Infectious diseases are diseases that are caused by pathogens that enter the body, hijack the body’s immune system and multiply, causing an infection. Five of the deadliest infectious diseases are measles, tuberculosis, malaria, diarrhoeal disease and influenza, according to the World Economic Forum.
While Our World in Data statistics suggest that there has been almost a 44% decline in the global burden of communicable diseases, among others like maternal and nutritional diseases, from 1990 to 2019, there is a growing need to bolster vaccine development in eradicating fatal transmittable diseases, and prevent future pandemics from upending lives.
Many infectious disease biotech companies began to garner attention during the COVID-19 pandemic as they raced to develop vaccines, and even so now as newer variants emerge.
In a bid to tackle pathogenic outbreaks, many biotech companies are ahead of the game and taking their drug and vaccine candidates to the clinic. Here are eight biotech companies that have come a long way in the fight against infectious diseases.
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An emerging player in the field of vaccine development to treat and prevent infectious diseases, Danish biotech company Bavarian Nordic is committed to bringing its chikungunya vaccine to the market soon.
Chikungunya, a viral disease transmitted by mosquitoes, has been identified in more than 110 countries, with over 2 million cases being reported since 2005, according to the World Health Organization (WHO). Bavarian Nordic’s virus-like particle (VLP)-based vaccine candidate CHIKV VLP, met all the co-primary endpoints of a phase 3 study, recently. The trial found that in 98% of the 3254 participants, chikungunya neutralizing antibodies were strongly induced, for up to 22 days post vaccination.
In another study conducted earlier this year, the candidate was able to induce chikungunya neutralizing antibodies in 87% of vaccinees, 22 days after a single vaccination in healthy adults over the age of 64. Having previously obtained Breakthrough Therapy designation and Fast Track designation from the U.S. Food and Drug Administration (FDA), and PRIME designation from the EMA, the company looks to submit its candidate for regulatory approval next year.
Moreover, Bavarian Nordic has other vaccine candidates in the mix. MVA-BN WEV is being developed to prevent the spread of equine encephalitis viruses, a rare yet potentially fatal infectious disease transmitted to humans via mosquitoes. It is presently undergoing phase 1 studies, with phase 2 trials set to begin next year.
While the company’s COVID booster and respiratory syncytial virus (RSV) vaccine candidate have been dropped due to limited effectiveness and not having arrived at the primary endpoint, the company has an extensive product line, which includes infectious disease vaccines for tick-borne encephalitis, cholera, typhoid, smallpox and rabies, that are commercially available.
mRNA vaccines grew popular after the technology behind COVID vaccines came to light. German company Curevac has a pipeline dedicated to infectious diseases that is based on mRNA technology. One of the earlybirds in COVID vaccine development, the company started out more than two decades ago to harness mRNA to create drugs. The company is currently in a legal battle with BioNTech and Pfizer, owing to a patent infringement dispute surrounding COVID vaccines.
Most advanced in its infectious disease pipeline are COVID-19 vaccine candidates CV0601 and CV0701 currently in phase 2 trials after the first patient was dosed in August this year, in collaboration with global biopharma GSK. The biotech company is also working on other COVID-19 vaccines as well as several for influenza and other infectious diseases. Curevac’s goal to tackle infectious diseases has been supported by the Bill & Melinda Gates Foundation, with both having partnered to develop a prophylactic vaccine to protect against respiratory syncytial virus (RSV) in 2015, and the latter offering €46 million ($49 million) in funds.
It had recently announced that one of its mRNA vaccine candidates designed to treat seasonal flu would proceed to phase 2 after interim results showed promise.
Apart from infectious diseases, Curevac is also developing cancer vaccines – two in phase 1 and others in preclinical – and molecular therapies for liver and eye diseases, which are in their discovery stages.
The co-developer of the famed Comirnaty vaccine against COVID, BioNTech is a German company founded in 2008, focused on bringing immunotherapies to market. Comirnaty is set to make around $60 billion in revenue by the end of this year.
