dog trial (companion animals) and in mouse studies.

Prokarium is pioneering the field of microbial immunotherapy. Our pipeline is designed to unlock the next level of immuno-oncology by building on the most recent advances in cancer immunology. Prokarium’s lead program is focused on transforming the treatment paradigm in bladder cancer by orchestrating immune-driven, long-lasting antitumor effects.

ProMIS Neurosciences is focused on the treatment of Alzheimer’s disease, amyotrophic lateral sclerosis and multiple system atrophy through the discovery and development of antibodies selective for toxic misfolded proteins driving these diseases.

Quratis Inc operates as a developer of vaccines and therapies designed to treat tuberculosis. The company develops youth and adults tuberculosis vaccines, messenger ribonucleic acids, and other related immune-related vaccines.

ReCode Therapeutics is a clinical-stage genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s selective organ targeting (SORT) lipid nanoparticle (LNP) platform is a next-generation, genetic medicines technology that enables precise delivery to target organs and cells beyond the liver.

ReiThera is a company devoted to developing and producing biopharmaceutical products based on gene delivery technologies doe advanced therapies, in order to prevent and treat several serious or life-threatening diseases.

Rokote Laboratories Finland Oy is a Finnish vaccine development company. We are developing the Finnish COVID-19 vaccine.

SpyBiotech is a UK-based company with a novel vaccine platform to target infectious diseases, cancer and chronic diseases. SpyBiotech was spun out of the University of Oxford in 2017. Its proprietary protein superglue technology binds antigens to vaccine delivery platforms in a way which minimizes delivery risk and enhances immunogenicity and efficacy. The company’s current lead candidate is against human cytomegalovirus (HCMV), with clinical studies planned for this year.

Turnstone Biologics is a clinical-stage biotechnology company developing new medicines to treat and cure solid tumors by pioneering a differentiated approach to TIL therapy. Our innovative TIL therapy is based upon the identification, selection, and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TILs that have demonstrated objective responses only in limited tumor types. Our most advanced program, TIDAL-01, is currently being evaluated in two Phase 1 studies in patients with melanoma, breast cancer, and colorectal cancer. We are also actively advancing a pipeline of preclinical programs, including TIDAL-02, our next Selected TIL program, and our TIDAL-01 and viral immunotherapy combination program.

Valo Therapeutics (ValoTx) is a developer of novel immunotherapies in cancer and infectious disease. Our unique approach to immunotherapy, based on oncolytic viruses and viral vectors combined with disease-specific peptides, delivers highly adaptable and immunogenic therapeutic vaccination platforms. A spin-out company from the University of Helsinki, Finland, Valo Tx has assembled a talented team of immunotherapy experts, who together with the founding scientists have the necessary expertise to take its patented technology through clinical development and make it available to patients.

Vaxxas is commercializing novel technology that dramatically enhances the performance of existing and next-generation vaccines. The company believes its innovative needle-free technology will help the world in rethinking what's possible with vaccines.

Vicebio uses the molecular clamp technology to develop innovative vaccines against life-threatening respiratory viruses. The Molecular Clamp technology provide unique stabilisation of viral envelop glycoproteins making possible highly effective, ready-to-use, and multivalent single shot respiratory virus vaccines.

At Virion Therapeutics, We Believe a Future Free of Cancer and Chronic Infectious Diseases Is Within Reach​ Driven by science, our mission is to revolutionize the immunotherapy treatment landscape, focusing on the development of novel, adaptable, and accessible CD8+ T cell-based technologies.​ Our transformative platform is first in its class, offering a unique methodology that combines innovative and established approaches to elicit a superior CD8+ T cell response. Novel genetically encoded checkpoint modifiers are delivered alongside optimized target-specific antigens via an immunogenic and adaptable viral vector platform that promotes potent, prolonged, and broad CD8+ T cell responses. With potential applications across a range of cancers and chronic infectious diseases, our proprietary technology provides us with a robust pipeline. Our lead product, VRON-0200, is under investigation as a potential functional cure for the treatment of chronic hepatitis B virus (HBV) – a first-in-human clinical study is planned to initiate in late 2022. Founded in 2018 to advance technology licensed from The Wistar Institute, we have assembled a world-class management team and an industry-leading global Board of Directors, with proven experience in the biotechnology sector, as well as extensive preclinical and clinical expertise in antiviral, vaccine, oncology, and immuno-oncology.​

Virometix is a privately held Swiss biotechnology company developing a new generation of vaccines and immunotherapeutic drugs for the prevention and treatment of infectious and oncology diseases

VLP Therapeutics, Inc. (VLPT) was established in 2013 by seasoned biopharmaceutical veterans with mission to develop innovative medical treatment which transforms traditional vaccine and targeted antibody therapies to address global unmet medical needs. Its vision is to combat the 21st century global public health problems through revolutionary next generation i-αVLP (inserted alpha VLP) Technology. The company is headquartered in Gaithersburg, Maryland.