New Jersey has been called the medicine chest of the world, so it’s no surprise that many pharmaceutical companies along the Route 1 corridor and beyond are hard at work on treatments and therapies for the novel coronavirus. Even as the state begins to reopen and people resume normal activities, the race is still on to develop an effective vaccine and devise ways to prevent or minimize the more harmful effects of the virus.
BioNJ, the Hamilton-based trade organization for life sciences companies in the state, hosted two virtual “COVID-19 Rapid Fire Research Showcases” in June featuring presentations from the leaders of 25 companies in the biotechnology industry.
These companies, BioNJ CEO Debbie Hart said in her opening remarks at the first showcase, “looked in their portfolios, found something that they hoped or thought could work on COVID-19, and they will literally be pouring their hearts and souls and spending hundreds of millions of dollars to try to make a difference, so we applaud them.”
A number of the companies that presented at these showcases have a presence in the Princeton area. Several are working on vaccines.
Oncosec is a Pennington-based cancer immunotherapy company focused on skin and breast cancer (U.S. 1, July 11, 2018), but its scientists have theorized that the same protein that it uses to fight tumors could play an important role in a potential vaccine to combat COVID-19.
Its product, TAVO, uses the cytokine protein interleukin 12 (IL-12), which is injected into tumors through a process called electroporation that exposes cells to an electric field that makes its membranes more permeable to allow drugs to enter the cell.
“When this pandemic first occurred we looked at ourselves as cancer researchers and said, ‘What can we do to help solve this problem?’” OncoSec CEO Dan O’Connor said in his presentation to BioNJ. “In that connection we realized that IL-12 has the ability to be obviously a very strong pro-inflammatory signaling cytokine and could potentially increase the efficacy of a vaccination.”
OncoSec brought its idea to the attention of the National Institutes of Health (NIH) as well as Providence Cancer Institute. The cancer immunologists at Providence, O’Connor said, “realized that the application of their understanding of cancer immunotherapy could be translated to an infectious disease setting.” The NIH also saw value in OncoSec’s idea and licensed to the company the novel coronavirus spike protein it had developed.
A spike protein is a key part of the virus molecule that allows it to invade human cells. Having access to that protein gives researchers a way to ensure that a vaccine can properly target the virus. A study has now been developed by Providence that, with FDA approval, would use Oncosec’s investigational Apollo electroporation device to deliver the spike protein alone and the spike protein supplemented by IL-12. The hope is that the addition of IL-12 will enhance the body’s immune response to the vaccination.
OncoSec, 24 North Main Street, Pennington 08534. Daniel O’Connor, CEO. www.oncosec.com.
Emmons Drive-based Soligenix, which develops and commercializes products for rare diseases, is working in partnership with the University of Hawaii at Manoa on potential vaccines for the novel coronavirus.
Its vaccine platform includes the important spike protein as well as an adjuvant — a substance that enhances the body’s immune response — called CoVaccine HT that has been exclusively licensed to Soligenix from BTG Specialty Pharmaceuticals.
Soligenix’s platform is also thermostabilized, meaning that the vaccine can be kept at room temperature and is not compromised even with prolonged exposure to temperatures upwards of 100 degrees Fahrenheit.
“At the end of the day, when you want broad distribution, it’s really important to have a clinically convenient product,” said Oreola Donini, Soligenix’s senior vice president and chief scientific officer, in her presentation to BioNJ.
Soligenix Inc., 29 Emmons Drive, Suite B-10, Princeton 08540. 609-538-8200. Christopher J. Schaber, chairman, president, and CEO. www.soligenix.com.
In the absence of a vaccine, public health officials have constantly reminded people to wash their hands and frequently disinfect high-touch surfaces such as countertops and doorknobs. But what if those surfaces disinfected themselves?
College Road-based Orthobond is seeking to prevent the spread of COVID-19 not with a vaccine, but with a coating for high-touch surfaces that would attract and kill the virus.
Orthobond grew out of professor Jeffrey Schwartz’s chemistry lab at Princeton University and made a name for itself when it developed a novel way to bond molecules to surfaces, an invention that held great promise for the durability of a range of medical implants (U.S. 1, September 9, 2009). In 2010 it identified a molecule that could be bound to surfaces to create an antimicrobial coating.
After years of testing and development, the company has reached the commercialization stage for medical implants with this antimicrobial coating, and it has now turned its attention to potential applications in the fight against COVID-19.
In a presentation to BioNJ Orthobond CEO David Nichols explained, “We know that our surfaces have proven safety and efficacy against bacteria, against mold, and against yeast, and we’re confident that it will show efficacy against viruses, so as we look at the needs around us today we can imagine a surface” — be it plastic, stainless steel, aluminum, or titanium — “that would kill — not only remove but also attract and kill — a pathogen that would harm us every day.”