Currently in its infectious diseases pipeline, the biotech company has a variety of candidates in the making. Its seasonal influenza mRNA candidate BNT161 is in phase 3 trials at present. The candidate is a quadrivalent vaccine – meaning that it protects against four flu virus strains – being investigated as a single-dose regimen in adults.
Apart from BNT161, it has engineered mRNA candidates designed to treat shingles, human immunodeficiency virus (HIV), tuberculosis, herpes and malaria, among others. These are all in phase 1 and 2 studies, except for the HIV vaccine, which is in its preclinical phase.
Besides mRNA vaccines, the company’s bacterial vaginosis candidate is in preclinical studies. This candidate is based on protein therapeutics where proteins are engineered to target pathogens while leaving the body’s microbiome unaffected.
Recently, the company decided to partner with the Coalition for Epidemic Preparedness Innovations (CEPI) headquartered in Norway, in an effort to advance its mRNA mpox vaccine towards phase 1/2 trials as well as in support of the latter’s 100 day mission to develop vaccines to prevent future pandemics.
Earlier this year, BioNTech, along with pharma giant Pfizer, was granted emergency use authorization for its Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for patients aged six months and older, by the FDA. This is because new virus variants are constantly emerging and because antibody responses to vaccines wane over time, demanding vaccines that target different COVID strains.
Another contender tapping into the infectious diseases space, American biotech company Gritstone Bio has three candidates that aim to take on these diseases.
Its prophylactic mRNA vaccine CORAL targets COVID-19. Currently in phase 2 trials, it has previously shown its ability to elicit antibody responses in participants. CORAL is a self-amplifying mRNA vaccine – a kind of mRNA vaccine that has shown enhanced antigen expression at lower doses when compared to typical mRNA vaccines, reducing side effects in patients. It is designed to boost T cell and B cell immunity in patients. In a trial completed last year, CORAL had built a favorable safety and tolerability profile.
Additionally, in HIV research, the company has partnered with global pharmaceutical Gilead to develop a vaccine-based immunotherapy to fight the virus. The candidate was born out of Gritstone’s prime-boost vaccine platform, which can accommodate a large payload, and therefore target multiple viral antigens. In preclinical studies, the company used antigens from the simian immunodeficiency virus (SIV) – a retrovirus similar to HIV-1 that infects certain monkeys. Trials showed that it was able to induce strong and durable anti-SIV CD8+ T cell responses, and the vaccine has progressed to phase 1.
Gritstone is also working on another vaccine aimed at preventing the flu, human papillomavirus (HPV) and other multi-respiratory conditions.
The clinical-stage biotech, which is also focused on cancer therapies, was awarded $433 million to accelerate its 10,000-person phase 2 CORAL program, as part of Biomedical Advanced Research and Development Authority’s (BARDA’s) Project NextGen in COVID prevention.
Pioneers in mRNA technology, global pharma Moderna, headquartered in the bustling biotech hub of Cambridge, Massachusetts, in the U.S., has around 30 vaccine candidates designed to treat and prevent infectious diseases.
Apart from its notable Spikevax that contributed to billions receiving at least one dose of a COVID vaccine, Moderna’s vast pipeline includes a next-generation COVID vaccine along with multiple other ones targeting coronavirus, numerous flu vaccines, as well as candidates against HSV, HIV, Zika and Nipah, which are all in various stages in the clinic.
In a phase 3 trial for one of its influenza and COVID-19 mRNA candidates, Moderna dosed its first participant this year. This was following a successful phase 1/2 trial with the candidate (mRNA-1083), which achieved hemagglutination inhibition antibody titers similar to licensed influenza vaccines and SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster, according to a press release.
Like BioNtech, Moderna has also embarked on CEPI’s 100-day mission to develop vaccines against viral outbreaks. While the company axed its cardiovascular disease candidate among three others earlier this year, the company has pledged to bring 15 drugs to the market as well as advance 50 candidates in the clinic, over the next five years.
Barinthus Biotherapeutics, formerly known as Vaccitech, is a U.K.-based spin-off at The Jenner Institute, at the University of Oxford. While its autoimmune disease and cancer programs are gaining ground, its infectious disease pipeline is no less relevant to the company’s immunotherapy focus.