The company, Nichols said, is now in the process of raising $10 million for projects including the commercialization of solutions for high-touch surface areas.
Orthobond, Princeton Innovation Center BioLabs, 303 College Road East, Suite A, Princeton 08540. 609-423-1540. David Nichols, CEO. www.orthobond.com.
While the public is focused on a vaccine, several companies are working not on a vaccine or a cure, but rather on products that can help mitigate one of the more dangerous complications of a severe case of COVID-19: the cytokine storm.
A cytokine storm is an extreme immune response in which an overabundance of cytokines, an inflammation-causing protein, is released into the blood. In its most severe form, a cytokine storm can cause multiple organ failure and can be fatal.
In that arena, North Brunswick-based BioAegis Therapeutics has high hopes for its recombinant human plasma gelsolin.
Plasma gelsolin is a naturally occurring protein present in abundance in healthy humans. It was discovered by the late Tom Stossel, a 1963 Princeton University alumnus who was a professor of medicine at Harvard University. Gelsolin’s role within the body is to help reduce inflammation, but that protein becomes depleted as the body uses it to fight off infection.
There are, of course, anti-inflammatory drugs that are widely available, but all of them work by suppressing the immune system to some degree. Inflammation is part of the immune system’s response to injuries or infections, so it follows that reducing inflammation requires reducing the immune response.
Gelsolin, on the other hand, is unique in that it fights inflammation without weakening the immune system. It is also unique in that it is not pathogen-specific. It has the potential to be effective in helping the body fight any number of infections with either viral or bacterial causes.
Stossel’s discovery was the basis for founding BioAegis, which has licensed gelsolin-related intellectual property from Harvard. Stossel died in September, 2019, but his co-founder, CEO Susan Levinson, is leading the company’s testing of its recombinant human plasma gelsolin (rhu-pGSN) as a potential therapy for patients severely ill with COVID-19.
Prior to the pandemic BioAegis’ product was already showing promise in patients hospitalized with pneumonia, and more than 20 animal models have also shown the approach to be successful. Levinson, who holds a PhD in biomedical sciences from the Mount Sinai School of Medicine, said in her BioNJ presentation that in June the company was set to begin testing on patients with severe COVID-19.
BioAegis’ hope is that replenishing the body’s supply of this naturally occurring protein will help limit a potential cytokine storm while also reducing long-term damage to the lungs.
A statement on the company’s website explains: “Gelsolin’s unique role is to modulate this necessary inflammatory response so that what was intended to be a mechanism of healing does not become an instrument of long term morbidity or death. In extreme circumstances like those present in COVID-19, gelsolin can become dangerously depleted, leaving the body exposed to the ravages of an unrestrained immune response.”
“While many companies are pursuing antivirals and vaccines for the pandemic, there are few that are addressing this severe cytokine storm that are not also immunosuppressive,” Levinson said in her presentation at the BioNJ showcase. “Recombinant human plasma gelsolin has the unique property that it is not pathogen specific and thus will be a solution not just for COVID-19 but for future threats which emerge as well.”
BioAegis Therapeutics, 675 Route 1, North Brunswick 08902. 203-952-6373. Susan Levinson PhD, chief executive officer. www.bioaegistherapeutics.com.
Princeton-based Genovation Bioscience is another company whose product is aimed at quelling the deleterious effects of the cytokine storm that can occur as an immune response in severe cases of COVID-19.
Its focus is on the production of synthetic antibodies that are engineered to have an affinity for specific proteins. Specifically, the company has produced a synthetic antibody that works against histones, a type of cytokine that promotes inflammation.
These nanoparticles work by sequestering the histones and neutralizing their effect. The approach has already shown promising results in studies of mice that were injected with a lethal dose of histones followed by Genovation’s nanoparticles.
“Synthetic antibodies are an innovation with high impact potential. A breakthrough application such as a sepsis intervention can open the door to an alternative to many traditional biological therapies,” Laurence Berger, executive chairman, said in his BioNJ presentation.
Genovation Bioscience, 421 Alexander Street, Princeton 08540. 609-216-4275. www.genovationbio.com.
Several companies are working on medicines that seek to halt the progression of COVID-19 before a cytokine storm can occur.
Ayma Therapeutics, a self-funded startup based in Princeton Junction, was founded just last year but is already working with the FDA on its investigational new drug, AYX-101.
AYX-101 is intended for COVID-19 patients who develop ARDS, or acute respiratory distress syndrome, and would be administered intravenously in a hospital setting. It uses triciribine (TCN), a drug synthesized in the 1970s that is currently being tested as a possible treatment for various cancers, that also shows potential for treating lung injury. TCN works by inhibiting the protein known as Akt, which can have the effect of suppressing inflammation and promoting repair to damaged lungs.