The company’s ChAdOx vector platform consists of an adenovirus that has been modified after it was isolated from a chimpanzee. The ChAdOx adenoviral vector particles are inserted into the vaccine to deliver the genetic material that can induce an immune response. ChAdOx binds to the cells to make copies of the antigen to induce T and B cell responses. Activated CD8+ cytotoxic T cells then identify the infected cells and eliminate them.
Its vaccine candidates for hepatitis B virus (HBV) and HPV are in phase 2 trials. The HBV candidate VTP-300 derived from the ChAdOx platform uses modified vaccinia Ankara (MVA) encoding multiple hepatitis B antigens, and is supposedly the first antigen-specific immunotherapy to show sustained reductions in the surface antigen.
Furthermore, its HPV candidate is a double immunotherapy where the first dose is based on the ChAdOx platform and the second dose from MVA encoding multiple HPV antigens. Its development marks the onset of non-invasive therapeutic options against not only HPV infections but also for cervical cancer prevention. Results of the ongoing phase 1b/2 trial are expected to come out next year.
American biotech company Novavax is solely focused on research in the field of infectious diseases. Three of its drugs, two COVID and one malaria vaccine are on the market, and are based on the company’s Matrix-M adjuvant technology.
The Matrix-M adjuvant, which has immunogenicity-enhancing properties, is derived from saponins, chemicals found in the soapbark tree. The bark of the tree is processed and freeze-dried after which the saponins are extracted. With the help of phospholipids and cholesterol, the molecules form nanostructures, which are then mixed with the vaccine antigen.
In the case of its malaria vaccine, the CSP gene and HBsAg protein gene are combined to form recombinant DNA that is inserted into a plasmid and into yeast genome. Then, a lysis buffer is used to break down cell membranes in the yeast and express proteins that become virus-like particles. These particles and the Matrix-MTM adjuvant make up the vaccine. The R21 malaria vaccine has now received a WHO recommendation for its rollout on a global scale.
Novavax is also working on a seasonal influenza and a COVID-seasonal influenza vaccine, both of which are in phase 2 trials. The combination vaccine is made of two antigens – recombinant spike (rS) protein of the SARS-CoV-2 virus and 4 wild-type recombinant Hemagglutinin (rHA) proteins from the influenza virus. These antigens are assembled into nanoparticle complexes and mixed with the Matrix-M adjuvant to create the vaccine.
Although the company aspires to climb the ladder in the COVID market, as a means to rein in costs, it had announced plans to slash 25% of its workforce earlier this year.
Innoviva Specialty Therapeutics
Although U.S.-based Innoviva Specialty Therapeutics only sprouted up this year, it has been doing the rounds in the press since its launch two months ago, largely due to its promising gonorrhea antibiotic.
82.4 million new infections were estimated in 2020, according to WHO, and although certain antibiotics can cure the disease, it has been almost two decades since a drug was approved by the FDA to treat the sexually transmitted disease.
Innoviva Specialty Therapeutics’ drug candidate not only hit the endpoint in a pivotal phase 3 trial – the largest of its kind – but also met the current standard-of-care for drug-resistant gonorrhea treatment.
The oral candidate zoliflodacin was compared against the combination of injectable ceftriaxone and oral azithromycin, and showed statistical non-inferiority of microbiological cure. The results could pave the way to an FDA nod that could bring it to the market soon. The trial was conducted in collaboration with the non-profit Global Antibiotic Research & Development Partnership (GARDP).
Preparing for future pandemics
Since Edward Jenner’s smallpox vaccine in 1796, we have come a long way in vaccine development and expanding treatment options for infectious diseases. WHO’s latest Preparedness and Resilience for Emerging Threats Initiative (PRET) was launched earlier this year to improve preparedness in combating and potentially eradicating future pandemics. The initiative aims to direct more funds towards addressing the gaps identified in previous pandemics and epidemics as well as boosting connectivity among stakeholders. Similarly, various other projects like the $150 million Pandemic Prevention Initiative (PPI) run by The Rockefeller Foundation in the U.S., looks to partner with organizations around the world to heighten surveillance against pathogens that cause infectious diseases.