“AYX-101 is designed to be administered in the hospital setting when a patient shows difficulty in breathing and requires respirator support,” AYMA co-founder Ramesh Gopalan said in a presentation to BioNJ.
Hospitals would be provided a blood bag containing a dose of TCN phosphate, to which the patient’s own blood is added. The contents of the bag are then mixed, allowing the drug to become encapsulated in the patient’s red blood cells. The resulting product, AYX-101, is then re-infused into the patient.
Ayma hopes for approval from the FDA to begin testing its product in August.
Ayma Therapeutics Inc., Princeton Junction. Narayanan Surendran, founder and CEO. www.aymatx.com.
“While prophylactic vaccines are an important solution we’ll always need treatments like BalinBac’s for infected patients to keep them from progressing to the hospital, ICU, and ventilator support,” says John Gregg, CEO of Princeton-based BalinBac.
Gregg, a graduate of the University of Chicago with an MBA from New York University, has worked in marketing and product planning at prominent pharmaceutical companies including Pfizer, Johnson & Johnson, and Bristol-Myers Squibb. At BalinBac, the team is focused on bringing new and repurposed antiviral and antibacterial drugs to market.
The company’s research on COVID-19 in particular, which started in January, is focused on repurposing existing drugs whose safety and efficacy are already known in order to expedite the process of getting medicine to patients.
The drugs, known as the BB-700 series, are all combinations of existing, generic antiviral drugs that each have a different mechanism for attacking the virus. It is thought that a drug working against the virus in multiple ways is more likely to be effective than one that only works in one specific way.
In addition to the new combinations of drugs, BalinBac also has a novel delivery system that allows the drugs to go directly to the lungs by having the patients inhale the drugs through readily available electronic cigarettes.
“They’ll be used at the time of diagnosis and the onset of first symptoms, and we’ll have the best chance of success because the viral load is low and major immunological responses like cytokine storms have not yet happened,” Gregg said in his BioNJ presentation.
BalinBac Therapeutics, 657 Rosedale Road, Princeton 08540. John Gregg, president and CEO. www.balinbac.com.
Other companies are working on the research and diagnostic issues that have arisen with this novel coronavirus, including tests that are easy to administer but also accurate and materials that make it easier to undertake drug discovery research.
Chromocell Corporation, based in North Brunswick, sees multiple applications of its Chromovert technology in the fight against COVID-19, and it has made that technology available to researchers working on drugs and vaccines for COVID-19.
Chromovert enables researchers to quickly identify rare cells that are best suited for work on cell-based drug discovery. The company is also able to produce stable, laboratory cells that express the same proteins as the virus that causes COVID-19. Unlike the actual virus cells, the laboratory cells are not infectious and not toxic to cell cultures, which creates an opportunity for more labs to focus research on COVID-19.
In a statement, Chromocell CEO Christian Kopfli noted, “We recognize the substantial potential of our Chromovert Technology to accelerate the development of treatments against COVID-19 disease. Leveraging our unique cellular engineering platform, we are open to collaborate with any interested party as the scientific community searches for a much-needed cure.”
Chromocell Corporation, 685 Route 1, North Brunswick 08902. 732-565-1113. Christian Kopfli, CEO. www.chromocell.com.
Maven Diagnostic, a spinoff of Intelligent Material Solutions based in the SRI complex on Washington Road in West Windsor, has more than 10 years of experience developing rapid diagnostic tests for a range of tropical diseases and has now turned its attention to applying its technology to COVID-19 testing.
CEO Richard Einhorn, in his presentation during the BioNJ showcase, explained that Maven is “focused on developing and commercializing what we call high impact tests.”
Most tests on the market, he said, are either very accurate or very quick and easy to administer, but the high-sensitivity tests that offer the most accurate results can take hours or days to process, and the easily administered tests can give a high volume of false negatives.
Maven, he said, “is working to develop solutions that combine the benefits of the two primary solutions that exist today” without the downsides. Maven offers an intelligent lateral flow assay kit — a test that functions in the same way a pregnancy test does — that can be used with a customized reader to give results in under 15 minutes.
In addition to potential use for point-of-care nasal or saliva swabs for quick diagnoses in settings such as urgent care clinics or nursing homes, Einhorn noted that an important potential use of the testing technology is to detect levels of the protein interleukin 6 (IL6), a cytokine that plays a key role in inflammation and rises quickly in COVID-19 patients. “Finding that early might allow us to do earlier treatments for patients they get to a cytokine storm,” Einhorn explained.
Maven anticipates being granted emergency use authorizations from the FDA for its tests over the course of the summer.
Maven Diagnostic, 201 Washington Road, Princeton 08540. 609-514-4033. Richard Einhorn www.mavendiagnostic.com.
Full presentations can be viewed on BioNJ’s website: www.bionj.org.